Summary of Product Characteristics, Labelling and Package Leaflet

SUMMARY OF PRODUCT CHARACTERISTICS,
LABELLING AND PACKAGE LEAFLET

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Miflonide Breezhaler 200 microgram inhalation powder, hard capsules

Miflonide Breezhaler 400 microgram inhalation powder, hard capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 200 microgram capsule contains 230 micrograms of budesonide and delivers 200 micrograms of
budesonide from the mouthpiece of the device when used in conjunction with the (inhaler device called)
Miflonide Breezhaler.
Each 400 microgram capsule contains 460 micrograms of budesonide and delivers 400 micrograms of
budesonide from the mouthpiece of the device when used in conjunction with the (inhaler device called)
Miflonide Breezhaler.
Excipient with known effect:

The 200 microgram capsules contain 24.77 mg of lactose monohydrate.
The 400 microgram capsules contain 24.54 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Inhalation powder, hard capsule.

The 200 microgram capsule has a light pink opaque cap and a colourless transparent body, printed
logo/BUDE 200.
The 400 microgram capsule has a pink opaque cap and a colourless transparent body, printed logo/BUDE
400.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Miflonide Breezhaler is indicated in asthmatic patients aged 6 years and older for long term anti-
inflammatory control of persistent asthma including prophylaxis of acute exacerbations of asthma.
4.2 Posology and method of administration
Posology
The dosage should be carefully titrated individually to the minimum effective dose to control asthma
symptoms.
The lowest dosage in a single capsule is 200 micrograms. If a single dose of less than 200 micrograms is
required, this product cannot be used.
Miflonide Breezhaler is contraindicated in children under 6 years of age (see section 4.3).
Adults:
Treatment of adults with mild asthma may be initiated at the minimum effective dose of 200 micrograms
once daily.
Usual recommended daily dose is 200-1600 micrograms divided in 2 doses. The maintenance dose should be
titrated to the lowest dose at which effective control of Asthma is maintained.
Special populations
Paediatric patients (6 years of age and above):
Due to the absence of clinical experience in children under 6 years of age, Miflonide Breezhaler should not
be used in this age group.
Treatment of children aged 6 years and older with mild asthma may be initiated at a dosage of 200
micrograms once daily. Usual recommended daily dose is 200-400 micrograms divided in 2 doses daily. In
severe cases of asthma doses up to 800 micrograms daily in divided doses may be necessary.
The maintenance dose should be titrated to the lowest dose at which effective control of asthma is
maintained.
Patients maintained on oral glucocorticosteroids

Miflonide Breezhaler may permit replacement or significant reduction in dosage of oral glucocorticosteroids
while maintaining asthma control. When switching the therapy from oral steroids to Miflonide Breezhaler,
the patient should be in a relatively stable phase. A high dose of budesonide should be given in combination
with the previously used oral steroid for about 10 days. After that the oral dose should be gradually reduced
(by for example 2.5 mg prednisolone or the equivalent each month) to the lowest possible level. In many
cases, it is possible to completely substitute the oral steroid with Miflonide Breezhaler. For further
information on the withdrawal of corticosteroids, see section 4.4.
Patients with renal impairment

There are no data to suggest dosage adjustment in patients with renal impairment. On the basis of
pharmacokinetic data with oral budesonide it is unlikely that systemic exposure of the drug will be altered to
clinically significant level in such patients (see section 5.2).
Patients with hepatic impairment

There are no data to suggest dosage adjustment in patients with hepatic impairment. However, since
budesonide is predominantly cleared by hepatic metabolism caution should be exercised for use of Miflonide
Breezhaler in patients with severe hepatic impairment. Patients with mild to moderate hepatic impairment are
unlikely to have clinically significant alteration in drug exposure on the basis of pharmacokinetic data with
oral budesonide (see section 5.2).
Elderly (above 65 years of age)

There is no evidence to suggest that patients above 65 years of age require a different dosage from that used
in younger adult patients.
Administration
When switching from one inhalation device to another, the dose should be re-titrated individually. It is
recommended to rinse out the mouth well with water and subsequently spit out the rinsing water, after each
dose administration, in order to help prevent hoarseness, throat irritation and candida infection of the mouth
and throat and possibly reduce the risk of systemic effects. Patients should be instructed that the capsules are
only for inhalation use and not to be swallowed (see section 4.4). The contents of the capsule are inhaled by
means of an inhaler device called Miflonide Breezhaler.
Patients should be instructed in the proper use of the Miflonide Breezhaler in accordance with the user
instruction to ensure that the drug reaches the target areas in the lungs.
For instructions on use of the medicinal product before administration, see section 6.6.
4.3 Contraindications
Not to be used in children under 6 years of age.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Active pulmonary tuberculosis.
4.4 Special warnings and precautions for use
Prophylactic nature of therapy

Patients should be made aware of the prophylactic nature of therapy with inhaled budesonide, and it must be
taken regularly every day even when the patients are asymptomatic for optimum control of asthma.
Budesonide does not relieve an acute bronchospasm, nor is it appropriate for the primary treatment of status
asthmaticus nor other acute asthmatic episodes.
Concomitant conditions
Special caution is necessary in patients with concomitant disorders such as quiescent pulmonary
tuberculosis, and in patients with fungal or viral infections in the airways. These patients should be
monitored when treated with Miflonide Breezhaler as maintenance therapy in asthma.
Caution is necessary when treating patients suffering from pulmonary disorders such as bronchiectasis and
pneumoconiosis due to the possibility of fungal infections.
Asthma exacerbations
Acute exacerbations of asthma may need increase in the dose of budesonide or additional treatment with a
short course of oral corticosteroids and/or an antibiotic if there is an infection. Budesonide is not intended for
rapid relief of acute episodes of asthma where an inhaled short-acting bronchodilator is required.
Paradoxical bronchospasm
As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in
wheezing after dosing may occur in rare occasions. If this occurs, treatment with inhaled Miflonide must be
discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Patients should be advised to contact their doctor if their asthma deteriorates (increased frequency of short
acting inhaled bronchodilator treatment or persistent respiratory symptoms).The patient should be reassessed
and the need for increased anti-inflammatory therapy, an increase in the dose of inhaled or oral
corticosteroid, should be considered.
Systemic effects
Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged
periods. These effects are much less likely to occur with inhalation treatment than with oral corticosteroids.
Possible systemic effects include hyperadrenocorticism/Cushing’s syndrome, Cushingoid features, adrenal
suppression, reduction in growth velocity in children and adolescents, a decrease in bone mineral density,
cataract, glaucoma, and more rarely, a range of psychological or behavioral effects including psychomotor
hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). It is therefore
important that the dose of inhaled corticosteroid is titrated to the lowest effective dose in order to control
asthma .
Reduced liver function affects the elimination of corticosteroids, causing lower elimination rate and higher
systemic exposure. Be aware of possible systemic side effects.
Prolonged treatment with high doses of inhaled corticosteroids, particularly higher than the recommended
dose, may result in clinically significant adrenal suppression. These patients may exhibit signs and symptoms
of adrenal insufficiency when exposed to severe stress. Additional systemic corticosteroid cover should be
considered during periods of stress or elective surgery. Adrenal function should be monitored regularly as
the dose of systemic steroid is reduced when transferring patients on systemic corticosteroids to inhaled
corticosteroids and in those patients in whom high doses are used for prolonged periods.
Effect on growth
It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is
regularly monitored. If reduction of growth velocity is noted , therapy should be re-evaluated with the aim of
reducing the dose of the inhaled corticosteroid, if possible, to the lowest effective dose to control the
symptoms of asthma. The benefits of the corticosteroid therapy and the possible risks of growth suppression
must be carefully weighed. In addition, it should be considered whether to refer the patient to a paediatric
respiratory specialist. The long-term effects of this reduction in growth velocity associated with inhaled
corticosteroids, including the impact on final adult height, are unknown. The potential for “catch up” growth
following discontinuation of treatment with orally inhaled corticosteroids has not been adequately studied.
Concomitant medications
Concomitant treatment with itraconazole, ketoconazole, ritonavir or other potent CYP3A4 inhibitors (e.g.
several azole antimycotics, HIV protease inhibitors and macrolide antibiotics) should be avoided (see section
4.5).
Oral candidiasis may occur during the therapy with inhaled corticosteroids. This infection may require
treatment with appropriate antifungal therapy and in some patients discontinuation of treatment may be
necessary (see also section 4.2).
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with
symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to
an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare condition
diseases such as Central serous chorioretinopathy (CSCR) which have been reported after use of systemic
and topical corticosteroids.
Excipients
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-
galactose malabsorption should not take this medicine.
Special precautions:
Patients starting treatment with steroids
A therapeutic effect is usually reached within 10 days. In patients with excessive mucus secretion in the
bronchi, a short (about 2 weeks) additional corticosteroid regimen can be given initially.
Steroid dependent patients

The patient should be in a relatively stable phase when switching therapy from oral steroids to Miflonide
Breezhaler. A high dose of budesonide should be given in combination with the previously used oral steroid
for about 10 days. After that the oral dose should be gradually reduced (by for example 2.5 mg prednisolone
or equivalent each month) to the lowest possible level. In many cases, it is possible to completely substitute
the oral steroid with Miflonide Breezhaler.
During switching from oral steroid therapy to Miflonide Breezhaler, a number of patients will experience a
reduced general steroid effect. Previous allergic symptoms such as rhinitis and eczema may reoccur and
patients may suffer from lethargy, muscle or joint pain, and sometimes nausea and vomiting. In these cases
active medical support may be necessary in order to encourage patients to continue therapy with Miflonide
Breezhaler and continue the withdrawal of the oral steroid, unless this is not medically justified.
The allergies should be treated with antihistamines and/or topical preparations, including topical
corticosteroids. A temporary increase of the oral steroid dose might also be justified.
Treatment with supplementary systemic corticosteroids or budesonide should not be stopped abruptly.
Particular caution is is required in the first few months after switching from systemic corticosteroids to
inhaled budesonide to ensure that the patient's adrenocortical reserve is adequate to counter specific crisis
situations such as trauma, surgery or severe infections.
Incorrect route of administration

There have been reports of patients who have mistakenly swallowed Miflonide Breezhaler capsules instead
of placing the capsules in the inhalation device. The majority of these ingestions were not associated with
side effects. Healthcare providers should instruct the patient on the correct use of Miflonide Breezhaler (see
section 4.2). If a patient who is prescribed Miflonide Breezhaler does not experience an improvement in
breathing , the healthcare provider should ask how the patient is using Miflonide Breezhaler.
4.5 Interaction with other medicinal products and other forms of interaction
Agents resulting in CYP3A4 inhibition
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the
risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased
risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic
corticosteroid side-effects.
The main route of metabolism of budesonide and also cause for major first-pass metabolism is catalysed by
CYP3A4. Co- administration of known inhibitors of CYP3A4 (e.g. itraconazole, ketoconazole, ritonavir,
saquinavir, nelfinavir, amiodarone, clarithromycin, telithromycin and erythromycin) may markedly increase
the systemic exposure to budesonide (see section 4.4). Concomitant use of potent CYP3A4 inhibitors should
be avoided. If this is not possible the time interval between the administrations of the interacting drugs
should be as long as possible and the adrenocortical function should be monitored. A reduction of the
budesonide dose could also be considered.
Limited data about this interaction for high-dose inhaled budesonide indicate that marked increases in
plasma levels (on average four- fold) may occur if itraconazole, 200 mg once daily, is administered
concomitantly with inhaled budesonide (single dose of 1000 µg).
Agents resulting in CYP3A4 induction

Co- administration of strong inducers of CYP3A4 (e.g. rifampicin) increases the metabolism of, and decrease
the systemic exposure to budesonide (see section 5.2). It is unknown whether the pulmonary exposure is
affected.
Raised plasma concentrations of and enhanced effects of corticosteroids have been observed in women also
treated with oestrogens and contraceptive steroids, but no effect has been observed with budesonide and
concomitant intake of low dose combination oral contraceptives.
Because adrenal function may be suppressed, an ACTH stimulation test for diagnosing pituitary
insufficiency might show false results (low values).
4.6 Pregnancy and lactation
Pregnancy
There are no adequate and well-controlled studies using Miflonide in pregnant women. Most results from
prospective epidemiological studies and world-wide post-marketing data have not been able to detect an
increased risk for adverse effects for the foetus and newborn child from the use of inhaled budesonide during
pregnancy. It is important for both foetus and mother to maintain an adequate asthma treatment during
pregnancy. As with other drugs administered during pregnancy, the benefit of the administration of
budesonide for the mother should be weighed against the risks to the foetus.
The lowest effective dose of budesonide needed to maintain adequate asthma control should be used.
Data on approximately 2000 exposed pregnancies indicate no increased teratogenic risk associated with the
use of inhaled budesonide. In animal studies glucocorticoids have been shown to induce malformations (see
section 5.3). This is not likely to be relevant for humans given recommended inhalation doses.
Animal studies have also identified an involvement of excess prenatal glucocorticoids in increased risk for
intrauterine growth retardation, adult cardiovascular disease and permanent changes in glucocorticoid
receptor density, neurotransmitter turnover and behaviour at exposures below the teratogenic dose range.
Breast-feeding
Budesonide is excreted in breast milk. However, at therapeutic doses of budesonide no effects on the
suckling child are anticipated. Budesonide can be used during breast feeding.
Maintenance treatment with inhaled budesonide (200 or 400 microgram twice daily) in asthmatic nursing
women results in negligible systemic exposure to budesonide in breast-fed infants. In a pharmacokinetic
study, the estimated daily infant dose was 0.3% of the daily maternal dose for both dose levels, and the
average plasma concentration in infants was estimated to be 1/600th of the concentrations observed in
maternal plasma, assuming complete infant oral bioavailability. Budesonide concentrations in infant plasma
samples were all less than the limit of quantification.
Based on data from inhaled budesonide and the fact that budesonide exhibits linear PK properties within the
therapeutic dosage intervals after nasal, inhaled, oral and rectal administrations, at therapeutic doses of
budesonide, exposure to the suckling child is anticipated to be low.
Fertility
There are no data available on the use of budesonide and its effect on fertility in humans. In rats,
subcutaneously administered budesonide did not have an adverse effect on fertility. There is no special
recommendation for women of child-bearing potential.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Such an effect is
considered unlikely to occur.
4.8 Undesirable effects
Adverse reactions are grouped according to their frequency which is defined as: very common (≥1/10),
common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare
(<1/10,000), not known (cannot be estimated from the available data).
Table 1 below contains adverse reactions reported in patients treated with budesonide compiled according to
MedDRA standard organ classes.
Infections and Infestations

Common Oropharyngeal candidiasis
Immune System Disorders
Rare Immediate and delayed hypersensitivity reactions including rash, contact dermatitis,
urticaria, angioedema, pruritus and anaphylactic reaction
Endocrine disorders
Rare Signs and symptoms of systemic corticosteroid effects, including adrenal
suppression, reduction in growth velocity*, hypoadrenocorticism,
hyperadrenocorticism, Cushing’s syndrome
Psychiatric disorders
Rare Restlessness, nervousness, behavioral changes (predominantly in children)
Uncommon Anxiety, depression**
Not known Sleep disorders, psychomotor hyperactivity, aggression
Eye disorders
Uncommon Cataract***, Vision blurred****
Rare Glaucoma,
Respiratory, thoracic and mediastinal disorders
Common Dysphonia, cough, hoarseness, throat irritation
Rare Bronchospasm, including paradoxical bronchospasm
Skin and subcutaneous tissue disorders

Rare Bruising
Musculoskeletal and connective tissue disorders
Uncommon Muscle spasm, tremor
Rare Decrease in bone mineral density
*refer to paediatric population below

**Clinical trials with 13119 patients on inhaled budesonide and 7278 patients on placebo have been pooled.
The frequency of anxiety was 0.52% on inhaled budesonide and 0.63% on placebo; that of depression was
0.67% on inhaled budesonide and 1.15% on placebo
*** In placebo-controlled studies, cataract was equally observed with frequency uncommon in the placebo
group
**** see also section 4.4.
There is an increased risk of pneumonia in patients with newly diagnosed COPD starting treatment with
inhaled corticosteroids. However a weighted assessment of 8 pooled clinical trials involving 4643 COPD
patients treated with budesonide and 3643 patients randomized to non-ICS treatments does did not
demonstrate an increased risk for pneumonia. The results from the first 7 of these 8 trials have been
published as a metaanalysis.
Occasionally, signs or symptoms of systemic glucocorticosteroid-side effects may occur with inhaled
glucocorticosteroids, probably depending on dose, exposure time, concomitant and previous
corticosteroid exposure, and individual sensitivity.”
Paediatric population
Due to the risk of growth retardation in the paediatric population, growth should be monitored as described
in section 4.4.
Hoarseness and irritation of the throat is reversible and disappears after discontinuation of therapy, reduction
of the dose and/or resting of the voice.
If Candida infection in the oropharynx occurs patients are advised to rinse out their mouth with water or
brush their teeth after each administration. In most cases, this condition will respond to topical anti-fungal
therapy without having to discontinue treatment with Budesonide.
As with other inhalation therapy, paradoxical bronchospasm is possible. If it occurs budesonide treatment
must be discontinued immediately and an alternative therapy should be instituted, if necessary and treatment
with a fast-acting inhaled bronchodilator should be immediate.
Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked
to report any suspected adverse reactions via the national reporting system listed in Appendix V.
4.9 Overdose
The acute toxicity of budesonide is low. Suppression of the hypothalamic-pituitary-adrenal (HPA) function
is the main harmful effect resulting from inhalation of large amounts of the drug over a short period of time .
No special emergency action needs to be taken. Treatment with Miflonide should be continued at the lowest
dose at which effective control of asthma is maintained.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other drugs for obstructive airways diseases, inhalants; Glucocorticoids.
ATC code: R 03 BA 02
Budesonide is a corticosteroid with topical action. Like other inhaled glucocorticoids, budesonide exerts its
pharmacologic effects by interacting with intracellular glucocorticoid receptors. The production of many
different cytokines, chemokines, enzymes, and cell adhesion molecules is inhibited. Maximum benefit of the
treatment with budesonide inhalation powder is reached within approximately 10 days of initiation of
treatment. Regular use of budesonide reduces the chronic inflammation of the asthmatic lungs. Thereby,
budesonide improves lung function and asthma symptoms, reduces bronchial hyperreactivity and prevents
asthma exacerbations.
Paediatric population
While there is no specific data available for Miflonide Breezhaler, data from inhaled budesonide delivered
via different type of inhaler in 157 children aged 5-16 years was not associated with an increased occurrence
of posterior subcapsular cataract.
Influence on plasma cortisol concentration

Studies in healthy volunteers with budesonide have shown dose-related effects on plasma and urinary
cortisol. At recommended doses, data from another inhaled budesonide product demonstrated significantly
less effect on adrenal function than prednisone 10 mg, as shown by ACTH test.
5.2 Pharmacokinetic properties
Absorption
The amount of budesonide deposited in the lungs is rapidly and completely absorbed. After administration
the peak concentration is reached within 5-10 minutes. About 25-30 % of a single dose is deposited in the
lungs. Only 10 to 13 % of the swallowed fraction of an inhaled dose is bioavailable due to significant
presystemic metabolism in the liver.
Distribution
The plasma protein binding of budesonide is 85 to 90 % over the concentration range 1 to 100 nmoL.
Budesonide is widely distributed into the tissues, the volume of distribution of budesonide at steady state is
approximately 183 to 301 liters.
Budesonide passes into the breast milk, with milk to plasma concentration ratio of around 0.46. The
estimated daily infant dose is 0.3% of the daily maternal dose, and the average plasma concentration in
infants is estimated to be 1/600th of the concentrations observed in maternal plasma, even after assuming
complete infant oral bioavailability has taken place.
Biotransformation
Budesonide is not metabolised in the lungs. After absorption budesonide is extensively metabolised in the
liver and converted to metabolites (including 6 -hydroxybudesonide and 16 -hydroxyprednisolone) with
low glucocorticosteroid activity.
The main route of metabolism of budesonide is via CYP3A4 and may be affected by known inhibitors or
inducers of this enzyme (see section 4.5).
Elimination
In human volunteers who inhaled radiolabelled budesonide (via metered dose inhaler) approximately 32 %
of the discharged dose was recovered in the urine and 15 % of the dose was recovered in the faeces.
Following inhalation, budesonide was not detected in the urine whereas 16 -hydroxyprednisolone was
detected.
Budesonide shows high plasma clearance (84 L/h) following intravenous dosing. The elimination half-life of
budesonide was around 2.8 to 5 h.
Special populations
Elderly (above 65 years of age)

The pharmacokinetics of budesonide when administered as Miflonide Breezhaler has not been studied in
geriatric patients. However, based on the limited data in patient aged more than 65 years, suggests there is
no significant difference in pharmacokinetics in elderly as compared to younger adults after oral and
intravenous administration of budesonide.
Paediatric patients
The pharmacokinetics of budesonide when administered as Miflonide Breezhaler has not been studied in the
paediatric population. However, data with other inhalational budesonide products suggest that body weight
normalized clearance in children above 3 years of age is around 50% higher as compared to adults.
Patients with hepatic impairment

The pharmacokinetics of inhaled budesonide has not been studied in patients with hepatic impairment.
However, it is reported that systemic availability of budesonide was 2.5-times higher after oral
administration in patients with cirrhosis compared with healthy controls. Mild hepatic impairment is reported
to have little effect on systemic exposure of oral budesonide.
5.3 Preclinical safety data
Preclinical data from repeated dose toxicity studies, as well as from skin sensitization, mutagenicity and
carcinogenicity studies with budesonide revealed no specific hazard for humans at the intended therapeutic
doses.
Reproductive toxicity
Glucocorticosteroids, including budesonide, have produced teratogenic effects in animals, including cleft
palate and skeletal abnormalities. Similar effects are considered unlikely to occur in humans at therapeutic
doses.
In rats administered with 0.25 microgram/kg inhaled budesonide, there were no teratogenic effects.
Subcutaneously administered budesonide showed teratogenic effects at greater than or equal to 100
µg/kg/day in rats and greater than or equal to 5 µg/kg/day in rabbits with the maternal exposure margins
approximately 2.4 and 0.24 times the maximum human inhaled dose of 400 microgram/day, respectively,
based on body surface area. In rats administered budesonide subcutaneously in a pre- and postnatal
developmental study, there were no effects on the pregnant rats or their offspring. As with other
glucocorticoids, subcutaneously administered budesonide has been shown to be teratogenic and fetotoxic
(decreased viability of pups) in rats. Fetotoxicity was also noted in rabbits (reduction in growth velocity and
fetal death observed at maternally toxic dose levels).
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose monohydrate (which contains small amounts of milk proteins).
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
PVC/PVDC/Aluminium blister strip. Each blister contains 10 hard capsules.

Single pack containing 2x10 or 6x10 hard capsules and 1 inhaler.
Multipacks containing 120 (bundle of 2 single packs of 6x10) hard capsules and 2 inhalers.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling

It is important for the patient to understand that the gelatin capsule may very occasionally break up and small
pieces of gelatin reach the mouth or throat after inhalation. The patient may be reassured that the gelatin will
soften in the mouth and can be swallowed. The tendency for the capsule to break up is minimized by not
piercing the capsule more than once.
The capsule should be removed from the blister pack only immediately before use.
Instructions for handling and use
Pull off the cap
Open inhaler
Hold the base of the inhaler firmly and tilt the mouthpiece. This opens the
inhaler.
Prepare capsule
Immediately before use, with dry hands, remove one capsule from the blister.
Do not swallow the capsule.
Insert capsule
Place the capsule into the capsule chamber.
Never place a capsule directly into the mouthpiece.
Close the inhaler

Close the inhaler until you hear a “click”.
Pierce the capsule

 Hold the inhaler upright with the mouthpiece pointing up.
 Pierce the capsule by firmly pressing together both side buttons at the same
time. Do this only once.
 You should hear a “click” as the capsule is being pierced.
Release the side buttons fully
Breathe out
Before placing the mouthpiece in your mouth, breathe out fully.
Do not blow into the mouthpiece.
Inhale the medicine

To breathe the medicine deeply into your airways:
 Hold the inhaler as shown in the picture. The side buttons should be facing
left and right. Do not press the side buttons.
 Place the mouthpiece in your mouth and close your lips firmly around the
mouthpiece.
 Breathe in rapidly but steadily and as deeply as you can.
Note:
As you breathe in through the inhaler, the capsule spins around in the chamber
and you should hear a whirring noise. You may experience a sweet flavour as
the medicine goes into your lungs.
Additional information
Occasionally, very small pieces of the capsule can get past the screen and enter
your mouth. If this happens, you may be able to feel these pieces on your
tongue. It is not harmful if these pieces are swallowed or inhaled. The chances
of the capsule shattering will be increased if the capsule is accidentally pierced
more than once (step 6).
If you do not hear a whirring noise

The capsule may be stuck in the capsule chamber. If this happens:
 Open the inhaler and carefully loosen the capsule by tapping the base of
the inhaler. Do not press the side buttons.
 Close the inhaler and inhale the medicine again by repeating steps 8 and 9.
Hold breath
After you have inhaled the medicine:
 Hold your breath for at least 5-10 seconds or as long as you comfortably
can while taking the inhaler out of your mouth.
 Then breathe out.
 Open the inhaler to see if any powder is left in the capsule.
If there is powder left in the capsule

 Close the inhaler.
 Repeat steps 8, 9, 10 and 11.
Most people are able to empty the capsule with one or two inhalations.
Additional info
If the capsule is empty, you have received enough of your medicine.
 Open the mouthpiece again and remove the empty capsule by tipping it out
of the capsule chamber. Put the empty capsule in your household waste.
If your prescription requires you to take more than 1 capsule, repeat steps 3 –
12 as necessary.
After you have finished taking your medicine

 Close the inhaler and replace the cap.
Rinse your mouth well with water after using your medicine. Spit out the rinse
water. This will reduce the risk of developing a fungal infection (thrush) in the
mouth.
Do not store the capsules in the Miflonide Breezhaler inhalation device.
7. MARKETING AUTHORISATION HOLDER
[To be completed nationally]
8. MARKETING AUTHORISATION NUMBERS
Miflonide Breezhaler 200 microgram: <[To be completed nationally]>

Miflonide Breezhaler 400 microgram: <[To be completed nationally]>
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: Date of last renewal:

10. DATE OF REVISION OF THE TEXT

LABELLING AND PACKAGE LEAFLET
LABELLING
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON OF THE UNIT PACK
Miflonide Breezhaler 200 microgram inhalation powder, hard capsule

Budesonide
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each capsule contains 230 micrograms of budesonide and delivers 200 micrograms of budesonide when used
with the Miflonide Breezhaler inhaler.
3. LIST OF EXCIPIENTS
Lactose monohydrate
4. PHARMACEUTICAL FORM AND CONTENTS
Inhalation powder, hard capsule
20 hard capsules + 1 inhaler

5. METHOD AND ROUTE(S) OF ADMINISTRATION
Inhalation use.
Do not swallow. Intended for inhalation with the Miflonide Breezhaler inhalation device.
Read the package leaflet before use.
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF

THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE
EXP
9. SPECIAL STORAGE CONDITIONS

Do not store above 25°C.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
12. MARKETING AUTHORISATION NUMBER(S)
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Miflonide Breezhaler 200 microgram

17. UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC: SN:
NN:
OUTER LABEL OF MULTIPACK (INCLUDING BLUE BOX)

Budesonide
Lactose monohydrate
Multipack: 120 (2 packs of 6x10) hard capsules + 2 inhalers.

Inhalation use.

8. EXPIRY DATE
EXP

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
13. BATCH NUMBER
Lot
PC:
SN: NN:
INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)

Budesonide
with the Miflonide Breezhaler  inhaler.
Lactose monohydrate
6x10 hard capsules + 1 inhaler. Component of a multipack. Not to be sold separately.
Inhalation use.

8. EXPIRY DATE
EXP

APPROPRIATE
13. BATCH NUMBER
Lot

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTER

Budesonide
2. NAME OF THE MARKETING AUTHORISATION HOLDER
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. OTHER
OUTER CARTON OF THE UNIT PACK

Budesonide
Lactose monohydrate

Inhalation use.

8. EXPIRY DATE
EXP


WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
13. BATCH NUMBER
Lot
PC:
SN:
NN:
OUTER LABEL OF MULTIPACK (INCLUDING BLUE BOX)

Budesonide
Lactose monohydrate

Inhalation use.

8. EXPIRY DATE
EXP

APPROPRIATE
13. BATCH NUMBER
Lot
PC: SN: NN:

INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)

Budesonide
Lactose monohydrate
6x10 hard capsules + 1 inhaler. Component of a multipack. Not to be sold separately.
Inhalation use.

8. EXPIRY DATE
EXP

APPROPRIATE

13. BATCH NUMBER
Lot

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTER

Budesonide
2. NAME OF THE MARKETING AUTHORISATION HOLDER
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Lot
5. OTHER
PACKAGE LEAFLET
Package leaflet: Information for the user

Budesonide
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:

1. What Miflonide Breezhaler is and what it is used for
2. What you need to know before you use Miflonide Breezhaler
3. How to use Miflonide Breezhaler
4. Possible side effects
5. How to store Miflonide Breezhaler
6. Contents of the pack and other information
1. What Miflonide Breezhaler is and what it is used for
What Miflonide Breezhaler is

Miflonide Breezhaler is provided as a capsule to be put in an inhaler called Miflonide Breezhaler®. The
inhaler opens the capsule and releases a dry powder that is delivered to the lungs by breathing in.
Miflonide Breezhaler contains a substance called budesonide. It belongs to a group of medicines called
“corticosteroids”. Some people call this their “steroid” or “preventer” medicine.
What Miflonide Breezhaler is used for

Miflonide Breezhaler is used to prevent asthma attacks and ease breathing problems in adults and children 6
years of age and older. This medicine should be used regularly every day, even if you feel better, as this
medicine will help to prevent future breathing problems.
It should not be used to treat a sudden asthma attack when you have one. You will need to use a different
inhaler (“reliever”) to deal with these asthma attacks, such as albuterol or salbutamol.
How Miflonide Breezhaler works

Asthma is caused by inflammation of the small airways in your lungs, which become swollen and make it
difficult to breathe.
Miflonide Breezhaler reduces and prevents the inflammation and helps keep the airways open to reduce
asthma symptoms, allowing you to breathe more easily.
2. What you need to know before you use Miflonide Breezhaler
Do not use Miflonide Breezhaler

If you are allergic to budesonide or any of the other ingredients of this medicine (listed in Section 6).
If you have or ever had a problem with your airways called pulmonary tuberculosis (TB).
In children under the age of 6 years.
If any of the above applies to you, do not use Miflonide Breezhaler. If you are not sure, talk to your doctor
or pharmacist before using Miflonide Breezhaler.
Warnings and precautions

Talk to your doctor before using Miflonide Breezhaler:
If you ever had tuberculosis.
If you have a fungal or viral infection in your airways.
If you have any other lung or breathing problems with an increased risk of fungal infection.
If you have any liver disease or suffer from jaundice. Your doctor will prescribe the right dose for you.
Contact your doctor if you experience blurred vision or other visual disturbances.
If any of the above applies to you (or you are not sure) tell your doctor before taking Miflonide
Breezhaler.
Tell your doctor immediately

If you have difficulty breathing with wheezing or coughing after using the medicine. If this happens,
stop taking this medicine immediately. Your doctor may give you another medicine to use instead.
If you get a rash, itching, hives, swelling of your face and throat, have difficulty breathing or swallowing
or feel dizzy while using Miflonide Breezhaler. You may be having a severe allergic reaction to the
medicine.
If you develop extreme weakness, weight loss, you feel sick (nausea), and often get diarrhoea while
using Miflonide Breezhaler. These can be symptoms of an underactive adrenal gland.
If you develop a weight gain, moon-shaped face, weakness, and/or abdominal obesity while using
Miflonide Breezhaler. These can be the symptoms of a hormonal disorder called Cushing’s syndrome.
If you get blurred or changed vision while using Miflonide Breezhaler.
If you experience sleeping problems, depression or feeling worried, restless, nervous, over-excited or
irritated during treatment with Miflonide Breezhaler.
If you develop fungal infection in mouth during the use of Miflonide Breezhaler.
If you get any of the above, tell your doctor immediately.
Your doctor may test your kidneys (adrenal glands function) from time to time.
If this medicine has been used for a long time by a child, then the doctor will regularly check their height.
Do not swallow the capsules - they must only be used with the Miflonide Breezhaler inhalation device.
Other medicines and Miflonide Breezhaler

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may increase the effects of Miflonide Breezhaler and your doctor may wish to monitor you
carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
In particular, please tell your doctor if you are using:

Medicines used to treat infections such as itraconazole, ketoconazole, clarithromycin, telithromycin,
erythromycin or rifampicin.
Medicines used to treat HIV infection such as ritonavir, saquinavir or nelfinavir.
Medicines used to treat problems with your heart beat (cardiac arrhythmias) such as amiodarone.
If any of the above applies to you (or you are not sure) tell your doctor.
If you have been taking steroid tablets

If you have been taking steroid tablets for your asthma for a long time, your doctor may slowly lower the
amount you take after you have been using Miflonide Breezhaler for about 10 days. Do not suddenly stop
taking your steroid tablets.
Sometimes when you lower the amount of tablets you take, you may get symptoms such as,
a stuffy or runny nose, joint or muscle pain,
a rash (eczema)
tiredness, feeling sick (nausea) or being sick (vomit).
If you get any of these symptoms, please tell your doctor as soon as possible.
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist
for advice before using this medicine. You should use this medicine during pregnancy only as directed by
your doctor.
Breast-feeding
If you are breast-feeding, ask your doctor or pharmacist for advice before using this medicine. Your doctor
will discuss with you the potential risks of using Miflonide Breezhaler during breast feeding. Ask your
doctor for advice before taking any medicine.
Driving and using machines

Miflonide Breezhaler is not likely to affect your ability to drive or use machines.
Miflonide Breezhaler contains lactose monohydrate

Miflonide Breezhaler 200 microgram: This medicine contains lactose (24.77 mg per capsule).
Miflonide Breezhaler 400 microgram: This medicine contains lactose (24.54 mg per capsule).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
using this medicine.
3. How to use Miflonide Breezhaler
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure.
How much Miflonide Breezhaler to use

 Your doctor will adjust your dose so that you use the lowest possible amount of this medicine that
works for you.
 It is important to use the inhaler every day, even if you feel better, as this medicine will help to prevent
future breathing problems.
 If you notice that your wheezing or breathlessness is getting worse, tell your doctor as soon as
possible. You may feel that your medicine is not working as well as it should.
 If you or your child needs to use less than 200 micrograms each day, you cannot use this medicine.
Children under 6 years of age

Miflonide Breezhaler is not to be used in children under the age of 6 years.
Children aged 6 years and over

 The usual dose is between 200 and 400 micrograms of this medicine each day. The dose should
normally be divided into two separate equal inhalations a day, when possible. If you require 400
microgram dose a day; this means breathing in one capsule of 200 microgram twice a day. If you
require 200 microgram dose a day; this means breathing in 200 microgram once per day.
 Your doctor may ask you to use a different number of capsules or to use your inhaler only once a day.
 If your child has severe asthma, your doctor may ask you to use up to 800 micrograms each day. This
means breathing in two capsules of 200 microgram twice a day or one capsule of 400 microgram
twice a day.
Adults
 The usual dose is between 200 and 1600 micrograms of this medicine each day. This is normally
breathed in twice a day, half each time. This means breathing in between 1-8 capsules of 200
micrograms or up to 4 capsules of 400 micrograms. The dose should be divided into two
separate inhalations when possible.
 Your doctor may ask you to use a different number of capsules or use your inhaler only once a day.
If you are not sure how many capsules to use, ask your doctor or pharmacist before using Miflonide
Breezhaler.
How to use Miflonide Breezhaler with your Breezhaler inhalation device

 Only use the Miflonide Breezhaler capsules with the inhaler provided in the pack. The capsules should
remain in the blister pack until you need to use them.
 Do not swallow the capsules. The powder in the capsules is to be used for inhalation only.
 To prevent getting a fungal infection called “thrush” in your mouth, rinse your mouth well with water
after using your inhaler.
 Please read the section “Instructions for use of Miflonide Breezhaler” carefully for more information
about how to use the Miflonide Breezhaler capsules with the Miflonide Breezhaler inhalation device.
If you use more Miflonide Breezhaler than you should

It is important that you take your dose as stated on the pharmacist’s label or as advised by your doctor. You
should not increase or decrease your dose without seeking medical advice.
If you use more of this medicine than you should, or someone else uses your capsules, tell your doctor
immediately or go to the nearest emergency unit. Take the medicine pack with you.
If you forget to use Miflonide Breezhaler

 If you forget to breathe in a dose, breathe in the next dose at the usual time.
 Do not breathe in a double dose to make up for the one you missed.
If you stop using Miflonide Breezhaler

Stopping your treatment with Miflonide Breezhaler may increase the chance of worsening your asthma. Do
not suddenly stop using Miflonide Breezhaler unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some rare side effects can be serious
Tell your doctor immediately

 If you have difficulty breathing with wheezing or coughing after using the medicine. If this happens,
stop taking this medicine immediately. Your doctor may give you another medicine to use instead.
 If you get a rash, itching, hives, swelling of your face and throat, have difficulty breathing or
swallowing or feel dizzy while using Miflonide Breezhaler. You may be having a severe allergic
reaction to the medicine.
 If you develop extreme weakness, weight loss, you feel sick (nausea), and often get diarrhoea while
using Miflonide Breezhaler. These can be symptoms of an underactive adrenal gland.
 If you develop a weight gain, moon-shaped face, weakness, and/or abdominal obesity while using
Miflonide Breezhaler. These can be the symptoms of a hormonal disorder called Cushing’s syndrome
or hyperadrenocorticism.
 If you get blurred or changed vision while using Miflonide Breezhaler.
If you get any of the above, tell your doctor immediately.
Other side effects may include :

Common: may affect up to 1 in 10 people
 Fungal infections in your mouth and throat. To prevent getting a fungal infection called “thrush” in
your mouth, rinse your mouth well with water after using your inhaler.
 Hoarse voice and throat irritation. These effects go away when you stop using your inhaler, use less
capsules or rest your voice.
 Cough
Uncommon: may affect up to 1 in 100 people

 Anxiety
 Depression
 Cataract
 Blurred vision
 Muscle spasm
 Tremor
Rare: may affect up to1 in 1,000 people

 Slow growth in children and adolescents.
 Thinning of your bones.
 Feeling hyperactive or restless.
 Behaviour problems, including depression, especially in children.
 Itchy rash.
 Bruising.
Not known: frequency cannot be estimated from the available data

 Sleeping problems.
 Feeling worried, nervous, over-excited or irritable.
These effects are more likely to occur in children.
Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix
V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Miflonide Breezhaler
Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to
the last day of that month.
Do not use this medicine if you notice damaged or shows signs of tampering.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Miflonide Breezhaler contains
Miflonide Breezhaler 200 microgram:

 The active substance is budesonide. Each capsule contains 230 micrograms of budesonide and delivers
200 micrograms of budesonide when used in the Miflonide Breezhaler inhalation device.
 The other ingredient is lactose monohydrate. The capsules are made of edible gelatin.
Miflonide Breezhaler 400 microgram:
 The active substance is budesonide. Each capsule contains 460 micrograms of budesonide and delivers
400 micrograms of budesonide when used in the Breezhaler inhalation device.
 The other ingredient is lactose monohydrate. The capsules are made of edible gelatin.
What Miflonide Breezhaler looks like and contents of the pack

Miflonide Breezhaler is a dry powder that you breathe in using the Miflonide Breezhaler inhalation device.
The powder comes in a capsule.
 The 200 microgram capsule has a light pink opaque cap and a colourless transparent body, with the
printed logo “BUDE 200”.
 The 400 microgram capsule has a pink opaque cap and a colourless transparent body, with the printed
logo “BUDE 400”.
The following pack sizes are available:
Single pack containing 2x10 or 6x10 hard capsules and 1 inhaler.
Not all pack sizes may be marketed.
Marketing Authorisation Holder

Manufacturer
Novartis Pharmaceuticals UK Ltd
Wimblehurst Road, Horsham, West Sussex, RH125AB
United Kingdom
Novartis Farmaceutica SA
Ronda Santa Maria 158, 08210 Barberá del Vallés, Barcelona
Spain
Novartis Farma – Productos Farmacêuticos S.A.

Avenida Professor Doutor Cavaco Silva, n. º 10E, Taguspark, 2740-255 Porto Salvo
Portugal
Novartis Farma S.p.A.

Via Provinciale Schito 131, 80058 Torre Annunziata, NA
Italy
Novartis (Hellas) SA
12th km National Road Athinon-Lamias
Metamorfosi Attiki, 14451
Greece
Novartis Healthcare A/S

Edvard Thomsens Vej 14, DK-2300 Copenhagen S
Denmark
Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17, 1020 Wien
Austria
Novartis Pharma GmbH

Roonstrasse 25, 90429 Nürnberg
Germany
Novartis Pharma nv/sa

Medialaan 40/Bus , 1800 Vilvoorde
Belgium
<This medicinal product is authorised in the Member States of the EEA under the following names:>
Austria Miflonide Breezhaler

Belgium Miflonide Breezhaler
Denmark Miflonide Breezhaler
Germany Miflonide Breezhaler
Greece Miflonide Breezhaler
Italy Miflonide Breezhaler
Portugal Miflonide Breezhaler
Spain Miflonide Breezhaler
This leaflet was last revised in
Instruction for use of Miflonide Breezhaler
Please read the following instructions carefully to learn how to use Miflonide Breezhaler capsules with the
Miflonide Breezhaler inhalation device.
Use the Miflonide Breezhaler capsules only with the Miflonide Breezhaler inhalation device provided in the
pack.
 Do not use a different type of inhaler.
 Do not swallow the capsules. The powder in the capsules is for you to breathe in.
 Remember that Miflonide Breezhaler is only used to prevent asthma attacks. You will need to use your
“reliever” inhaler to treat an asthma attack.
Your Miflonide Breezhaler pack:
Cap
Inhaler with
cap on
Base
Blister strip
containing
capsules
Blister strip
Mouthpiece
Screen
Inhaler base
Side button
Capsule chamber
How to use your inhaler
Each Miflonide Breezhaler pack contains:

 one Miflonide Breezhaler inhalation device
 one or more blister strips containing Miflonide Breezhaler capsules to be used in the inhaler.
The Miflonide Breezhaler inhalation device enables you to inhale the medicine contained in a
Miflonide Breezhaler capsule.
How to use your Miflonide Breezhaler inhalation device
Pull off the cap
Open inhaler
Hold the base of the inhaler firmly and tilt the mouthpiece. This opens the
inhaler.
Prepare capsule
Immediately before use, with dry hands, remove one capsule from the blister.
Do not swallow the capsule.
Insert capsule
Place the capsule into the capsule chamber.
Never place a capsule directly into the mouthpiece.
Close the inhaler

Close the inhaler until you hear a “click”.
Pierce the capsule

 Hold the inhaler upright with the mouthpiece pointing up.
 Pierce the capsule by firmly pressing together both side buttons at the same
time. Do this only once.
 You should hear a “click” as the capsule is being pierced.
Release the side buttons fully

Breathe out
Before placing the mouthpiece in your mouth, breathe out fully.
Do not blow into the mouthpiece.
Inhale the medicine

To breathe the medicine deeply into your airways:
 Hold the inhaler as shown in the picture. The side buttons should be facing
left and right. Do not press the side buttons.
 Place the mouthpiece in your mouth and close your lips firmly around the
mouthpiece.
 Breathe in rapidly but steadily and as deeply as you can.
Note:
As you breathe in through the inhaler, the capsule spins around in the chamber
and you should hear a whirring noise. You may experience a sweet flavour as
the medicine goes into your lungs.
Additional information
Occasionally, very small pieces of the capsule can get past the screen and enter
your mouth. If this happens, you may be able to feel these pieces on your
tongue. It is not harmful if these pieces are swallowed or inhaled. The chances
of the capsule shattering will be increased if the capsule is accidentally pierced
more than once (step 6).
If you do not hear a whirring noise

The capsule may be stuck in the capsule chamber. If this happens:
 Open the inhaler and carefully loosen the capsule by tapping the base of
the inhaler. Do not press the side buttons.
 Close the inhaler and inhale the medicine again by repeating steps 8 and 9.
Hold breath
After you have inhaled the medicine:
 Hold your breath for at least 5-10 seconds or as long as you comfortably
can while taking the inhaler out of your mouth.
 Then breathe out.
 Open the inhaler to see if any powder is left in the capsule.
If there is powder left in the capsule

 Close the inhaler.
 Repeat steps 8, 9, 10 and 11.
Most people are able to empty the capsule with one or two inhalations.
Additional info
If the capsule is empty, you have received enough of your medicine.
 Open the mouthpiece again and remove the empty capsule by tipping it out
of the capsule chamber. Put the empty capsule in your household waste.
If your prescription requires you to take more than 1 capsule, repeat steps 3 –
12 as necessary.
After you have finished taking your medicine

 Close the inhaler and replace the cap.
Rinse your mouth well with water after using your medicine. Spit out the rinse
water. This will reduce the risk of developing a fungal infection (thrush) in the
mouth.
Do not store the capsules in the Miflonide Breezhaler inhalation device.
How to clean your inhaler
Never wash your inhaler with water. If you want to clean your inhaler, wipe the mouthpiece inside
and outside with a clean, dry, lint-free cloth to remove any powder residue. Keep the inhaler dry.
Remember
 Do not swallow Miflonide Breezhaler capsules.
 Only use the Miflonide Breezhaler inhalation device contained in this pack.
 Capsules must always be stored in the blister, and only removed immediately before use.
 Never place a Miflonide Breezhaler capsule directly into the mouthpiece of the Miflonide
Breezhaler inhalation device.
 Do not press the side buttons more than once.
 Never blow into the mouthpiece of the Miflonide Breezhaler inhalation device.
 Always release the side buttons before inhalation.
 Never wash the Miflonide Breezhaler inhalation device with water. Keep it dry. See “How to
clean your inhaler”.
 Never take the Miflonide Breezhaler inhalation device apart.
 Always use the new Miflonide Breezhaler inhalation device that comes with your new Miflonide
Breezhaler medication pack. Dispose of each inhaler after after finishing the pack.
 Do not store the capsules in the Miflonide Breezhaler inhalation device.
 Always keep the Miflonide Breezhaler inhalation device and Miflonide Breezhaler capsules in a
dry place.

Summary of Product Characteristics, Labelling and Package Leaflet

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Summary of Product Characteristics, Labelling and Package Leaflet

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SUMMARY OF PRODUCT CHARACTERISTICS,

LABELLING AND PACKAGE LEAFLET

Miflonide Breezhaler 200 microgram inhalation powder, hard capsules

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Excipient with known effect:

For the full list of excipients, see section 6.1.

Inhalation powder, hard capsule.

4.1 Therapeutic indications

4.2 Posology and method of administration

Patients maintained on oral glucocorticosteroids

Patients with renal impairment

Patients with hepatic impairment

Elderly (above 65 years of age)

Not to be used in children under 6 years of age.

4.4 Special warnings and precautions for use

Prophylactic nature of therapy

Steroid dependent patients

Incorrect route of administration

Agents resulting in CYP3A4 induction

4.6 Pregnancy and lactation

4.7 Effects on ability to drive and use machines

4.8 Undesirable effects

Infections and Infestations

Skin and subcutaneous tissue disorders

*refer to paediatric population below

Reporting of suspected adverse reactions

5.1 Pharmacodynamic properties

Influence on plasma cortisol concentration

5.2 Pharmacokinetic properties

Elderly (above 65 years of age)

Patients with hepatic impairment

5.3 Preclinical safety data

6.1 List of excipients

Lactose monohydrate (which contains small amounts of milk proteins).

6.3 Shelf life

6.4 Special precautions for storage

Do not store above 25°C

6.5 Nature and contents of container

PVC/PVDC/Aluminium blister strip. Each blister contains 10 hard capsules.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Pull off the cap

Close the inhaler

Pierce the capsule

Inhale the medicine

If you do not hear a whirring noise

If there is powder left in the capsule

After you have finished taking your medicine

7. MARKETING AUTHORISATION HOLDER

[To be completed nationally]

8. MARKETING AUTHORISATION NUMBERS

Miflonide Breezhaler 200 microgram: <[To be completed nationally]>

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: Date of last renewal:

[To be completed nationally]

OUTER CARTON OF THE UNIT PACK

1. NAME OF THE MEDICINAL PRODUCT

Miflonide Breezhaler 200 microgram inhalation powder, hard capsule

2. STATEMENT OF ACTIVE SUBSTANCE(S)

4. PHARMACEUTICAL FORM AND CONTENTS

Inhalation powder, hard capsule

20 hard capsules + 1 inhaler

5. METHOD AND ROUTE(S) OF ADMINISTRATION