®

Aeronid Aeronid® is now CFC-Free

to help protect our environment more Important Information for the Patients
HFA Inhalation Aerosol kKrPmvPT IJPrJ nJunJPm rãJ TrJr \jq ßrJVLPhr \jq k´P~J\jL~ fgq
Budesonide BP FqJPrJKjc® FUj KxFlKx oMÜ
Before using your Aeronid® inhaler, please read this leaflet carefully and
Description depression, despite maintenance or even improvement of respiratory function. Budesonide follow these instructions to get the results you expect from this prescribed
Budesonide BP Inhaler is a corticosteroid designated that exhibits potent glucocorticoid activity Inhaler will often permit control of asthma symptoms with less suppression of HPA function than
and weak mineralocorticoid activity. Corticosteroids have been shown to have a wide range of
medication.
therapeutically equivalent oral doses of prednisone. Since budesonide is absorbed into the
inhibitory activities against multiple cell types (e.g., mast cells, eosinophils, neutrophils, circulation and can be systemically active at higher doses, the full beneficial effects of Budesonide FqJPrJKjc® AjPyuJr mqmyJPrr IJPV IJkKj FA KulPuaKa kzMj FmÄ xfTtfJr xJPg FA mqmyJrKmKi
macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and Inhaler in minimizing HPA dysfunction may be expected only when recommended dosages are IjMxre TÀjÇ FPf IJkKj nJu lu kJPmjÇ
cytokines) involved in allergic and non-allergic-mediated inflammation. These anti-inflammatory not exceeded and individual patients are titrated to the lowest effective dose. Since individual
actions of budesonide contribute to their efficacy in asthma. sensitivity to effects on cortisol production exists, physicians should consider this information What does it mean when we say “Aeronid ®
is CFC - FREE”?
Indications and Usage when prescribing Aeronid Inhaler. Because of the possibility of systemic absorption of inhaled FqJPrJKjc® KxFlKx oMÜ muPf KT mM^J~?
Budesonide Inhaler is indicated for the maintenance treatment of asthma as prophylactic therapy corticosteroids, patients treated with these drugs should be observed carefully for any evidence
in adult and pediatric patients six years of age or older. It is also indicated for patients requiring of systemic corticosteroid effects. Particular care should be taken in observing patients The CFC propellant that was once in Aeronid® inhaler has now been
oral corticosteroid therapy for asthma. Many of those patients may be able to reduce or eliminate postoperatively or during periods of stress for evidence of inadequate adrenal response. It is replaced with a more environment friendly 'non CFC' propellant, called
their requirement for oral corticosteroids over time. Budesonide Inhaler is NOT indicated for the possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may HFA.
relief of acute bronchospasm. appear in a small number of patients, particularly at higher doses. If such changes occur,
Dosage and administration If you have used the old (CFC-containing) Aeronid®, you may notice a
Budesonide Inhaler should be reduced slowly, consistent with accepted procedures for
Budesonide Inhaler should be administered by the orally inhaled route in asthmatic patients age management of asthma symptoms and for tapering of systemic steroids. A reduction of growth difference in the taste, and a softer feel of the 'puff'
6 years and older. Individual patients will experience a variable onset and degree of symptom velocity in children or teenagers may occur as a result of inadequate control of chronic diseases Even though you may feel that the puff is softer, the amount of Aeronid®
relief. Generally, Budesonide Inhaler has a relatively rapid onset of action for an inhaled such as asthma or from use of corticosteroids for treatment. Physicians should closely follow the
corticosteroid. Improvement in asthma control following inhaled administration of Budesonide
in each puff is the same as in the old CFC Aeronid®.
growth of all pediatric patients taking corticosteroids by any route and weigh the benefits of
Inhaler can occur within 24 hours of initiation of treatment, although maximum benefit may not be corticosteroid therapy and asthma control against the possibility of growth suppression. Although KxFlKx k´PkuqJ≤ pJ IJPV FqJPrJKjc® AjPyuJPr mqmyJr TrJ yf fJ FUj kKrPmv mJºm KxFlKx
achieved for 1 to 2 weeks, or longer. The safety and efficacy of Budesonide Inhaler when patients in clinical trials have received Budesonide Inhaler on a continuous basis for periods of 1 oMÜ k´PkuqJ≤, FAY Fl F KhP~ k´Kf˙Jkj TrJ yP~PZÇ
administered in excess of recommended doses have not been established. to 2 years, the long-term local and systemic effects of Budesonide Inhaler in human subjects are pKh IJkKj kMrJfj (KxFlKx pMÜ) FqJPrJKjc® AjPyuJr mqmyJr TPr gJPTj fJyPu FaJ mqmyJr TrPu
The recommended starting dose and the highest recommended dose of Budesonide Inhaler, not completely known. In particular, the effects resulting from chronic use of Budesonide Inhaler
based on prior asthma therapy, are listed in the following table. ˝JPh KnjúfJ kJPmj FmÄ kJPl jro IjMnm yPmÇ
on developmental or immunological processes in the mouth, pharynx, trachea, and lung are
Previous Recommended Highest unknown. In clinical trials with Budesonide Inhaler, localized infections with Candida albicans pKhS IJkKj Fr kJPl jro IjMnKë f kJPmj KT∂á ßp kKroJj SwMi k´Kf kJPl ßmr yPm fJ kMrJfj KxFlKx
Therapy Starting Dose Recommended
Dose occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, it pMÜ AjPyuJPrr xoJjÇ
Adults: Bronchodilators 200 to 400 mcg 400 mcg twice should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still
alone twice daily daily
continuing with Budesonide Inhaler therapy, but at times therapy with Budesonide Inhaler may
Inhaled 200 to 400 mcg 800 mcg twice
need to be temporarily interrupted under close medical supervision. Inhaled corticosteroids Prime your Aeronid® Inhaler
Corticosteroids* twice daily daily
Oral 400 to 800 mcg 800 mcg twice should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of IJkjJr FqJPrJKjc® FAYFlF AjPyuJrKa k´JAo TÀj
Corticosteroids twice daily daily the respiratory tract, untreated systemic fungal, bacterial, viral or parasitic infections; or ocular
Children: Bronchodilators
alone
200 mcg twice
daily
400 mcg twice
daily
herpes simplex. Rare instances of glaucoma, increased intraocular pressure, and cataracts have Aeronid® inhaler should be primed before using it for the first time. You
Inhaled 200 mcg twice 400 mcg twice been reported following the inhaled administration of corticosteroids. should also prime your inhaler when the inhaler has not been used for
Corticosteroids* daily daily Side Effects
Oral
more than 10 days.
The highest recommended dose in children The following adverse reactions were reported in patients treated with Budesonide Inhaler.
Corticosteroids is 400 mcg twice daily
Body as a Whole: Headache, flu syndrome, pain, back pain, fever, neck pain, asthenia; k´go mJr FqJPrJKjc® AjPyuJr mqmyJPrr xo~ IJkjJPT AjPyuJr k´JAo TPr KjPf yPmÇ FojKT 10
*In patients with mild to moderate asthma who are well controlled on inhaled corticosteroids, Respiratory System: Respiratory infection, pharyngitis, sinusitis, rhinitis, voice alteration, cough Khj mJ fJr ßYP~ ßmvL KmrKfPf AjPyuJr mqmyJr TrJ yPu FKaPT k´JAo TPr ßj~J k´P~J\jÇ
dosing with Budesonide Inhaler 200 mcg or 400 mcg once daily may be considered. Budesonide aggravation; Digestive System: Oral candidiasis, dyspepsia, gastroenteritis, nausea, abdominal
Inhaler can be administered once daily either in the morning or in the evening. If the once-daily pain, dry mouth, vomiting; Cardiovascular: syncope; Metabolic and Nutritional: weight gain;
treatment with Budesonide Inhaler does not provide adequate control of asthma symptoms, the
total daily dose should be increased and/or administered as a divided dose. Patients Maintained
Musculoskeletal: fracture, myalgia; Nervous: hypertonia, migraine; Platelet, Bleeding and
Clotting: ecchymosis; Psychiatric: insomnia; Resistance Mechanisms: infection; Special Senses:
What do we mean by 'Priming' of the inhaler?
on Chronic Oral Corticosteroids. Initially, Budesonide Inhaler should be used concurrently with the taste perversion; Musculoskeletal: arthralgia. Pediatric Studies: There were no clinically relevant AjPyuJr k´JAo TrJ muPf KT mM^J~?
patient's usual maintenance dose of systemic corticosteroid. After approximately one week, differences in the pattern or severity of adverse events in children compared with those reported When using your new inhaler for the first time or if it has not been used for
gradual withdrawal of the systemic corticosteroid is started by reducing the daily or alternate daily in adults. Adverse Event Reports From Other Sources: Rare adverse events reported include:
dose. The next reduction is made after an interval of one or two weeks, depending on the 10 days or more, you should prime your inhaler before use. This is known
immediate and delayed hypersensitivity reactions including rash, contact dermatitis, urticaria,
response of the patient. Generally, these decrements should not exceed 2.5 mg of prednisone or angioedema and bronchospasm; symptoms of hypocorticism and hypercorticism; psychiatric as priming.
its equivalent. A slow rate of withdrawal is strongly recommended. During reduction of oral symptoms including depression, aggressive reactions, irritability, anxiety and psychosis. AjPyuJr k´go mqmyJPrr xo~ IgmJ 10 Khj mJ Fr ßmvL KmrKfPf mqmyJPrr xo~ FKar krLãJoNuT
corticosteroids, patients should be carefully monitored for asthma instability, including objective Pharmaceutical Precautions
measures of airway function, and for adrenal insufficiency. During withdrawal, some patients may
mqmyJr k´P~J\jÇ FPTA k´JAo TrJ mPuÇ
Pressurised canister, do not puncture, break or incinerate even when apparently empty. Avoid
experience symptoms of systemic corticosteroid withdrawal, e.g., joint and/or muscular pain,
lassitude and depression, despite maintenance or even improvement in pulmonary function. Such
storage in direct sunlight or heat. Store below 30oC. Keep away from eyes. Keep away from How to prime the inhaler?
children.
patients should be encouraged to continue with Budesonide Inhaler but should be monitored for KTnJPm k´JAo TrPmj?
Commercial Pack
objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic Aeronid ® : Each canister contains 200 metered doses for inhalation aerosol with each actuation To prime simply release two actuations into the air away from your face.
corticosteroid doses should be increased temporarily and thereafter withdrawal should continue (Puff) containing 200 mcg of Budesonide BP.
more slowly. During periods of stress or a severe asthma attack, transfer patients may require
k´JAo TrJr \jq TqJKjˆJrKaPT 2 mJr YJk Khj IgJt“ 2 Ka oJ©J mJfJPx KjÏíf TPr ßhUPf yPmÇ
supplementary treatment with systemic corticosteroids.
Contraindications
Why priming of the inhaler is important?
Manufactured by AjPyuJr k´JAo TrJ k´P~J\j ßTj?
Budesonide inhalation aerosol is contraindicated in the primary treatment of status asthmaticus
or other acute episodes of asthma where intensive measures are required. Hypersensitivity to BEXIMCO PHARMACEUTICALS LTD. Priming ensures that your inhaler delivers the correct dose. Once primed,
budesonide contraindicates the use of Budesonide Inhaler. Tongi, Bangladesh 5000096 230408
Precautions
your inhaler is ready to use and deliver the correct amount of medicine.
® Aeronid is a registered trademark of Beximco Pharmaceuticals Ltd.
General k´JAKoÄ IJkjJr AjPyuJrKa xKbTnJPm SwMi xrmrJy TPr KTjJ KjKÁf TPrÇ k´JAo yS~Jr xJPg xJPg
PTG-3836/11-06/60,000ARK
During withdrawal from oral corticosteroids, some patients may experience symptoms of FaJ mqmyJr CkPpJVL yPm FmÄ xKbT oJ©J~ SwMi xrmrJy TrPf kJrPmÇ
systemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and

Aeronid 240 mm x 188 mm FS

HOW TO USE YOUR INHALER CORRECTLY

KTnJPm IJkKj xKbT k≠KfPf AjPyuJr mqmyJr TrPmj

Actuator
(FqJTYMP~ar) Canister
(TqJKjˆJr)
Mouthpiece
(oJCgKkx&)

Cap
(TqJk)
1. Remove the cap from the mouthpiece of the actuator 2. Make sure the mouthpiece is clean inside and outside. 3. Hold the inhaler by placing your index finger on top of the
1. FqJTYMP~ar oJCgKkx& ßgPT TnJrKa k´gPo xrJPf yPmÇ 2. FqJTYMP~aPrr oMU kKrÛJr KTjJ xfTtfJr xJPg krLãJ TrPf yPmÇ metal canister and thumb on the bottom of the plastic
mouthpiece. Shake it well.
3. f\tjL S mMPzJ IJñMPur oPiq AjPyuJrKaPT irPf yPmÇ If:kr AjPyuJrKa
nJunJPm ^JÅTJPf yPmÇ

4. Raise the Inhaler to your mouth. Put the mouthpiece
between your teeth, but do not bite it. Close your lips around
the mouthpiece. Breathe out slowly and gently through the
Inhaler until your lungs feel comfortably empty.
4. AjPyuJrKa oMPUr oPiq rJUPf yPmÇ AjPyuJPrr Kj:xreÆJr oMPUr oPiq hJÅPfr
lJÅPT ˙Jkj TrPf yPm KT∂á TJozJPjJ pJPm jJÇ FqJTYMP~aPrr oMU KjP\r ßbJÅa KhP~
FojnJPm iÀj ßpj ßTJj lJÅT jJ gJPT, If:kr oMU KhP~ iLPr iLPr mJfJx ßmr TPr
KhPf yPm pfãj jJ IJkjJr láxláxKa UJKu y~Ç
A handy tip for Children
5. Tilt your head back slightly. Start to breathe in slowly
through your mouth. As you start to breathe in, press down
firmly on the top of the can to release your medicine
continue to breathe in steadily and deeply.
5. oJgJ xJoJjq ßkZj KhPT ßyuJPf yPmÇ oMU KhP~ iLPr iLPr võJx V´ye TrPf yPm
FmÄ FTA xoP~ TqJKjˆJrKaPT YJk KhPf yPmÇ FnJPm iLPr iLPr VnLrnJPm võJx
ßj~Jr xo~ FTKa oJ©J KjPf yPmÇ
Cleaning your Inhaler
6. Hold your breath. Remove the inhaler from your mouth.
Continue to hold your breath as long as possible, up to 10
seconds. Then breathe out gently. If you are taking a second
puff, wait about one minute, then repeat steps 3 to 6.
6. võJx iPr rJUPf yPmÇ AjPyuJrKaPT oMU ßgPT xKrP~ ßluPf yPmÇ 10 ßxPT¥
IgmJ pfãj x÷m võJx iPr rJUPf yPmÇ If:kr iLPr iLPr võJx ZJzPf yPmÇ pKh
FTJKiT oJ©J V´yPer hrTJr y~ fPm TokPã 1 KoKja IPkãJ TrJr kr kMPrJ
k≠KfKa kMjrJmOK• TrPf yPmÇ
How to clean your Inhaler?
KTnJPm IJkjJr AjPyuJr kKrÛJr TrPmj?
7. Replace the mouthpiece cap after each use
7. mqmyJPrr kr TnJrKa FqJTYMP~aPrr oMPUr xKbT \J~VJ~ ˙Jkj TrPf yPmÇ
In case of emergency situation when you feel you are not
relieved despite using your inhaler, you can use inhaler
along with spacer (a device that your doctor advise to use
with your inhaler). This may save your life on the way to
hospital. For more information, consult with your doctor.
pUj \ÀrL k´P~J\Pj AjPyuJr mqmyJr xP•ôS Ckvo yPmjJ, fUj IJkKj
߸xJr (FTKa KcnJAx pJ IJkjJr cJÜJr IJkjJPT AjPyuJPrr xJPg mqmyJr
TrPf muPmj) mqmyJr TrPf kJPrjÇ

Children and others who Precaution (xfTtfJ)

Keeping the plastic actuator clean is very important to 1. Remove the metal canister from the plastic casing of the
have weaker hands may inhaler and remove the mouthpiece cover.
Pressurised canister, do not puncture, break or
prevent medicine buildup and blockage. The actuator
have difficulty pressing xJmiJPj iJfm TqJKjˆJrKaPT käJKˆPTr mKyrJmre ßgPT oMÜ TÀj, oJCgKkx TnJrKa incinerate even when apparently empty.
should be washed, shaken to remove excess water and
down on the top of the UMPu ßluMjÇ YJkpMÜ TqJKjˆJr, IJkJfhOKˆPf UJKu oPj yPuS KZhs TrJ, nJñJ
air-dried thoroughly at least once a week. The inhaler may
can with just one hand. 2. Rinse the actuator thoroughly with warm water. IgmJ ßkJzJPjJ pJPm jJÇ
stop spraying if not properly cleaned.
They can use both käJKˆT mKyrJmre FmÄ oJCgKkx TnJrKaPT Vro kJKj KhP~ iMP~ ßluMjÇ Avoid storage in direct sunlight or heat.
FqJTYMP~aPrr oMU SwMi \Po gJTJ mJ SwMi KhP~ mº yP~ pJS~J ßgPT rãJ TrPf 3. Dry the actuator thoroughly inside and outside.
hands to make their xrJxKr xNpJtPuJT mJ fJk ßgPT hNPr rJUMjÇ
käJKÓPTr FqJTYMP~arKa kKrÛJr rJUJ UMmA \ÀrLÇ x¬JPy I∂f: FTmJr ÊTJPjJr \jq ßTJj ÊÏ ˙JPj rJUMjÇ
Inhaler work. Store below 30°C
FqJTYMP~arKa kKrÛJr TrPf yPm If:kr IKfKrÜ kJKj hMr TrPf FqJTYMP~arKa 4. Replace the metal canister and the mouthpiece cover
TqJKjˆJr FmÄ oJCgKkx TnJrKaPT xKbT \J~VJ~ ˙Jkj TÀjÇ
300 ßx: Fr jLPY xÄrãe TÀjÇ
KvÊ FmÄ IjqJjq ßrJVL pJPhr yJPf nJunJPm ^JÅTJPf yPm FmÄ mJfJPx ÊTJPf yPmÇ pKh AjPyuJr KbTof kKrÛJr
5. Do not put the metal canister in water. Keep away from eyes
ß\Jr To fJrJ FT yJf KhP~ TrJ jJ y~ fPm FaJ KhP~ ߸s TrJ pJPm jJÇ
iJfm TqJKjˆJrKaPT TUPjJA kJKjPf ßn\JPmj jJÇ ßYJPUr xĸPvt IJxPf ßh~J pJPm jJÇ
TqJKjˆJPrr CkKrnJPV nJunJPm YJk k´P~JV TrPf kJPr jJÇ lPu AjPyuJr ßgPT
Shake well the inhaler before each use Your Inhaler should be cleaned at least once a week Keep away from children
SwMi KbTof ßmr y~ jJÇ ßxPãP© fJrJ fJPhr hMyJf FTxJPg mqmyJr TrPf
k´KfmJr mqmyJPrr kNPmt ImvqA nJunJPm ^JÅKTP~ KjPmjÇ k´Kf x¬JPy I∂f: FTmJr IJkjJr AjPyuJr kKrÛJr TÀjÇ KvÊPhr jJVJPur mJAPr rJUMjÇ
kJPrÇ

Aeronid 240 mm x 188 mm FS