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Sinufed Syrup&10Tablets PIL
Sinufed Syrup&10Tablets PIL
Sinufed Syrup&10Tablets PIL
0314F
מבוגרים וילדים מעל גיל 12שנים: בתרופה
10מ"ל כל 6שעות .אין לעבור על מינון של בילדים מעל לגיל שנה עד גיל 6שנים יש
4מנות ( 40מ"ל) ביממה. לפנות לרופא.
101258010
PATIENT PACKAGE INSERT IN Do not use this medicine without Children 6-12 years of age: • Hallucinations and paranoia (rare),
ACCORDANCE WITH THE PHARMACISTS’ consulting a doctor before beginning 5 ml every 6 hours. Do not exceed the reported especially in children.
REGULATIONS (PREPARATIONS) – 1986 dosage of 4 doses (20 ml) in 24 hours.
treatment if: Refer to the doctor immediately if the
• you suffer from impaired liver or kidney Children from one year to 6 years of age: following effects occur:
SINUFED function.
• you suffer from impaired function of the
Dosage will be determined according to
the doctor’s instruction.
Nervousness, agitation, insomnia, nausea
or vomiting, headache, dry mouth.
10 Tablets/Syrup urinary bladder.
• you are about to undergo surgery, due
This medicine is not intended for infants
under one year of age.
Additional side effects:
Glaucoma (increased intraocular pressure),
to a possible reaction with anesthetics. Attention: blood circulation problems (such as feeling
Sinufed Tablets: • you are sensitive to any food or 1. With liquid medications, you must use a cold sensation in the hands and feet).
Pseudoephedrine hydrochloride 60 mg medicine. a measuring cup, syringe or dropper Adverse reactions and drug interactions
Sinufed Syrup: If you are taking or have recently meant for measuring the correct amount in children and infants: Parents must
Each 5 ml contains: taken other medicines, including of medicine. The enclosed measuring inform the attending doctor about any side
Pseudoephedrine hydrochloride 30 mg non-prescription medicines and cup is not suitable for measuring the effects, as well as any additional medicine
For inactive ingredients in the preparation – nutritional supplements, tell the doctor dose for children under 2 years of age. given to the child! See above for details of
see section 6 “Further Information”. or pharmacist. Especially tell the doctor Consult a pharmacist in order to choose special side effects and drug interactions.
Read this package insert carefully in its or pharmacist if you are taking: an appropriate measuring device. Do If any of the side effects worsen, or if you
entirety before using the medicine. This • appetite suppressants not use a household spoon to measure experience a side effect not mentioned in
leaflet contains concise information about • medicines that stimulate the nervous the amount of the medicine. Household the leaflet, consult the doctor.
the medicine. If you have further questions, system (e.g., medicines used to treat spoons differ in size and you may not get 5. HOW SHOULD THE MEDICINE BE
refer to the doctor or pharmacist. narcolepsy or medicines used to treat the correct amount of medicine. STORED?
You must use the medicine in the correct attention deficit disorder ADD) 2. Child-proof caps have significantly • Avoid poisoning! This medicine and any
manner. Consult the pharmacist if you need • medicines to lower blood pressure (e.g., reduced the number of cases of other medicine must be kept in a safe
further information. Consult the doctor if beta blockers) medicine-induced poisoning each year. place out of the reach of children and/or
signs of the illness (symptoms) worsen or • antipsychotics However, if you find it difficult to open the infants to avoid poisoning. Do not induce
if they do not improve after 7 days. • medicines for treatment of depression container, you can ask the pharmacist to vomiting unless explicitly instructed to
For children below 12 years of age, it is (e.g., monoamine oxidase inhibitors MAOI) remove the safety mechanism of the cap do so by the doctor.
recommended that the medicine be taken • digoxin, quinidine and make it a regular easy-to-open cap. • Do not use the medicine after the expiry
in the syrup form. The syrup dosage form • medicines to treat Parkinson’s disease Adhere to the treatment regimen date (exp. date) that appears on the
is not intended for infants under one year (selegiline and rasagiline) recommended by the doctor. package/blister/label. The expiry date
of age. For children over one year and • medicines to treat migraine (ergot Duration of treatment: If there is no refers to the last day of that month.
under 6 years of age, a doctor should be alkaloids) improvement in your condition within 7 • Store in a dark and cool place, below
consulted. • antacids (kaolin and aluminium days, contact the doctor. 25°C.
hydroxide) Do not exceed the recommended dose.
1. WHAT IS THe MEDICINE INTENDED 6. FURTHER INFORMATION
FOR? • furazolidone (antibiotic) If you accidentally took an overdose • In addition to the active ingredient, the
The medicine is intended for symptomatic • apraclonidine (medicine for glaucoma) or if a child accidentally swallowed the preparations also contain the following
treatment of nasal congestion in cases of • other sympathomimetics (e.g., to reduce medicine, refer to the doctor immediately inactive ingredients:
acute rhinitis and relief of eustachian tube congestion) or proceed to a hospital emergency room Sinufed Tablets: Calcium hydrogen
congestion due to ear infection. • oxytocin and bring the package of the medicine with phosphate, microcrystalline cellulose,
Therapeutic group Alpha-agonist. Pregnancy and breastfeeding you. The signs you may experience are: povidone, carmelose sodium LS,
If you are pregnant or breastfeeding, do Agitation, palpitations, elevated blood colloidal silicon dioxide, magnesium
2. BEFORE USING THE MEDICINE not use the preparation. pressure, difficulty passing urine, nausea/ stearate, titanium dioxide, HPMC 2910,
Do not use the medicine if: Sinufed and your daily life vomiting, increased thirst or seizures. PEG400, erythrosine aluminium lake,
• you are sensitive to the active Sometimes Sinufed may cause insomnia. To If you forgot to take this medicine at the quinoline yellow aluminium lake.
ingredient or to any of the other prevent this, the last dose of the day should required time, take a dose as soon as you Sinufed Syrup: Sucrose, glycerol,
ingredients the medicine contains be taken several hours before bedtime. remember; however, under no circumstances strawberry flavor, saccharin sodium,
(see section 6). Important information about some of should two doses be taken together! methyl hydroxybenzoate sodium, citric
• Do not use in infants under one year the ingredients of the syrup Do not take medicines in the dark! Check acid anhydrous, propyl hydroxybenzoate
of age. The preparation contains 3 grams of the label and the dose each time you take sodium, purified water.
• you are pregnant or breastfeeding. sucrose and 2.5 mg of sodium in every medicine. Wear glasses if you need them. Each 5 ml contains 3 g sucrose and
• you are being treated concomitantly 5 ml syrup. If you have further questions regarding 2.5 mg sodium.
with medicines from the monoamine use of the medicine, consult the doctor • What does the medicine look like
oxidase inhibitors (MAOI) group (for 3. HOW SHOULD THE MEDICINE BE or pharmacist.
USED? and what are the contents of the
treatment of depression), or within 14 4. SIDE EFFECTS package?
days of stopping treatment with this Always use according to the doctor’s
instructions. Check with the doctor or As with any medicine, use of Sinufed may Sinufed Tablets: The package contains
group of medicines. cause side effects in some users. Do not be 10 round red-coated tablets.
• you suffer from heart diseases such pharmacist if you are not sure. The usual
dosage is generally: alarmed when reading the list of side effects. Sinufed Syrup: A bottle with 115 ml of
as: ischemic heart disease, occlusive You may not suffer from any of them. syrup and a measuring cup.
vascular disease or hypertension. Tablets:
Adults and children above 12 years of age: Discontinue use and refer to the doctor • M a n u f a c t u r e r : Tr i m a I s r a e l
• you have diabetes. immediately if the following effects Pharmaceutical Products Ltd., Maabarot
• you suffer from severe kidney function One tablet every 6 hours. Do not take more
than 4 tablets within 24 hours. occur: 4023000, Israel.
impairment. • Breathing difficulties, fever, swelling of • This leaflet was checked and approved by
• you have a phaeochromocytoma (a Swallow the tablets with a small amount
of water. Do not crush or halve the tablets the face, neck, tongue or throat, severe the Ministry of Health in: January 2014.
rare tumor of the adrenal glands). rash, itching or stomach pain (may • Registration numbers of the medicine in
• you have an overactive thyroid gland. since the tablets are coated.
Children below 12 years of age: indicate a severe allergic reaction). the National Drug Registry of the Ministry
• you have glaucoma. • Heart rhythm disturbances, palpitations, of Health:
• you have an enlarged prostate gland. It is recommended that the medicine be
taken in the syrup dosage form. high blood pressure, anxiety, tremor, Sinufed Tablets: 030.06.25464.00
• you are taking other medicines to treat urine retention (in men), rash. Sinufed Syrup: 118.91.29978.00
congestion including nasal sprays. Syrup:
Adults and children above 12 years of
0314F
Special warnings regarding use of the
medicine age:
For children over one year and under 6 10 ml every 6 hours. Do not exceed the
years of age, consult a doctor. dosage of 4 doses (40 ml) in 24 hours.
101258010