Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE
McNeil Products Limited
N02BE51
DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE
FILM-COATED TABLET
DIPHENHYDRAMINE HYDROCHLORIDE 12.5 milligram(s) ; PARACETAMOL 500 milligram(s) ; PSEUDOEPHEDRINE HYDROCHLORIDE 22.5 milligram(s)
OTC
ANALGESICS
Authorised
2016-05-06
_FLU_ TABLETS TM FOUR Q This medicine is used for the treatment of cold and flu symptoms, including aches, pains and fever (high temperature), cough and congestion. Q This medicine is for use by adults and children aged 10 years and over. Q DO NOT USE THIS MEDICINE: Q There are some people who should not use this medicine. To find out if you are one of them _see section 2_ Q If you have ever had a BAD REACTION to any of the ingredients. For the list of ingredients _see section 6_ Q SPEAK TO YOUR DOCTOR: Q If you suffer from any of the conditions mentioned in section 2. _See section 2_ Q If you are taking ANY OTHER MEDICINES. _See section 2_ Q FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. Children and adults need different amounts. _See section 3_ 1 WHAT THE MEDICINE IS FOR Benylin 4 Flu Tablets are used to help relieve cold and flu symptoms. The tablets contain paracetamol which helps to relieve aches and pains and fever (high temperature), diphenhydramine, which is an antihistamine that helps relieve coughing, sneezing and runny nose and pseudoephedrine, which is a decongestant that helps unblock stuffy noses. The medicine is for use in adults and children aged 10 years and over. 2 BEFORE USING THIS MEDICINE This medicine is suitable for most people, but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist. DO NOT USE THIS MEDICINE… Q If you are taking any other medicines containing PARACETAMOL. Q If you have ever had a BAD REACTION to any of the ingredients. Q If you have HEART DISEASE or HIGH BLOOD PRESSURE. Q If you have DIABETES. Q If you have an OVERACTIVE THYROID. Q If you have PHAEOCHROMOCYTOMA (rare tumour which affects your heart rate and blood pressure). Q If you are taking, or have taken in the last two weeks, DRUGS FOR DEPRESSION known as Monoamine Oxidase Inhibitors (MAOIs) or Reversible Inhibitors of Monoamine Oxidase (RIMAs). Q If you SUFFER FROM OR HAVE HAD CLOSED ANGLE GLAUCOMA (increased pressure in the eye). Q If you are taking BETA BLOCKER Leggi il documento completo
1 SUMMARY OF PRODUCT CHARACTERISTICS BENYLIN FOUR FLU TABLETS 1. NAME OF THE MEDICINAL PRODUCT Benylin Four Flu tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Diphenhydramine hydrochloride 12.5 mg Paracetamol 500 mg Pseudoephedrine hydrochloride 22.5 mg Also contains: Sunset yellow E110 For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orange, oval, biconvex, film coated tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of symptoms associated with colds and flu; including relief of nasal congestion and congestion of mucous membranes of the upper respiratory tract, sneezing, runny nose, coughing, fever, headache, muscular aches and pains. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use ADULTS, THE ELDERLY AND CHILDREN AGED 16 YEARS AND OVER: Two tablets, up to four times daily, as required. Do not take more frequently than every four hours. CHILDREN 10 TO 15 YEARS One tablet, up to four times daily, as required. Do not take more frequently than every four hours. Not to be used for more than five days without the advice of a doctor. Parents or carers should seek medical attention if the child’s condition deteriorates during treatment. 2 CHILDREN UNDER 10 YEARS Benylin Four Flu Tablets are contraindicated in children under the age of 10 years (see section 4.3). Do not exceed the stated dose. 4.3 CONTRAINDICATIONS Known hypersensitivity to diphenhydramine, paracetamol, pseudoephedrine or to any of the excipients. Concomitant use of other sympathomimetic agents including those given by other routes, beta-blockers (see section 4.5) and monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOI treatment (see section 4.5) Cardiovascular disease including hypertension Diabetes mellitus Phaeochromocytoma Hyperthyroidism Closed angle glaucoma Severe renal impairment Not to be used in children under the age of 10 years. 4.4_ _ SPECIAL WARNINGS AND PRECAUTIONS FOR USE As both diphenhydramine and pseudoephedrine have been associate Leggi il documento completo