Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE
McNeil Products Limited Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom
R05X
DIPHENHYDRAMINE HYDROCHLORIDE 25 µg/dose PARACETAMOL 1000 µg/dose PSEUDOEPHEDRINE HYDROCHLORIDE 45 µg/dose
ORAL SOLUTION
DIPHENHYDRAMINE HYDROCHLORIDE 25 µg/dose PARACETAMOL 1000 µg/dose PSEUDOEPHEDRINE HYDROCHLORIDE 45 µg/dose
OTC
COUGH AND COLD PREPARATIONS
Withdrawn
2006-08-10
■ If you are taking ANY OTHER MEDICINES, including: ■ _Antimuscarinic_ drugs e.g.: - _tricyclic_ _antidepressants _(drugs to treat MOOD DISORDERS). - _atropine _(used to treat some EYE CONDITIONS and occasionally BOWEL CONDITIONS). ■ CNS depressants e.g.: - _hypnotics_ (SLEEPING TABLETS including barbiturates). - _minor tranquillisers _(drugs used to RELAX MUSCLES or DECREASE ANXIETY). - _opioid analgesics_ (drugs used to RELIEVE PAIN e.g. codeine, tramadol, morphine). - _antipsychotics_ (drugs used to treat MOOD DISORDERS). ■ _Antihypertensives_ (drugs used to treat HIGH BLOOD PRESSURE including alpha and beta blockers). ■ _Moclobemide_ (used to TREAT MOOD DISORDERS)._ _ ■ _Cardiac glycosides _(drugs used to CONTROL HEART RHYTHMS OR CONTRACTIONS) e.g. digoxin. ■ _Ergot alkaloids _(drugs used to TREAT MIGRAINE such as ergotamine and methysergide). ■ _Oxytocin _(drug used to help contractions during childbirth). ■ _ Oral contraceptives _(“the pill”)_._ ■ _ Metoclopramide_ or _domperidone_ (used to treat NAUSEA AND VOMITING)_._ ■ _ Colestyramine_ (used to treat HIGH CHOLESTEROL)_._ ■ _ Anticoagulants_ (drugs that THIN THE BLOOD, such as warfarin)_._ ■ _ Anticonvulsants_ (drugs to treat EPILEPSY)_._ If you are not sure about the medicine you are taking, show the bottle or pack to your pharmacist. If any of these bullet points apply, TALK TO A DOCTOR OR PHARMACIST. IF YOU ARE PREGNANT OR BREAST-FEEDING ■ Ask your doctor or pharmacist for advice before taking this medicine if you might be pregnant or are breast-feeding. SPECIAL WARNINGS ABOUT THIS MEDICINE ■ You can use this medicine while you are taking oral contraceptives (“the pill”) or anticonvulsant tablets used to treat epilepsy, but the medicine may not work so well on your pain or fever. 2 BEFORE TAKING THIS MEDICINE This medicine is suitable for most people b Olvassa el a teljes dokumentumot
1 SUMMARY OF PRODUCT CHARACTERISTICS BENYLIN FOUR FLU LIQUID 1. NAME OF THE MEDICINAL PRODUCT Benylin Four Flu liquid 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 20 ml contains: Diphenhydramine hydrochloride 25 mg Paracetamol 1000 mg Pseudoephedrine hydrochloride 45 mg 3. PHARMACEUTICAL FORM Oral solution A clear orange to brown oral solution 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 AGED12 YEARS AND OVER: One 20 ml dose up to four times daily, as required. Do not take more frequently than every four hours. CHILDREN UNDER 12 YEARS: Benylin Four Flu Liquid is contra-indicated in children under the age of 12 years (see section 4.3). Do not exceed the stated dose. Keep out of the reach and sight of children. 2 4.3 CONTRAINDICATIONS Known hypersensitivity to any of the ingredients. Concomitant use of other sympathomimetic decongestants, 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 12 years. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Use with caution in occlusive vascular disease If any of the following occur, Benylin Four Flu Liquid should be stopped Hallucinations Restlessness Sleep Olvassa el a teljes dokumentumot