Страна: Мальта
Язык: английский
Источник: Medicines Authority
PROMETHAZINE TEOCLATE
Manx Pharma Ltd Taylor Group House, Wedgnock Lane Warwick, CV34 5YA, United Kingdom
R06AD02
PROMETHAZINE TEOCLATE 25 mg
TABLET
PROMETHAZINE TEOCLATE 25 mg
OTC
ANTIHISTAMINES FOR SYSTEMIC USE
Withdrawn
2007-03-02
severe headaches with blurred vision, severe stomach pains with vomiting, dizziness, difficulty with keeping your balance, ringing in the ears or other ear problems as well as feeling sick a bad cough Reye's Syndrome or symptoms of Reye's Syndrome (including persistent vomiting, feeling tired or sleepiness). Do not take Avomine for more than 7 days without contacting your doctor. TAKING OTHER MEDICINES Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. YOU MUST TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE ALREADY TAKING ANY OF THE FOLLOWING MEDICINES: anticholinergic agents medicines to help you sleep (hypnotics) medicines for depression, mental illness or anxiety (tricyclic antidepressants, sedatives) medicines for crampy stomach pains, Parkinson's disease or bladder problems. If you are having skin tests for allergy, do not take this medicine as it interferes with the results. You should stop taking this medicine at least 72 hours before the skin tests. TAKING AVOMINE WITH FOOD AND DRINK While taking Avomine, you should avoid drinking alcohol as the tablets will add to the effects of alcohol. PREGNANCY AND BREAST-FEEDING If you are pregnant, think you may be pregnant or are breast-feeding your baby, you should not take Avomine, unless they have been recommended for you by a doctor. If you are breast-feeding your baby, Avomine may cause your baby to be irritable and excited. If you are having a pregnancy test, do not take this product as it interferes with the results. DRIVING AND OPERATING MACHINERY These tablets may make you feel dizzy, sleepy, disorientated or confused or cause you to have a headache. You should not drive or operate machinery for the first few days, and until you are sure that you are not affected by these unwanted effects. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS IN THIS PRODUCT These tablets contain sodium metabisulphite which may rarely cause hypersensitivity (allergic) reactions a Прочитать полный документ
1. NAME OF THE MEDICINAL PRODUCT Avomine 25mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Promethazine teoclate 25 mg. 3. PHARMACEUTICAL FORM Tablet. White to pale cream, plain, circular biconvex tablets of 8.5 mm marked “AVOMINE” on one side with a score line on the reverse. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Avomine is a long acting anti-emetic, indicated for: - prevention and treatment of nausea and vomiting, including motion sickness and post operative vomiting; - vertigo due to Meniere’s syndrome, labyrinitis and other causes. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _Motion sickness_ Adults For the prevention on long journeys: one 25 mg tablet each evening at bedtime, starting the day before setting out. The duration of action is such that a second dose in 24 hours is not often necessary. For the prevention of motion sickness on short journeys: one 25 mg tablet one or two hours before travelling or as soon after as possible. Treatment of motion sickness: One 25 mg tablet as soon as possible and repeated the same evening followed by a third tablet the following evening. _Nausea and vomiting due to other causes _ _ _ Adults Page 1 of 7 One 25 mg tablet at night is often sufficient, but two or three tablets are sometimes necessary. Alternatively, more frequent administration such as 25 mg two or three times a day may be required for some patients. It is often not necessary to give more than four of the 25 mg Avomine tablets in 24 hours. Children In the above indications children over 10 years of age may be given the lower adult doses described above. Children between 5 and 10 years may be given half the adult dose. Tablets are not suitable for administration to children aged between 2 and 5 years. An oral liquid preparation is recommended in this age group. Not for use in children under 2 years of age (see section 4.3). Elderly No specific dosage recommendations. _Administration: _ Oral. 4.3 CONTRAINDICATIONS Avomine should not be u Прочитать полный документ