Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DIMENHYDRINATE
SUNWARD PHARMACEUTICAL SDN. BHD.
DIMENHYDRINATE
1000 Tablets; 1000 Tablet Tablets; 500 Tablet Tablets; 100 Tablet Tablets
SUNWARD PHARM PTE LTD
SW DIMENHYDRINATE TABLET Dimenhydrinate (50mg) 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What SW Dimenhydrinate Tablet is used for 2. How SW Dimenhydrinate Tablet works 3. Before you use SW Dimenhydrinate Tablet 4. How to use SW Dimenhydrinate Tablet 5. While you are using it 6. Side effects 7. Storage and disposal of SW Dimenhydrinate Tablet 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT SW DIMENHYDRINATE TABLET IS USED FOR SW Dimenhydrinate Tablet is used for the prevention and treatment of nausea, vomiting or spinning sensation and motion sickness. HOW SW DIMENHYDRINATE TABLET WORKS The active ingredient in the medicine is Dimenhydrinate. Dimenhydrinate is in a class of medications called antihistamines. It works by maintaining body balance. BEFORE YOU USE SW DIMENHYDRINATE TABLET _- When you must not use it _ Do not use SW Dimenhydrinate Tablet:- if you are allergic to Dimenhydrinate or any other ingredients of this medicine (listed in Product Description). as local anaesthetic because of the risk of local death of body tissues. for new born or premature infants and nursing mother. _ _ _- Before you start to use it _ You should check with your doctor if :- you have asthma, glaucoma (increased eye pressure), or enlargement of the prostate gland. _Pregnancy and lactation _ You should check with your doctor if you are or think you may be pregnant, planning for pregnancy or if you are breastfeeding. It is not recommended for pregnant women and nursing mothers unless the expected benefit outweighs any potential risks. _ _ _ _ _ _ _ _ _ _ _- Taking other medicines _ There are a few medicines which may interact with SW Dimenhydrinate Tablet. Tell your doctor if you are taking any other medicines, including any that you buy without a prescrip- tion from a pharmacy, supermarket or health food shop. You should talk to your doctor or pharmacist if you are taking:- Central Nervous System (CNS) depressants, tricycli Прочитать полный документ
PREGNANCY AND LACTATION: Although clinical studies in pregnant women have not indicated that dimenhydrinate increases the risk of fetal abnormalities, like any drug, it should be used during pregnancy only if benefits outweigh the risks. As small amounts of dimenhydrinate are excreted in breast milk, benefits of therapy must be weighed against potential adverse reactions in nursing infants. SIDE EFFECTS/ADVERSE REACTIONS: Drowsiness is the most common side effect, especially on high dosage. The others are disturbed coordination, fatigue, restlessness, confusion, nervousness, blurred vision, tinnitus, tremor, irritability, epigastric distress, photosensitivity, dryness of mouth, nose and throat, excessive perspiration, drug rash and hypotension. Haemolytic anaemia, agranulocytosis, headache, difficult urination and thickening of bronchial secretions are also reported. INTERACTION WITH OTHER MEDICAMENT: Dimenhydrinate may enhance the sedative effects of CNS depressants. MAO inhibitors may enhance the antimuscarinic effects of dimenhydrinate. Dimenhydrinate have an additive antimuscarinic action with other antimuscarinic drugs, such as atropine and tricyclic antidepressants. SYMPTOMS AND TREATMENT FOR OVERDOSAGE AND ANTIDOTE(S): Symptoms of overdosage includes hallucination, severe delirium, extrapyramidal symptoms, vomiting, vertigo, convulsions led to coma, cyanosis and death from respiratory failure. If vomiting has not occurred spontaneously, the patient should be induced to vomit. This is best done by having the patient drink a glass of water or milk, after which the patient should be made to gag. Precautions against aspiration must be taken especially in infants and children. If vomiting is unsuccessful, gastric lavage is indicated within 3 hours after ingestion and even later if large amount of milk or cream were given beforehand. Isotonic or ½ isotonic saline is the lavage solution of choice. Saline cathartics, such as milk of magnesia, by osmosis draw water into bowel, and therefore are valuable for the Прочитать полный документ