País: Malta
Idioma: anglès
Font: Medicines Authority
DIMENHYDRINATE
J. Uraich & Cia S.A. Av. Cami Reial, 51-57, 08184 Palau- solita I Plegamans, Barcelona, Spain
A04AD
DIMENHYDRINATE 50 mg
TABLET
DIMENHYDRINATE 50 mg
OTC
ANTIEMETICS AND ANTINAUSEANTS
Authorised
2007-07-09
BIODRAMINA TABLETS Dimenhydrinate Prevention and treatment of motion sickness Dimenhydrinate, the active substance of Biodramina is a compound with known efficacy in the prevention and treatment of the sickness, vertigo, nausea and vomiting caused by motion (kinetosis). The therapeutic response appears a few minutes after the administration and lasts during some hours. INDICATIONS Prevention and symptomatic treatment of motion sickness due to sea, overland or air travel. POSOLOGY AND METHOD OF ADMINISTRATION For oral use. Always use the lowest effective dose. Children aged 2 to 6 years: 1/4 to 1/2 tablet every 6–8 hours, if necessary. Do not exceed 1 and 1/2 tablet (75 mg of dimenhydrinate) per day in any case. Children aged 7 to 12 years: 1/2 to 1 tablet every 6 to 8 hours, if necessary. Do not exceed 3 tablets (150 mg of dimenhydrinate) per day in any case. Adults and children olden than 12 years: 1 or 2 tablets every 4 – 6 hours, if necessary. Do not exceed 8 tablets (400 mg of dimenhydrinate) per day in any case. The first intake should be at least half an hour before starting the trip. It can be taken with food, water or milk to minimise gastric irritation. The tablets can be swallowed whole or crushed and mixed with water, juice or any sweetened drink. CONTRAINDICATIONS Do not take Biodramina in the following cases: • Allergy (hypersensitivity) to dimenhydrinate or any of the ingredients of this medicinal product. • Newborns and premature infants. • Patients with asthma crises. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Take special care with Biodramina: • Do not exceed the maximum daily dose recommended under_ “Posology and method of _ _administration”_ • If you suffer from bronchitis, emphysema or asthma, glaucoma, gastrointestinal or urinary obstruction, peptic ulcer, Llegiu el document complet
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT BIODRAMINA Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Dimenhydrinate 50 mg Excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. Round, biconvex tablets scored crosswise on one side. Yellow. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Prevention and symptomatic treatment of motion sickness due to sea, overland or air travel. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For oral use. Always use the lowest effective dose. Children aged 2 to 6 years: 12,5 – 25 mg of dimenhydrinate (¼ - ½ tablet) every 6–8 hours, if necessary. Do not exceed 75 mg (1 and ½ tablet) of dimenhydrinate per day in any case. Children aged 7 to 12 years: 25 – 50 mg of dimenhydrinate (½ - 1 tablet) every 6 to 8 hours, if necessary. Do not exceed 150 mg (3 tablets) of dimenhydrinate per day in any case. Adults and children olden than 12 years: 50 – 100 mg of dimenhydrinate (1 – 2 tablets) every 4 – 6 hours, if necessary. Do not exceed 400 mg (8 tablets) of dimenhydrinate per day in any case. The first intake should be at least half an hour before starting the trip. It can be taken with food, water or milk to minimise gastric irritation. The tablets can be swallowed whole or crushed and mixed with water, juice or any sweetened drink. 4.3. CONTRAINDICATIONS • Hypersensitivity to dimenhydrinate or any of the ingredients of this medicinal product. Page 2 of 5 • Newborns and premature infants. • Patients with asthma crises. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE • Do not exceed the maximum daily dose (see section_ 4.2. Posology and method of administration_) • Caution should be exercised in patients with ch Llegiu el document complet