Biodramina Tablets

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

DIMENHYDRINATE

Disponible depuis:

J. Uraich & Cia S.A. Av. Cami Reial, 51-57, 08184 Palau- solita I Plegamans, Barcelona, Spain

Code ATC:

A04AD

DCI (Dénomination commune internationale):

DIMENHYDRINATE 50 mg

forme pharmaceutique:

TABLET

Composition:

DIMENHYDRINATE 50 mg

Type d'ordonnance:

OTC

Domaine thérapeutique:

ANTIEMETICS AND ANTINAUSEANTS

Statut de autorisation:

Authorised

Date de l'autorisation:

2007-07-09

Notice patient

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,

Résumé des caractéristiques du produit

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