Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Promethazine hydrochloride
A A H Pharmaceuticals Ltd
R06AD02
Promethazine hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100; GTIN: 5025903017721
_CHILDREN 5-10 YEARS: _A single dose of either one or two tablets (10 mg or 20 mg) given at night or one tablet (10 mg) given twice a day. DO NOT give more than two tablets (20 mg) each day. _CHILDREN OVER 10 YEARS AND ADULTS (INCLUDING THE _ _ELDERLY): _Start with one tablet (10 mg) twice a day. This may be increased to a maximum of two tablets (20 mg) three times a day. FOR TREATMENT AND PREVENTION OF FEELING SICK OR BEING SICK (SUCH AS IN TRAVEL SICKNESS) _CHILDREN 2-5 YEARS: _A liquid form of this medicine should be used in this age group. _CHILDREN 5-10 YEARS: _A single tablet to be taken the night before the journey. This may be repeated after 6-8 hours if necessary. _CHILDREN OVER 10 YEARS AND ADULTS (INCLUDING THE _ _ELDERLY): _Two tablets (20 mg) to be taken the night before the journey. This may be repeated after 6-8 hours if necessary. AS A SHORT TERM PAEDIATRIC SEDATIVE AND FOR SHORT TERM TREATMENT OF INSOMNIA IN ADULTS. _CHILDREN 2-5 YEARS: _A liquid form of this medicine should be used in this age group. _CHILDREN 5-10 YEARS: _ Two tablets (20 mg) given as a single dose at night time. _CHILDREN OVER 10 YEARS AND ADULTS (INCLUDING THE _ _ELDERLY): _Two to five tablets (20 mg to 50 mg) as a single dose at night time. CHILDREN UNDER 2 YEARS DO NOT give this medicine to children under 2 years of age. Use this medicine only as recommended. Do not exceed the recommended dose. EXPOSURE TO SUNLIGHT Promethazine Tablets can make your skin more sensitive to sunlight. Keep out of direct sunlight while taking this medicine. IF YOU TAKE MORE PROMETHAZINE THAN YOU SHOULD If you or your child takes more Promethazine Tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you or your child has taken. The following effects may occur: IN CHILDREN: excitation, moving unsteadily or stumbling, uncontrolled writhing movements especially of the hands or feet, hearing or seeing things that are not there (hallucinatio Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Promethazine Hydrochloride 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of the active substance Promethazine Hydrochloride BP Also contains 23.6 mg of lactose and 33.7 mg of Sucrose For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Sugar-coated tablet Blue sugar coated tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As symptomatic treatment for allergic conditions of the upper respiratory tract and skin including allergic rhinitis, urticaria and anaphylactic reactions to drugs and foreign proteins As an antiemetic For short term use: - Treatment of insomnia in adults - As a paediatric sedative 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral Not for use in children under the age of 2 years (see section 4.3). _AS AN ANTIHISTAMINE IN ALLERGY: _ Children 2-5 years The use of Promethazine liquid is recommended for this age group. Children 5-10 years Either 10 or 20 mg as a single dose*. Or 10 mg bd. Maximum daily dose 20 mg. Children over 10 years and adults (including elderly) Initially 10 mg bd. Increasing to a maximum of 20 mg tds as required. *Single doses are best taken at night. _AS AN ANTIEMETIC: _ Children 2-5 years The use of Promethazine liquid is recommended for this age group. Children 5-10 years 10 mg to be taken the night before the journey. To be repeated after 6–8 hours as required. Children over 10 years and adults (including elderly) 20 mg to be taken the night before the journey. To be repeated after 6–8 hours as required. _AS A PAEDIATRIC SEDATIVE FOR SHORT TERM USE AND FOR SHORT TERM TREATMENT OF INSOMNIA _ _IN ADULTS: _ Children 2-5 years The use of Promethazine liquid is recommended for this age group. Children 5-10 years 20 mg as a single night time dose. Children over 10 years and adults (including elderly) 20 to 50 mg as a single night time dose 4.3 CONTRAINDICATIONS Promethazine should not be used in patients in coma or suffering fr Διαβάστε το πλήρες έγγραφο