Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Betahistine dihydrochloride
Viatris UK Healthcare Ltd
N07CA01
Betahistine dihydrochloride
16mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 5012781055655
OBJECT 1 SERC - 16 MG TABLETS Summary of Product Characteristics Updated 23-Feb-2018 | Mylan • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Serc ® -16 2. Qualitative and quantitative composition Each tablet contains 16 mg betahistine dihydrochloride equivalent to 10.42 mg betahistine. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet: Round, biconvex, scored, white to almost white tablets imprinted '267' on one face of the tablet. 4. Clinical particulars 4.1 Therapeutic indications Vertigo, tinnitus and hearing loss associated with Ménière's syndrome. 4.2 Posology and method of administration _Adults (including the elderly):_ initially 16mg three times daily taken preferably with meals. Maintenance doses are generally in the range 24-48 mg daily. _Paediatric population: _not recommended for use in children below 18 years due to insufficient data on safety and efficacy. _Geriatric population: _Although there are limited data from clinical studies in Read the complete document