Serc 16mg tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Betahistine dihydrochloride

MAH:

Viatris UK Healthcare Ltd

ATC_code:

N07CA01

INN:

Betahistine dihydrochloride

dosage:

16mg

pharmaceutical_form:

Oral tablet

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 04060000; GTIN: 5012781055655

SPC

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
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4.1 Therapeutic indications
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4.2 Posology and method of administration
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4.3 Contraindications
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4.4 Special warnings and precautions for use
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4.5 Interaction with other medicinal products and other forms of
interaction
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4.6 Pregnancy and lactation
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4.7 Effects on ability to drive and use machines
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4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
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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