SERC

Main information

  • Trade name:
  • SERC Tablets 8 Milligram
  • Available from:
  • Abbott Healthcare Products Ltd
  • Dosage:
  • 8 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine type:
  • Human

Documents

Localization

  • Available in:
  • SERC Tablets 8 Milligram
    Ireland
  • Language:
  • English

Other information

Status

  • Source:
  • IMB
  • Authorization date:
  • 01-04-1979
  • Last update:
  • 23-04-2015

Summary of Product characteristics


Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Serc 8mg Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 8 mg betahistine dihydrochloride.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablet

A white to almost white, round, flat tablet, imprinted ‘256’ on one face.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Vertigo, tinnitus and hearing loss associated with Ménière's syndrome.

4.2 Posology and method of administration

The usual daily dose is 8 to 16 mg, three times daily taken preferably with meals.

4.3 Contraindications

Hypersensitivity to any component of the product.

Use in phaeochromocytoma.

Use concurrently with antihistamines.

Use in children.

4.4 Special warnings and precautions for use

Caution is advised in the treatment of patients with a history of peptic ulcer. Clinical intolerance to Serc in bronchial

asthma patients has been shown in a relatively few patients and therefore caution should be exercised when

administering betahistine to patients with bronchial asthma.

4.5 Interaction with other medicinal products and other forms of interaction

Although an antagonism between Serc and antihistamines could be expected on a theoretical basis, no such interactions

have been reported.

4.6 Fertility, pregnancy and lactation

Irish Medicines Board

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Date Printed 25/10/2011 CRN 2107201 page number: 1

4.7 Effects on ability to drive and use machines

It has been shown that at over 4 times the recommended daily dose, betahistine does not affect driving or psychomotor

ability.

4.8 Undesirable effects

Gastrointestinal disorders

In some cases mild gastric complaints have been observed. These can normally be dealt with by taking the dose during

meals or by lowering the dose.

Nervous system disorders

In some cases headaches have been reported.

Skin and subcutaneous tissue disorders

In very rare cases cutaneous hypersensitivity reactions have been reported, in particular rash, puritus and urticaria.

4.9 Overdose

A few overdose cases have been reported. In most cases no overdose symptoms were reported. Some patients

experienced mild to moderate symptoms at doses above 200 mg. At a dose of 728 mg a convulsion was reported. In all

cases recovery was complete. Treatment of overdose should include standard supportive measures.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

The mechanism of action of betahistine is not known. Pharmacological testing in animals has shown that the blood

circulation in the striae vascularis of the inner ear improves, probably by means of a relaxation of the precapillary

sphincters of the microcirculation of the inner ear.

In pharmacological studies, betahistine was found to have weak H

1 receptor agonistic and considerable H

3 antagonistic

properties in the CNS and autonomic nervous system. Betahistine was also found to have a dose-dependent inhibiting

effect on spike generation of neurons in lateral and medial vestibular nuclei. The importance of this observation in the

action against Ménière's syndrome or vestibular vertigo, however, remains unclear.

5.2 Pharmacokinetic properties

Betahistine dihydrochloride is completely absorbed after oral administration. Only one metabolite 2-pyridylacetic acid,

which is excreted in the urine, is known.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other

Irish Medicines Board

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Date Printed 25/10/2011 CRN 2107201 page number: 2

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Microcrystalline cellulose

Mannitol (E421)

Citric acid monohydrate

Colloidal anhydrous silica

Talc

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

5 years.

6.4 Special precautions for storage

Do not store above 25°C. Store in the original package.

6.5 Nature and contents of container

120 tablets in blister strips. The blister strips are made of PVC/PVDC film with a covering aluminium foil.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Abbott Healthcare Products Limited

Mansbridge Road

West End

Southampton

SO18 3JD

United Kingdom

8 MARKETING AUTHORISATION NUMBER

PA 108/11/1

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 01 April 1979

Date of last renewal: 01 April 2009

10 DATE OF REVISION OF THE TEXT

Irish Medicines Board

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Date Printed 25/10/2011 CRN 2107201 page number: 3

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