Serc-16mg

1. Name Of The Medicinal Product

Serc^®-16/Betahistine Tablets 16 mg

2. Qualitative And Quantitative Composition

Each tablet contains 16 mg betahistine dihydrochloride.

3. Pharmaceutical Form

Tablet:

Round, biconvex, scored, white to almost white tablets imprinted '267' on one face and '

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 16 mg three times daily taken preferably with meals. Maintenance doses are generally in the range 24-48 mg daily.

Children: no dosage recommendations are made for children.

4.3 Contraindications

Phaeochromocytoma. Hypersensitivity to the active substance or to any of the excipients.

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. These patients need to be carefully monitored during the therapy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No in-vivo interaction studies have been performed. Based on in-vitro data no in-vivo inhibition on Cytochrome P450 enzymes is expected.

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

4.6 Pregnancy And Lactation

Pregnancy:

There are no adequate data from the use of betahistine in pregnant women.

Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans is unknown. Betahistine should not be used during pregnancy unless clearly necessary.

Lactation:

It is not known whether betahistine is excreted in human milk. There are no animal studies on the excretion of betahistine in milk. The importance of the drug to the mother should be weighed against the benefits of nursing and the potential risks for the child.

4.7 Effects On Ability To Drive And Use Machines

Betahistine is regarded to have no or negligible effects on the ability to drive and use machines as no effects potentially influencing this ability were found to be related to betahistine in clinical studies.

4.8 Undesirable Effects

The following undesirable effects have been experienced with the below indicated frequencies in betahistine-treated patients in placebo-controlled clinical trials [very common (

Gastrointestinal disorders

Common: nausea and dyspepsia

In addition to those events reported during clinical trials, the following undesirable effects have been reported spontaneously during post-marketing use and in scientific literature. A frequency cannot be estimated from the available data and is therefore classified as “not known”.

Immune System disorders

Hypersensitivity reactions, e.g. anaphylaxis have been reported.

Gastrointestinal disorders

Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal distension and bloating) have been observed. These can normally be dealt with by taking the dose during meals or by lowering the dose.

Nervous System disorders

Headache

Skin and subcutaneous tissue disorders

Cutaneous and subcutaneous hypersensitivity reactions have been reported, in particular angioneurotic oedema, urticaria, rash, and pruritus.

4.9 Overdose

A few overdose cases have been reported. Some patients experienced mild to moderate symptoms with doses up to 640 mg (e.g. nausea, somnolence, abdominal pain). More serious complications (e.g. convulsion, pulmonary or cardiac complications) were observed in cases of intentional overdose of betahistine especially in combination with other overdosed drugs. Treatment of overdose should include standard supportive measures.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The active ingredient is a specific histamine agonist with virtually no H₂-activity. It appears to act on the precapillary sphincter in the stria vascularis of the inner ear, thus reducing the pressure in the endolymphatic space.

5.2 Pharmacokinetic Properties

Betahistine is rapidly and completely absorbed after oral administration of the drug in tablets. It is excreted almost quantitatively in urine as 2-pyridylacetic acid within 24 hours after administration. No unchanged betahistine has been detected.

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 sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Microcrystalline cellulose, mannitol, citric acid monohydrate, colloidal anhydrous silica and 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

PVC/PVdC blister packs containing 84 tablets.

HDPE tablet containers containing 500 or 1000 tablets.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Solvay Healthcare Limited/Solvay Healthcare Limited T/A Mansbridge Pharmaceuticals Ltd

Mansbridge Road

West End

Southampton

SO18 3JD

8. Marketing Authorisation Number(S)

PL 00512/0088

9. Date Of First Authorisation/Renewal Of The Authorisation

15 October 1997/ 14 October 2002

10. Date Of Revision Of The Text

03/07/2009