ALFINOR Tablet (2014)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Alfinor 8 mg tablets.

2. Qualitative and quantitative composition

Each tablet contains 8 mg of betahistine dihydrochloride. Excipient with known effect: mannitol. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Tablet. White, flat, round, scored on one side tablets.

4.1. Therapeutic indications

Betahistine dihydrochloride is indicated for: vertigo, tinnitus and hearing loss associated with Ménières syndrome.

4.2. Posology and method of administration

Posology Adults The initial dose is 8 to 16 mg three times daily, taken preferably with meals. Maintenance doses are generally in the range of 24 to 48 mg daily. Elderly No dosage adjustment is necessary. ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients suffering from phaeochromocytoma.

4.4. Special warnings and precautions for use

Betahistine dihydrochloride should be given with caution to patients with a history or active peptic ulcer. Betahistine has caused bronchoconstriction when inhaled. Since there is a possibility for the ...

4.5. Interaction with other medicinal products and other forms of interaction

Although theoretical antagonism between betahistine and antihistamines may occur, clinical practice did not show any interactions. Betahistine does not produce false positive results in standard diagnostic ...

4.6. Pregnancy and lactation

Pregnancy Animal studies showed no adverse effects neither to the mother nor to the foetus. Since there are no well-controlled studies in pregnant women the drug should be administered with caution and ...

4.7. Effects on ability to drive and use machines

Betahistine does not affect the patients ability to drive or operate machinery.

4.8. Undesirable effects

Betahistine is well tolerated. The main adverse reactions are gastro-intestinal disturbances (including dyspepsia), headache, skin rash and pruritus. Reporting of suspected adverse reactions Reporting ...

4.9. Overdose

There is no specific antidote for betahistine. The patient should undergo gastric lavage. Symptomatic treatment is recommended.

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antivertigo preparations, Other Nervous System Drugs ATC code: N07CA01 Betahistine didydrochloride is a histamine analogue which can be administered orally. Studies ...

5.2. Pharmacokinetic properties

After oral administration, betahistine is quickly and completely absorbed. Peak plasma levels occur one hour after administration. It is metabolised to liver to at least two inactive metabolites. The majority ...

5.3. Preclinical safety data

When betahistine was administered orally to rats and dogs at doses up to 250 mg/kg/day no adverse reactions were observed. Parenteral administration (IV) of betahistine to dogs and monkeys at dose of 120 ...

6.1. List of excipients

Mannitol Cellulose microcrystalline Povidone Crospovidone Anhydrous colloidal silica Talc Magnesium stearate

6.2. Incompatibilities

None known.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Stored below 25°C in the original package, to protect from light and moisture.

6.5. Nature and contents of container

Alfinor tablets are packed into PVC-Aluminum blisters. Boxes of 100 tablets (10 PVC-Al blisters x 10 tablets).

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

8. Marketing authorization number(s)

19971

9. Date of first authorization / renewal of the authorization

13-08-1996 / 21-12-2005

10. Date of revision of the text

01/2014

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