VERTIMED Tablet (2018)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Vertimed 8mg tablets. Vertimed 16mg tablets. Vertimed 24mg tablets.

2. Qualitative and quantitative composition

Vertimed 8mg tablets: Each tablet contains 8 mg betahistine dihydrochloride. Vertimed 16mg tablets: Each tablet contains 16 mg betahistine dihydrochloride. Vertimed 24mg tablets: Each ...

3. Pharmaceutical form

Tablet. Vertimed 8mg tablets: White, round, flat tablets with bevelled edge, breakline on one side, diameter 6.6 mm. The scoreline is only to facilitate breaking for ease of swallowing and not to ...

4.1. Therapeutic indications

Symptomatic treatment of Meniéres disease. Symptomatic treatment of vestibular vertigo.

4.2. Posology and method of administration

Posology Adults 24 mg – 48 mg betahistine dihydrochloride daily, in divided doses. 8 mg tablets 16 mg tablets 24 mg tablets 1-2 tablets 3 times daily ½-1 tablet 3 times daily 1 tablet 2 times daily ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Phaeochromocytoma.

4.4. Special warnings and precautions for use

Patients with a history of bronchial asthma and peptic ulcer disease, should be carefully monitored during treatment. Vertimed contains lactose. Patients with rare hereditary problems of galactose intolerance, ...

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

In vivo interaction studies have not been conducted. Based on the in vitro data, betahistine is not expected to inhibit the cytochrome P450 enzymes. In vitro data indicate an ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of betahistine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically ...

4.7. Effects on ability to drive and use machines

Betahistine is indicated for the symptomatic treatment of Meniéres disease and vestibular vertigo. Both diseases can negatively affect the ability to drive and use machines. Based on the clinical data, ...

4.8. Undesirable effects

In placebo-controlled clinical trials, the following side effects were reported in patients taking betahistine, whose frequencies are defined as follows: Very common (≥1/10), Common (≥1/100 to <1/10), ...

4.9. Overdose

Symptoms Cases of overdose have been reported in rare cases. Up to 640 mg administered betahistine have been reported in some patients with mild or moderate symptoms (eg., nausea, drowsiness, stomach pain). ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: antivertigo preparations ATC code: N07CA01 The mechanism of action of betahistine is only partially known. There are several hypothesis supported by animal experiments ...

5.2. Pharmacokinetic properties

Absorption Following oral administration betahistine is rapidly and almost completely absorbed. It is then rapidly and almost completely metabolized to 2-pyridylacetic acid (2-PAA). Betahistine plasma ...

5.3. Preclinical safety data

Chronic toxicity Adverse effects in the nervous system were seen in dogs and baboons after intravenous doses at and above 120 mg/kg. Chronic oral toxicity testing for 18 months in rats at a dose of 500 ...

6.1. List of excipients

Lactose monohydrate Maize starch Cellulose microcrystalline, E460 Citric acid, anhydrous, E330 Povidone K25, E1201 Crospovidone type A, E1202 Hydrogenated vegetable oil

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Blisters of PVC / PE / PVDC – aluminium. Packs of 20, 24, 30, 48, 50, 60, 90, 96, and 100 tablets are available. Not all pack sizes may be marketed

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

10. Date of revision of the text

01/2018

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