Betahistine tablets 24mg, No. 30 Vertran

Meniere's disease; syndromes characterized by dizziness, tinnitus and / or progressive hearing loss, incl. dropsy of the labyrinth of the inner ear, vestibular and labyrinthine disorders (including dizziness, noise and ear pain, headache, nausea, vomiting, hearing loss), vestibular neuritis, labyrinthitis, benign positional vertigo (including after neurosurgical operations); vertebrobasilar insufficiency, post-traumatic encephalopathy, cerebral atherosclerosis (as part of complex therapy).

Inside, during meals.

The dose of the drug is:

Tablets 8 mg: 1-2 tablets 3 times a day.

Tablets 16 mg: 1/2 - 1 tablet 3 times a day.

Tablets 24 mg: 1 tablet 2 times a day.

The maximum daily dose is 48 mg.

The dose and duration of treatment should be selected individually, depending on the patient's response to treatment.

Improvement is usually noted already at the beginning of therapy, but it can be gradual and appear even after several weeks of treatment. In some cases, a stable therapeutic effect is achieved after several months of treatment.

No dose adjustment is required in elderly patients, as well as in patients with renal and / or hepatic insufficiency.

Active ingredient: - betahistine dihydrochloride 24 mg;

Excipients:

microcrystalline cellulose 455.43 mg,

mannitol 162.12 mg,

citric acid monohydrate 14.1 mg,

colloidal silicon dioxide 14.1 mg,

talc 35.25 mg.

Hypersensitivity to betahistine, pheochromocytoma, gastric ulcer and duodenal ulcer in the acute phase, bronchial asthma, I trimester of pregnancy.

With care: II and III trimesters of pregnancy, breastfeeding period; childhood.

Tablets are white or almost white, round, flat, with beveled edges.

Composition:

Active ingredient: - betahistine dihydrochloride 24 mg;

Excipients:

microcrystalline cellulose 455.43 mg,

mannitol 162.12 mg,

citric acid monohydrate 14.1 mg,

colloidal silicon dioxide 14.1 mg,

talc 35.25 mg.

Pharmachologic effect:

Synthetic analogue of histamine. Acts like histamine, mainly on histamine H1 receptors. Causes expansion of precapillaries, in particular, facilitates microcirculation in the labyrinth. In addition, betahistine regulates endolymph pressure in the labyrinth and cochlea, leading to clinical improvement in vertigo of various etiologies. Reduces the frequency and intensity of dizziness, reduces tinnitus, improves hearing in cases of hearing loss. Increases the tone of the smooth muscles of the bronchi, gastrointestinal tract. May cause increased gastric acid secretion.

Pharmacokinetics:

After oral administration of betahistine, dihydrochloride is rapidly and almost completely absorbed from the gastrointestinal tract. Plasma protein binding is low.

It is almost completely excreted in the urine within 24 hours. T1 / 2 - 3-4 hours.

Indications:

Meniere's disease; syndromes characterized by dizziness, tinnitus and / or progressive hearing loss, incl. dropsy of the labyrinth of the inner ear, vestibular and labyrinthine disorders (including dizziness, noise and ear pain, headache, nausea, vomiting, hearing loss), vestibular neuritis, labyrinthitis, benign positional vertigo (including after neurosurgical operations); vertebrobasilar insufficiency, post-traumatic encephalopathy, cerebral atherosclerosis (as part of complex therapy).

Method of administration and dosage:

Inside, during meals.

The dose of the drug is:

Tablets 8 mg: 1-2 tablets 3 times a day.

Tablets 16 mg: 1/2 - 1 tablet 3 times a day.

Tablets 24 mg: 1 tablet 2 times a day.

The maximum daily dose is 48 mg.

The dose and duration of treatment should be selected individually, depending on the patient's response to treatment.

Improvement is usually noted already at the beginning of therapy, but it can be gradual and appear even after several weeks of treatment. In some cases, a stable therapeutic effect is achieved after several months of treatment.

No dose adjustment is required in elderly patients, as well as in patients with renal and / or hepatic insufficiency.

Side effect:

On the part of the digestive system: mild nausea, a feeling of heaviness in the epigastrium are possible.

Allergic reactions: in some cases - skin rash, itching, urticaria.

Contraindications for use:

Hypersensitivity to betahistine, pheochromocytoma, gastric ulcer and duodenal ulcer in the acute phase, bronchial asthma, I trimester of pregnancy.

With care: II and III trimesters of pregnancy, breastfeeding period; childhood.

Application during pregnancy and lactation:

Use is contraindicated in the first trimester of pregnancy. It should be used with caution in the II and III trimesters of pregnancy. Use during breastfeeding is not recommended.

Application in children:

Use with caution in children.

Special instructions:

It should be used with caution in patients with a history of gastric ulcer or duodenal ulcer, in the II and III trimesters of pregnancy, as well as in children.

It should be borne in mind that the desired clinical effect is achieved after several months of treatment.

For dyspeptic symptoms, betahistine is recommended to be taken during or after meals.

Drug interactions:

Antihistamines, when taken simultaneously, reduce the effect of betahistine.

Special instructions:

It should be used with caution in patients with a history of gastric ulcer or duodenal ulcer, in the II and III trimesters of pregnancy, as well as in children.

It should be borne in mind that the desired clinical effect is achieved after several months of treatment.

For dyspeptic symptoms, betahistine is recommended to be taken during or after meals.

Pregnancy and lactation:

Use is contraindicated in the first trimester of pregnancy. It should be used with caution in the II and III trimesters of pregnancy. Use during breastfeeding is not recommended.

Childhood use:

Use with caution in children.

Release form

Tablets 8 mg, 16 mg, 24 mg.
Tablets 8 mg : 30 or 60 tablets in a dark glass bottle. 1 bottle together with instructions for use is placed in a cardboard box.
Tablets 16 mg : 15 tablets each in PVC / PVDC // Al blister. Two or four blisters, together with instructions for use, are placed in a cardboard box.
Tablets 24 mg : 10 tablets each in PVC / PVDC // Al blister. Two, three, five or six blisters, together with instructions for use, are placed in a cardboard box.

Storage conditions

At a temperature not exceeding 25 ? C.
Keep out of the reach of children!

Shelf life

3 years.
Do not use after the expiration date.

Vacation conditions

On prescription.