Betaserc Long tablets 48mg, # 28

• 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. While eating.

The BetasercЃ Long tablet cannot be divided into parts, as it is covered with a film coating in order to gradually release the active substance.

The dose of BetasercЃ Long for adults is: 1 tablet a day in the morning.

1 modified release film-coated tablet, 48 mg, contains:

Core:

Active ingredient: betahistine dihydrochloride - 24.00 mg

Excipients: Kollidon SR [polyvinyl acetate, povidone-KZO, sodium lauryl sulfate, silicon dioxide], microcrystalline cellulose 102, lactose monohydrate, citric acid, magnesium stearate, talc.

Film casing (first layer of film coating):

Active ingredient: betahistine dihydrochloride 24.00 mg

Excipients: citric acid; Opadry white 03F180011 [hypromellose, titanium dioxide (E171), macrogol-6000].

Film casing (second layer of film coating (colored)): Opadray II yellow 85F220031 [polyvinyl alcohol, titanium dioxide (E171), macrogol-4000, talc, iron oxide yellow oxide (E172)].

• Hypersensitivity to betahistine,

• pheochromocytoma,

• peptic ulcer of the stomach and duodenum in the acute phase,

• bronchial asthma,

• Not recommended for use in children under 18 years of age due to insufficient data on efficacy and safety.

• I trimester of pregnancy.

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

Clinical and pharmacological group: A drug that improves the microcirculation of the labyrinth, used for pathology of the vestibular apparatus

Pharmaco-therapeutic group: Histamine preparation

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).

Dosage regimen

Inside. While eating.

The BetasercЃ Long tablet cannot be divided into parts, as it is covered with a film coating in order to gradually release the active substance.

The dose of BetasercЃ Long for adults is: 1 tablet a day in the morning.

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,

• peptic ulcer of the stomach and duodenum in the acute phase,

• bronchial asthma,

• Not recommended for use in children under 18 years of age due to insufficient data on efficacy and safety.

• 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.

Storage

Store at a temperature not exceeding 25 ? C.

Keep out of the reach of children!

Shelf life

2 years. Do not use after the expiration date.

Conditions of dispensing from pharmacies

Dispensed by prescription.