Betahistine (Tablets) Instructions for Use

Instructions
Dosage forms

ATC Code

N07CA01 (Betahistine)

Active Substance

Betahistine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug improving microcirculation of the labyrinth, used for pathology of the vestibular apparatus

Pharmacotherapeutic Group

Other agents for the treatment of nervous system diseases; medications for the treatment of dizziness

Pharmacological Action

A synthetic analogue of histamine. It acts similarly to histamine, mainly on histamine H₁ receptors. It causes dilation of precapillaries, in particular, facilitates microcirculation in the labyrinth.

Furthermore, Betahistine regulates endolymph pressure in the labyrinth and cochlea, leading to clinical improvement in dizziness of various etiologies. It reduces the frequency and intensity of dizziness, decreases tinnitus, and contributes to hearing improvement in cases of its reduction.

It increases the tone of the smooth muscles of the bronchi and gastrointestinal tract. It may cause increased gastric juice secretion.

Pharmacokinetics

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

It is almost completely eliminated from the body with urine within 24 hours. T_1/2 is 3-4 hours.

Indications

Ménière’s disease; syndromes characterized by dizziness, tinnitus and/or progressive hearing loss, including labyrinthine hydrops of the inner ear, vestibular and labyrinthine disorders (including dizziness, tinnitus 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 combination therapy).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
G45.0	Vertebro-basilar artery syndrome
H81	Vestibular function disorders
H81.0	Ménière's disease
H81.1	Benign paroxysmal vertigo
H81.2	Vestibular neuronitis
H81.3	Other peripheral vertigo
H83.0	Labyrinthitis
H83.8	Other specified diseases of inner ear
H90	Conductive and sensorineural hearing loss
H93.0	Degenerative and vascular disorders of ear
H93.1	Tinnitus (subjective)
I67.2	Cerebral atherosclerosis
T90	Sequelae of injuries of head

ICD-11 code	Indication
8B10.Y	Other specified transient ischaemic attack
AB30.0	Vestibular neuronitis
AB30.1	Labyrinthitis
AB31.0	Ménière's disease
AB31.2	Benign paroxysmal positional vertigo
AB34.1	Other peripheral vestibular vertigo
AB34.Z	Unspecified vestibular function disorders
AB3Z	Diseases of inner ear, unspecified
AB51.Z	Acquired hearing loss, unspecified
AB71	Degenerative or vascular disorders of the ear
BD55	Asymptomatic stenosis of intracranial or extracranial artery
MC41	Tinnitus
NA0Z	Head injury, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

Orally, with meals.

8 mg tablets: 1-2 tablets 3 times/day.

16 mg tablets: 1/2 tablet 3 times/day.

24 mg tablets: 1 tablet 2 times/day.

The course of treatment is determined individually. Improvement is usually noted already at the beginning of therapy, a stable therapeutic effect occurs after two weeks of treatment and may increase over several months of treatment. Treatment is long-term. The duration of the drug administration is selected individually.

Adverse Reactions

From the digestive system, mildly expressed nausea, feeling of heaviness in the epigastrium are possible.

Allergic reactions in some cases – skin rash, itching, urticaria.

Contraindications

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

With caution second and third trimesters of pregnancy, period of breastfeeding; children.

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy. Should be used with caution in the second and third trimesters of pregnancy. Use is not recommended during breastfeeding.

Pediatric Use

Should be used with caution in children.

Special Precautions

Should be used with caution in patients with a history of gastric or duodenal ulcer, in the second and third trimesters of pregnancy, as well as in children.

It must be taken into account that the desired clinical effect is achieved after several months of treatment.

In case of dyspeptic symptoms, Betahistine is recommended to be taken during or after meals.

Drug Interactions

Antihistamine drugs with simultaneous administration reduce the effect of betahistine.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Betahistine [Aliym, JSC (Russia)]
Tablets 8 mg: 5, 7, 10, 14, 20, 28, 30, 40, 50, 60, 80, or 100 pcs.
Tablets 16 mg: 5, 7, 10, 14, 20, 28, 30, 40, 50, 60, 80, or 100 pcs.
Tablets 24 mg: 5, 7, 10, 14, 20, 28, 30, 40, 50, 60, 80, or 100 pcs.

Marketing Authorization Holder

Aliym, JSC (Russia)

Dosage Forms

	Betahistine	Tablets 8 mg: 5, 7, 10, 14, 20, 28, 30, 40, 50, 60, 80, or 100 pcs.
		Tablets 16 mg: 5, 7, 10, 14, 20, 28, 30, 40, 50, 60, 80, or 100 pcs.
		Tablets 24 mg: 5, 7, 10, 14, 20, 28, 30, 40, 50, 60, 80, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Betahistine dihydrochloride	16 mg

5 pcs. – blister packs (1) – cardboard packs.
5 pcs. – blister packs (2) – cardboard packs.
5 pcs. – blister packs (3) – cardboard packs.
5 pcs. – blister packs (4) – cardboard packs.
5 pcs. – blister packs (5) – cardboard packs.
7 pcs. – blister packs (1) – cardboard packs.
7 pcs. – blister packs (2) – cardboard packs.
7 pcs. – blister packs (3) – cardboard packs.
7 pcs. – blister packs (4) – cardboard packs.
7 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
14 pcs. – blister packs (1) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.
14 pcs. – blister packs (3) – cardboard packs.
14 pcs. – blister packs (4) – cardboard packs.
14 pcs. – blister packs (5) – cardboard packs.
20 pcs. – blister packs (1) – cardboard packs.
20 pcs. – blister packs (2) – cardboard packs.
20 pcs. – blister packs (3) – cardboard packs.
20 pcs. – blister packs (4) – cardboard packs.
20 pcs. – blister packs (5) – cardboard packs.

Tablets	1 tab.
Betahistine dihydrochloride	24 mg

Tablets	1 tab.
Betahistine dihydrochloride	8 mg

Betahistine [Izvarino Pharma LLC (Russia)]
Tablets 8 mg: 10, 20, or 30 pcs.

Marketing Authorization Holder

Izvarino Pharma LLC (Russia)

Dosage Form

Betahistine

Tablets 8 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Betahistine dihydrochloride	8 mg

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
30 pcs. – orange glass jars (1) – cardboard packs.

Betahistine [Izvarino Pharma LLC (Russia)]
Tablets 16 mg: 10, 20, or 30 pcs.

Marketing Authorization Holder

Izvarino Pharma LLC (Russia)

Dosage Form

Betahistine

Tablets 16 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Betahistine dihydrochloride	16 mg

Betahistine [Izvarino Pharma LLC (Russia)]
Tablets 24 mg: 10, 20, or 30 pcs.

Marketing Authorization Holder

Izvarino Pharma LLC (Russia)

Dosage Form

Betahistine

Tablets 24 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Betahistine dihydrochloride	24 mg

Betahistine [Canonpharma Production, CJS (Russia)]
Tablets 8 mg: 10, 20, or 30 pcs.
Tablets 16 mg: 10, 20, or 30 pcs.
Tablets 24 mg: 10, 20, 30, or 60 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Forms

	Betahistine	Tablets 8 mg: 10, 20, or 30 pcs.
		Tablets 16 mg: 10, 20, or 30 pcs.
		Tablets 24 mg: 10, 20, 30, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a creamy tint, flat-cylindrical, with a bevel.

	1 tab.
Betahistine dihydrochloride	8 mg

Excipients: lactose, microcrystalline cellulose, copovidone VA 64, magnesium stearate.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
30 pcs. – blister packs (1) – cardboard packs.

Tablets white or white with a creamy tint, flat-cylindrical, with a bevel and a score.

	1 tab.
Betahistine dihydrochloride	16 mg

Excipients: lactose, microcrystalline cellulose, copovidone VA 64, magnesium stearate.

Tablets white or white with a creamy tint, flat-cylindrical, with a bevel and a score.

	1 tab.
Betahistine dihydrochloride	24 mg

Excipients: lactose, microcrystalline cellulose, copovidone VA 64, magnesium stearate.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
30 pcs. – blister packs (1) – cardboard packs.

Betahistine [N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)]
Tablets 16 mg: 20, 30, or 50 pcs.

Marketing Authorization Holder

N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)

Contact Information

MOSKHIMFARMPREPARATY im. N.A.Semashko JSC (Russia)

Dosage Form

Betahistine

Tablets 16 mg: 20, 30, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, biconvex, with a score on one side.

	1 tab.
Betahistine dihydrochloride	16 mg

Excipients: microcrystalline cellulose, lactose (milk sugar), citric acid monohydrate, colloidal silicon dioxide (aerosil), crospovidone, talc, magnesium stearate.

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.

Betahistine [Ozon, LLC (Russia)]
Tablets 8 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 180, 240, or 300 pcs.
Tablets 16 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 180, 240, or 300 pcs.

Marketing Authorization Holder

Ozon, LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Ozon Pharm, LLC (Russia)

Dosage Forms

	Betahistine	Tablets 8 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 180, 240, or 300 pcs.
		Tablets 16 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 180, 240, or 300 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white with a light brownish tint, round, flat-cylindrical, with a bevel and a score.

	1 tab.
Betahistine dihydrochloride	8 mg

Excipients: microcrystalline cellulose (MCC-101) – 66.5 mg, corn starch 10 mg, copovidone 9 mg, sodium carboxymethyl starch 5 mg, magnesium stearate 1 mg, colloidal silicon dioxide 0.5 mg.

Tablets white or almost white with a light brownish tint, round, flat-cylindrical, with a bevel and a score.

	1 tab.
Betahistine dihydrochloride	16 mg

Excipients: microcrystalline cellulose (MCC-101) – 133 mg, corn starch – 20 mg, copovidone – 18 mg, sodium carboxymethyl starch – 10 mg, magnesium stearate – 2 mg, colloidal silicon dioxide – 1 mg.

Betahistine [Ozon, LLC (Russia)]
Tablets 24 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 160, 180, 200, 240, or 300 pcs.

Marketing Authorization Holder

Ozon, LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Ozon Pharm, LLC (Russia)

Dosage Form

Betahistine

Tablets 24 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 160, 180, 200, 240, or 300 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white with a light brownish tint, round, flat-cylindrical, with a bevel and a score.

	1 tab.
Betahistine dihydrochloride	24 mg

Excipients: microcrystalline cellulose (MCC-101) – 199.5 mg, corn starch – 30 mg, copovidone – 27 mg, sodium carboxymethyl starch – 15 mg, magnesium stearate – 3 mg, colloidal silicon dioxide – 1.5 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (6) – cardboard packs.
20 pcs. – contour cell packs (8) – cardboard packs.
20 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – contour cell packs (4) – cardboard packs.
30 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – contour cell packs (8) – cardboard packs.
30 pcs. – contour cell packs (10) – cardboard packs.

Betahistine [Pranapharm, LLC (Russia)]
Tablets 8 mg: 10, 14, 20, 21, 28, 30, 40, or 50 pcs.

Marketing Authorization Holder

Pranapharm, LLC (Russia)

Dosage Form

Betahistine

Tablets 8 mg: 10, 14, 20, 21, 28, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a yellowish tint, round, biconvex, without a score, slight marbling is allowed.

	1 tab.
Betahistine dihydrochloride	8 mg

Excipients: lactose monohydrate – 122.7 mg, microcrystalline cellulose – 5.37 mg, magnesium stearate – 1.38 mg, colloidal silicon dioxide – 0.7 mg, corn starch – 1.85 mg.

7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.

Betahistine [Pranapharm, LLC (Russia)]
Tablets 16 mg: 10, 14, 20, 21, 28, 30, 40, or 50 pcs.

Marketing Authorization Holder

Pranapharm, LLC (Russia)

Dosage Form

Betahistine

Tablets 16 mg: 10, 14, 20, 21, 28, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a yellowish tint, round, biconvex, with a score, slight marbling is allowed.

	1 tab.
Betahistine dihydrochloride	16 mg

Excipients: lactose monohydrate – 254.4 mg, microcrystalline cellulose – 10.74 mg, magnesium stearate – 2.76 mg, colloidal silicon dioxide – 1.4 mg, corn starch – 3.7 mg.

Betahistine [Pranapharm, LLC (Russia)]
Tablets 24 mg: 10, 14, 20, 21, 28, 30, 40, or 50 pcs.

Marketing Authorization Holder

Pranapharm, LLC (Russia)

Dosage Form

Betahistine

Tablets 24 mg: 10, 14, 20, 21, 28, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a yellowish tint, round, flat-cylindrical, with a score and a bevel, slight marbling is allowed.

	1 tab.
Betahistine dihydrochloride	24 mg

Excipients: lactose monohydrate – 368.1 mg, microcrystalline cellulose – 16.11 mg, magnesium stearate – 4.14 mg, colloidal silicon dioxide – 2.1 mg, corn starch – 5.55 mg.

Betahistine [Rapharma, JSC (Russia)]
Tablets 8 mg: 10, 12, 20, 24, 30, 36, 40, 50, or 60 pcs.

Marketing Authorization Holder

Rapharma, JSC (Russia)

Dosage Form

Betahistine

Tablets 8 mg: 10, 12, 20, 24, 30, 36, 40, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Betahistine dihydrochloride	8 mg

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
12 pcs. – contour cell packs (1) – cardboard packs.
24 pcs. – contour cell packs (1) – cardboard packs.
36 pcs. – contour cell packs (1) – cardboard packs.
500 pcs. – polymer jars (1) – cardboard boxes.
500 pcs. – polymer jars (2) – cardboard boxes.
500 pcs. – polymer jars (3) – cardboard boxes.
500 pcs. – polymer jars (4) – cardboard boxes.
500 pcs. – polymer jars (5) – cardboard boxes.
500 pcs. – polymer jars (6) – cardboard boxes.
1000 pcs. – polymer jars (1) – cardboard boxes.
1000 pcs. – polymer jars (2) – cardboard boxes.
1000 pcs. – polymer jars (3) – cardboard boxes.
1000 pcs. – polymer jars (4) – cardboard boxes.
1000 pcs. – polymer jars (5) – cardboard boxes.
1000 pcs. – polymer jars (6) – cardboard boxes.
2000 pcs. – polymer jars (1) – cardboard boxes.
2000 pcs. – polymer jars (2) – cardboard boxes.
2000 pcs. – polymer jars (3) – cardboard boxes.
2000 pcs. – polymer jars (4) – cardboard boxes.
2000 pcs. – polymer jars (5) – cardboard boxes.
2000 pcs. – polymer jars (6) – cardboard boxes.