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Betahistine (Tablets) Instructions for Use

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 secretion of gastric juice.

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. T1/2 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 vascular atherosclerosis (as part of complex therapy).

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.

Administer the tablets orally with water.

Take a single dose of 8 mg to 16 mg.

Maintain a frequency of three times per day.

Initiate therapy at the lower end of the dosage range.

Titrate the dose based on individual patient response and tolerability.

For management of dyspeptic symptoms, take doses during or immediately after meals.

Adhere to a long-term treatment schedule for optimal therapeutic effect.

Be aware that the full clinical benefit may require several months of continuous therapy.

Do not discontinue treatment abruptly without consulting a physician.

For patients with a history of peptic ulcer disease, exercise particular caution and monitor for gastrointestinal adverse effects.

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

Use is contraindicated in the first trimester of pregnancy. It 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, and in children.

It is necessary to consider 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

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Bottle Rx Icon Betahistine-Vertex Tablets 8 mg: 10, 20, 30, 40, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel.

1 tab.
Betahistine dihydrochloride 8 mg

Excipients: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, talc, citric acid monohydrate, calcium stearate.

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

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Bottle Rx Icon Betahistine-Vertex Tablets 24 mg: 10, 20, 30, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel and a score line.

1 tab.
Betahistine dihydrochloride 24 mg

Excipients: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, talc, citric acid monohydrate, calcium stearate.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
15 pcs. – contour cell packaging (2) – cardboard packs.
15 pcs. – contour cell packaging (4) – cardboard packs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Bottle Rx Icon Betahistine-Vertex Tablets 16 mg: 10, 20, 30, 40, 50, or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel and a score line.

1 tab.
Betahistine dihydrochloride 16 mg

Excipients: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, talc, citric acid monohydrate, calcium stearate.

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

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Forms

Bottle Rx Icon Betahistine Canon Tablets 8 mg
Tablets 16 mg
Tablets 24 mg

Dosage Form, Packaging, and Composition

Tablets

1 tab.
Betahistine 8 mg

10 pcs. – contour cell blisters – cardboard packs (10 pcs.) – Prescription only
10 pcs. – contour cell blisters (2 pcs.) – cardboard packs (20 pcs.) – Prescription only
10 pcs. – contour cell blisters (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – contour cell blisters (6 pcs.) – cardboard packs (60 pcs.) – Prescription only
30 pcs. – contour cell blisters – cardboard packs (30 pcs.) – Prescription only
30 pcs. – contour cell blisters (2 pcs.) – cardboard packs (60 pcs.) – Prescription only

Tablets

1 tab.
Betahistine 16 mg

10 pcs. – contour cell blisters – cardboard packs (10 pcs.) – Prescription only
10 pcs. – contour cell blisters (2 pcs.) – cardboard packs (20 pcs.) – Prescription only
10 pcs. – contour cell blisters (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – contour cell blisters (6 pcs.) – cardboard packs (60 pcs.) – Prescription only
30 pcs. – contour cell blisters – cardboard packs (30 pcs.) – Prescription only
30 pcs. – contour cell blisters (2 pcs.) – cardboard packs (60 pcs.) – Prescription only

Tablets

1 tab.
Betahistine 24 mg

10 pcs. – contour cell blisters – cardboard packs (10 pcs.) – Prescription only
10 pcs. – contour cell blisters (2 pcs.) – cardboard packs (20 pcs.) – Prescription only
10 pcs. – contour cell blisters (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – contour cell blisters (6 pcs.) – cardboard packs (60 pcs.) – Prescription only
15 pcs. – contour cell blisters (2 pcs.) – cardboard packs (30 pcs.) – Prescription only
15 pcs. – contour cell blisters (4 pcs.) – cardboard packs (60 pcs.) – Prescription only

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle Rx Icon Betahistine Renewal Tablets 8 mg: 28 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel.

1 tab.
Betahistine dihydrochloride 8 mg,
   Equivalent to betahistine content 5.21 mg

Excipients: microcrystalline cellulose 101 – 80.8 mg, mannitol (E421) – 25 mg, talc – 6.3 mg, citric acid monohydrate – 2.5 mg, colloidal silicon dioxide (aerosil) – 2.5 mg.

10 pcs. – contour cell blisters (3) – cardboard packs.
14 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Forms

Bottle Rx Icon Betahistine Renewal Tablets 16 mg: 30 pcs.
Tablets 24 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel and a score line.

1 tab.
Betahistine dihydrochloride 16 mg

Excipients: microcrystalline cellulose 102, mannitol (E421), talc, citric acid monohydrate, colloidal silicon dioxide (aerosil).

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.

Tablets white or almost white, round, flat-cylindrical, with a bevel and a score line.

1 tab.
Betahistine dihydrochloride 24 mg

Excipients: microcrystalline cellulose 102, mannitol (E421), talc, citric acid monohydrate, colloidal silicon dioxide (aerosil).

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.

Marketing Authorization Holder

Grotex, LLC (Russia)

Dosage Forms

Bottle Rx Icon Betahistine solopharm Tablets 8 mg
Tablets 16 mg
Tablets 24 mg

Dosage Form, Packaging, and Composition

Tablets

1 tab.
Betahistine 8 mg

10 pcs. – contour cell blisters – cardboard packs (10 pcs.) – Prescription only
10 pcs. – contour cell blisters (10 pcs.) – cardboard packs (100 pcs.) – Prescription only
10 pcs. – contour cell blisters (2 pcs.) – cardboard packs (20 pcs.) – Prescription only
10 pcs. – contour cell blisters (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – contour cell blisters (4 pcs.) – cardboard packs (40 pcs.) – Prescription only
10 pcs. – contour cell blisters (5 pcs.) – cardboard packs (50 pcs.) – Prescription only
10 pcs. – contour cell blisters (6 pcs.) – cardboard packs (60 pcs.) – Prescription only
10 pcs. – contour cell blisters (7 pcs.) – cardboard packs (70 pcs.) – Prescription only
10 pcs. – contour cell blisters (8 pcs.) – cardboard packs (80 pcs.) – Prescription only
10 pcs. – contour cell blisters (9 pcs.) – cardboard packs (90 pcs.) – Prescription only
120 pcs. – bottles – cardboard packs (120 pcs.) – Prescription only
14 pcs. – contour cell blisters – cardboard packs (14 pcs.) – Prescription only
14 pcs. – contour cell blisters (10 pcs.) – cardboard packs (140 pcs.) – Prescription only
14 pcs. – contour cell blisters (2 pcs.) – cardboard packs (28 pcs.) – Prescription only
14 pcs. – contour cell blisters (3 pcs.) – cardboard packs (42 pcs.) – Prescription only
14 pcs. – contour cell blisters (4 pcs.) – cardboard packs (56 pcs.) – Prescription only
14 pcs. – contour cell blisters (5 pcs.) – cardboard packs (70 pcs.) – Prescription only
14 pcs. – contour cell blisters (6 pcs.) – cardboard packs (84 pcs.) – Prescription only
14 pcs. – contour cell blisters (7 pcs.) – cardboard packs (98 pcs.) – Prescription only
14 pcs. – contour cell blisters (8 pcs.) – cardboard packs (112 pcs.) – Prescription only
14 pcs. – contour cell blisters (9 pcs.) – cardboard packs (126 pcs.) – Prescription only
14 pcs. – bottles – cardboard packs (14 pcs.) – Prescription only
200 pcs. – bottles – cardboard packs (200 pcs.) – Prescription only
28 pcs. – bottles – cardboard packs (28 pcs.) – Prescription only
30 pcs. – bottles – cardboard packs (30 pcs.) – Prescription only
50 pcs. – bottles – cardboard packs (50 pcs.) – Prescription only
60 pcs. – bottles – cardboard packs (60 pcs.) – Prescription only
7 pcs. – contour cell blisters – cardboard packs (7 pcs.) – Prescription only
7 pcs. – contour cell blisters (10 pcs.) – cardboard packs (70 pcs.) – Prescription only
7 pcs. – contour cell blisters (2 pcs.) – cardboard packs (14 pcs.) – Prescription only
7 pcs. – contour cell blisters (3 pcs.) – cardboard packs (21 pcs.) – Prescription only
7 pcs. – contour cell blisters (4 pcs.) – cardboard packs (28 pcs.) – Prescription only
7 pcs. – contour cell blisters (5 pcs.) – cardboard packs (35 pcs.) – Prescription only
7 pcs. – contour cell blisters (6 pcs.) – cardboard packs (42 pcs.) – Prescription only
7 pcs. – contour cell blisters (7 pcs.) – cardboard packs (49 pcs.) – Prescription only
7 pcs. – contour cell blisters (8 pcs.) – cardboard packs (56 pcs.) – Prescription only
7 pcs. – contour cell blisters (9 pcs.) – cardboard packs (63 pcs.) – Prescription only
90 pcs. – bottles – cardboard packs (90 pcs.) – Prescription only

Tablets

1 tab.
Betahistine 16 mg

10 pcs. – contour cell packs – cardboard packs (10 pcs.) – By prescription
10 pcs. – contour cell packs (10 pcs.) – cardboard packs (100 pcs.) – By prescription
10 pcs. – contour cell packs (2 pcs.) – cardboard packs (20 pcs.) – By prescription
10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – By prescription
10 pcs. – contour cell packs (4 pcs.) – cardboard packs (40 pcs.) – By prescription
10 pcs. – contour cell packs (5 pcs.) – cardboard packs (50 pcs.) – By prescription
10 pcs. – contour cell packs (6 pcs.) – cardboard packs (60 pcs.) – By prescription
10 pcs. – contour cell packs (7 pcs.) – cardboard packs (70 pcs.) – By prescription
10 pcs. – contour cell packs (8 pcs.) – cardboard packs (80 pcs.) – By prescription
10 pcs. – contour cell packs (9 pcs.) – cardboard packs (90 pcs.) – By prescription
120 pcs. – bottles – cardboard packs (120 pcs.) – By prescription
14 pcs. – contour cell packs – cardboard packs (14 pcs.) – By prescription
14 pcs. – contour cell packs (10 pcs.) – cardboard packs (140 pcs.) – By prescription
14 pcs. – contour cell packs (2 pcs.) – cardboard packs (28 pcs.) – By prescription
14 pcs. – contour cell packs (3 pcs.) – cardboard packs (42 pcs.) – By prescription
14 pcs. – contour cell packs (4 pcs.) – cardboard packs (56 pcs.) – By prescription
14 pcs. – contour cell packs (5 pcs.) – cardboard packs (70 pcs.) – By prescription
14 pcs. – contour cell packs (6 pcs.) – cardboard packs (84 pcs.) – By prescription
14 pcs. – contour cell packs (7 pcs.) – cardboard packs (98 pcs.) – By prescription
14 pcs. – contour cell packs (8 pcs.) – cardboard packs (112 pcs.) – By prescription
14 pcs. – contour cell packs (9 pcs.) – cardboard packs (126 pcs.) – By prescription
14 pcs. – bottles – cardboard packs (14 pcs.) – By prescription
200 pcs. – bottles – cardboard packs (200 pcs.) – By prescription
28 pcs. – bottles – cardboard packs (28 pcs.) – By prescription
30 pcs. – bottles – cardboard packs (30 pcs.) – By prescription
50 pcs. – bottles – cardboard packs (50 pcs.) – By prescription
60 pcs. – bottles – cardboard packs (60 pcs.) – By prescription
7 pcs. – contour cell packs – cardboard packs (7 pcs.) – By prescription
7 pcs. – contour cell packs (10 pcs.) – cardboard packs (70 pcs.) – By prescription
7 pcs. – contour cell packs (2 pcs.) – cardboard packs (14 pcs.) – By prescription
7 pcs. – contour cell packs (3 pcs.) – cardboard packs (21 pcs.) – By prescription
7 pcs. – contour cell packs (4 pcs.) – cardboard packs (28 pcs.) – By prescription
7 pcs. – contour cell packs (5 pcs.) – cardboard packs (35 pcs.) – By prescription
7 pcs. – contour cell packs (6 pcs.) – cardboard packs (42 pcs.) – By prescription
7 pcs. – contour cell packs (7 pcs.) – cardboard packs (49 pcs.) – By prescription
7 pcs. – contour cell packs (8 pcs.) – cardboard packs (56 pcs.) – By prescription
7 pcs. – contour cell packs (9 pcs.) – cardboard packs (63 pcs.) – By prescription
90 pcs. – bottles – cardboard packs (90 pcs.) – By prescription

Tablets

1 tab.
Betahistine 24 mg

10 pcs. – contour cell packs – cardboard packs (10 pcs.) – By prescription
10 pcs. – contour cell packs (10 pcs.) – cardboard packs (100 pcs.) – By prescription
10 pcs. – contour cell packs (2 pcs.) – cardboard packs (20 pcs.) – By prescription
10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – By prescription
10 pcs. – contour cell packs (4 pcs.) – cardboard packs (40 pcs.) – By prescription
10 pcs. – contour cell packs (5 pcs.) – cardboard packs (50 pcs.) – By prescription
10 pcs. – contour cell packs (6 pcs.) – cardboard packs (60 pcs.) – By prescription
10 pcs. – contour cell packs (7 pcs.) – cardboard packs (70 pcs.) – By prescription
10 pcs. – contour cell packs (8 pcs.) – cardboard packs (80 pcs.) – By prescription
10 pcs. – contour cell packs (9 pcs.) – cardboard packs (90 pcs.) – By prescription
120 pcs. – bottles – cardboard packs (120 pcs.) – By prescription
14 pcs. – contour cell packs – cardboard packs (14 pcs.) – By prescription
14 pcs. – contour cell packs (10 pcs.) – cardboard packs (140 pcs.) – By prescription
14 pcs. – contour cell packs (2 pcs.) – cardboard packs (28 pcs.) – By prescription
14 pcs. – contour cell packs (3 pcs.) – cardboard packs (42 pcs.) – By prescription
14 pcs. – contour cell packs (4 pcs.) – cardboard packs (56 pcs.) – By prescription
14 pcs. – contour cell packs (5 pcs.) – cardboard packs (70 pcs.) – By prescription
14 pcs. – contour cell packs (6 pcs.) – cardboard packs (84 pcs.) – By prescription
14 pcs. – contour cell packs (7 pcs.) – cardboard packs (98 pcs.) – By prescription
14 pcs. – contour cell packs (8 pcs.) – cardboard packs (112 pcs.) – By prescription
14 pcs. – contour cell packs (9 pcs.) – cardboard packs (126 pcs.) – By prescription
14 pcs. – bottles – cardboard packs (14 pcs.) – By prescription
200 pcs. – bottles – cardboard packs (200 pcs.) – By prescription
28 pcs. – bottles – cardboard packs (28 pcs.) – By prescription
30 pcs. – bottles – cardboard packs (30 pcs.) – By prescription
50 pcs. – bottles – cardboard packs (50 pcs.) – By prescription
60 pcs. – bottles – cardboard packs (60 pcs.) – By prescription
7 pcs. – contour cell packs – cardboard packs (7 pcs.) – By prescription
7 pcs. – contour cell packs (10 pcs.) – cardboard packs (70 pcs.) – By prescription
7 pcs. – contour cell packs (2 pcs.) – cardboard packs (14 pcs.) – By prescription
7 pcs. – contour cell packs (3 pcs.) – cardboard packs (21 pcs.) – By prescription
7 pcs. – contour cell packs (4 pcs.) – cardboard packs (28 pcs.) – By prescription
7 pcs. – contour cell packs (5 pcs.) – cardboard packs (35 pcs.) – By prescription
7 pcs. – contour cell packs (6 pcs.) – cardboard packs (42 pcs.) – By prescription
7 pcs. – contour cell packs (7 pcs.) – cardboard packs (49 pcs.) – By prescription
7 pcs. – contour cell packs (8 pcs.) – cardboard packs (56 pcs.) – By prescription
7 pcs. – contour cell packs (9 pcs.) – cardboard packs (63 pcs.) – By prescription
90 pcs. – bottles – cardboard packs (90 pcs.) – By prescription

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Manufactured By

Abdi Ibrahim Ilac Sanayi ve Tic., A.S. (Turkey)

Dosage Forms

Bottle Rx Icon Betahistine-Akrikhin Tablets 8 mg: 30 pcs.
Tablets 16 mg: 30 pcs.
Tablets 24 mg: 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, biconvex.

1 tab.
Betahistine dihydrochloride 8 mg

Excipients: mannitol, microcrystalline cellulose, polyplasdone XL, citric acid monohydrate, colloidal silicon dioxide, talc, stearic acid.

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

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

1 tab.
Betahistine dihydrochloride 16 mg

Excipients: mannitol, microcrystalline cellulose, polyplasdone XL, citric acid monohydrate, colloidal silicon dioxide, talc, stearic acid.

15 pcs. – contour cell packs (2) – cardboard packs.

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

1 tab.
Betahistine dihydrochloride 24 mg

Excipients: mannitol, microcrystalline cellulose, polyplasdone XL, citric acid monohydrate, colloidal silicon dioxide, talc, stearic acid.

10 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.

Marketing Authorization Holder

Severnaya Zvezda NAO (Russia)

Dosage Form

Bottle Rx Icon Betahistine-SZ Modified-release tablets, film-coated 48 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Modified-release tablets, film-coated (upper) brownish-yellow, round, biconvex; on cross-section the tablet core is white or almost white, the first film coating layer is white.

1 tab.
Betahistine dihydrochloride 48 mg

Excipients: microcrystalline cellulose 102, lactose monohydrate (milk sugar), citric acid, Kollidon SR [polyvinyl acetate 80%, povidone K30 19%, sodium lauryl sulfate 0.8%, silicon dioxide 0.2%], magnesium stearate, talc.

Coating composition (first film coating layer) betahistine dihydrochloride, citric acid, hypromellose (hydroxypropyl methylcellulose), macrogol 6000, titanium dioxide (E171); second film coating layer hypromellose (hydroxypropyl methylcellulose), polysorbate 80 (tween 80), talc, titanium dioxide (E171), dye yellow iron oxide (E172).

10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
30 pcs. – polymer bottles (1) – cardboard packs.

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