IND2187577 (v1.0), 07 MAY 2021
Vertin MDS

Abbreviated Prescribing Information. GENERIC NAME: Betahistine Dihydrochloride Orally Disintegrating Strips 24 mg. BRAND NAME: Vertin MDS. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each Orally Disintegrating Strip contains: Betahistine Dihydrochloride I.P. 24 mg. Excipients: q.s., Colour: Titanium Dioxide I.P. THERAPEUTIC INDICATIONS: Betahistine is indicated for the treatment of vertigo, tinnitus, hearing loss and nausea associated with Meniere's syndrome. Treatment of vestibular vertigo. POSOLOGY AND METHOD OF ADMINISTRATION: Adults (including the elderly): Initial oral treatment is 8 to 16 mg three times daily, taken with food. Maintenance doses are generally in the range 24 - 48 mg daily. Dosage can be adjusted to suit individual patient needs. Children: Betahistine strips are not recommended for use in children. Betahistine efficacy and safety have not been studied in children and adolescents below the age of 18 years. CONTRAINDICATIONS: Betahistine is contraindicated in patients with pheochromocytoma. As Betahistine is a synthetic analogue of histamine it may induce the release of catecholamines from the tumor resulting in severe hypertension. Known hypersensitivity to Betahistine hydrochloride and/or any other excipient. SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Respiratory - Although clinical intolerance to Betahistine dihydrochloride has been shown in a relatively few patients with bronchial asthma, caution should be exercised when giving the product to asthmatic patients. Gastrointestinal - Several patients with a history of peptic ulcer have experienced an exacerbation of symptoms while using Betahistine. Although experiments in animals and in humans have shown that the gastrointestinal side eects associated with Betahistine dihydrochloride are not related to gastric acid production, Betahistine dihydrochloride is contraindicated in the presence of patients with peptic ulcer and in patients with a history of this condition. Pediatrics (< 18 years of age) - The safety and efficacy of Betahistine dihydrochloride in pediatric patients below 18 years of age have not been evaluated, therefore its use in this population is not recommended. Geriatrics (> 65 years of age) - Limited data from clinical studies suggest that a dosage adjustment is unlikely to be required in this patient group. In general, however, the risk of adverse reactions to any drug may be greater in elderly patients as they are more likely to have decreased renal and/or hepatic function, and are more likely to be taking concomitant medications. Therefore, as with all drugs, caution should be exercised in this patient population. PREGNANCY AND LACTATION: Pregnant Women - The safety of Betahistine dihydrochloride in human pregnancy has not been established. Animal studies are insufficient with respect to effects on pregnancy, embryonic / foetal development, parturition and postnatal development. The potential risk for humans is unknown. Betahistine dihydrochloride should not be used during pregnancy unless the potential benefits to the mother outweigh the potential risk to the fetus. Nursing Women - It is not known whether Betahistine dihydrochloride is excreted in human milk. There are no animal studies on the excretion of Betahistine dihydrochloride in milk. The importance of the drug to the mother should be weighed against the benefits of nursing and the potential risks for the child. UNDESIRABLE EFFECTS: The following undesirable effects have been experienced with the below indicated frequencies in Betahistine-treated patients in placebo-controlled clinical trials [very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000)]. Gastrointestinal disorders: Common: nausea and dyspepsia. Nervous System disorders: Common: headache. In addition to those events reported during clinical trials, the following undesirable effects have been reported spontaneously during post- marketing use and in scientific literature. A frequency cannot be estimated from the available data and is therefore classified as “not known”. Immune System disorders: Hypersensitivity reactions e.g. anaphylaxis have been reported. Gastrointestinal disorders: Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal distension and bloating) have been observed. These can normally be dealt with by taking the dose during meals or by lowering the dose. Skin and subcutaneous tissue disorders: Cutaneous and subcutaneous hypersensitivity reactions have been reported, angioneurotic oedema, urticaria, rash, and pruritus. ISSUED ON: 14 Aug 2020. SOURCE: Prepared based on full prescribing information, version 01 dated 08 Jun 2020. ® Regd. Trade Mark of Abbott Products Operations AG. For full prescribing information, please contact: Medical Sciences Division, Abbott India Limited, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E), Mumbai – 400 051.

VERTIN*

(Betahistine Hydrochloride IP....8, 16 and 24mg), LABEL CLAIM: Vertin*8, Each uncoated tablet contains: Betahistine Hydrochloride IP 8 mg, Vertin* 16 Each uncoated tablet contains: Betahistine Hydrochloride IP 16 mg, Vertin* 24 Each uncoated tablet contains: Betahistine Hydrochloride IP 24 mg. INDICATION: Ménière's disease as defined by the following triad of core symptoms: Vertigo (with nausea/vomiting), hearing loss (hardness of hearing), tinnitus. Symptomatic treatment of vestibular vertigo. DOSAGE AND ADMINISTRATION: The dosage for adults is 24-48 mg divided over the day. CONTRAINDICATIONS: Hypersensitivity to the active substance or to any of the excipients. Pheochromocytoma. WARNINGS & PRECAUTIONS: Patients with bronchial asthma and a history of peptic ulcer need to be carefully monitored during therapy. May cause allergic reactions (possibly delayed). PREGNANCY & LACTATION: There are no adequate data from the use of Betahistine in pregnant women. It is not known whether Betahistine is excreted in human milk. ADVERSE REACTIONS: Undesirable eects reported during clinical trials (common > 1/100, < 1/10) include nausea, dyspepsia, and headache. Hypersensitivity reactions, e.g., anaphylaxis. Mild gastric complaints (e.g., vomiting, gastrointestinal pain, abdominal distension, and bloating). These can normally be dealt with by taking the dose during meals or by lowering the dose. Cutaneous and subcutaneous hypersensitivity reactions, in particular angioneurotic edema, urticaria, rash, and pruritus. Issued on: 19 Dec 2019. Source: Prepared based on full prescribing information (version 5) dated 15/Apr/2019 TM / * Trademark of the Abbott Group of Companies. For full prescribing information, please contact: Medical Sciences Division, Abbott India Limited/Abbott Healthcare Private Limited, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E), Mumbai – 400 051.

VERTIN OD*

[Betahistine Hydrochloride Sustained Release Tablets 24, and 48 mg] INDICATION: Menier’s Syndrome, characterized by unilateral or bilateral tinnitus, vertigo, sensorineural hearing loss. For the symptomatic treatment of peripheral vertigo. DOSAGE AND ADMINISTRATION: The dosage for adults is 24-48 mg per day. CONTRAINDICATIONS: Hypersensitivity to the active substance or to any of the excipients. Phaeochromocytoma. ADVERSE REACTIONS: Undesirable effects reported during clinical trials (common >1/100, <1/10) with betahistine immediate release include nausea and dyspepsia and headache. Hypersensitivity reactions, e.g. anaphylaxis Mild gastric complaints (e.g. vomiting, gastrointestinal pain, abdominal distension and bloating). These can normally be dealt with by taking the dose during meals or by lowering the dose. Cutaneous and subcutaneous hypersensitivity reactions, in particular angioneurotic oedema, urticaria, rash, and pruritus. PRECAUTIONS: Patients with bronchial asthma and history of peptic ulcer need to be carefully monitored during therapy. May cause allergic reactions (possibly delayed). STORAGE: Store in a cool & dry place. SHELF – LIFE: Vertin OD tablets are stable for 2 years from the date of manufacture when stored at recommended storage conditions. MANUFACTURED BY: The Madras Pharmaceuticals, 137-B, Old Mahabalipuram Road, Karapakkam, Chennai- 600 096. MARKETED BY: Abbott India Ltd. 3-4, Corporate Park, Sion- Trombay Road, Mumbai-400071. ISSUED ON: October 2013.