Tiniril 8

• Meniere's disease
• Meniere-like syndromes (vertigo, tinnitus, hearing loss)

The mechanism of action of betahistine is multifactorial. Meniere's disease is thought to result from a disruption of endolymphatic fluid homeostasis in the ear. Betahistine mainly acts as a histamine H1-receptor agonist. The stimulation of H1-receptors in the inner ear causes a vasodilatory effect leading to increased permeability of blood vessels and a reduction in endolymphatic pressure; this action prevents the rupture of the labyrinth, which can contribute to the hearing loss associated with Meniere's disease. Betahistine also acts by reducing the asymmetrical functioning of sensory vestibular organs and increasing vestibulocochlear blood flow, relieving symptoms of vertigo.

In addition, betahistine also acts as a histamine H3-receptor antagonist, increasing the turnover of histamine from postsynaptic histaminergic nerve receptors, subsequently leading to an increase in H1-agonist activity. H3-receptor antagonism elevates levels of neurotransmitters including serotonin in the brainstem, inhibiting the activity of vestibular nuclei, thus restoring proper balance and decreasing vertigo symptoms.

Adults:

• Initial dose: 8-16 mg three times daily (preferably with meals)
• Maintenance dose: 24-48 mg daily (maximum 48 mg/day)
• Dosage can be adjusted according to individual needs

Children and adolescents (under 18 years): Not recommended due to lack of safety and efficacy data.

• Headache
• Nausea
• Dyspepsia
• Stomach pain and bloating
• Skin rash and pruritus (rare)

[CONSULT YOUR DOCTOR] The safety of betahistine in human pregnancy has not been completely established. Animal studies have shown no teratogenic effects. Use only if potential benefit justifies the potential risk.

• Caution in patients with peptic ulcer or a history of ulceration
• Caution in patients with bronchial asthma
• Caution in patients with urticaria, rashes, or allergic rhinitis
• Caution in patients with severe hypotension
• Patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine
• Caution during pregnancy and lactation
• May cause drowsiness; avoid driving or operating machinery if affected

Symptoms: Nausea, vomiting, dyspepsia, ataxia, and seizures. In severe cases (intentional overdose), convulsions, pulmonary or cardiac complications may occur.

Treatment: No specific antidote. Gastric lavage and symptomatic treatment are recommended.

Keep below 30°C, away from light and moisture. Keep out of reach of children.