Steadyfutal Tablets

Betahistine dihydrochloride  8, 16 & 24mg

 

Usage and indications:

Vertigo, tinnitus and hearing loss associated with Ménière's syndrome.

Dosage and administration:  The patient should not score the tablet. 

Adults: (including the elderly): initially 48mg/day taken in divided doses and preferably with meals.

 Maintenance doses range (24-48) mg daily divided in 2 or 3 doses

Pediatric population: not recommended for use in children below 18 years due to insufficient data on safety and efficacy.   

Geriatric population: Although there are limited data from clinical studies in this patient group, extensive post marketing experience suggests that no dose adjustment is necessary in this patient population.

Renal impairment: There are no specific clinical trials available in this patient group,

but according to post-marketing experience no dose adjustment appears to be necessary.                          

Hepatic impairment: There are no specific clinical trials available in this patient group, 

but according to post-marketing experience no dose adjustment appears to be necessary.

Undesirable effects: 

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, in particular angioneurotic oedema, urticaria, rash, and pruritus.

Warnings and precautions:

Caution is advised in the treatment of patients with a history of peptic ulcer.

Clinical intolerance to Betahistine in bronchial asthma patients has been shown in a relatively few patients. These patients need to be carefully monitored during the therapy.

Pack:

Steadyfutal 8mg tablets: Carton box containing 1 or 3 strips, each of 10 tablets.

Steadyfutal 16mg tablets: Carton box containing 2 strips, each of 10 tablets.

Steadyfutal 24mg tablets: Carton box containing 2 strips, each of 10 tablets

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