Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Takeda GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Germany Telephone: 0800 825332 4 Telefax: 0800 825332 9
SOMAC Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
The recommended dose is 20 mg pantoprazole (one tablet) per day.
It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms. Once complete relief of symptoms has occurred, treatment should be discontinued. The treatment should not exceed 4 weeks without consulting a doctor.
If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor.
No dose adjustment is necessary in elderly patients or in those with impaired renal or liver function.
SOMAC Control is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
SOMAC Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.
Doses up to 240 mg administered intravenously over 2 minutes were well tolerated. As pantoprazole is extensively protein bound, it is not readily dialysable.
In the case of overdose with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.
3 years.
Store in the original package in order to protect from moisture.
Alu/Alu blisters with or without cardboard reinforcement containing 7 or 14 gastro-resistant tablets
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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