SOMAC CONTROL Gastro-resistant tablet Ref.[49865] Active ingredients: Pantoprazole

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

4.1. Therapeutic indications

SOMAC Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.

4.2. Posology and method of administration

Posology

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.

Special populations

No dose adjustment is necessary in elderly patients or in those with impaired renal or liver function.

Paediatric population

SOMAC Control is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.

Method of administration

SOMAC Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.

4.9. Overdose

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.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store in the original package in order to protect from moisture.

6.5. Nature and contents of container

Alu/Alu blisters with or without cardboard reinforcement containing 7 or 14 gastro-resistant tablets

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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