DUSPATALIN Modified release capsule, hard Ref.[51014] Active ingredients: Mebeverine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2022  Publisher: Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland

4.1. Therapeutic indications

Adults:

  • Symptomatic treatment of abdominal pain and cramps, bowel disturbances and intestinal discomfort related to irritable bowel syndrome.
  • Treatment of gastro-intestinal spasm secondary to organic diseases.

4.2. Posology and method of administration

Posology

Adults

One capsule of 200 mg twice daily, to be given one in the morning and one in the evening.

Paediatric population

Duspatalin Retard 200mg capsules are not recommended for use in children and adolescents below 18, due to insufficient data on safety and efficacy.

Duration of use is not limited.

In case of one or more dose(s) is (are) missed, the patient should continue with the next dose prescribed; the missed dose(s) is (are) not to be taken in addition to the regular dose.

Special Population

No posology studies in elderly, renal and/or hepatic impaired patients have been performed. No specific risk for elderly, renal and/or hepatic impaired patients could be identified from available post-marketing data. No dosage adjustment is deemed necessary in elderly, renal and/or hepatic impaired patients.

Method of administration

For oral use.

The capsules should be swallowed with a sufficient amount of water (at least 100ml water). They should not be chewed because the coating is intended to ensure a prolonged release mechanism (see 5.2).

4.9. Overdose

Symptoms

Theoretically, CNS excitability may occur in cases of overdose. In cases where mebeverine was taken in overdose, symptoms were either absent or mild and usually rapidly reversible.

Treatment

No specific antidote is known and symptomatic treatment is recommended. Gastric lavage should only be considered in case of multiple intoxication discovered within about one hour. Absorption reducing measures are not necessary.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store in the original package below 30°C. Do not Freeze.

6.5. Nature and contents of container

PVC-Al or PVC/PVDC-Al press through strips. Duspatalin Retard 200mg is available in pack size of 30 capsules.

6.6. Special precautions for disposal and other handling

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

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