TANYZ Hard modified-release capsule Ref.[50006] Active ingredients: Tamsulosin

Posology

One capsule daily, to be taken after breakfast or the first meal of the day.

No dose adjustment is warranted in renal impairment. No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see also 4.3 Contraindications).

Paediatric population

There is no relevant indication for use of tamsulosin in children. The safety and efficacy of tamsulosine in children <18 years have not been established. Currently available data are described in section 5.1

Method of administration

For oral use.

The capsule should not be broken or pulled apart as this may have an effect on the release of the long-acting active ingredient.

Symptoms

Overdosage with tamsulosin hydrochloride can potentially result in severe hypotensive effects. Severe hypotensive effects have been observed at different levels of overdosing.

Management

In case of acute hypotension occurring after overdosage cardiovascular support should be given. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this does not help then volume expanders and, when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as tamsulosin is very highly bound to plasma proteins.

Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.

3 years.

This medicinal product does not require any special storage conditions.

PVC/PE/PVDC/Aluminium blisters in boxes containing 20, 30, 90 and 100 hard modified-release capsules.

Not all pack sizes may be marketed.

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