FLOMAXTRA Film-coated prolonged-release tablet Ref.[27753] Active ingredients: Tamsulosin

Posology

One tablet daily, to be taken with or without food.

Paediatric Population

The safety and efficacy of tamsulosin in children <18 years have not been established. Currently available data are described in Section 5.1.

Method of administration

For oral use.

The tablet should be swallowed whole and should not be crunched or chewed as this will interfere with the prolonged release of the active ingredient.

Symptoms

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

Treatment

In case of acute hypotension occurring after overdose, 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 sulfate, can be administered.

3 years.

There are no special storage instructions.

Aluminium foil blister packs containing 30 tablets.

No special requirements.