CONTIFLO XL Prolonged release capsule Ref.[50634] Active ingredients: Tamsulosin

Posology

Oral use.

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

The capsule must be swallowed whole and should not be crunched or chewed, as this interferes with the modified release of the active ingredient.

Use in renal impairment

No dose adjustment is warranted in renal impairment.

Use in hepatic impairment

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

Paediatric population

There is no relevant indication for use of this medicine product in children.

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

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 overdosage cardiovascular support should be given.

Blood pressure can be restored and heart rate can be 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/PVdC/Alu blisters.

Packs of 1, 2, 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100 or 200 prolonged release capsules.

Not all packs sizes may be marketed.

No special requirements.