Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
One capsule daily.
No dose adjustment is warranted in renal impairment (see section 4.4).
No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see also section 4.3).
There is no relevant use of Omsula in the 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.
For oral use. One capsule daily, to be taken after breakfast or the first meal of the day. The capsule must be swallowed whole and must not be crunched or chewed as this interferes with the prolonged release of the active substance.
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.
Acute overdose with 5 mg of tamsulosin has been reported. Acute hypotension (systolic blood pressure 70 mm Hg), vomiting and diarrhoea were observed, which were treated with fluid replacement and the patient could be discharged the same day.
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.
Do not store above 30°C.
Store in the original package in order to protect from light.
30, 90 or 100 capsules are packed into clear or white opaque PVC/PVDC//Aluminium blisters.
The blisters are packed into folding box with a package leaflet.
Not all pack sizes may be marketed.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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