Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Zentiva Pharma UK Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom Trading as: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
One capsule daily after breakfast or after the first daily meal.
No dose adjustment is warranted in renal impairment.
No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see section 4.3).
The safety and efficacy of tamsulosin hydrochloride in children <18 years have not been established. Currently available data are described in section 5.1.
Oral use.
The capsule is swallowed whole, without crushing or chewing, because otherwise the controlled release of the active ingredient would be affected.
Overdosage with tamsulosin hydrochloride can potentially result in severe hypotensive effects. Severe hypotensive effects have been observed at different levels of overdosing.
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.
Transparent PVC/PVDC-Al blister, folding box.
Size of package: 10, 20, 30, 50, 90, 100 capsules.
Not all pack sizes may be marketed.
No special requirements.
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