Source: Web Search Revision Year: 2019 Publisher: Astellas Pharmaceuticals A.E.B.E., 6-8 Agisilaou Str., 15123 Marousi, Athens-Greece Tel: +30 210 8189900 Fax: +30 216 8008998
Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
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 modified release of the active ingredient.
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).
There is no relevant indication for use of Omnic 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.
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.
4 years.
Store in the original package.
Polypropylene-aluminium blister packs containing 10 capsules per strip; cardboard boxes containing 10, 20, 30, 50, 60, 90, 100 and 200 capsules.
PVC/PVDC-aluminium blister packs containing 5 capsules per strip: cardboard boxes containing 50 capsules.
Not all pack sizes may be marketed.
No special requirements.
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