TACAP 400 MICROGRAMS MODIFIED-RELEASE CAPSULES, HA
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
TAMSULOSIN HYDROCHLORIDE
Available from:
Kiron Pharmaceutica BV
Dosage:
400 Microgram
Pharmaceutical form:
Capsules Modified Release
Authorization date:
2006-02-24
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tacap 400 micrograms Modified-release Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains as active ingredient tamsulosin hydrochloride 0.4 mg.
For a full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Modified-release capsule, hard
Orange/olive-green capsule, with the black printed mark ‘TSL 0.4’ and with a black stripe at both ends. The capsules
contain white to off-white pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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).
_Paediatric population_
There is no relevant indication for use of tamsulosin 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.
4.3 CONTRAINDICATIONS
Hypersensitivity to tamsulosin, including drug-induced angio-oedema, or to any of the excipients.
A history of orthostatic hypotension.
Severe hepatic insufficiency.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 20/04/2012_
_CRN 2110613_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with other
1-adrenoceptors antagonists, a reduction in blood pressure can occur in indivi
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