Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Tamsulosin hydrochloride
Synthon BV
G04CA; G04CA02
Tamsulosin hydrochloride
400 microgram(s)
Modified-release capsule, hard
Oral use
Pack containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 modified-release capsules
Product subject to prescription which may be renewed (B)
alfa 1-adrenoceptor antagonist
Alpha-adrenoreceptor antagonists; tamsulosin
Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
Not marketed
2006-01-20
1/6 M1.3.1_03.TSL.hcl.mrc.037.06.IE.1620.05 1.3.1 Package Leaflet PACKAGE LEAFLET: INFORMATION FOR THE USER TAMSULOSIN HYDROCHLORIDE 400 MICROGRAMS, MODIFIED-RELEASE CAPSULE, HARD Tamsulosin hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist . This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET : 1. What Tamsulosin hydrochloride 400 micrograms is and what it is used for 2. What you need to know before you take Tamsulosin hydrochloride 400 micrograms 3. How to take Tamsulosin hydrochloride 400 micrograms 4. Possible side effects 5. How to store Tamsulosin hydrochloride 400 micrograms 6. Contents of the pack and other information 1. WHAT TAMSULOSIN HYDROCHLORIDE 400 MICROGRAMS IS AND WHAT IT IS USED FOR Tamsulosin is an alpha 1A -adrenoreceptor blocker. It relaxes the muscles in the prostate and urinary tract. Tamsulosin is prescribed to alleviate urinary symptoms caused by an enlarged prostrate (benign prostatic hyperplasia). By relaxing the muscle it enables a more easily pass of urine and helps urination. 2. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMSULOSIN HYDROCHLORIDE 400 MICROGRAMS DO NOT TAKE TAMSULOSIN HYDROCHLORIDE 400 MICROGRAMS IF YOU: are ALLERGIC to tamsulosin or any of the other ingredients of this medicine (listed in section 6) (symptoms may include: SWELLING OF YOUR FACE AND THROAT (angio-oedema)). have a history of a fall in blood pressure on standing up, which causes DIZZINESS, LIGHT- HEADEDNESS OR FAINTING . have SEVERE LIVER PROBLEMS _ _ 2/6 M1.3.1_03.TSL.hcl.mrc.037.06.IE.1620.05 WARNINGS AND PRECAUTIONSTAMSULO Aqra d-dokument sħiħ
Health Products Regulatory Authority 27 January 2021 CRN00C0R7 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tamsulosin hydrochloride 400 micrograms modified-release capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains as active ingredient tamsulosin hydrochloride 400 micrograms. For a full list of excipients, see Section 6.1 3 PHARMACEUTICAL FORM Modified-release capsule, hard Orange/olive-green capsule (19.3 x 6.4 mm). 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 Posology 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. Method of administration 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. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance, including drug-induced angio-oedema, or to any of the excipients listed in section 6.1. A history of orthostatic hypotension. Severe hepatic insufficiency. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Health Products Regulatory Authority 27 January 2021 CRN00C0R7 Page 2 of 7 As with other α 1 -adrenoceptors antagonists, a reduction in blood pressure can occur in individual cases during treatment with tamsulosin, as a result of which, rarely, syncope can occur. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down until the symptoms have di Aqra d-dokument sħiħ