Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Tamsulosin hydrochloride
McDermott Laboratories Ltd., T/A Gerard Laboratories
G04CA; G04CA02
Tamsulosin hydrochloride
400 microgram(s)
Modified-release capsule, hard
Product subject to prescription which may be renewed (B)
Alpha-adrenoreceptor antagonists; tamsulosin
Marketed
2006-03-24
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TAMSULOSIN 400 MICROGRAMS MODIFIED-RELEASE CAPSULES, 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. WHAT IS IN THIS LEAFLET : 1. What Tamsulosin is and what it is used for 2. What you need to know before you take Tamsulosin 3. How to take Tamsulosin 4. Possible side effects 5. How to store Tamsulosin 6. Contents of the pack and further information 1. WHAT TAMSULOSIN IS AND WHAT IT IS USED FOR Tamsulosin contains the active ingredient tamsulosin hydrochloride which belongs to a group of medicines called alpha-adrenoreceptor antagonists (alpha 1A-blockers). These medicines are used to reduce muscle contraction in the prostate and urethra. This facilitates the flow of urine through the urethra and aids urination. Tamsulosin is used for the treatment of lower urinary tract symptoms caused by an enlarged prostate, known as benign prostatic hyperplasia (BPH). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMSULOSIN DO NOT TAKE TAMSULOSIN: • If you are allergic to tamsulosin or any of the other ingredients of this medicine (listed in section 6). Allergy to tamsulosin can express itself as sudden swelling of hands or feet, difficulties in breathing and/or itch and rash swollen lips, tongue or throat, (angioedema). • If you have experienced dizziness or have fainted due to lowered blood pressure (e.g. when suddenly sitting or standing up). • If you have severe liver problems. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist bef Aqra d-dokument sħiħ
Health Products Regulatory Authority 09 March 2021 CRN009ZR1 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tamsulosin 400 micrograms Modified-release Capsules, Hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 400 micrograms of tamsulosin hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified-release capsule, hard Orange body/olive-green cap. The capsules contain white to off-white spheres. 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 Posology One capsule a day to be taken after breakfast or the first meal of the day. _Patients with renal impairment_ No dose adjustment is warranted in renal impairment. _Patients with hepatic impairment_ No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see also section 4.3, Contraindications). _Paediatric population_ The safety and efficacyof tamsulosin in children < 18 years have not been established. Currently available data are described in section 5.1. Method of administration For oral use. Thecapsulemust be swallowedwholeand must not be crunched or chewed as this interferes with the modified release of theactiveingredient. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance, including drug-induced angioedema, 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 09 March 2021 CRN009ZR1 Page 2 of 7 As with other α 1 -adrenoceptor 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 disappeared. Before therapy with tam Aqra d-dokument sħiħ