Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Tamsulosin hydrochloride
Wockhardt UK Limited
G04CA; G04CA02
Tamsulosin hydrochloride
400 microgram(s)
Prolonged-release capsule, hard
Product subject to prescription which may be renewed (B)
Alpha-adrenoreceptor antagonists; tamsulosin
Marketed
2010-09-24
PACKAGE LEAFLET: INFORMATION FOR THE USER KIRNOM XL 400 MICROGRAMS PROLONGED-RELEASE HARD CAPSULES 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, please ask your doctor or nurse. - 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. The name of your medicine is Kirnom XL 400 micrograms Prolonged-Release Hard Capsules. In the rest of this leaflet it is called Kirnom XL Capsules. WHAT IS IN THIS LEAFLET: 1. What Kirnom XL Capsules are and what they are used for 2. What you need to know before you take Kirnom XL Capsules 3. How to take Kirnom XL Capsules 4. Possible side effects 5. How to store Kirnom XL Capsules 6. Contents of the pack and other information 1. WHAT KIRNOM XL CAPSULES ARE AND WHAT THEY ARE USED FOR The active substance in Kirnom XL Capsules is tamsulosin (as hydrochloride), which belongs to a group of medicines called alpha- blockers (alpha- adrenoreceptor antagonists). It acts by relaxing the muscles in the prostate and urethra (the tube that carries urine to the outside), and lets urine pass more readily through the urethra and aids urination. In the prostate gland, bladder and urethra there are specialised cells containing alpha1A- receptors that cause the muscles in the urethra to tighten. Kirnom XL is an alpha1A- adrenoceptor blocker, which reduces the action of these specialised cells and relaxes the muscles making it easier to pass water. Kirnom XL Capsules is used to treat the symptoms associated with benign prostatic hyperplasia (BPH) which is enlargement of the prostate gland. These symptoms include difficulty in starting to pass water, frequent trips to the to Lugege kogu dokumenti
Health Products Regulatory Authority 30 October 2019 CRN009FDZ Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kirnom XL 400 micrograms Prolonged-Release Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains tamsulosin hydrochloride 400 microgram, equivalent to 367 microgram tamsulosin. For full list of the excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release capsule, hard Kirnom XL Capsules consist of a light green opaque cap and light yellowopaque body containing white to off white pellets, imprinted with on the cap with black ink. 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 For oral use One Capsule daily, to be taken after the same meal each day. The capsule should be swallowed whole and should not be crunched or chewed as this will interfere with the modified release of the active ingredient. Paediatric Population The safety and efficacy of tamsulosin in children <18 years have not been established. Currently available data are described in section 5.1. 4.3 CONTRAINDICATIONS Hypersensitivity to tamsulosin hydrochloride or to any other component of the product (see section 6.1); a history of orthostatic hypotension; severe hepatic insufficiency. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As with other alpha 1 blockers, a reduction in blood pressure can occur in individual cases during treatment with Kirnom XL, 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 Kirnom XL is initiated the patient should be examined in order to exclude the presence of other conditions which can cause the same symptoms as benign prostatic hyperplasia. Digital rectal examination and when necessary determination of prostate specific antigen (PSA) should be performed befor Lugege kogu dokumenti