Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Tamsulosin hydrochloride
Clonmel Healthcare Ltd
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
2006-04-28
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TAMNIC 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 Tamnic 400 micrograms is and what it is used for 2. What you need to know before you take Tamnic 400 micrograms 3. How to take Tamnic 400 micrograms 4. Possible side effects 5. How to store Tamnic 400 micrograms 6. Contents of the pack and other information 1. WHAT TAMNIC 400 MICROGRAMS IS AND WHAT IT IS USED FOR Tamsulosin is an α 1A -adrenoreceptor blocker. It relaxes the muscles in the prostate and urinary tract. Tamsulosin is prescribed to alleviate urinary symptoms caused by an enlarged prostate (benign prostatic hyperplasia). By relaxing the muscle it enables a more easily pass of urine and helps urination. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMNIC 400 MICROGRAMS DO NOT TAKE TAMNIC 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 (angioedema)]. • Have a history of a fall in blood pressure on standing up, which causes dizziness, light- headedness or fainting. • Have severe liver problems. WARNINGS AND PRECAUTIONS: Talk to your doctor or pharmacist before taking Tamnic 400 micrograms: • Experience dizziness or light-headedness, especially after standing up. Tamnic 400 micrograms may lower your blood pressure, causing these symptoms. You should sit or lie down un সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 23 October 2020 CRN009WTY Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tamnic 400 micrograms Modified-release Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 0.4 mg of tamsulosin hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified-release capsule, hard. Orange/olive-green capsule. 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 One capsule a day after breakfast or the first meal of the day. The capsule is swallowed whole with a glass of water while standing or sitting (not lying down). The capsule should not be broken or pulled apart as this may have an effect on the release of the long-acting 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 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 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 disappeared. The patient should be examined before commencement of therapy with tamsulosin to exclude the presence of other conditions that can produce similar symptoms to those of BPH. The prostate should be examined via the rectum and, if necessary, the PSA count determined prior to commencement of treatment and again later at regular in সম্পূর্ণ নথি পড়ুন