Country: Afrika t’Isfel
Lingwa: Ingliż
Sors: South African Health Products Regulatory Authority (SAHPRA)
Ranbaxy Pharmaceutical (Pty) Ltd û Roodepoort
See ingredients
CAPSULES
EACH CAPSULE CONTAINS TAMSULOSIN HYDROCHLORIDE 0,4 mg
Registered
2008-09-12
Page 1 of 8 SCHEDULING STATUS: S4 1. NAME OF THE MEDICINE BENIPROSIN SR Tamsulosin hydrochloride 0,4 mg (capsules) Sugar free READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING BENIPROSIN SR Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist, nurse or other health care provider. BENIPROSIN SR has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET 1. What BENIPROSIN SR is and what it is used for 2. What you need to know before you take BENIPROSIN SR 3. How to use BENIPROSIN SR 4. Possible side effects 5. How to store BENIPROSIN SR 6. Contents of the pack and other information 1.WHAT BENIPROSIN SR IS AND WHAT IT IS USED FOR BENIPROSIN SR capsules contains tamsulosin hydrochloride 0,4 mg Page 2 of 8 BENIPROSIN SR capsules are indicated for the treatment of functional symptoms of benign prostatic hyperplasia (BPH). 2.WHAT YOU NEED TO KNOW BEFORE YOU TAKE BENIPROSIN SR DO NOT TAKE BENIPROSIN SR : If you are hypersensitive (allergic) to tamsulosin hydrochloride or any of the other ingredients of BENIPROSIN SR. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. If you suffer from dizziness when you want to sit up or stand up from the lying position If you suffer from serious infection of the liver. If you have a history of fainting while urinating or right after urinating If you are using in combination with ketoconazole (a strong CYP3A4 inhibitor) used to treat fungal infections Do not take BENIPROSIN SR if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before receiving BENIPROSIN SR. Do this even if they have applied in the past WARNINGS AND PRECAUTIONS BENIPROSIN SR capsules are intended for male patients only TAKE SPECIAL CARE WITH BENIPROSIN SR : If you have a de Aqra d-dokument sħiħ
Page 1 of 11 SCHEDULING STATUS S4 1. NAME OF THE MEDICINE BENIPROSIN SR ( Capsule 0,4 mg) 2. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION BENIPROSIN SR Each capsule contains tamsulosin hydrochloride 0,4 mg Sugar free. For full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Capsule Brown, opaque cap/ orange opaque body, of size '2' imprinted with 'R' on cap and 'TSN400' on body in black edible ink, containing white to off-white granular beads. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION BENIPROSIN SR capsules are indicated for the treatment of functional symptoms of benign prostatic hyperplasia (BPH). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION One 0,4 mg of BENIPROSIN SR capsule to be taken daily after breakfast or after first daily meal BENIPROSIN SR capsules should be swallowed whole with water (about 150 ml) in the standing or sitting position. BENIPROSIN SR capsules should not be crushed or chewed, as this will interfere with the sustained release property of this active ingredient . Page 2 of 11 4.3 CONTRAINDICATIONS: BENIPROSIN SR capsules are contra-indicated in the following conditions: In patients hypersensitive to tamsulosin hydrochioride or any other components of the product. A history of orthostatic hypotension. Hepatic insufficiency. Micturition syncope history Should not be used in combinations with strong inhibitors of CYP3A4 eg ketoconazole (See section 4.5) 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE A decrease in blood pressure with orthostatic hypotension and syncope may occur during treatment with BENIPROSIN SR. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down until the symptoms have disappeared. Before therapy with BENIPROSIN SR 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 ant Aqra d-dokument sħiħ