Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
NOVUGEN PHARMA SDN. BHD.
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
3x10 Capsules; 5x6 Capsules; 1x10 Capsules; 6x10 Capsules; 10x10 Capsules; 50x10 Capsules; 100x10 Capsules
SAG MANUFACTURING, S.L.U
_Consumer Medication Information Leaflet (RiMUP) _ DUORIDE-T 0.5MG/0.4MG CAPSULES Dutasteride/Tamsulosin Hydrochloride (0.5mg/0.4mg) 1 WHAT IS IN THIS LEAFLET 1. What Duoride-T is used for 2. How Duoride-T works 3. Before you use Duoride-T 4. How to use Duoride-T 5. While you are using Duoride-T 6. Side effects 7. Storage and Disposal of Duoride- T 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT DUORIDE-T IS USED FOR Duoride-T is used to treat men with moderate to severe symptoms of benign prostatic hyperplasia (BPH) - a non- cancerous growth of the prostate gland caused by producing too much of a hormone called DHT (dihydrotestosterone). Duoride-T reduces the risk of acute urinary retention and the need for surgery in people with moderate to severe symptoms of BPH. HOW DUORIDE-T WORKS Duoride-T capsules are a combination of two different medicines called dutasteride and tamsulosin. Dutasteride belongs to a group of medicines called 5-alpha reductase inhibitors, and tamsulosin belongs to a group of medicines called alpha- blockers. As the prostate grows, it can lead to urinary problems, such as difficulty in passing urine and a need to go to the toilet more frequently. It can also cause the flow of the urine to be slower and less forceful. If left untreated, there is a risk that your urine flow will be completely blocked. Dutasteride helps to shrink the prostate and relieve symptoms, by reducing the amount of DHT your body produces. Tamsulosin acts by relaxing the muscles in your prostate gland, making it easier to pass urine, and improving your symptoms. BEFORE YOU USE DUORIDE-T − _When you must not use it _ Do not take Duoride-T: • if you are allergic (hypersensitive) to dutasteride, tamsulosin or to any of the other ingredients of Duoride- T, or to other medicines known as 5-alpha reductase inhibitors. • if you are female or age 21 years and below. This medicine is for adult men only. If any of these apply to you, don’t take Duoride-T u Belgenin tamamını okuyun
DUT-T/S1/PI/L3/M1-04 DUORIDE-T DUTASTERIDE/TAMSULOSIN HYDROCHLORIDE 1. NAME OF THE MEDICINAL PRODUCT Duoride-T 0.5mg/0.4mg Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 0.5mg Dutasteride and 0.4mg Tamsulosin hydrochloride (equivalent to 0.367mg Tamsulosin). Excipients with known effect: Each capsule contains lecithin (which may contain soya oil) and sunset yellow FCF (E 110). Each capsule contains ≤ 0.1 mg sunset yellow FCF. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsules. Oblong, around 24mm length, hard capsules with a brown body and orange cap. Each hard capsule contains one dutasteride soft gelatin capsule and tamsulosin hydrochloride modified release pellets. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Duoride-T is indicated as combination therapy for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Duoride-T reduces the risk of acute urinary retention and the need for surgery in patients with moderate to severe symptoms of BPH. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION PATIENTS >21 YEARS OLD (INCLUDING ELDERLY PATIENTS) The recommended dose of Duoride-T is one capsule daily (0.5 mg / 0.4 mg). Duoride-T must always be taken with a glass of water, up to 30 minutes after a meal. It must never be taken on an empty stomach. Ideally it should be taken at the same time of the day (this means with the same meal). The capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa. SPECIAL DOSAGE INSTRUCTIONS ELDERLY PATIENTS: No age-related dose adjustment is required. RENAL IMPAIRMENT There is no experience available in patients with renal impairment. Duoride-T should therefore be used with caution especially in patients with severe renal impairment (creatinine clearance <10ml/ min). HEPATIC IMPAIRMENT There is no experience available in patients with hepatic impairment. Duoride-T should be used with caution in Belgenin tamamını okuyun