국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
30Capsule Capsules
Catalent Germany Schorndorf GmbH
_ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ DUODART CAPSULES Dutasteride/ Tamsulosin hydrochloride (0.5 mg/0.4 mg) 1 WHAT IS IN THIS LEAFLET 1. What Duodart is used for 2. How Duodart works 3. Before you use Duodart 4. How to use Duodart 5. While you are using it 6. Side Effects 7. Storage and Disposal of Duodart 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT DUODART IS USED FOR Duodart 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_ ). Duodart reduces the risk of acute urinary retention and the need for surgery in people with moderate to severe symptoms of BPH. HOW DUODART WORKS Duodart 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 DUODART - _When you must not use it _ Don’t take Duodart • if you are allergic ( _hypersensitive_ ) to dutasteride, tamsulosin or to any of the other ingredients of Duodart, 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 Duodart until you have checked with your doctor. Duodart must 전체 문서 읽기
1 PRESCRIBING INFORMATION Duodart 0.5mg/0.4mg capsules COMPOSITION _Active principle: _Dutasteride / Tamsulosin hydrochloride. _Excipients: _Antioxidant: E 321, colouring agent: E 110, excipients for capsules. PHARMACEUTICAL FORM AND QUANTITY OF ACTIVE PRINCIPLE PER UNIT Capsules: 0.5 mg dutasteride / 0.4 mg tamsulosin hydrochloride (equivalent to 0.367mg tamsulosin). Description: Oblong hard-shell capsules with a brown body and an orange cap with GS 7CZ printed on in black ink. INDICATIONS/USES Duodart is indicated as combination therapy for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Duodart reduces the risk of acute urinary retention and the need for surgery in patients with moderate to severe symptoms of BPH. DOSAGE/ADMINISTRATION PATIENTS >21 YEARS OLD _(INCLUDING ELDERLY PATIENTS) _ _ _ The recommended dose of Duodart is one capsule daily (0.5 mg / 0.4 mg). Duodart 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 (see “Warnings and Precautions”). _SPECIAL DOSAGE INSTRUCTIONS _ _Elderly patients: _ No age-related dose adjustment is required. 2 _Renal impairment _ There is no experience available in patients with renal impairment. Duodart should therefore be used with caution especially in patients with severe renal impairment (creatinine clearance <10ml/ min) (see “Pharmacokinetics”). _Hepatic impairment _ There is no experience available in patients with hepatic impairment. Duodart should be used with caution in patients with mild to moderate hepatic impairment (see “Warnings and Precautions” and “Pharmacokinetics”). In patients with severe hepatic impairment, the use of Duodart is contraindicated. _Patients ≤21 years old: _ Duodart is not ind 전체 문서 읽기