Prostetrol Film Coated Tablet 10 mg

Страна: Танзания

Език: английски

Източник: Tanzania Medicinces & Medical Devices Authority

Активна съставка:

Alfuzosin HCl

Предлага се от:

EVA Pharma for Pharmaceuticals and Medical Appliances, EGYPT

INN (Международно Name):

Alfuzosin HCl

дозиране:

10 mg

Лекарствена форма:

Film Coated Tablet

Произведено от:

Eva Pharma for Pharmaceuticals And Medical Appliances, EGYPT

Каталог на резюме:

Physical description: White to off white round film coated tablets; Local technical representative: Melody Pharma (T) Ltd (6418)

Статус Оторизация:

Registered/Compliant

Дата Оторизация:

2019-08-02

Данни за продукта

Summary of Product Characteristics
1. Name of the medicinal product
Prostetrol (Alfuzosin Hydrochloride Film coated 10mg Tablets)
2. Qualitative and quantitative composition
Each tablet contains 10mg alfuzosin hydrochloride.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Film coated tablets.
White to off white round film coated tablets.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of the functional symptoms of benign prostatic hypertrophy (BPH).
For information on use in acute urinary retention (AUR) related to BPH see sections 4.2 and 5.1.
4.2 Posology and method of administration
Alfuzosin tablets should be swallowed whole.
BPH: The recommended dose is one 10mg tablet to be taken once daily after a meal.
AUR: In patients 65 years and older, one 10 mg tablet daily after a meal to be taken from the first
day of catheterization. The treatment should be administered for 3-4 days, 2-3 days during
catheterization and 1 day after its removal. In this indication no benefit has been established in
patients under 65 years of age or if treatment is extended beyond 4 days.
Paediatric population
Efficacy of alfuzosin has not been demonstrated in children aged 2 to 16 years (see section 5.1).
Therefore, alfuzosin is not indicated for use in the paediatric population.
4.3 Contraindications
• Hypersensitivity to the active substance or any of the excipients.
• History of orthostatic hypotension.
• Combination with other -alpha-1 receptor blockers.
• Concomitant administration with potent CYP3A4 inhibitors (see Section 4.5)
• Hepatic insufficiency.
4.4 Special warnings and precautions for use
Warnings