Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
VARDENAFIL HYDROCHLORIDE
BAYER CO. (MALAYSIA) SDN. BHD.
VARDENAFIL HYDROCHLORIDE
2tablet Tablets; 1tablet Tablets; 4tablet Tablets
BAYER AG
LEVITRA ® ORODISPERSIBLE TABLETS Vardenafil (10 mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _Levitra_ is used for 2. How _Levitra_ works 3. Before you use _Levitra_ 4. How to use _Levitra_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Levitra_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _LEVITRA_ IS USED FOR _Levitra_ contains vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors. They are used for the treatment of erectile dysfunction in adult men, a condition which implies difficulties in getting or keeping an erection. At least one in ten men has trouble getting or keeping an erection at some time. There may be physical or psychological causes, or a mixture of both. Whatever the cause is, due to muscle and blood vessel changes not enough blood stays in the penis to make it hard and keep it hard. HOW _LEVITRA_ WORKS _Levitra_ will only work when you are sexually stimulated. It reduces the action of the natural chemical in your body which makes erections go away. _Levitra_ allows an erection to last long enough for you to satisfactorily complete sexual activity. BEFORE YOU USE _LEVITRA _ - When you must not use it DO NOT TAKE _LEVITRA_ - If you are allergic (hypersensitive) to vardenafil or any of the other ingredients of _Levitra_ . See the ingredients in section Ingredients. Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of breath. - If you are taking medicines containing nitrates, such as glycerol trinitrate for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with _Levitra_ could seriously affect your blood pressure. - If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections. - If you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (e.g. high blood pressure in the lungs) and chronic thromboembolic p Прочитайте повний документ
Date of Revision: 14 th May 2020 Reference: CCDS 18/14 th May 2020-EU Dependency LEVITRA 10 MG ORODISPERSIBLE TABLET 1. NAME OF THE MEDICINAL PRODUCT Levitra 10 mg orodispersible tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 10 mg of vardenafil (as hydrochloride). Excipients: 7.96 mg sorbitol (E420), and 1.80 mg aspartame (E951) per orodispersible tablet. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible tablet. White round tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION(S) Treatment of erectile dysfunction (inability to achieve or maintain penile erection sufficient for satisfactory sexual performance). In order for Levitra to be effective, sexual stimulation is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Levitra 10 mg orodispersible tablet is not bioequivalent to Levitra 10 mg film-coated tablet (see section 5.1). The maximum dose for Levitra orodispersible tablet is 10 mg/day. _Use in adult men _ Levitra 10 mg orodispersible tablets are taken as needed approximately 25-60 minutes before sexual activity. _Special populations _ _Elderly _ ( ≥ 65 years old) Dose adjustments are not required in elderly patients. However, an increase to a maximum dose of Levitra 20 mg film-coated tablets should be carefully considered depending on the individual tolerability (see sections 4.4 and 4.8). Date of Revision: 14 th May 2020 Reference: CCDS 18/14 th May 2020-EU Dependency _Hepatic impairment _ Levitra 10 mg orodispersible tablets are not indicated as a starting dose in patients with mild hepatic impairment (Child-Pugh A). Patients with mild hepatic impairment should start treatment with Levitra 5 mg film-coated tablets. Based on tolerability and efficacy, the dose may be increased to Levitra 10 mg and 20 mg film- coated tablets, or Levitra 10 mg orodispersible tablets. The maximum dose recommended in patients with moderate hepatic impairment (Child-Pugh B) is Levitra 10 mg as film-coated tablets (see section 5.2). Прочитайте повний документ