Nchi: Umoja wa Ulaya
Lugha: Kiingereza
Chanzo: EMA (European Medicines Agency)
tenofovir alafenamide fumarate
Gilead Sciences Ireland UC
J05AF
tenofovir alafenamide
Antivirals for systemic use,
Hepatitis B
Vemlidy is indicated for the treatment of chronic hepatitis B in adults and adolescents (aged 12 years and older with body weight at least 35 kg).,
Revision: 14
Authorised
2017-01-09
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VEMLIDY 25 MG FILM-COATED TABLETS tenofovir alafenamide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Vemlidy is and what it is used for 2. What you need to know before you take Vemlidy 3. How to take Vemlidy 4. Possible side effects 5. How to store Vemlidy 6. Contents of the pack and other information 1. WHAT VEMLIDY IS AND WHAT IT IS USED FOR Vemlidy contains the active substance _tenofovir alafenamide._ This is an _antiviral medicine,_ known as a _nucleotide reverse transcriptase inhibitor_ (NtRTI). Vemlidy is used to TREAT CHRONIC (LONG-TERM) HEPATITIS B in adults and adolescents 12 years of age and older, who weigh at least 35 kg. Hepatitis B is an infection affecting the liver, caused by the hepatitis B virus. In patients with hepatitis B, this medicine controls the infection by stopping the virus from multiplying. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VEMLIDY DO NOT TAKE VEMLIDY • IF YOU ARE ALLERGIC to tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6). If this applies to you, DO NOT TAKE VEMLIDY AND TELL YOUR DOCTOR IMMEDIATELY. WARNINGS AND PRECAUTIONS • TAKE CARE NOT TO PASS ON YOUR HEPATITIS B TO OTHER PEOPLE. You can still infect others when taking this medicine. This medicine does not reduce the risk of passing on hepatitis B to others through sexual contact or blood contamination. You must continue to take precautions to avoid this. Discuss with your doctor Soma hati kamili
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Vemlidy 25 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide. Excipient with known effect Each tablet contains 95 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Yellow, round, film-coated tablets, 8 mm in diameter, debossed with “GSI” on one side of the tablet and “25” on the other side of the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vemlidy is indicated for the treatment of chronic hepatitis B (CHB) in adults and adolescents (aged 12 years and older with body weight at least 35 kg) (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of CHB. Posology Adults and adolescents (aged 12 years and older with body weight at least 35 kg): one tablet once daily. _Treatment discontinuation _ Treatment discontinuation may be considered as follows (see section 4.4): • In HBeAg-positive patients without cirrhosis, treatment should be administered for at least 6- 12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBs seroconversion or until there is loss of efficacy (see section 4.4). Regular reassessment is recommended after treatment discontinuation to detect virological relapse. • In HBeAg-negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or until there is evidence of loss of efficacy. With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient. 3 _Missed dose _ If a dose is missed and less than 18 hours have passed from the time it is usually taken, the patient should take this medicinal product as soon as possible an Soma hati kamili