Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Etravirine
Janssen-Cilag Ltd
J05AG04
Etravirine
200mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5012674902356
1 PACKAGE LEAFLET: INFORMATION FOR THE USER INTELENCE 200 MG TABLETS etravirine 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 INTELENCE is and what it is used for 2. What you need to know before you take INTELENCE 3. How to take INTELENCE 4. Possible side effects 5. How to store INTELENCE 6. Contents of the pack and other information 1. WHAT INTELENCE IS AND WHAT IT IS USED FOR INTELENCE contains the active substance etravirine. INTELENCE belongs to a group of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). INTELENCE is a medicine used for the treatment of Human Immunodeficiency Virus (HIV) infection. INTELENCE works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection. INTELENCE is used in combination with other anti-HIV medicines to treat adults and children 6 years of age and older who are infected by HIV and who have used other anti-HIV medicines before. Your doctor will discuss with you which combination of medicines is best for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INTELENCE DO NOT TAKE INTELENCE - if you are allergic to etravirine or any of the other ingredients of this medicine (listed in section 6) - if you are taking elbasvir/grazoprevir (a medicine to treat hepatitis C infection). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking INTELENCE. INTELENCE is not a cure for HIV infection. It is part of a treatment reducing the Izlasiet visu dokumentu
OBJECT 1 INTELENCE 200MG TABLETS Summary of Product Characteristics Updated 30-Oct-2018 | Janssen-Cilag Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product INTELENCE 25 mg tablets INTELENCE 100 mg tablets INTELENCE 200 mg tablets 2. Qualitative and quantitative composition INTELENCE 25 mg tablets Each tablet contains 25 mg of etravirine. Excipient with known effect Each tablet contains 40 mg lactose (as monohydrate). INTELENCE 100 mg tablets Each tablet contains 100 mg of etravirine. Excipient with known effect Each tablet contains 160 mg lactose (as monohydrate). INTELENCE 200 mg tablets Each tablet contains 200 mg of etravirine. For the full list of excipients, see section 6.1. 3. Pharmaceutical form INTELENCE 25 mg tablets Tablet White to off-white, oval, scored tablet, debossed with “TMC” on one side. The tablet can be divided into two equal doses. INTELENCE 100 mg tablets Tablet White to off-white, oval tablet debossed with “T125” on one side and “100” o Izlasiet visu dokumentu