Intelence 200mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Etravirine

Tillgänglig från:

Janssen-Cilag Ltd

ATC-kod:

J05AG04

INN (International namn):

Etravirine

Dos:

200mg

Läkemedelsform:

Tablet

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: ; GTIN: 5012674902356

Bipacksedel

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

Produktens egenskaper

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