Viramune 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nevirapine

Available from:

Boehringer Ingelheim Ltd

ATC code:

J05AG01

INN (International Name):

Nevirapine

Dosage:

200mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05030100; GTIN: 5012816050006 5012816050136

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIRAMUNE 200 MG TABLETS
nevirapine
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 further questions, please 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 Viramune is and what it is used for
2.
What you need to know before you take Viramune
3.
How to take Viramune
4.
Possible side effects
5.
How to store Viramune
6.
Contents of the pack and other information
1.
WHAT VIRAMUNE IS AND WHAT IT IS USED FOR
Viramune belongs to a group of medicines called antiretrovirals, used
in the treatment of Human
Immunodeficiency Virus (HIV-1) infection.
The active substance of your medicine is called nevirapine. Nevirapine
belongs to a class of anti-HIV
medicines called non-nucleoside reverse transcriptase inhibitors
(NNRTIs). Reverse transcriptase is an
enzyme that HIV needs in order to multiply. Nevirapine stops reverse
transcriptase from working. By
stopping reverse transcriptase from working, Viramune helps control
HIV-1 infection.
Viramune is indicated for the treatment of HIV-1 infected adults,
adolescents, and children of any age.
You must take Viramune together with other antiretroviral medicines.
Your doctor will recommend
the best medicines for you.
IF VIRAMUNE HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL
INFORMATION IN THIS LEAFLET IS
ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD”
INSTEAD OF “YOU”).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIRAMUNE
DO NOT TAKE VIRAMUNE
-
if you are allergic to nevirapine or any of the other ingredients of
this medicine (listed in section
6
_“What Viramune

Summary of Product characteristics

OBJECT 1
VIRAMUNE 200MG TABLETS
Summary of Product Characteristics Updated 02-Oct-2018 | Boehringer
Ingelheim Limited
•
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
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5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
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6. Pharmaceutical particulars
•
6.1 List of excipients
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6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
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6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
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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
Viramune 200 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 200 mg of nevirapine (as anhydrous).
Excipient with known effect
Each tablet contains 318 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
White, oval, biconvex tablets. One side is embossed with the code “54
193“, with a single bisect
separating the “54“ and “193“. The opposite side is marked with
the company symbol. The score line
is not intended for breaking the tablet.
4. Clinical particulars
4.1 Therapeutic indications
Viramune is indicated in combination with other anti-retroviral
medicinal products for the treatment of
HIV-1 infected adults, adolescents, and children of any age (see
section 4.2).
Most of the experience with Viramune is in combina