Nevirapine 200mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Nevirapine

Disponible depuis:

Milpharm Ltd

Code ATC:

J05AG01

DCI (Dénomination commune internationale):

Nevirapine

Dosage:

200mg

forme pharmaceutique:

Tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 05030100

Notice patient

Pharmacode position may change as per Supplier's m/c requirement
&additional
small pharma code may appear on the front / back panel
Additional Information :
TEAM LEADER
Tarique
INITIATOR
Viswanath
Nevirapine 200 mg
PRODUCT NAME
CUSTOMER / COUNTRY
Milpharm_UK
DIMENSIONS
240 x 540 mm
PHARMACODE
8346
COMPONENT
01
Leaflet
VERSION NO.
REASON OF ISSUE
Revision
P1508346
ITEM CODE
REVIEWED / APPROVED BY
DATE & TIME
08.08.2014 &10:30 AM
SIGN / DATE
COLOURS :
Artist:
Supersede Code: P1507609
NO OF COLOURS : 01
Black
Size: 240 x 540 mm
BOOKLET SIZE: 60 X 35 MM
NEVIRAPINE 200 MG TABLETS
P1508346
NEVIRAPINE 200 MG TABLETS
P1508346
NEVIRAPINE 200 MG TABLETS
Nevirapine
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 or
nurse.
-
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 or
nurse. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1.
What Nevirapine is and what it is used for
2.
What you need to know before you take Nevirapine
3.
How to take Nevirapine
4.
Possible side effects
5.
How to store Nevirapine
6.
Contents of the pack and other information
Nevirapine 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
reduces the amount of viruses in the blood thus improving your medical
condition.
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

Résumé des caractéristiques du produit

OBJECT 1
NEVIRAPINE 200MG TABLETS
Summary of Product Characteristics Updated 02-Aug-2017 | Aurobindo
Pharma - Milpharm 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
Nevirapine 200 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 200 mg of nevirapine (as anhydrous).
Excipient with known effect: Each tablet contains 340 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
White to off-white, oval shaped, biconvex tablets, debossed with "J"
and "80" on either side of break line
on one side and with break line on the other side. The size is 19.2 mm
X 9.3 mm. The score line is only to
facilitate breaking for ease of swallowing and not to divide into
equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Nevirapine 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