Lamivudine 300mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Lamivudine

Tilgængelig fra:

Milpharm Ltd

ATC-kode:

J05AF05

INN (International Name):

Lamivudine

Dosering:

300mg

Lægemiddelform:

Tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 05030100

Indlægsseddel

Pharma code position may change as per customer requirement
&additional
small pharma code may appear on the front / back panel
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMIVUDINE 300 MG FILM-COATED TABLETS
lamivudine
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 Lamivudine is and what it is used for
2.
What you need to know before you take Lamivudine
3.
How to take Lamivudine
4.
Possible side effects
5.
How to store Lamivudine
6.
Contents of the pack and other information
1. WHAT LAMIVUDINE IS AND WHAT IT IS USED FOR
LAMIVUDINE IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS)
INFECTION IN ADULTS AND CHILDREN.
The active ingredient in Lamivudine is lamivudine. Lamivudine is a
type of
medicine known as an anti-retroviral. It belongs to a group of
medicines called
_nucleoside analogue reverse transcriptase inhibitors (NRTIs)._
Lamivudine does not completely cure HIV infection; it reduces the
amount
of virus in your body, and keeps it at a low level. It also increases
the CD4
cell count in your blood. CD4 cells are a type of white blood cells
that are
important in helping your body to fight infection.
Not everyone responds to treatment with Lamivudine in the same way.
Your
doctor will monitor the effectiveness of your treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMIVUDINE
DO NOT TAKE LAMIVUDINE:
-
if you are ALLERGIC to lamivudine or any of the other ingredients of
this
medicine (listed in section 6).
CHECK WITH YOUR DOCTOR if you think this applies to you.
WARNINGS AND PRECAUTIONS
Som

Produktets egenskaber

OBJECT 1
LAMIVUDINE TABLET 300MG
Summary of Product Characteristics Updated 07-Nov-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Lamivudine 300 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 300 mg lamivudine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Grey, film-coated, diamond shaped tablets, debossed with 'Z26' on one
side and plain on other side. The
size is 17.5 mm X 8.6 mm.
4. Clinical particulars
4.1 Therapeutic indications
Lamivudine is indicated as part of antiretroviral combination therapy
for the treatment of Human
Immunodeficiency Virus (HIV) infected adults and children.
4.2 Posology and method of administration
The therapy should be initiated by a physician experienced in the
management of HIV infection.
Lamivudine may be administered with or without food.
To ensure administration of the entire dose, the tablet(s) should
ideally be swallowed without crushing.
An oral solution may be available for children over three months of
age and who weigh less than 14 kg or
for patients who are unable to swallow tablets (see section 4.4).
Alternatively for patients who are unable to swallow tablets, the
tablets may be crushed and added to a
small amount of semi-solid food or liquid, all of which should be
consumed immediately (see section
5.2).
_Adults and adolescents and children (weighing at least 25 kg): _the
recommended dose of Lamivudine is
300 mg daily. This may be administered as either 150 mg twice daily or
300 mg once daily (see section
4.4). The 300 mg tablet is only suitable for the once a day regimen.
_Children (weighing less than 25 kg):_
Dosing according to weight bands is recommended for Lamivudine
tablets.
_Children weighing ≥ 20 kg to <25 kg: _The recommended dose is 225
mg daily. This may beadministered
as either 75 mg (one-half of a 150 mg tablet) taken in the morning and
150 mg (one whole 150 mg tablet)
taken in the evening, or 225 mg (one and a half 150 mg table