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LAMIVUDINE 100 MG FILM-COATED TABLETS

Active substance(s): LAMIVUDINE

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Package leaflet:
Information for the patient

Lamivudine 100 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 long term
(chronic) hepatitis B infection in adults.

TBC

The active ingredient in Lamivudine is
lamivudine. Lamivudine is an antiviral
medicine that suppresses the hepatitis
B virus and belongs to a group of
medicines called nucleoside analogue
reverse transcriptase inhibitors (NRTIs).
Hepatitis B is a virus which infects
the liver, causes long term (chronic)
infection, and can lead to liver damage.
Lamivudine can be used in people
whose liver is damaged, but still
functions normally (compensated
liver disease) and in combination with
other medicines in people whose liver
is damaged and does not function
normally (decompensated liver disease).

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

Talk to your doctor or pharmacist before
taking Lamivudine.
Some people taking lamivudine or
other similar medicines are more at risk
of serious side effects. You need to be
aware of the extra risks:
• if you have ever had other types of
liver disease, such as hepatitis C
• if you’re seriously overweight
(especially if you’re a woman).
Talk to your doctor if any of these apply
to you. You may need extra check-ups,
including blood tests, while you’re taking
your medication. See Section 4 for more
information about the risks.
Don’t stop taking lamivudine without
your doctor’s advice, as there is a risk of
your hepatitis getting worse. When you
stop taking lamivudine your doctor will
monitor you for at least four months to
check for any problems. This will mean
taking blood samples to check for any
raised liver enzyme levels, which may
indicate liver damage. See section 3 for
more information about how to take
this medicine.

Look out for important symptoms
Some people taking medicines for
hepatitis B infection develop other
conditions, which can be serious. You
need to know about important signs
and symptoms to look out for while
you’re taking lamivudine.

Protect other people

Hepatitis B infection is spread by sexual
contact with someone who has the
infection, or by transfer of infected
blood (for example, by sharing injection
needles). Lamivudine will not stop you
passing hepatitis B infection on to other
people. To protect other people from
becoming infected with hepatitis B:
Use a condom when you have oral or
penetrative sex.
Don’t risk blood transfer — for example,
don’t share needles.

Other medicines and Lamivudine

Tell your doctor or pharmacist if you are
taking, have recently taken or might
take any other medicines, including
herbal medicines or other medicines you
bought without a prescription.
Remember to tell your doctor or
pharmacist if you begin taking a
new medicine while you are taking
Lamivudine.

These medicines should not be
used with Lamivudine:

• o
 ther medicines containing
lamivudine, used to treat HIV
infection (sometimes called the
AIDS virus)
• emtricitabine used to treat HIV or
hepatitis B infection
• cladribine, used to treat hairy
cell leukaemia
Tell your doctor if you’re being treated
with any of these.

Pregnancy and breast-feeding
Pregnancy

If you are pregnant, think you may be
pregnant, or are planning to have a baby:
Talk to your doctor about the risks and
benefits of taking lamivudine during
your pregnancy.
Do not stop treatment with lamivudine
without your doctor’s advice.

Breast-feeding

Lamivudine can pass into breast-milk.
If you are breast-feeding, or thinking
about breast-feeding:
Talk to your doctor before you
take Lamivudine.

Driving and using machines

Lamivudine may make you feel tired,
which could affect your ability to drive or
use machines.
Do not drive or use machines unless you
are sure you’re not affected.

TBC

Treatment with lamivudine can reduce
the amount of hepatitis B virus in your
body. This should lead to a reduction
in liver damage and an improvement
in your liver function. Not everyone
responds to treatment with lamivudine
in the same way. Your doctor will
monitor the effectiveness of your
treatment with regular blood tests.

Read the information ‘Other possible
side effects of therapy for Hepatitis B’
in Section 4 of this leaflet.

3. How to take Lamivudine
Always take this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are
not sure.

Stay in regular contact with
your doctor

Lamivudine helps to control your hepatitis
B infection. You need to keep taking it
every day to control your infection and
stop your illness getting worse.
Keep in touch with your doctor, and
don’t stop taking Lamivudine without
your doctor’s advice.

How much to take

The recommended dose of Lamivudine
is one tablet (100 mg lamivudine) once
a day.
Your doctor may prescribe a lower
dose if you have problems with your
kidneys. An oral solution of lamivudine
is available for people who need a
lower than usual dose, or who can’t
take tablets.
Talk to your doctor if this applies to you.
If you are already taking another
medicine that contains lamivudine for
HIV infection, your doctor will continue
to treat you with the higher dose,
(usually 150 mg twice a day), because
the dose of lamivudine in Lamivudine
(100 mg) is not enough to treat HIV
infection. If you are planning to change
your HIV treatment, discuss this change
with your doctor first.
Swallow the tablet whole, with some
water. Lamivudine can be taken with or
without food.

If you take more Lamivudine than
you should

Accidentally taking too much
Lamivudine is unlikely to cause any
serious problems. If you accidentally
take too much, tell your doctor or your
pharmacist, or contact your nearest
hospital emergency department for
further advice.
683010

Description Lamivudine 100 mg all
Component Type Leaflet

Pharma Code tbc

Affiliate Item Code 683010

SAP No. NA

Superceded Affiliate Item Code 640411
TrackWise PR No. 683010
MA No. 04569/1472
Packing Site/Printer NA

Vendor Job No. 260840
Trackwise Proof No. 3
Glams Proof No. NA
Client Market United Kingdom

Supplier Code 11300330 MI-01 Keyline/Drawing No. NA
Barcode Info NA

Date: 30 Oct 2015
No. of colours 1
Colours

Time: 15:42
Page Count 1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 155x520

Body Text Size 10.5 pt
Min Text Size used 10.5 pt

Sign-offs

v1/May 2015

If you forget to take Lamivudine

Lactic acidosis is caused by a build-up
of lactic acid in the body. It is rare; if
it happens, it usually develops after
a few months of treatment. It can be
life-threatening, causing failure of
internal organs.

If you stop taking Lamivudine

Lactic acidosis is more likely to develop
in people who have liver disease, or
in obese (very overweight) people,
especially women.

If you forget to take a dose, take it as
soon as you remember. Then continue
your treatment as before. Do not
take a double dose to make up for a
forgotten dose.
You must not stop taking Lamivudine
without consulting your doctor. There is
a risk of your hepatitis getting worse (see
‘Warnings and precautions’ in section 2).
When you stop taking this medicine
your doctor will monitor you for at least
four months to check for any problems.
This will mean taking blood samples to
check for any raised liver enzyme levels,
which may indicate liver damage.
If you have any further questions on the
use of this medicine, ask your doctor
or pharmacist.

4. Possible side effects
Like all medicines, this medicine
can cause side effects, although not
everybody gets them.
As well as the side effects listed below
for lamivudine, other conditions can
develop during therapy for hepatitis B.
It is important to read the information
under ‘Other possible side effects of
therapy for Hepatitis B’.
Side effects that were commonly
reported in lamivudine clinical trials
were tiredness, respiratory tract
infections, throat discomfort, headache,
stomach discomfort and pain, nausea,
vomiting and diarrhoea, increases in
liver enzymes and enzymes produced in
the muscles (see below).

Allergic reaction

These are rare (may affect up to 1 in
1,000 people). Signs include:
• sudden wheeziness and chest pain
or tightening
• swelling of eyelids, face or lips
• difficulty swallowing or breathing
Contact a doctor immediately if you
get these symptoms. Stop taking
Lamivudine.
Side effects thought to be caused by
lamivudine
A very common side effect (these may
affect more than 1 in 10 people) which
may show up in blood tests is:
• an increase in the level of some liver
enzymes (transaminases), which may
be a sign of inflammation or damage
in the liver.
A common side effect (these may affect
up to 1 in 10 people) is:
• cramps and muscle pains
• skin rash or ‘hives’ anywhere on
the body
A common side effect which may show
up in blood tests is:
• an increase in the level of an enzyme
produced in the muscles (creatine
phosphokinase) which may be a sign
that body tissue is damaged.

Other side effects

Other side effects have occurred in a
very small number of people but their
exact frequency is unknown
• breakdown of muscle tissue
• a worsening of liver disease after
lamivudine is stopped or during
treatment if the hepatitis B virus
becomes resistant to lamivudine. This
can be fatal in some people.
• lactic acidosis (see the next section,
‘Other possible side effects of therapy
for Hepatitis B’)
A side effect which may show up in
blood tests is:
• a decrease in the number of
cells involved in blood clotting
(thrombocytopenia).

If you get any side effects

Talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet.

Signs of lactic acidosis include:

 eep, rapid, difficult breathing
d
drowsiness
numbness or weakness in the limbs
feeling sick (nausea), being sick
(vomiting)
• stomach pain.





During your treatment, your doctor will
monitor you for signs of lactic acidosis.
If you have any of the symptoms listed
above, or any other symptoms that
worry you:
See your doctor as soon as possible.

Reporting of side effects

If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. You can also report side effects
directly via via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help
provide more information on the safety
of this medicine.

5. How to store Lamivudine
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the carton and
blister/bottle. The expiry date refers to
the last day of that month.
This medicinal product does not require
any special storage conditions.
Bottles only - After first opening, use
within 100 days.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.

6. Contents of the pack and
other information
What Lamivudine contains

The active substance is lamivudine.
Each film-coated tablet contains
100 mg lamivudine.
The other ingredients are
microcrystalline cellulose, sodium
starch glycolate, magnesium stearate,
hypromellose, titanium dioxide (E171),
propylene glycol, iron oxide yellow
(E172) and iron oxide red (E172).

What Lamivudine looks like and
contents of the pack

Lamivudine 100 mg film-coated tablets
are peach, film-coated, capsule shaped,
biconvex, bevelled edge tablets marked
with “LN1” on one side and “M” on the
other side.
Lamivudine 100 mg film-coated tablets
are available in blister packs of 28 or
84 tablets and bottles of 84 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan
Potters Bar,
Hertfordshire,
EN6 1TL,
United Kingdom

Manufacturer

McDermott Laboratories t/a Gerard
Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft, H-2900 Komárom,
Mylan utca 1, Hungary
This leaflet was last revised in
May 2015.

Other possible side effects of
therapy for Hepatitis B

Lamivudine and related medicines
(NRTIs) may cause other conditions to
develop during hepatitis B treatment.

Lactic acidosis is a rare but serious
side effect

Some people taking Lamivudine, or
other medicines like it (NRTIs), develop a
condition called lactic acidosis, together
with an enlarged liver.

683010
11300330 MI-01

Description Lamivudine 100 mg all
Component Type Leaflet

Pharma Code tbc

Affiliate Item Code 683010

SAP No. NA

Superceded Affiliate Item Code 640411
TrackWise PR No. 683010
MA No. 04569/1472
Packing Site/Printer NA

Vendor Job No. 260840
Trackwise Proof No. 3
Glams Proof No. NA
Client Market United Kingdom

Supplier Code 11300330 MI-01 Keyline/Drawing No. NA
Barcode Info NA

Date: 30 Oct 2015
No. of colours 1
Colours

Time: 15:42
Page Count 2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 155x520

Body Text Size 10.5 pt
Min Text Size used 10.5 pt

Sign-offs

v1/May 2015

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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