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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
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.
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).
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.

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.
Do not 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.

Description Lamivudine 100 mg 28,84

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.
• Do not risk blood transfer - for
example, do not 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:

• other 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.

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 do not 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.
968647

Date: 09 Aug 2017

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 968647

SAP No. N/A

Colours

Superceded Affiliate Item Code 683010
TrackWise PR No. 968647
MA No. 04569/1472

Vendor Job No. 288658
Trackwise Proof No. 5
Client Market United Kingdom

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

1

Time: 18:15
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 155 x 520 mm

Body Text Size 11 pt
Min Text Size used 11 pt

Sign-offs

v2/Oct 2016

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.

If you forget to take Lamivudine

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.

If you stop taking Lamivudine

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.
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).

If you notice any of the following
side effects, stop taking
lamivudine and contact your
doctor immediately:
Rare (may affect up to 1 in
1,000 people):
• swelling of eyelids, face, mouth,
lips, tongue or throat causing
difficulty breathing or swallowing
(angioedema) and possibly with
sudden wheeziness and chest pain or
tightening (allergic reaction)
Very rare (may affect up to 1 in
10,000 people):
• deep, rapid, difficult breathing,
drowsiness, numbness or weakness
in the limbs, feeling sick (nausea),
being sick (vomiting) and stomach
pain. These may be signs of
excess lactic acid in the blood
(lactic acidosis)
Not known (frequency cannot be
estimated from the available data):
• breakdown of muscle tissue with
symptoms that may include muscle
pains, vomiting and confusion
(rhabdomyolysis)
• 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.
• a decrease in the number of
cells involved in blood clotting
(thrombocytopenia) resulting in
bleeding or bruising more easily
than normal, which may show up in
blood tests

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

Manufacturers

McDermott Laboratories Limited t/a
Gerard Laboratories
35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
Mylan Hungary Kft
Mylan utca 1, 2900 Komárom, Hungary

This leaflet was last revised in
August 2017.

Other side effects:

Very common (may affect more than
1 in 10 people):
• an increase in the level of some liver
enzymes (transaminases), which
may show up in blood tests and be
a sign of inflammation or damage in
the liver
Common (may affect up to 1 in
10 people):
• cramps and muscle pains
• skin rash or ‘hives’ anywhere on
the body
• an increase in the level of an enzyme
produced in the muscles (creatine
phosphokinase), which may show
up in blood tests and be a sign that
body tissue is damaged
968647

Description Lamivudine 100 mg 28,84

Date: 09 Aug 2017

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 968647

SAP No. N/A

Colours

Superceded Affiliate Item Code 683010
TrackWise PR No. 968647
MA No. 04569/1472

Vendor Job No. 288658
Trackwise Proof No. 5
Client Market United Kingdom

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code N/A

Barcode Info N/A

1

Time: 18:15
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 155 x 520 mm

Body Text Size 11 pt
Min Text Size used 11 pt

Sign-offs

v2/Oct 2016

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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