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LAMIVUDINE HETERO 100 MG FILM-COATED TABLETS

Active substance(s): LAMIVUDINE

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Always take this medicine exactly as your doctor has told you to. Check with your
doctor or pharmacist if you are not sure.
Swallow the tablet whole, with some water. Lamivudine tablets can be taken with or
without food.
Stay in regular contact with your doctor
Lamivudine tablets help 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 tablets without
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How much to take
The usual dose of Lamivudine tablets 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
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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 tablets (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.

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 pack.
This medicinal product does not require any special storage conditions
Do not throw away any medicines wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help to protect the
environment.

6. Contents of the pack and other information
What Lamivudine tablets contain
The active substance is lamivudine. Each film-coated tablet contains 100 mg of lamivudine.
The other ingredients are: isomalt (E953), crospovidone A, magnesium stearate (E572),
hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80 (E433), red
and yellow iron oxides (E172).
What Lamivudine tablets looks like and contents of the pack
Lamivudine film-coated tablets are supplied in Alu/PVC-Alu-OPA blister pack containing
28 and 84 tablets.
The tablets are pink capsule shaped, biconvex, film coated tablets with a dimension of
12.00 x 6.00 mm, debossed with '37' on one side and 'I' on the other side.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Hetero Europe S.L., Viladecans Business Park – Edificio Brasil, Catalunya 83-85,
08840 Viladecans (Barcelona), Spain
Manufacturer
Pharmadox Healthcare Ltd., KW 20A - Kordin Industrial Park, PLA 3000 Paola, Malta
Distributed by
Creo Pharma, Felsted Business Centre, Felsted, Dunmow, Essex CM6 3LY
This leaflet was last revised in 07/2013.
Detailed information on this medicine is available on the web site of Medicines and
Healthcare Products Regulatory Agency (www.mhra.gov.uk).

Typefaces
Myriad Pro, 9 / 10 pt
Artwork prepared by David Heaton +44 (0)1462 4312777 dc.heaton@ntlworld.com

3. How to take Lamivudine tablets

5. How to store Lamivudine tablets

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Black

Do not take Lamivudine tablets:
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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 tablets.
Some people taking Lamivudine tablets or other similar medicines are more at risk of
serious side effects. You need to be aware of the extra risks:
t JGZPVIBWFFWFSIBEPUIFSUZQFTPGliver disease, such as hepatitis C
t JGZPVSFTFSJPVTMZoverweight FTQFDJBMMZJGZPVSFBXPNBO

Talk to your doctor if any of these apply to you. You may need extra check-ups,
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information.
Don’t stop taking Lamivudine tabletsXJUIPVUZPVSEPDUPSTBEWJDF BTUIFSFJTBSJTLPG
your hepatitis getting worse. When you stop taking Lamivudine tablets your doctor will
monitor you for at least the following four months to check for any problems. This will
mean taking blood samples to check for any abnormal liver enzymes, indicating liver
damage.
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
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Read the information “Other possible side effects of therapy for Hepatitis B” in
section 4 of this leaflet.
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 tablets
will not stop you passing hepatitis B infection on to other people. To protect other people
from becoming infected with hepatitis B:
t Use a condom when you have oral or penetrative sex.
t Don’t risk blood transferoGPSFYBNQMF EPOUTIBSFOFFEMFT
There is an effective vaccine available to protect those at risk from becoming infected with
hepatitis B virus.
Other medicines and Lamivudine tablets
Tell your doctor or pharmacist if you’re taking any other medicines PSJGZPVWFUBLFOBOZ
recently, 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
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These medicines should not be used with Lamivudine tablets:
t [BMDJUBCJOFPSMBNJWVEJOF VTFEUPUSFBUHIV infection (sometimes called the AIDS virus)
t FNUSJDJUBCJOFVTFEUPUSFBUHIV or hepatitis B infection
t DMBESJCJOF VTFEUPUSFBUhairy cell leukaemia
Tell your doctorJGZPVSFCFJOHUSFBUFEXJUIBOZPGUIFTF
Pregnancy and breast-feeding:
Pregnancy
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Talk to your doctor immediately about the risks and benefits of taking Lamivudine
tablets during your pregnancy.
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Breast-feeding
The ingredients in Lamivudine tablets can pass into breast-milk. If you are breast-feeding,
or thinking about breast-feeding:
Talk to your doctor before you take Lamivudine tablets.
Driving and using machines:
Lamivudine tablets are unlikely to affect your ability to drive or use machines.
Lamivudine tablets contain Isomalt
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.

Job No. CRE-LMV-PIL-080

2. What you need to know before you take Lamivudine tablets

1

Lamivudine is used to treat long term (chronic) hepatitis B infection in adults.
The active ingredient in Lamivudine tablets is lamivudine. Lamivudine is an antiviral drug
that suppresses the hepatitis B virus infection and belongs to a group 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 tablets can be used in people whose liver is damaged,
but still functions normally (compensated liver disease) and in people whose liver is
damaged and does not function normally (decompensated liver disease).
Treatment with Lamivudine tablets 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 tablets in the same way.
Your doctor will monitor the effectiveness of your treatment.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As well as the side effects listed below for Lamivudine tablets, other conditions can
develop during 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 very rare in people taking Lamivudine tablets. Signs include:
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Contact a doctor immediately if you get these symptoms. Stop taking Lamivudine
tablets.
Side effects thought to be caused by Lamivudine tablets
A very common side effect (these may affect more than 1 in 10 people) which may show
up in blood tests is:
t BOJODSFBTFJOUIFMFWFMPGTPNFMJWFSFO[ZNFT 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:
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A common side effect which may show up in blood tests is:
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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
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the hepatitis B virus becomes resistant to Lamivudine tablets. This can be fatal in some
people.
t MBDUJDBDJEPTJT TFFUIFOFYUTFDUJPO iOther possible side effects of therapy for Hepatitis B”)
A side effect which may show up in blood tests is;
t BEFDSFBTFJOUIFOVNCFSPGDFMMTJOWPMWFEJOCMPPEDMPUUJOH thrombocytopenia).
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
(www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more
information on the safety of this medicine.
If you get any side effects
Talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet.
Other possible side effects of therapy for Hepatitis B
Lamivudine tablets 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 tablets, or other medicines like it (NRTIs), develop a
condition called lactic acidosis, together with an enlarged liver.
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.
Lactic acidosis is more likely to develop in people who have liver disease, or in obese (very
overweight) people, especially women.
Signs of lactic acidosis include:
t deep, rapid, difficult breathing
t drowsiness
t numbness or weakness in the limbs
t feeling sick (nausea), being sick (vomiting)
t 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.

No of Colours

1. What Lamivudine is and what it is used for

4. Possible side effects

Important
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In this leaflet:
1. What Lamivudine is and what it is used for
2. What you need to know before you take Lamivudine tablets
3. How to take Lamivudine tablets
4. Possible side effects
5. How to store Lamivudine tablets
6. Contents of the pack and other information

No. of Draft Date
Reason for Draft
_01
21/05/2013 New file
_02
17/07/2013 Text revisions
_03
_04

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.

Date
21/05/2013
Client Creo Pharma
Country UK

lamivudine

If you take more Lamivudine tablets than you should
Accidentally taking too much Lamivudine tablets 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 tablets
If you forget to take a dose, take it as soon as you remember. Then continue your treatment
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If you stop taking Lamivudine tablets
You must not stop taking Lamivudine tablets without consulting your doctor. There is a risk
of your hepatitis getting worse (see “Warnings and precautions” in section 2).
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

Lamivudine
100 mg
130 x 480 mm

Lamivudine 100 mg Film-coated tablets

Product Title
Strength
PIL Format

Package leaflet: Information for the user

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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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