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LAMIVUDINE SANDOZ 100 MG FILM COATED TABLETS

Active substance(s): LAMIVUDINE

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Package leaflet: Information for the user

SZ00000LT000

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 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 drug that suppresses the hepatitis B virus and Lamivudine 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 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.

2

What you need to know before you take Lamivudine

Do not take Lamivudine:
• if you are allergic (hypersensitive) to lamivudine or to any of the other
ingredients of this medicine (listed in section 6).
Check with your doctor if you think this applies to you.
Take special care with 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 youʼre seriously overweight (especially if youʼre a woman).

Talk to your doctor if any of these apply to you. You may need extra
check-ups, including blood tests, while youʼre taking your medication. See
Section 4 for more information.

Donʼt stop taking Lamivudine without your doctorʼs 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 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 while youʼre taking Lamivudine.

Read the information ʻOther possible side effects of therapy for
Hepatitis Bʼ 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 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.
• Donʼt risk blood transfer — for example, donʼt share needles.

There is an effective vaccine available to protect those at risk from
becoming infected with hepatitis B virus.

Other medicines and Lamivudine
Tell your doctor or pharmacist if youʼre taking any other medicines, or
if youʼve taken any 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 youʼre taking Lamivudine.

These medicines should not be used with Lamivudine:
• zalcitabine or 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 youʼre being treated with any of these.
Pregnancy
If you are pregnant, if you become pregnant, or if youʼre planning to
become pregnant:
Talk to your doctor immediately about the risks and benefits of taking
Lamivudine during your pregnancy.
Do not stop treatment with Lamivudine without your doctorʼs advice.

Breast-feeding
The ingredients in 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 is unlikely to affect your ability to drive or use machines.

Lamivudine contains 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.

3

How to take Lamivudine

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

Swallow the tablet whole, with some water. Lamivudine can be taken with
or without food.

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 donʼt stop taking Lamivudine
without your doctorʼs advice.

How much to take
The usual 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 canʼt 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.
If you take too much Lamivudine
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. Donʼt take a double dose to make up for
a missed dose.

Donʼt stop taking Lamivudine
You must not stop taking Lamivudine without consulting your doctor. There
is a risk of your hepatitis getting worse (see ʻTake special care with
Lamivudineʼ in section 2).

Continued on the next page >>

4

Possible side effects

Like all medicines, this medicine can cause side effects, but not everyone
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 ʻOther possible side effects of
therapy for hepatitis Bʼ.

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. Signs include:
• sudden wheeziness and chest pain or tightening
• swelling of eyelids, face or lips
• skin rash or ʻhivesʼ anywhere on the body.
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.

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, ʻOther possible side effects of
therapy for Hepatitis Bʼ).

A side effect which may show up in blood tests is:
• a decrease in the number of cells involved in blood clotting
(thrombocytopenia).

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 (www.mhra.gov.uk/yellowcard). By reporting side
effects you can help provide more information on the safety of this
medicine.

6

Contents of the pack and other information

What Lamivudine contains
The active substance is lamivudine. Each tablet contains 100 mg of
lamivudine.

The other ingredients are: isomalt (E953), crospovidone Type A,
magnesium stearate (E572), hypromellose 6cp (E464), titanium dioxide
(E171), macrogol 400, polysorbate 80 (E433), iron oxide red (E172), iron
oxide yellow (E172).

What Lamivudine looks like and contents of the pack
Lamivudine 100 mg film-coated tablets
Pink capsule shaped, biconvex, film coated tablets with a dimension of
12 x 6 mm, debossed with '37' on one side and 'I' on the other side.

Alu-Alu blister pack: 14, 28, 30, 56, 60, 84, 90 and 120 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR,
UK.

Manufacturer
Lek Pharmaceuticals d.d.,
Verovškova 57, 1526 Ljubljana,
Slovenia
Or

Lek S.A.,
ul. Podlipie 16, 95-010 Strykow,
Poland
Or

Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben,
Germany
Or

S.C. Sandoz, S.R.L.,
Str. Livezeni nr. 7A, RO-540472 Targu-Mures,
Romania
This leaflet was last revised in 05/2013.

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.

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:
• deep, rapid, difficult breathing
• 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.

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 label
and carton after EXP (month, year).
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions

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.

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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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