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Lamivudine Sandoz 100 Mg Film Coated Tablets

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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


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 you’re being treated with any of these.

Pregnancy

If you are pregnant, if you become pregnant, or if you’re 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 doctor’s 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.


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 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.

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 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 you’re taking Lamivudine.

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 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.

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 you’re taking any other medicines, or

if you’ve 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 you’re taking Lamivudine.


3 How to take Lamivudine


Always take this medicine exactly as your doctor has told you to.

Check with your doctor or pharmacist if you’re 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 don’t stop taking Lamivudine

without your doctor’s 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 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.

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. Don’t take a double dose to make up for a missed dose.

Don’t stop taking Lamivudine

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


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 ‘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 very rare in people taking Lamivudine. Signs include:

•    sudden wheeziness and chest pain or tightening

•    swelling of eyelids, face or lips

•    skin rash or ‘hives’ 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, ‘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).

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.

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.


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 12x6 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.,

Verovskova 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.


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.


SZ00000LT000