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PACKAGE LEAFLET: INFORMATION FOR THE USER

Lamivudine 300 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 HIV (human immunodeficiency virus) infection in adults and children.

The active ingredient in Lamivudine is lamivudine. Lamivudine is a type of medicine known as an anti-retroviral. It belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

Lamivudine does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection.

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 to lamivudine or any of the other ingredients of Lamivudine (listed in section 6).

Check with your doctor if you think this applies to you.

Warnings and precautions

Some people taking Lamivudine or other combination treatments for HIV are more at risk of serious side effects. You need to be aware of the extra risks:

•    if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, don’t stop Lamivudine without your doctor’s advice, as your hepatitis may come back)

•    if you’re seriously overweight (especially if you’re a woman)

•    if you’re diabetic and using insulin

•    if you have a kidney problem, your dose may be altered.

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 medicine. See Section 4 for more information.

Look out for important symptoms

Some people taking medicines for HIV 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 combination therapy for HIV’ in Section 4 of this leaflet.

Protect other people

HIV 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 HIV infection on to other people. To protect other people from becoming infected with HIV:

•    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 any other medicines, or if you have 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.

These medicines should not be used with Lamivudine:

•    other medicines containing lamivudine, (used to treat HIV infection or hepatitis B infection)

•    emtricitabine (used to treat HIV infection)

•    high doses of co-trimoxazole, an antibiotic.

•    cladribine (used to treat hairy cell leukaemia)

Tell your doctor if you’re being treated with any of these.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

If you are pregnant, if you become pregnant, or are planning to become pregnant, talk to your doctor about the risks and benefits to you and your baby of taking Lamivudine.

Lamivudine and similar medicines may cause side effects in unborn babies. If you become pregnant while you’re taking Lamivudine, your baby may be given extra check-ups (including blood tests) to make sure it is developing normally.

Children whose mothers took NRTIs (medicines like Lamivudine) during pregnancy had a reduced risk of being infected with HIV.

This benefit is greater than the risk of having side effects.

Breast-feeding

Women who are HIV-positive must not breast-feed, because HIV infection can be passed on to the baby in breast milk.

If you’re breast-feeding, or thinking about breast-feeding:

Talk to your doctor immediately.

Driving and using machines

Lamivudine is unlikely to affect your ability to drive or use machines.

3. How to take Lamivudine

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Swallow the tablet, with some water. Lamivudine can be taken with or without food.

If you cannot swallow the tablet whole, you may crush and combine with a small amount of food or drink, and take all the dose immediately.

Stay in regular contact with your doctor

Lamivudine helps to control your condition. You need to keep taking it every day to stop your illness getting worse. You may still develop other infections and illnesses linked to HIV infection.

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 for adults and children who weigh at least 30 kg is:

• one tablet once a day.

An oral solution is also available for the treatment of children over 3 months of age, or for people who need a lower dose than usual, or who can’t take tablets.

If you have a kidney problem, your dose may be altered.

Talk to your doctor if this applies to you.

If you take more Lamivudine than you should

Accidentally taking too much Lamivudine is unlikely to cause any serious problems. If you 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 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.

When you’re being treated for HIV, it can be hard to tell whether a symptom is a side effect of Lamivudine or other medicines you are taking, or an effect of the HIV disease itself. So it is very important to talk to your doctor about any changes in your health.

As well as the side effects listed below for Lamivudine, other conditions can develop during combination therapy for HIV.

It is important to read the information later in this section under ‘Other possible side effects of combination therapy for HIV’.

Common side effects

These may affect up to 1 in 10 people:

•    headache

•    feeling sick (nausea)

•    being sick (vomiting)

•    diarrhoea

•    stomach pains

•    tiredness, lack of energy

•    fever (high temperature)

•    general feeling of being unwell

•    muscle pain and discomfort

•    joint pain

•    difficulty in sleeping (insomnia)

•    cough

•    irritated or runny nose

•    rash

•    hair loss (alopecia).

Uncommon side effects

These may affect up to 1 in 100 people:

Uncommon side effects that may show up in blood tests are:

•    a decrease in the number of cells involved in blood clotting (thrombocytopenia)

•    a low red blood cell count (anaemia) or low white blood cell count (neutropenia)

•    an increase in the level of liver enzymes.

Rare side effects

These may affect up to 1 in 1000 people:

•    serious allergic reaction causing swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing

•    lactic acidosis (see the next section, ‘Otherpossible side effects of combination therapy for HIV)

•    inflammation of the pancreas (pancreatitis)

•    breakdown of muscle tissue

•    liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis).

A rare side effect that may show up in blood tests is:

•    increase in an enzyme called amylase.

Very rare side effects

These may affect up to 1 in 10,000 people:

•    tingling or numbness of the arms, legs, hands or feet.

A very rare side effect that may show up in blood tests is:

•    a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).

If you get side effects

Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.

Other possible side effects of combination therapy for HIV

Combination therapy including Lamivudine may cause other conditions to develop during HIV treatment.

Old infections may flare up

People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are probably caused by the body’s immune system becoming stronger, so that the body starts to fight these infections.

In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.

If you get any symptoms of infection while you’re taking Lamivudine:

Tell your doctor immediately. Don’t take other medicines for the infection without your doctor’s advice.

Your body shape may change

People taking combination therapy for HIV may find that their body shape changes, because of changes in fat distribution:

•    Fat may be lost from the legs, arms or face.

•    Extra fat may build up around the tummy (abdomen), or on the breasts or internal organs.

•    Fatty lumps (sometimes called buffalo hump) may appear on the back of the neck.

It is not yet known what causes these changes, or whether they have any long-term effects on your health. If you notice changes in your body shape:

Tell your doctor.

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.

You may have problems with your bones

Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone. People may be more likely to get this condition:

•    if they have been taking combination therapy for a long time

•    if they are also taking anti-inflammatory medicines called corticosteroids

•    if they drink alcohol

•    if their immune systems are very weak

•    if they are overweight.

Signs of osteonecrosis include:

•    stiffness in the joints

•    aches and pains (especially in the hip, knee or shoulder)

•    difficulty moving.

If you notice any of these symptoms:

Tell your doctor.

Other effects may show up in blood tests

Combination therapy for HIV can also cause:

•    increased levels of lactic acid in the blood, which on rare occasions can lead to lactic acidosis

•    increased levels of sugar and fats (triglycerides and cholesterol) in the blood

•    resistance to insulin (so if you’re diabetic, you may have to change your insulin dose to control your blood sugar).

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

The United Kingdom

Yellow Card Scheme Website:www.mhra.gov.uk/yellowcard

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. The expiry date refers to the last day of that month.

Store below 30⁰C.

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 300 mg of lamivudine.

-    The other ingredients are:

Tablet core: Microcrystalline cellulose (E460), sodium starch glycolate (Type A), magnesium stearate (E572)

Film-coat: Hypromellose (E464), macrogol 400, titanium dioxide (E171), polysorbate 80 (E433) and iron oxide black (E172).

What Lamivudine looks like and contents of the pack

Film-coated tablet

Grey, film coated, diamond shaped tablets, debossed with ‘Z26’ on one side and plain on the other side.

Lamivudine film-coated tablets are available in clear PVC/Aclar -Aluminium blister packs and HDPE bottle packs with polypropylene closure.

Blister pack: 1, 14, 30, 60, 120 and 500 tablets Bottle pack: 30 and 500 tablets.

Marketing Authorisation Holder

Milpharm Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom

Manufacturer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta

or

Milpharm Limited Ares, Odyssey Business Park West End Road South Ruislip HA4 6QD United Kingdom

This leaflet was last revised in 11/2013.