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Lamivudine Hetero 150 Mg Film-Coated Tablets

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PACKAGE LEAFLET

Package leaflet: Information for the user

Lamivudine 150 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.

What is in this leaflet:

1.    What Lamivudine 150 mg is and what it is used for

2.    What you need to know before you take Lamivudine 150 mg

3.    How to take Lamivudine 150 mg

4.    Possible side effects

5.    How to store Lamivudine 150 mg

6.    Contents of the pack and other information

1. What Lamivudine 150 mg is and what it is used for

Lamivudine 150 mg is used to treat HIV (human immunodeficiency virus) infection in adults and children.

The active ingredient in Lamivudine 150 mg is lamivudine. Lamivudine 150 mg 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 150 mg 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 Lamivudine 150 mg in the same way. Your doctor will monitor the effectiveness of your treatment.

2. What you need to know before you take Lamivudine 150 mg Do not take Lamivudine 150 mg:

if you are allergic 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lamivudine 150 mg.

Some people taking Lamivudine 150 mg 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 150 mg 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 or your child has 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 150 mg.

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 150 mg 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 150 mg

Some medicines may affect the action of Lamivudine 150 mg. Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

Remember to tell your doctor or pharmacist if you begin taking a new medicine while you’re taking Lamivudine 150 mg.

These medicines should not be used with Lamivudine 150 mg:

•    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 and breast-feeding

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 150 mg.

Lamivudine 150 mg and similar medicines may cause side effects in unborn babies. If you become pregnant while you’re taking Lamivudine 150 mg, 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 150 mg) 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 150 mg 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 150 mg

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

Swallow the tablets, with some water. Lamivudine 150 mg can be taken with or without food.

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

Stay in regular contact with your doctor

Lamivudine 150 mg 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 150 mg without your doctor’s advice.

How much to take

Adults and children who weigh at least 30 kg:

The usual dose of Lamivudine 150 mg is 300 mg a day to be taken as:

•    one 150 mg tablet twice a day, approximately 12 hours apart

Children weighing 21 - 30 kg

•    one half (%) of an Lamivudine 150 mg tablet (75 mg) in the morning, and

•    one whole Lamivudine 150 mg tablet (150 mg) in the evening.

Children weighing 14 - 21 kg

• one half (%) of an Lamivudine 150 mg tablet (75 mg) in the morning, and

• one half (%) of an Lamivudine 150 mg tablet (75 mg) in the evening.

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 or your child has a kidney problem, your dose may be altered.

Talk to your doctor if this applies to you or your child.

If you take more Lamivudine 150 mg than you should

Accidentally taking too much Lamivudine 150 mg 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 150 mg

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.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. Y ou 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.

When you’re being treated for HIV, it can be hard to tell whether a symptom is a side effect of Lamivudine 150 mg 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 150 mg, 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, ‘Other possible 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:

•    an 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 150 mg 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. If you get any symptoms of infection while you’re taking Lamivudine 150 mg:

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 150 mg, 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).

5. How to store Lamivudine 150 mg

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pack. Do not use this medicine after three months of first opening the HDPE container.

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 150 mg contains

The active substance is lamivudine. Each film-coated tablet contains 150 mg of lamivudine.

The other ingredients are: isomalt (E953), crospovidone A, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80 (E433).

What Lamivudine 150 mg looks like and contents of the pack

Lamivudine 150 mg film-coated tablets are supplied in Alu/PVC-Alu-OPA blister pack containing 60 tablets and in HDPE container with child resistant polypropylene cap containing 60 tablets.

The tablets are White capsule shaped, biconvex scored film coated tablets with a dimension of 15.00 x 6.50 mm, debossed with J on one side and 16 on the other side, 1 and 6 separated by a score line.

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

This medicinal

Germany:

Hungary:

Italy:

Netherlands:

Spain:

UK:


product is authorised in the Member States of the EEA under the following names: Lamivudin Hetero 150 mg Filmtabletten Lamivudine HSPT 150 mg tabletta Lamivudina Hetero

Lamivudine Hetero 150 mg, filmomhulde tabletten

Lamivudina Hetero 150 mg, comprimidos recubiertos con pelicula EFG

Lamivudine 150 mg Film-coated tablets

This leaflet was last revised in 05/2013.

Detailed information on this medicine is available on the web site of Medicines and Healthcare Products Regulatory Agency (www.mhra.gov.uk).