Package leaflet: Information for the user

Lamivudine/Zidovudine 150 mg/300 mg film-coated tablets

lamivudine/zidovudine

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/Zidovudine is and what it is used for

2.    What you need to know before you take Lamivudine/Zidovudine

3.    How to take Lamivudine/Zidovudine

4.    Possible side effects

5.    How to store Lamivudine/Zidovudine

6.    Contents of the pack and other information

1. What Lamivudine/Zidovudine is and what it is used for

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

Lamivudine/Zidovudine contains two active ingredients that are used to treat HIV infection: lamivudine and zidovudine. Both of these belong to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

Lamivudine/Zidovudine 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/Zidovudine in the same way. Your doctor will monitor the effectiveness of your treatment.

2. What you need to know before you take Lamivudine/Zidovudine

Do not take Lamivudine/Zidovudine:

•    if you are allergic to lamivudine or zidovudine, or any of the other ingredients of this medicine (listed in section 6).

•    if you have a very low red blood cell count (anaemia) or a very low white blood cell count (neutropenia).

Check with your doctor if you think any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lamivudine/Zidovudine.

Some people taking Lamivudine/Zidovudine 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/Zidovudine without your doctor’s advice, as your hepatitis may come back)

•    if you have kidney disease

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

•    if you’re diabetic and using insulin.

Talk to your doctor if any of these apply to you. Your doctor will decide if the active substances are suitable for 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/Zidovudine.

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/Zidovudine 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/Zidovudine 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/Zidovudine.

These medicines should not be used with Lamivudine/Zidovudine:

•    other medicinal products containing lamivudine, to treat HIV infection or hepatitis B infection

•    emtricitabine, to treat HIV infection

•    stavudine or zalcitabine, to treat HIV infection

•    ribavirin, or injections of ganciclovir to treat viral infections

•    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.

Some medicines can make it more likely that you’ll have side effects, or make side effects worse. These include:

•    sodium valproate, to treat epilepsy

•    interferon, to treat viral infections

•    pyrimethamine, to treat malaria and other parasitic infections

•    dapsone, to prevent pneumonia and treat skin infections

•    fluconazole or flucytosine, to treat fungal infections such as candida

•    pentamidine or atovaquone to treat parasitic infections such as PCP

•    amphotericin or co-trimoxazole, to treat fungal and bacterial infections

•    probenecid, to treat gout and similar conditions, and given with some antibiotics to make them more effective

•    methadone, used as a heroin substitute

•    vincristine, vinblastine or doxorubicin, to treat cancer Tell your doctor if you’re taking any of these.

Some medicines interact with Lamivudine/Zidovudine

These include:

•    clarithromycin, an antibiotic

if you’re taking clarithromycin, take your dose at least 2 hours before or after you take your Lamivudine/Zidovudine.

•    phenytoin, for treating epilepsy

Tell your doctor if you’re taking phenytoin. Your doctor may need to monitor you while you’re taking Lamivudine/Zidovudine.

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 or pharmacist for advice before taking this medicine.

Pregnancy

Lamivudine/Zidovudine and similar medicines may cause side effects in unborn babies. If you become pregnant while you’re taking Lamivudine/Zidovudine, 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/Zidovudine) 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/Zidovudine can make you dizzy and have other side effects that make you less alert.

Don’t drive or operate machines unless you’re feeling well.

3. How to take Lamivudine/Zidovudine

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 Lamivudine/Zidovudine tablets, with some water. Lamivudine/Zidovudine 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/Zidovudine 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/Zidovudine without your doctor’s advice.

How much to take

Adults and adolescents 30 kg or more

The usual dose of Lamivudine/Zidovudine is one tablet twice a day.

Take the tablets at regular times, leaving approximately 12 hours between each tablet.

Children who weigh between 21 and 30 kg

The usual starting dose of Lamivudine/Zidovudine is one half tablet (%) taken in the morning and one whole tablet taken in the evening.

Children who weigh between 14 and 21 kg

The usual starting dose of Lamivudine/Zidovudine is one half tablet (%) taken in the morning and one half tablet (%) taken in the evening.

For children who weigh less than 14 kg lamivudine and zidovudine (the ingredients of Lamivudine/Zidovudine) should be taken separately.

If you take more Lamivudine/Zidovudine than you should

If you accidentally take too much Lamivudine/Zidovudine, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.

If you forget to take Lamivudine/Zidovudine

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/Zidovudine or other medicines you’re 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/Zidovudine, 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’.

Very common side effects

These may affect more than than 1 in 10 people:

•    headache

•    feeling sick (nausea)

Common side effects

These may affect up to 1 in 10 people:

•    being sick (vomiting)

•    diarrhoea

•    stomach pains

•    loss of appetite

•    feeling dizzy

•    tiredness, lack of energy

•    fever (high temperature)

•    general feeling of being unwell

•    difficulty in sleeping (insomnia)

•    muscle pain and discomfort

•    joint pain

•    cough

•    irritated or runny nose

•    skin rash

•    hair loss (alopecia)

Common side effects that might show up in blood tests are:

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

•    an increase in the level of liver enzymes

•    an increased amount in the blood of bilirubin (a substance produced in the liver) which may make your skin appear yellow.

Uncommon side effects

These may affect up to 1 in 100 people:

•    feeling breathless

• wind (flatulence)

•    itching

•    muscle weakness

An uncommon side effect that may show up in blood test is:

•    a decrease in the number of cells involved in blood clotting (thrombocytopenia) or in all kinds of blood cells (pancytopenia).

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

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

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

•    inflammation of the pancreas (pancreatitis)

•    chest pain; disease of the heart muscle (cardiomyopathy)

• fits (convulsions)

•    feeling depressed or anxious, not being able to concentrate, feeling drowsy

•    indigestion, taste disturbance

•    changes in the colour of your nails, your skin or the skin inside your mouth

•    a flu-like feeling - chills and sweating

•    tingly feelings in the skin (pins and needles)

•    sensation of weakness in the limbs

•    breakdown of muscle tissue

•    numbness

•    passing urine more often

•    enlarged breasts in men

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

•    an increase in an enzyme called amylase

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

Very rare side effects

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

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

•    a failure of the bone marrow to produce new red or white blood cells (aplastic anaemia).

If you get side effects

Tell your doctor or pharmacist if any of the side effects get 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 such as Lamivudine/Zidovudine 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/Zidovudine:

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/Zidovudine, 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/Zidovudine

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the label, carton, and blister after EXP. The expiry date refers to the last day of that month.

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/Zidovudine contains

-    The active substances are lamivudine and zidovudine. Each film-coated tablet contains lamivudine 150 mg and zidovudine 300 mg.

-    The other ingredients are

Tablet core: Cellulose microcrystalline, sodium starch glycolate (Type A), silica colloidal anhydrous, magnesium Stearate Tablet film-coat: Hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80.

What Lamivudine/Zidovudine looks like and contents of the pack

Film-coated tablet.

White to off-white modified capsule-shaped, biconvex film-coated tablets with deep break line in between ‘J’ and ’59 on one side and break line on other side. The tablet can be divided into equal doses.

Lamivudine/Zidovudine film-coated tablets are available in PVC/PVdC- Aluminium foil blisters and HDPE bottle with polypropylene closures. Each pack type contains 60 film-coated tablets.

Marketing Authorisation Holder

Milpharm Limited

Ares Block, Odyssey Business Park West End Road 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 Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom

This leaflet was last revised in 11/2013.