The final size is 314 X 400

P18-1055R/10

000647

Package leaflet: Information for the user

Abacavir/Lamivudine PharOS 600 mg/300 mg film-coated tablets

abacavir/lamivudine

Pregnancy

Abacavir/Lamivudine PharOS is not recommended for use during pregnancy. Abacavir/Lamivudine PharOS and similar medicines may cause side effects in unborn babies. If you become pregnant while you are taking Abacavir/ Lamivudine PharOS, your baby may be given extra check-ups (including blood tests) to make sure it is developing normally.

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, pharmacist or nurse.

-    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

IMPORTANT — Hypersensitivity reactions

Abacavir/Lamivudine PharOS contains abacavir (which is also an active substance in other related medicines). Some people who take abacavir may develop a hypersensitivity reaction (a serious allergic reaction), which can be life-threatening if they continue to take abacavir containing products.

You must carefully read all the information under ‘Hypersensitivity reactions’ in the panel in Section 4.

The Abacavir/Lamivudine PharOS pack includes an Alert Card, to remind you and medical staff about abacavir hypersensitivity. Detach this card and keep it with you at all times.

What is in this leaflet

1.    What Abacavir/Lamivudine PharOS is and what it is used for

2.    What you need to know before you take Abacavir/Lamivudine PharOS

3.    How to take Abacavir/Lamivudine PharOS

4.    Possible side effects

5.    How to store Abacavir/Lamivudine PharOS

6.    Contents of the pack and other information

1. What Abacavir/Lamivudine PharOS is and what it is used for

Abacavir/Lamivudine PharOS is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents and in children weighing at least 25 kg.

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

Abacavir/Lamivudine PharOS 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.

If you are pregnant, if you become pregnant, or if you are planning to become pregnant:

Talk to your doctor immediately about the risks and benefits of taking Abacavir/Lamivudine PharOS, or other medicines for treating HIV infection, during your pregnancy.

Breast-feeding

Women who are HIV-positive must not breast-feed, because HIV infection can be passed on to the baby in breast milk. A small amount of the ingredients in Abacavir/Lamivudine PharOS can also pass into your breast milk.

If you are breast-feeding, or thinking about breast-feeding:

Talk to your doctor immediately.

Driving and using machines

Abacavir/Lamivudine PharOS may cause side effects which could affect your ability to drive or use machines.

Talk to your doctor about your ability to drive or operate machines while taking Abacavir/Lamivudine PharOS.

Important information about some of the other ingredients of Abacavir/Lamivudine PharOS tablets

Abacavir/Lamivudine PharOS contains a colouring called sunset yellow Aluminium Lake (E110), this may cause allergic reactions in some people.

3. How to take Abacavir/Lamivudine PharOS

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

The recommended dose of Abacavir/Lamivudine PharOS for adults, adolescents and children weighing 25 kg or more is one tablet once a day.

Swallow the tablets whole, with some water. Abacavir/Lamivudine PharOS can be taken with or without food.

Stay in regular contact with your doctor

Abacavir/Lamivudine PharOS 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 do not stop taking Abacavir/Lamivudine PharOS without your doctor’s advice. If you take more Abacavir/Lamivudine PharOS than you should

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

Not everyone responds to treatment with Abacavir/Lamivudine PharOS in the same way. Your doctor will monitor the effectiveness of your treatment.

2. What you need to know before you take Abacavir/Lamivudine PharOS Do not take Abacavir/Lamivudine PharOS:

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

Carefully read all the information about hypersensitivity reactions in Section 4.

•    if you have severe liver disease

Check with your doctor if you think any of these apply to you. Do not take Abacavir/Lamivudine PharOS.

Take special care with Abacavir/Lamivudine PharOS

Some people taking Abacavir/Lamivudine PharOS 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, do not stop Abacavir/ Lamivudine PharOS without your doctor’s advice, as your hepatitis may come back)

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

•    if you are diabetic and using insulin

•    if you have a kidney problem

Talk to your doctor if any of these apply to you before using Abacavir/Lamivudine PharOS. You may need extra check-ups, including blood tests, while you are taking your medicine. See Section 4 for more information.

Abacavir hypersensitivity reactions

Even patients who don’t have the HLA-B¹5701 gene may still develop a hypersensitivity reaction (a serious allergic reaction).

Carefully read all the information about hypersensitivity reactions in Section 4 of this leaflet.

Risk of heart attack

It cannot be excluded that abacavir may increase the risk of having a heart attack.

Tell your doctor if you have heart problems, if you smoke, or have other illnesses that may increase your risk of heart disease such as high blood pressure, or diabetes. Do not stop taking Abacavir/Lamivudine PharOS unless your doctor advises you to do so.

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 are taking Abacavir/Lamivudine PharOS.

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). You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people.

Other medicines and Abacavir/Lamivudine PharOS

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 are taking Abacavir/Lamivudine PharOS.

These medicines should not be used with Abacavir/Lamivudine PharOS:

•    Emtricitabine, to treat HIV infection

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

•    high doses of trimethoprim/sulfamethoxazole, an antibiotic

•    cladribine, used to treat hairy cell leukaemia

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

Some medicines interact with Abacavir/Lamivudine PharOS

These include:

•    phenytoin, for treating epilepsy.

Tell your doctor if you are taking phenytoin. Your doctor may need to monitor you while you are taking Abacavir/ Lamivudine PharOS.

•    methadone, used as a heroin substitute. Abacavir increases the rate at which methadone is removed from the body. If you are taking methadone, you will be checked for any withdrawal symptoms. Your methadone dose may need to be changed.

Tell your doctor if you are taking methadone.

If you forget to take Abacavir/Lamivudine PharOS

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.

It is important to take Abacavir/Lamivudine PharOS regularly, because if you take it at irregular intervals, you may be more likely to have a hypersensitivity reaction.

If you have stopped taking Abacavir/Lamivudine PharOS

If you have stopped taking Abacavir/Lamivudine PharOS for any reason — especially because you think you are having side effects, or because you have other illness:

Talk to your doctor before you start taking it again. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If the doctor thinks they may have been related, you will be told never again to take Abacavir/ Lamivudine PharOS, or any other medicine containing abacavir. It is important that you follow this advice.

If your doctor advises that you can start taking Abacavir/Lamivudine PharOS again, you may be asked to take your first doses in a place where you will have ready access to medical care if you need it.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Abacavir/Lamivudine PharOS 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.

Even patients who don’t have the HLA-B¹5701 gene may still develop a hypersensitivity reaction (a serious allergic reaction), described in this leaflet in the panel headed ‘Hypersensitivity reactions’.

It is very important that you read and understand the information about this serious reaction.

As well as the side effects listed below for Abacavir/Lamivudine PharOS, 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’.

•    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 Abacavir/Lamivudine PharOS, 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:

•    feeling sick (nausea), being sick (vomiting)

•    stomach pain

•    generally feeling unwell

•    loss of appetite, weight loss

•    deep, rapid, difficult breathing

•    numbness or weakness in the limbs

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 are 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 or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

5.    How to store Abacavir/Lamivudine PharOS

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 carton and blister after <EXP>. The expiry date refers to the last day of that month.

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

This medicinal product does not require any special storage conditions.

For bottles:

After first opening:

Chemical, physical and microbiological in-use stability has been demonstrated for 30 days below 25°C.

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 Abacavir/Lamivudine PharOS contains

-    The active substances in each Abacavir/Lamivudine PharOS film-coated tablet are 600 mg of abacavir and 300 mg of lamivudine.

-    The other ingredients are cellulose, microcrystalline PH 102 (E460), cellulose, microcrystalline PH 200 (E460), sodium starch glycolate (Type A), povidone K 90 (E 1201), magnesium stearate (E470b), hypromellose 5 (E464), macrogol 400 (E1521), titanium dioxide (E171), sunset yellow FCF aluminium lake (E110)

What Abacavir/Lamivudine PharOS looks like and contents of the pack

Abacavir/Lamivudine PharOS film-coated tablets are orange, film-coated, modified capsule shaped tablets. The dimensions of the tablets are 19.4 mm x 10.4 mm.

Abacavir/Lamivudine PharOS is available in Aluminium-PVC/PE/PVDC white opaque blisters containing 30 tablets and Aluminium- PVC/PE/PVDC white opaque multipack blister packs containing 90 (3 x 30) tablets. Abacavir/Lamivudine PharOS is available in white, plastic HDPE bottles with a white, plastic (PP) cap containing 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

PharOS - Pharmaceutical Oriented Services Ltd

Lesvou str. (end), Thesi Loggos, Industrial Zone, 144 52 Metamorfossi Attikis

Greece

Remedica Ltd

Aharnon Street, Limassol Industrial Estate 3056 Limassol Cyprus

This medicinal product is authorised in the Member States of the EEA under the following names:

France    Abacavir/Lamivudine PharOS 600 mg/300 mg, comprimes pellicules

Germany Abacavir/Lamivudin PharOS 600 mg/300 mg Filmtabletten Italy    Abacavir e Lamivudina PharOS

Netherlands    Abacavir/Lamivudine PharOS, 600 mg/300 mg filmomhulde tabletten

Spain    Abacavir/Lamivudina PharOS 600 mg/300 mg comprimidos recubiertos con pehcula EFG

United Kingdom Abacavir/Lamivudine PharOS 600 mg / 300 mg film-coated tablets

This leaflet was last revised in 10/2016.

Your body shape may change

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

1

   ribavirin, for treating hepatitis C. Abacavir may make the combination of ribavirin and pegylated interferon less effective at reducing levels of hepatitis C virus in the body.

Tell your doctor if you are taking ribavirin.

Common side effects

These may affect up to 1 in 10 people:

•    hypersensitivity reaction

•    headache

•    being sick (vomiting)

•    feeling sick (nausea)

•    diarrhoea

•    stomach pains

•    loss of appetite

•    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.

Uncommon side effects

These may affect up to 1 in 100 people and may show up in blood tests:

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

•    an increase in the level of liver enzymes

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

Rare side effects

These may affect up to 1 in 1000 people:

•    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)

•    breakdown of muscle tissue.

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

•    increase in an enzyme called amylase

Very rare side effects

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

•    numbness, tingly feelings in the skin (pins and needles)

•    sensation of weakness in the limbs

•    skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)

•    a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).

If you notice any of these symptoms contact a doctor urgently.

Very rare side effects that may show up in blood tests are: