Package leaflet: Information for the user

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

abacavir/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.

IMPORTANT — Hypersensitivity reactions

Abacavir/Lamivudine contains abacavir (which is also an active substance in medicines such as Trizivir, Triumeq and Ziagen). 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 pack includes an Alert Card, to remind you and medical staff about abacavir hypersensitivity. Keep this card with you at all times.

What is in this leaflet

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

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

3.    How to take Abacavir/Lamivudine

4.    Possible side effects

5.    How to store Abacavir/Lamivudine

6.    Contents of the pack and other information

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

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

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

Do not take Abacavir/Lamivudine:

•    if you are allergic (hypersensitive) to abacavir (or any other medicine containing abacavir - (e.g. Trizivir, Triumeq or Ziagen), 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.

Take special care with Abacavir/Lamivudine

Some people taking abacavir/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, do not stop Abacavir/Lamivudine 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. 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 do not have the HLA-B*5701 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 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.

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

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.

These medicines should not be used with Abacavir/Lamivudine:

•    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

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.

•    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.

•    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.

Pregnancy

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

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, 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 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 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.

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

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

3. How to take Abacavir/Lamivudine

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 for adults, adolescents and children weighing 25 kg over 12 years old and weighing 40 kg or more is one tablet once a day.

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

Stay in regular contact with your doctor

Abacavir/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 do not stop taking Abacavir/Lamivudine without your doctor’s advice.

If you take more Abacavir/Lamivudine than you should

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

If you forget to take Abacavir/Lamivudine

If you forget totake 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 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

If you have stopped taking Abacavir/Lamivudine 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, or any other medicine containing abacavir (e.g. Trizivir or Ziagen). It is important that you follow this advice.

If your doctor advises that you can start taking Abacavir/Lamivudine 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.

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 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 do not have the HLA-B*5701 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, 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’.

Hypersensitivity reactions

Abacavir/Lamivudine contains abacavir (which is also an active substance in medicines such as Trizivir, Triumeq and Ziagen). Abacavir can cause a serious allergic reaction known as a hypersensitivity reaction. These hypersensitivity reactions have been seen more frequently in people taking medicines that contain abacavir.

Who gets these reactions?

Anyone taking Abacavir/Lamivudine could develop a hypersensitivity reaction to abacavir, which could be life threatening if they continue to take Abacavir/Lamivudine.

You are more likely to develop this reaction if you have a gene called HLA-B*5701 (but you can get a reaction even if you do not have this gene). You should have been tested for this gene before Abacavir/Lamivudine was prescribed for you. If you know you have this gene, tell your doctor before you take Abacavir/Lamivudine.

About 3 to 4 in every 100 patients treated with abacavir in a clinical trial who did not have the HLA-B*5701 gene developed a hypersensitivity reaction.

What are the symptoms?

The most common symptoms are:

•    fever (high temperature) and skin rash.

Other common symptoms are:

•    nausea (feeling sick), vomiting (being sick), diarrhoea, abdominal (stomach) pain, severe tiredness.

Other symptoms include:

Pains in the joints or muscles, swelling of the neck, shortness of breath, sore throat, cough, occasional headaches, inflammation of the eye (conjunctivitis), mouth ulcers, low blood pressure, tingling or numbness of the hands or feet.

SAP Code: 30100008739

242497Abacavir-Lamivu 600-300 mg F-c Tabs_V8.pdf

Issued For Final Production
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If you continue to take Abacavir/Lamivudine, the symptoms will get worse, and may be life-threatening.

When do these reactions happen?

Hypersensitivity reactions can start at any time during treatment with Abacavir/Lamivudine, but are more likely during the first 6 weeks of treatment.

Contact your doctor immediately:

1    if you get a skin rash, OR

2    if you get symptoms from at least 2 of the following groups:

-    fever

-    shortness of breath, sore throat or cough

-    nausea or vomiting, diarrhoea or abdominal pain

-    severe tiredness or achiness, or generally feeling ill.

Your doctor may advise you to stop taking Abacavir/Lamivudine.

If you have stopped taking Abacavir/Lamivudine.

If you have stopped taking Abacavir/Lamivudine because of a hypersensitivity reaction, you must NEVER AGAIN take Abacavir/Lamivudine, or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Ziagen). If you do, within hours, your blood pressure could fall dangerously low, which could result in death.

If you have stopped taking Abacavir/Lamivudine 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 again. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If the doctor thinks they may have been, you will then be told never again to take Abacavir/Lamivudine, or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Ziagen). It is important that you follow this advice. Occasionally hypersensitivity reactions have developed in people who start taking abacavir containing products again, but who had only one symptom on the Alert Card before they stopped taking it.

Very rarely patients who have taken medicines containing abacavir in the past without any symptoms of hypersensitivity have developed a hypersensitivity reaction when they start taking these medicines again.

If your doctor advises that you can start taking Abacavir/Lamivudine 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 are hypersensitive to abacavir/lamivudine, return all your unused Abacavir/ Lamivudine tablets for safe disposal. Ask your doctor or pharmacist for advice.

The Abacavir/Lamivudine pack includes an Alert Card, to remind you and medical staff about hypersensitivity reactions. This card contains important safety information, keep it with you at all times.

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:

• 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 such as abacavir/lamivudine may cause other conditions to develop during HIV treatment.

Symptoms of infection and inflammation Old infections may flare up

People with advanced HIV infection (AIDS) have weak immune systems, and are more likelyto develop serious infections (opportunistic infections). Such infections may have been “silent” and not detected by the weak immune system before treatment was started. After starting treatment, the immune system becomes stronger, and may attack the infections, which can cause symptoms of infection andor inflammation. Symptoms usually include fever, plus some of the following:

•    headache

•    stomach ache

•    difficulty breathing

In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders). The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection. Symptoms may include:

•    palpitations (rapid or irregular heartbeat) or tremor

•    hyperactivity (excessive restlessness and movement)

•    weakness beginning in the hands and feet and moving up towards the trunk of the body.

If you get any symptoms of infection and inflammation or if you notice any of the symptoms above:

Tell your doctor immediately. Do not 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 abacavir/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:

•    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 youfor 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 (triglyceridesand 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the MHRA Yellow Card Scheme Website: www.mhra.gov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Abacavir/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 carton after EXP. The expiry date refers to the last day of that month.

Store 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 contains

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

The other ingredients are microcrystalline cellulose, crospovidone (Type A), povidone (K-30), iron oxide yellow (E172) and magnesium stearate in the core of the tablet. The tablet coating contains hypromellose HPMC 2910 -3mPas, hypromellose HPMC 2910 -6mPas, titanium dioxide (E171), macrogol 400, polysorbate 80 and sunset yellow aluminium lake (E110). What Abacavir/Lamivudine looks like and contents of the pack Abacavir/Lamivudine are orange coloured, capsule shaped, biconvex, 20.6 mm x 9.1 film-coated tablets, engraved with“300” on one side and “600” on other side.

Abacavir/Lamivudine are supplied in blister packs containing 30, 60, or 90 film-coated tablets or multi blister packs containing 60 or 90 film-coated tablets, 30 film-coated tablets in bottles containing an activated carbon sachet or an activated carbon sachet and oxygen absorber to control the moisture in the bottle.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Lupin (Europe) Limited Victoria Court,

Bexton Road, Knutsford,

Cheshire, WA16 0PF United Kingdom

This leaflet was last revised in March 2016

Code No. GO/DRUGS/654    ID#: 242497

SAP Code: 30100008739

242497Abacavir-Lamivu 600-300 mg F-c Tabs_V8.pdf

Issued For Final Production
Issued For Re-Approval :-
Issued For Approval :-		4-APR-16 10:33:52
TEMPLE Packaging Pvt. Ltd. Tel:- 28476601, Email:-info@templepackaging.co.in
Customer :-	LUPIN LTD.		SAP Code :-	30100008739
Location :-	Goa		File No. :-	40010
Product Name :-	Abacavir & Lamivudine 600-30		Artwork Sr. No. :-	197/07/15
ProductCode :-	242497		Customer A/W No. :-	NA
Version No. :-	08		OldFileNo. :-	NA
Date :-	4-APR-16		Old Product Code :-	NA
ArtworkStatus :-	FINAL		Barcode :-	NA
Open Size :-	260 x 400 MM (LxW)		Pharmacode :-	2930
Folding Size :-	44 x 67 MM (LxW)		Perforation :-	NA
Substrate :-	40 GSM BIBLE PAPER		Gluing :-	NA
Cover Page (PAD) :-	NA		Font Name :-	Helvetica Condensed
Cover Pg Substrate :-	NA		Font Size :-	9 pt.
No.of Pages / PAD :-	NA
Remark :-
PrintingColours

K

Note - This approval will be considered for final printing. Please recheck for corrections indicated earlier, in this proof also.
Prepared by: 4-APR-16	Checked by:		Q.A. Checked :		Approved by:
george
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Checked By				Approved By
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