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«1 Package leaflet: Information for the user Abacavir/Lamivudine Lupin 600 mg/300 mg film-coated tablets abacavir/lamivudine Read all of this leaflet ...»

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PACKAGE LEAFLET

1

Package leaflet: Information for the user

Abacavir/Lamivudine Lupin 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 Lupin 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 Lupin 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 Lupin is and what it is used for

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

3. How to take Abacavir/Lamivudine Lupin

4. Possible side effects

5. How to store Abacavir/Lamivudine Lupin

6. Contents of the pack and other information

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

Abacavir/Lamivudine Lupin 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 Lupin 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 Lupin in the same way.

Your doctor will monitor the effectiveness of your treatment.

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

Do not take Abacavir/Lamivudine Lupin:

 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 Lupin.

Take special care with Abacavir/Lamivudine Lupin 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 Lupinwithout 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 Lupin.

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 Lupin 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 Lupin.

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 Lupin 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 Lupin.

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

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

–  –  –

Some medicines interact with Abacavir/Lamivudine Lupin

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 Lupin.

 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 Lupin 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 Lupin, 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 Lupin, 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 Lupin 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 Lupin 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 Lupin.

Important information about some of the other ingredients of Abacavir/Lamivudine Lupin Abacavir/Lamivudine Lupin contains a colouring called sunset yellow (E110), this may cause allergic reactions in some people.

3. How to take Abacavir/Lamivudine Lupin 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 Lupin for adults, adolescents and children weighing 25 kg or more is one tablet once a day.

–  –  –

Stay in regular contact with your doctor Abacavir/Lamivudine Lupin 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 Lupin without your doctor’s advice.

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

If you forget to take Abacavir/Lamivudine Lupin 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 Lupin 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 Lupin If you have stopped taking Abacavir/Lamivudine Lupin 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 Lupin, 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 Lupin 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 Lupin 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 Lupin, 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’.

–  –  –

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

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 Lupin was prescribed for you. If you know you have this gene, tell your doctor before you take Abacavir/Lamivudine Lupin.

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.

If you continue to take Abacavir/Lamivudine Lupin, 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 Lupin, 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 Lupin.

If you have stopped taking Abacavir/Lamivudine Lupin.

If you have stopped taking Abacavir/Lamivudine Lupin because of a hypersensitivity reaction, you must NEVER AGAIN take Abacavir/Lamivudine Lupin, 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.

6 If you have stopped taking Abacavir/Lamivudine Lupin for any reason - especially because you

think you are having side effects, or because you have other illness:



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