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«Package leaflet: Information for the patient Triumeq® 50 mg/600 mg/300 mg film-coated tablets dolutegravir/abacavir/lamivudine This medicine is ...»

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Package leaflet: Information for the patient

Triumeq® 50 mg/600 mg/300 mg film-coated tablets

dolutegravir/abacavir/lamivudine

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

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 Triumeq is and what it is used for

2. What you need to know before you take Triumeq

3. How to take Triumeq

4. Possible side effects

5. How to store Triumeq

6. Contents of the pack and other information

1. What Triumeq is and what it is used for Triumeq is a medicine that contains three active ingredients used to treat HIV infection: abacavir, lamivudine and dolutegravir. Abacavir and lamivudine belong to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs), and dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs).

Triumeq is used to treat HIV (human immunodeficiency virus) infection in adults and children over 12 years old who weigh at least 40 kg.

Before you are prescribed Triumeq your doctor will arrange a test to find out whether you carry a particular type of gene called HLA-B*5701. Triumeq should not be used in patients who are known to carry the HLA-B*5701 gene. Patients with this gene are at a high risk of developing a serious hypersensitivity (allergic) reaction if they use Triumeq (see ‘hypersensitivity reactions’ in section 4).

Triumeq does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It also increases the number of CD4 cells 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 Triumeq in the same way. Your doctor will monitor the effectiveness of your treatment.

1

2. What you need to know before you take Triumeq

Do not take Triumeq:

 if you are allergic (hypersensitive) to dolutegravir, abacavir (or any other medicine containing abacavir), or 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 are taking a medicine called dofetilide (to treat heart conditions).

 If you think any of these apply to you, tell your doctor.

Warnings and Precautions IMPORTANT — Hypersensitivity reactions Triumeq contains abacavir and dolutegravir. Both of these active ingredients can cause a serious allergic reaction known as a hypersensitivity reaction, which can be life threatening in people who continue to take abacavir-containing products.

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

The Triumeq pack includes an Alert Card to remind you and medical staff about hypersensitivity.

Detach this card and keep it with you at all times.

Some people taking Triumeq or other combination treatments for HIV are more at risk of serious side

effects than others. 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 Triumeq without your doctor’s advice, as your hepatitis may come back)  if you have a kidney problem  Talk to your doctor if any of these apply to you before using Triumeq. You may need extra check-ups, including blood tests, while you’re taking your medicine. See Section 4 for more information.

Abacavir hypersensitivity reactions Even patients who don’t 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 The possibility that abacavir increases the risk of having a heart attack cannot be excluded.

 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. Don’t stop taking Triumeq 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.

These include:

 symptoms of infections and inflammation  joint pain, stiffness and bone problems You need to know about important signs and symptoms to look out for while you’re taking Triumeq.

 Read the information ‘Other possible side effects of combination therapy for HIV’ in Section 4 of this leaflet.





2 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.

Children This medicine is not for children under 12 years of age. The use of Triumeq in children under 12 years of age has not yet been studied.

Other medicines and Triumeq Tell your doctor if you are taking, have recently taken or might take any other medicines, including herbal medicines and other medicines bought without a prescription.

Don't take Triumeq with the following medicine:

 dofetilide, used to treat heart conditions Some medicines can affect how Triumeq works, or make it more likely that you will have side effects.

Triumeq can also affect how some other medicines work.

Tell your doctor if you are taking any of the medicines in the following list:

 metformin, to treat diabetes  medicines called antacids, to treat indigestion and heartburn. Do not take an antacid during the 6 hours before you take Triumeq, or for at least 2 hours after you take it. (See also Section 3).

 calcium supplements, iron supplements and multivitamins. Do not take a calcium supplement, iron supplement or multivitamin during the 6 hours before you take Triumeq, or for at least 2 hours after you take it (see also Section 3).

 emtricitabine, etravirine, efavirenz, nevirapine or tipranavir/ritonavir, to treat HIV infection  other medicines containing lamivudine, used to treat HIV infection or hepatitis B infection  cladribine, used to treat hairy cell leukaemia  rifampicin, to treat tuberculosis (TB) and other bacterial infections  trimethoprim/sulfamethoxazole, an antibiotic to treat bacterial infections  phenytoin and phenobarbital, to treat epilepsy  oxcarbazepine and carbamazepine, to treat epilepsy and bipolar disorder  St. John’s wort (Hypericum perforatum), a herbal remedy to treat depression  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 or pharmacist if you are taking any of these. Your doctor may decide to adjust your dose or that you need extra checkups. Pregnancy

If you are pregnant, think you may be pregnant, or if you are planning to have a baby:

 Talk to your doctor about the risks and benefits of taking Triumeq.

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 Triumeq can also pass into your breast milk.

–  –  –

Driving and using machines Triumeq can make you dizzy and have other side effects that make you less alert.

 Don’t drive or operate machinery unless you are sure your alertness has not been affected.

–  –  –

Swallow the tablet with some liquid. Triumeq can be taken with or without food.

Use in children and adolescents Children and adolescents aged between 12 and 17 years and weighing at least 40 kg can take the adult dose of one tablet once a day.

Do not take an antacid during the 6 hours before you take Triumeq, or for at least 2 hours after you take it. Other acid-lowering medicines like ranitidine and omeprazole can be taken at the same time as Triumeq.

 Talk to your doctor for further advice on taking antacid medicines with Triumeq.

Do not take a calcium or iron supplement during the 6 hours before you take Triumeq, or for at least 2 hours after you take it.

Talk to your doctor for further advice on taking calcium supplements, iron supplements or multivitamins with Triumeq.

If you take more Triumeq than you should If you take too many tablets of Triumeq, contact your doctor or pharmacist for advice. If possible, show them the Triumeq pack.

If you forget to take Triumeq If you miss a dose, take it as soon as you remember. But if your next dose is due within 4 hours, skip the dose you missed and take the next one at the usual time. Then continue your treatment as before.

 Don't take a double dose to make up for a missed dose.

If you have stopped taking Triumeq If you have stopped taking Triumeq for any reason — especially because you think you are having

side effects, or because you have another 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 be related to a hypersensitivity reaction, you will be told never again to take Triumeq, or any other medicine containing abacavir or dolutegravir. It is important that you follow this advice.

If your doctor advises that you can start taking Triumeq 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.

–  –  –

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Like all medicines, this medicine can cause side effects, but 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 Triumeq 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-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 Triumeq, other conditions can develop during combination therapy for HIV.

It is important to read the information in this section under the heading ‘Other possible side effects of combination therapy for HIV’.

Hypersensitivity Reactions Triumeq contains abacavir and dolutegravir. Both of these active ingredients 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 Triumeq could develop a hypersensitivity reaction, which could be life threatening if they continue to take Triumeq.

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 don’t have this gene). You should have been tested for this gene before Triumeq was prescribed for you. If you know you have this gene, tell your doctor.

About 3 to 4 in every 100 patients treated with abacavir in a clinical trial who did not the HLAB*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.

–  –  –

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.

When do these reactions happen?

Hypersensitivity reactions can start at any time during treatment with Triumeq, 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 aches and pains, or generally feeling ill.

Your doctor may advise you to stop taking Triumeq.

If you have stopped taking Triumeq If you have stopped taking Triumeq because of a hypersensitivity reaction, you must NEVER AGAIN take Triumeq, or any other medicine containing abacavir. If you do, within hours, your blood pressure could fall dangerously low, which could result in death. You should also never again take medicines containing dolutegravir.

If you have stopped taking Triumeq for any reason — especially because you think you are having



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