TRIUMEQ 50 mg/600 mg/300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

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

dolutegravir/abacavir/lamivudine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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.

Contents of the pack and other information

1. What is Triumeq and what is it used for
2. What you need to know before you take Triumeq
3. How to take Triumeq
4. Possible side effects
5. Storing Triumeq
6. Contents of the pack and other information

1. What is Triumeq and what is it used for

Triumeq is a medicine that contains three active substances used to treat HIV infection: abacavir, lamivudine, and dolutegravir. Abacavir and lamivudine belong to a group of antiretroviral medicines (medicines used to treat HIV infection) called nucleoside analogue reverse transcriptase inhibitors (NRTIs), and dolutegravir belongs to a group of antiretroviral medicines called integrase inhibitors (INIs).

Triumeq is used to treat HIV infection(Human Immunodeficiency Virus)in adults, adolescents, and children who weigh at least 25 kg.

Before prescribing Triumeq, your doctor will do a test to find out if you have a particular gene called HLA-B*5701. Triumeq must not be used in patients who are known to have this HLA-B*5701 gene. Patients with this gene have a high risk of developing a severe allergic reaction if they take 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 cell that is important for helping your body fight infections.

Not everyone responds to treatment with Triumeq in the same way. Your doctor will monitor the effectiveness of your treatment.

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 that contains abacavir), or lamivudine or any of the other ingredients of this medicine (listed in section 6).

Read carefully all the information about hypersensitivity reactions in section 4.

• if you are taking a medicine called fampridine (also known as dalfampridine; used to treat multiple sclerosis).

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

Warnings and precautions

IMPORTANT — Hypersensitivity reactions

Triumeq contains abacavir and dolutegravir. These two active substances can cause a severe allergic reaction known as a hypersensitivity reaction. You must never take abacavir or medicines that contain abacavir again if you have had a hypersensitivity reaction: this can be life-threatening.

You must read carefully the information about “Hypersensitivity reactions” in section 4.

The pack of Triumeq includes a Warning Card to remind you and your healthcare professionals of the possibility of a hypersensitivity reaction. You should pull out this card and always carry it with you.

Be especially careful with Triumeq

Some people who take Triumeq or other anti-HIV combination treatments have a higher risk of developing serious side effects than others. You need to know that there is a higher risk:

• if you have moderate or severe liver disease
• if you have ever had liver disease,including hepatitis B or C (if you have hepatitis B, do not stop taking Triumeq without your doctor's advice, as it may get worse)
• if you have a kidney problem.

• Tell your doctor before you start taking Triumeq if any of these apply to you.You may need extra checks, including blood tests, while you are taking this medicine. For more information, see section 4.

Hypersensitivity reactions to abacavir

Even patients who do not have the HLA-B*5701 gene can develop a hypersensitivity reaction(severe allergic reaction).

• Read carefully all the information about hypersensitivity reactions in section 4 of this leaflet.

Risk of cardiovascular events

It cannot be excluded that abacavir increases the risk of having a heart attack or stroke.

• Tell your doctorif you have heart problems, if you smoke, or if you have any other illness that may increase your risk of heart disease, such as high blood pressure or diabetes. Do not stop taking Triumeq without your doctor's advice.

Be aware of important symptoms

Some people who take medicines for HIV infection develop other conditions that can be serious. These include:

• symptoms of infection and inflammation
• joint pain, stiffness, and bone problems.

You need to know what important signs and symptoms to look out for while you are taking Triumeq.

• Read the information about “Other possible side effects of anti-HIV combination therapy” in section 4 of this leaflet.

Children

This medicine is not recommended for children who weigh less than 25 kg, as the dose of each component of this medicine cannot be adjusted to their weight.

Other medicines and Triumeq

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Do not take Triumeq with the following medicine:

• fampridine (also known as dalfampridine), used to treat multiple sclerosis.

Some medicines may affect how Triumeq works, or increase the chance of side effects. Triumeq may also affect how other medicines work.

Tell your doctorif you are taking any of the following medicines:

• metformin, to treat diabetes
• medicines called antacids,to treat indigestionand heartburn.Do not take an antacidduring the 6 hours before taking Triumeq, or at least 2 hours after taking it (see also section 3)
• supplements or multivitamins that contain calcium, iron, or magnesium. If you take Triumeq with food,you can take supplements or multivitamins that contain calcium, iron, or magnesium at the same time as Triumeq. If you do not take Triumeq with food, do not takesupplements or multivitamins that contain calcium, ironor magnesiumduring the 6 hours before taking Triumeq, or at least 2 hours after taking it (see also section 3)
• emtricitabine, etravirine, efavirenz, nevirapine, or tipranavir/ritonavir, to treat HIV infection
• medicines (usually liquids) that contain sorbitol and other polyalcohols (such as xylitol, mannitol, lactitol, or maltitol), if taken regularly
• other medicines that contain lamivudine, used to treat HIV infectionor hepatitis B
• 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 epilepsyor bipolar disorder

• St John's Wort(Hypericum perforatum), a herbal medicine 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 may need to be monitored for signs of withdrawal. You may need to have your methadone dose changed
• riociguat, to treat high blood pressure in the blood vessels(arteries) that carry blood from the heart to the lungs. Your doctor may need to reduce your dose of riociguat, as abacavir may increase the levels of riociguat in your blood.

• Tell your doctor or pharmacistif you are taking any of these medicines. Your doctor may decide to adjust your dose or order extra checks.

Pregnancy

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

• Ask your doctorabout the risks and benefits of taking Triumeq.

Tell your doctor immediately if you become pregnant or plan to become pregnant. Your doctor will review your treatment. Do not stop taking Triumeq without your doctor's advice, as this can harm you and your baby.

Breast-feeding

It is not recommendedthat women with HIV infection breast-feed their babies because HIV infection can be passed to the baby through breast milk.

A small amount of the components of Triumeq may also pass into breast milk.

If you are breast-feeding or thinking of breast-feeding, consult your doctor as soon as possible.

Driving and using machines

Triumeqmay make you feel dizzyand may have other effects that reduce your ability to concentrate.

• Do not drive or operate machinery,unless you are sure that your reactions are not affected.

Triumeq contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is, essentially, “sodium-free”.

3. How to take Triumeq

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

• The usual dose is one tablet once a day.

Swallow the tablet with a little water. Triumeq can be taken with or without food.

Use in children and adolescents

Children and adolescents who weigh at least 25 kg can take the adult dose of one tablet once a day.

If you weigh less than 25 kg, you cannot take Triumeq film-coated tablets, as the dose of each component of this medicine cannot be adjusted to your weight. Your doctor will prescribe Triumeq dispersible tablets or the components separately.

Triumeq is available as film-coated tablets and dispersible tablets. The film-coated tablets and dispersible tablets are not the same. Therefore, you must not switch between the film-coated tablets and the dispersible tablets without first talking to your doctor.

Do not take an antacidduring the 6 hours before taking Triumeq, or at least 2 hours after taking it. Other medicines that reduce acidity, such as ranitidine and omeprazole, can be taken at the same time as Triumeq.

• Ask your doctor for advice on which acidity-reducing medicines you can take with Triumeq.

If you take Triumeq with food, you can take supplements or multivitamins that contain calcium, iron, or magnesiumat the same time as Triumeq. If you do not take Triumeq with food,do not take any supplement or multivitamin that contains calcium, iron, or magnesium during the 6 hours before taking Triumeq, or at least 2 hours after taking it.

• Ask your doctor for advice on how to take multivitamin supplements that contain calcium, iron, or magnesium with Triumeq.

If you take more Triumeq than you should

If you take more than the prescribed dose 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. However, if it is less than 4 hours until your next dose, skip the missed dose and take the next dose at the usual time. Then continue your treatment as before.

• Do not take a double doseto make up for a forgotten dose.

If you stop taking Triumeq

If you have stopped taking Triumeq for any reason — especially because you think you have had side effects or because you have another illness:

Consult your doctor before you start taking Triumeq again.Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If your doctor thinks they may have been, they will tell you that youmust never takeTriumeqor any other medicine that contains abacavir or dolutegravir again.It is very important that you follow this advice.

If your doctor advises you to restart treatment with Triumeq, they may ask you to take the first doses in a place where you can easily get medical help if you need it.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

When you are being treated for HIV, it can be difficult to distinguish whether a symptom is an adverse effect of Triumeq or of other medicines you are taking, or if it is due to an effect of the disease caused by HIV. Therefore, it is very important that you inform your doctor about any change in your health.

Abacavir can cause a hypersensitivity reaction (a severe allergic reaction), especially in people who have a certain type of gene called HLA-B*5701. Even patients who do not have the HLA-B*5701 gene can develop a hypersensitivity reaction, described under the heading "Hypersensitivity Reactions". It is very important that you read and understand the information about this serious reaction.

In addition to the adverse effects listed below for Triumeq, other disorders can develop during combined treatment for HIV.

It is important that you read the information under the heading “Other possible adverse effects of combined treatment for HIV” in this section.

Hypersensitivity Reactions

Triumeq contains abacavir and dolutegravir. These two active substances can cause a severe allergic reaction known as a hypersensitivity reaction.

These hypersensitivity reactions have been seen more frequently in people who take medicines that contain abacavir.

Who suffers from these reactions?

Anyone who is taking Triumeq could develop a hypersensitivity reaction, which could potentially be fatal 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 suffer from this reaction even if you do not have this gene). Before starting treatment with Triumeq, you should have been tested for this gene. If you know you have this gene, inform your doctor.

What are the symptoms?

The most frequent symptoms are:

fever(high temperature) and skin rash.

Other frequent symptoms are:

nausea(discomfort), vomiting, diarrhea, abdominal pain (stomach) and excessive tiredness.

Other symptoms may include:

joint or muscle pain, swelling of the neck, difficulty breathing, sore throat, cough, occasional headaches, eye inflammation (conjunctivitis), mouth ulcers, low blood pressure, tingling or numbness of the hands or feet.

When do these reactions occur?

Hypersensitivity reactions can appear at any time during treatment with Triumeq, but it is more likely that they will occur in the first 6 weeks of treatment.

Contact your doctor immediately:

fever

difficulty breathing, sore throat or cough

nausea or vomiting, diarrhea or abdominal pain

• excessive tiredness or aches and pains, or general discomfort.

Your doctor may advise you to stop taking Triumeq.

If you have stopped taking Triumeq

If you have stopped taking Triumeq due to a hypersensitivity reaction, NEVER TAKE Triumeq or any other medicine that contains abacavir AGAIN. If you do, within hours, you can experience a drop in blood pressure that can be potentially fatal or cause death. You should also never take medicines that contain dolutegravir again.

If for any reason, you have interrupted treatment with Triumeq — especially because you think you have adverse effects or due to another illness:

Consult your doctor before restarting treatment. Your doctor will check if your symptoms were related to a hypersensitivity reaction. If your doctor considers that there may have been a relationship, they will indicatethat you should never take Triumeq or any other medicine that contains abacavir AGAIN. You should also never take medicines that contain dolutegravir again. It is important that you follow this warning.

Occasionally, hypersensitivity reactions have developed in people who restart medicines that contain abacavir, after having had only one symptom of those on the Information Card before they stopped taking it.

Very rarely, patients who have taken medicines that contain 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 you to restart treatment with Triumeq, they may ask you to take the first doses in a place where you have easy access to medical assistance, in case it is necessary.

If you are hypersensitive to Triumeq, you must return all unused Triumeq tablets to be safely disposed of. Consult your doctor or pharmacist.

The packaging of Triumeq includes an Information Cardto remind you and medical personnel of the possibility of suffering a hypersensitivity reaction. You must remove the card and always carry it with you.

Very Common Adverse Effects

These can affect more than 1 in 10 people:

• headache
• diarrhea
• nausea
• difficulty sleeping (insomnia)
• lack of energy (fatigue).

Common Adverse Effects

These can affect up to 1 in 10 people:

• hypersensitivity reaction (see "Hypersensitivity Reactions" above in this section)
• loss of appetite
• skin rash
• itching (pruritus)
• vomiting
• stomach pain (abdominal pain)
• stomach discomfort (abdomen)
• weight gain
• indigestion
• gas (flatulence)
• dizziness
• abnormal dreams
• nightmares
• depression (feeling of deep sadness and lack of self-esteem)
• anxiety
• tiredness
• feeling of drowsiness
• fever (high temperature)
• cough
• irritated or runny nose
• hair loss
• muscle pain and discomfort
• joint pain
• feeling of weakness
• feeling of general discomfort.

The common adverse effects that can appear in blood tests are:

• an increase in the level of enzymes produced by the liver
• an increase in the level of enzymes produced in the muscles (creatine phosphokinase).

Uncommon Adverse Effects

These can affect up to 1 in 100 people:

• liver inflammation (hepatitis)
• suicidal thoughts and behaviors (especially in patients who have previously had depression or mental health problems)
• panic attacks.

The uncommon adverse effects that can appear in blood tests are:

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

• a low count of red blood cells (anemia) or a low count of white blood cells (neutropenia)
• an increase in blood sugar (glucose) levels
• an increase in triglyceride (a type of fat) levels in the blood.

Rare Adverse Effects

These can affect up to 1 in 1,000 people:

• pancreas inflammation (pancreatitis)
• muscle tissue rupture
• liver failure (the signs can include yellowing of the skin and the whites of the eyes or unusually dark urine)
• suicide (especially in patients who have previously had depression or mental health problems).

• Tell your doctor immediatelyif you experience any mental health problems (see also other mental health problems mentioned above).

The rare adverse effects that can appear in blood tests are:

• an increase in bilirubin (a liver function test)
• an increase in an enzyme called amylase.

Very Rare Adverse Effects

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

• numbness, tingling sensation in the skin (pins and needles)
• feeling of weakness in the limbs
• skin rash, which can form blisters that look like small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form that causes skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
• lactic acidosis (excess of lactic acid in the blood).

The very rare adverse effects that can appear in blood tests are:

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

If you suffer from any adverse effect

• Consult your doctor. This includes any possible adverse effect not mentioned in this leaflet.

Other Possible Adverse Effects of Combined Treatment for HIV

Combined treatments, such as Triumeq, can cause other disorders to develop during treatment for HIV.

Symptoms of Infection and Inflammation

People with advanced HIV infection or AIDS have a weakened immune system and are more likely to develop serious infections (opportunistic infections). Such infections may have developed in a "silent" way, not being detected by the weakened immune system before treatment was started. After starting treatment, the immune system becomes stronger and can fight these infections, which can cause symptoms of infection or inflammation. The symptoms usually include fever, as well as some of the following:

• headache
• stomach pain
• difficulty breathing.

In rare cases, as the immune system becomes stronger, it can also attack healthy tissues (autoimmune disorders). The symptoms of autoimmune disorders can appear many months after starting to take medicines to treat HIV. The symptoms can include:

• palpitations (irregular or rapid heartbeats) or tremors
• hyperactivity (excessive restlessness and movement)
• weakness that starts in the hands and feet and moves up towards the trunk of the body.

If you have any symptoms of infection and inflammationor if you notice any of the above symptoms:

• Consult your doctor immediately. Do not take other medicines for the infection without consulting your doctor first.

Joint Pain, Stiffness, and Bone Problems

Some people on combined treatment for HIV develop osteonecrosis. In this condition, parts of the bone tissue die due to reduced blood supply to the bones. People may be more prone to this condition:

• if they have been taking combined treatment for a long time
• if they are also taking anti-inflammatory medicines called corticosteroids
• if they drink alcohol
• if their immune system is severely weakened
• if they are overweight.

The signs of osteonecrosis include:

• stiffness in the joints
• discomfort and pain (especially in the hip, knee, or shoulder)
• difficulty moving.

If you notice any of these symptoms:

• Tell your doctor.

Effects on Weight, Lipids, and Blood Sugar

During treatment for HIV, there may be an increase in weight and in lipid and blood sugar levels. This is partly related to the recovery of health and lifestyle, and sometimes to the HIV medicines themselves. Your doctor will assess these changes.

Reporting of Adverse Effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Triumeq

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

Do not use this medicine after the expiry date that appears on the carton and bottle after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from moisture. Keep the bottle tightly closed. Do not throw away the desiccant.

This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Container Content and Additional Information

Composition of Triumeq

• The active ingredients are dolutegravir, abacavir, and lamivudine. Each tablet contains dolutegravir sodium equivalent to 50 mg of dolutegravir, 600 mg of abacavir (as sulfate), and 300 mg of lamivudine.
• The other components are mannitol (E421), microcrystalline cellulose, povidone (K29/32), sodium carboxymethyl starch, magnesium stearate, partially hydrolyzed poly(vinyl alcohol), titanium dioxide, macrogol/PEG, talc, black iron oxide, and red iron oxide.
• This medicinal product contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

Appearance and Container Content of the Product

The film-coated Triumeq tablets are oval, biconvex, purple with "572 Tri" engraved on one side.

The bottles contain 30 film-coated tablets.

The bottle contains a desiccant to reduce moisture. Once opened, keep the desiccant in the bottle, do not discard it.

Clinical packs containing 90 film-coated tablets (3 bottles of 30 film-coated tablets) are also available. Not all pack sizes may be marketed.

Marketing Authorization Holder

ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands

Manufacturer

Glaxo Wellcome, S.A., Avda. Extremadura 3, 09400 Aranda de Duero (Burgos), Spain.

or

Delpharm Poznan Spólka Akcyjna, UL.Grunwaldzka 189, 60-322 Poznan, Poland.

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet:(Month YYYY).

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.