Label: information for the patient

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

dolutegravir/abacavir/lamivudina

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist,even if they are not listed in this label. See section 4.

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

Triumeq is used to treatHIV infection(human immunodeficiency virus)in adults, adolescents, and children who weigh at least 25 kg.

Before prescribing Triumeq, your doctor will perform a test to determine if you have a particular gene called HLA-B*5701. Triumeq should not be used in patients known to be carriers of this HLA-B*5701 gene. Patients with this gene have a high risk of developing a severe hypersensitivity reaction (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 the blood. CD4 cells are a type of white blood cell that is important for helping your body fight infections.

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

Do not take Triumeq

• if you areallergic(hypersensitive) to dolutegravir, abacavir (or any other medication that contains abacavir), or lamivudine, or to any of the other components of this medication (listed in section 6).

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

• if you are taking a medication calledfampridine(also known as dalfampridine; used to treat multiple sclerosis).

• If you think any of this applies to you, consult 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. Never take abacavir or medications that contain abacavir again if you have had a hypersensitivity reaction: this can be potentially fatal.

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

The packaging of Triumeq includes aMedication Information Cardto remind you and healthcare professionals of the possibility of a hypersensitivity reaction.You must remove this card and carry it with you always.

Be especially careful with Triumeq

Some people taking Triumeq or other combined HIV treatments have a higher risk of developing severe side effects. You need to know that there is a higher risk:

• if you have moderate or severe liver disease
• if you have ever hadliver disease,including hepatitis B or C (if you have hepatitis B do not stop takingTriumeqwithout consulting your doctor, as it may worsen)
• if you have kidney problems.

• Consult your doctor before starting to take Triumeq if any of these situations apply to you.You may need additional tests, including blood tests, while taking this medication.For more information, see section 4.

Hypersensitivity reactions to abacavir

Even patients who do not have the HLA-B*5701 gene can develop ahypersensitivity 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 ruled out that abacavir may increase the risk of cardiovascular events.

• Inform your doctorif you have cardiovascular problems, if you smoke, or if you have any condition that may increase your risk of cardiovascular diseases such as high blood pressure or diabetes. Do not stop takingTriumequnless your doctor advises you to.

Be aware of important symptoms

Some people taking HIV medications develop other conditions, which can be serious. These include:

You need to know what important signs and symptoms to be aware of while taking Triumeq.

• Read the information about “Other possible side effects of combined HIV treatment” in section 4 of this leaflet.

Children

This medication is not indicated for children weighing less than 25kg as the dose of each component of this medication cannot be adjusted to their weight.

Other medications and Triumeq

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

Do not take Triumeq with the following medication:

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

Some medications may affect the functioning ofTriumeq, or increase the likelihood of side effects.Triumeqmay also affect the functioning of other medications.

Inform your doctorif you are taking any of the following medications:

• metformin, to treatdiabetes
• medications calledantacids,to treatindigestionandheartburn.Do not take an antacidwithin 6 hours of takingTriumeq, 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 magnesiumwithin 6 hours of taking Triumeq, or at least 2 hours after taking it(see also section 3)
• emtricitabine,etravirine, efavirenz, nevirapine, or tipranavir/ritonavir, to treatHIV infection
• medications (usually liquids) that containsorbitol and other polyols(such as xylitol, mannitol, lactitol, or maltitol), if taken regularly
• other medications that contain lamivudine, used to treatHIV infectionorhepatitis B
• cladribine, used to treatleukemia
• rifampicin, to treattuberculosis(TB) and otherbacterial infections
• trimethoprim/sulfamethoxazole, an antibiotic to treatbacterial infections
• phenytoin and phenobarbital, to treatepilepsy
• oxcarbazepine and carbamazepine, to treatepilepsyorbipolar disorder

• St. John's Wort(Hypericum perforatum), a herbal medication to treatdepression
• methadone, used as aheroin substitute. Abacavir increases the rate at which methadone is eliminated from the body. If you are taking methadone, you will need to be monitored for signs of withdrawal. You may need your methadone dose adjusted
• riociguat, to treathigh blood pressure in the blood vessels(pulmonary 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.

• Inform your doctor or pharmacistif you are taking any of these medications. Your doctor may decide to adjust your dose or order additional tests.

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant:

• Consult your doctorabout the risks and benefits of takingTriumeq.

Inform your doctor immediately if you become pregnant or plan to become pregnant. Your doctor will review your treatment. Do not stop takingTriumeqwithout consulting your doctor, as this could harm you and your fetus.

Breastfeeding

It is not recommendedthat women with HIV breastfeed, as the infection can be transmitted to the baby through breast milk.

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

If you are breastfeeding or plan to breastfeed,you must consult your doctor as soon as possible.

Driving and operating machinery

Triumeqmay cause dizziness and other side effectsthat may impair your attention.

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

Triumeq contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• The usual dose is one tablet once a day.

Swallow the tablet with a little liquid.Triumeqcan be taken with or without food.

Use in childrenand adolescents

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

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

Triumeq is available in film-coated tablets and dispersible tablets. Film-coated tablets and dispersible tablets are not the same. Therefore, do not change between film-coated tablets and dispersible tablets without first speaking with your doctor.

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

• Consult with your doctor to advise you on which antacids you can take withTriumeq.

If you take Triumeq with food, you can take supplements or multivitamins containing calcium, iron, or magnesiumat the same time as Triumeq.If you do not take Triumeq with food,do not take any supplements or multivitamins containing calcium, iron, or magnesiumwithin 6 hours before takingTriumeq, or at least 2 hours after taking it.

• Consult with your doctor to advise you on how to take supplements or multivitamins containing calcium, iron, or magnesium withTriumeq.

If you take moreTriumeqthan you should

If you exceed the number ofTriumeqtablets,contact your doctor or pharmacist for advice.If possible, show them theTriumeqbox.

If you forgot to takeTriumeq

If you forget a dose, take it as soon as you remember. But if there are less than 4 hours until your next dose, skip the missed dose and take the next one at the usual time. Then continue your treatment as before.

• Do not take a double doseto compensate for the missed doses.

If you have interrupted treatment with Triumeq

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

_Consult your doctor before resuming treatment.Your doctor will check if your symptoms were related to a hypersensitivity reaction. If your doctor considers that they may have been related to a hypersensitivity reaction,he will advise you thatyou should never takeTriumeqor any other medication containing abacavir or dolutegravir again.It is essential that you follow this warning.

If your doctor advises you to resume treatment withTriumeq, you can ask him to take the first doses in a place where you have easy access to medical assistance if necessary.

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

When you are on treatment for HIV, it may be difficult to distinguish whether a symptom is a side effect of Triumeq or of other medicines you are taking, or if it is due to an effect of the disease caused by HIV itself.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 ahypersensitivity reaction,described under the heading "Hypersensitivity Reactions".It is very important that you read and understand the information about this severe reaction.

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

It is important that you read the information under the heading “Other possible side effects of combined HIV treatment” 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 taking medicines that contain abacavir.

Who suffers these reactions?

Any person taking Triumeq could develop a hypersensitivity reaction, which could be potentially fatal if they continue taking Triumeq.

You are more likely to develop this reaction if you have a gene called HLA-B*5701 (but you can suffer this reaction even if you do not have this gene). Before starting treatment with Triumeq, you should have had a test to detect this gene. If you know that you have this gene, inform your doctor.

What are the symptoms?

The most frequent symptoms are:

fever(elevated temperature) andskin rash.

Other frequent symptoms are:

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

Other symptoms may include:

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

When do these reactions occur?

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

Contact your doctor immediately:

1if you have a skin rash, or

2if you have symptoms including at least 2 of the following groups:

- fever

- difficulty breathing, sore throat or cough

-nausea or vomiting, diarrhea or abdominal pain

-excessive fatigue 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 may experience a drop in blood pressure that can be potentially fatal or cause death. You should also never take any medicines that contain dolutegravir again.

If for any reason, you have interrupted treatment with Triumeq — especially because you think you are experiencing side effects or another illness:

Consult your doctor before resuming 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 advise youthatyou should never take Triumeq or any other medicine that contains abacavir again.You should also never take any medicines that contain dolutegravir again. It is essential that you follow this warning.

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

Very rarely, patients who have taken medicines that contained 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, you can ask them to take the first doses in a place where you have easy access to medical assistance, in case you need it.

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

The Triumeq package includes anInformation Cardto remind you and healthcare professionals of the possibility of hypersensitivity reactions.You must remove the card and carry it with you always.

Very common side effects

These may affectmore than 1 in 10people:

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

Common side effects

These may affectup to 1 in 10people:

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

The common side effects that may 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 side effects

These may affectup to 1 in 100 people:

• inflammation of the liver (hepatitis)
• thoughts and behaviors of suicide (especially in patients who have previously had depression or mental health problems)
• panic attack.

The uncommon side effects that may 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 the levels of sugar (glucose) in the blood
• an increase in the levels of triglycerides (type of fat) in the blood.

Rare side effects

These may affectup to 1 in 10000 people:

• inflammation of the pancreas(pancreatitis)
• muscle rupture
• liver insufficiency (the signs may include yellowing of the skin and the white of the eyes or dark-colored urine)
• suicide (especially in patients who have previously had depression or mental health problems).

• Inform your doctor immediatelyif you experience any mental health problems (see also other mental health problems that appear above).

The rare side effects that may appear in blood tests are:

• an increase in bilirubin (liver function test)
• an increase in an enzyme calledamylase.

Very rare side effects

These may affectup to 1 in 10000 people:

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

The very rare side effects that may appear in blood tests are:

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

If you experience any side effect:

• Consult your doctor.This includes any possible side effects not mentioned in this leaflet.

Other possible side effects of combined HIV treatment

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

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). These infections may have developed in a "silent" way, not being detected by the weakened immune system before treatment began. After starting treatment, the immune system becomes stronger and may fight these infections,causing symptoms of infection or inflammation. The symptoms usually includefever,in addition to some of the following:

• headache
• abdominal pain
• difficulty breathing.

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

• palpitations (irregular or rapid heartbeats) or tremor
• hyperactivity (excessive restlessness and movement)
• weaknessthat startsin the hands and feet and ascends to 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 any other medicines for the infection without consulting your doctor first.

Joint pain, stiffness, and bone problems

Some people on combined HIV treatment developosteonecrosis. 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 a 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 very 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:

• Inform your doctor.

Effects on weight, lipids, and blood glucose

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, evenif it is apossibleside effect not mentioned in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the bottle after CAD. The expiration date is the last day of the month indicated.

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

This medication does not require any special storage temperature.

Medications should not be disposed of through drains or trash.Ask your pharmacist how to dispose ofthe containers and medications that you no longerneed.By doing so, you will help protect the environment.

Triumeq Composition

• 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), carboxymethylstarch sodium, magnesium stearate, partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol/PEG, talc, iron oxide black, and iron oxide red .
• This medicinal product contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free". .

Appearance of the product and contents of the package

The Triumeq film-coated 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 humidity. Once opened, keep the desiccant in the bottle, do not discard.

Also available are clinical packs containing 90 film-coated tablets (3 packs of 30 film-coated tablets). Only some package sizes may be commercially available.

Marketing Authorization Holder

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

Responsible for manufacturing

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

or

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

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last date of revision of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.euro p a.eu .