Triumeq 5 mg/60 mg/30 mg comprimidos dispersables

Patient Information Leaflet: Product Information

Triumeq 5mg/60mg/30mg Dispersible Tablets

dolutegravir/abacavir/lamivudina

Read 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a child in your care. Do not give it to other people who have the same symptoms as the child in your care, as it may harm them.
• If the child experiences any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

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), callednucleoside reverse transcriptase inhibitors (NRTIs)(NRTIs), and dolutegravir belongs to a group of antiretroviral medications calledintegrase inhibitors (INIs)(INIs).

Triumeqis used to treatHIV infection(Human Immunodeficiency Virus)in children aged 3 months andwho weigh at least 6 kg and less than 25kg.

Before prescribing Triumeq to the child in their care, the child's doctor will perform a test to determine if they 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).

Triumeqdoes not cure HIV infection; it reduces the amount of virus in the 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 the body fight infections.

Not all people respond to treatment withTriumeqin the same way. The child's doctor will monitor the effectiveness of the treatment.

No use Triumeq

• if the child in your care isallergic(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 section6).

Read carefully all the information about hypersensitivity reactions in section4.

• if the child in your care is taking a medication calledfampridine(also known as dalfampridine; used to treat multiple sclerosis).

→If you think any of this applies to the child, consult your doctor.

Advertencias 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. The child in your care should never take abacavir or medications that contain abacavir again if they have had a hypersensitivity reaction: this can be potentially fatal.

You must read carefully the information about “Hypersensitivity reactions” in section4.

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 the child in your care has moderate or severe liver disease
• if the child in your care has ever hadliver disease, including hepatitis B or C (if the child in your care has hepatitis B do not stop takingTriumeqwithout consulting your doctor, as it may worsen)
• if the child in your care has a kidney problem.

→Consult your doctor before starting to use Triumeq if the child applies to any of these situations.You may need additional tests, including blood tests, while taking this medication.For more information, see section4.

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 section4 of this prospectus.

Risk of cardiovascular events

Abacavir may not be ruled out as increasing the risk of cardiovascular events.

→Inform your doctorif the child in your care has cardiovascular problems, if they smoke or has any disease that may increase their risk of cardiovascular diseases such as high blood pressure or diabetes. Do not stop administeringTriumequnless your doctor advises you to.

Be aware of important symptoms

Some people taking HIV medications develop other disorders, which can be severe. These include:

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

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

→Read the information about “Other possible side effects of combined HIV treatment” in section4 of this prospectus.

Children

Triumeq should not be used in children under 3 months of age or weighing less than 6 kg because it has not been evaluated below this dose in these groups.

Children mustattend scheduled medical appointments(see section3, How to use Triumeq, for more information).

Other medications and Triumeq

Inform your doctor if the child in your care is taking, has taken recently, or may need to take any other medication.

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

Inform your doctorif the child in your care is taking any of the following medications:

• metformin, to treatdiabetes
• medications calledantacids,to treatindigestionandheartburn.The child in your care should not take an antacidfor at least 6hours before takingTriumeq, or at least 2hours after taking it (see also section3)
• supplements or multivitamins that contain calcium, iron, or magnesium.If the child in your care takesTriumeqwith food, they may take supplements or multivitamins that contain calcium, iron, or magnesium at the same time asTriumeq. If they do not takeTriumeqwith food, they should not take supplements or multivitamins that contain calcium, iron, or magnesium for at least 6hours before takingTriumeq, or at least 2hours after taking it(see also section3)
• 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 the child in your care is taking methadone, they will need to be monitored for withdrawal symptoms. They may need their methadone dose adjusted.
• Riociguat, to treathigh blood pressure in the blood vessels(pulmonary arteries) that transport blood from the heart to the lungs. Your doctor may need to reduce their dose of riociguat, as abacavir may increase their blood levels of riociguat.

→Inform your doctor or pharmacistif the child in your care is taking any of these medications. Your doctor may decide to adjust their dose or order additional tests.

Pregnancy

If the patient is pregnant, thinks she may be pregnant, or intends to become pregnant:

→Consult your doctorabout the risks and benefits of takingTriumeq.

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

Breastfeeding

Do not recommendthat women living with HIV breastfeed because HIV 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 dizzinessand may have other side effectsthat reduce 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 1mmolof sodium (23mg) per dispersible 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.

Your doctor will decide on the correct dose of Triumeq for the child in their care, based on their weight.

If the child in their care is less than 3 months old or weighs less than 6 kg, Triumeq is not suitable for them, as its safety and efficacy are unknown. Their doctor will need to prescribe the components separately for the child.

Triumeq can be taken with or without food.

The dispersible tablets must be dispersed in potable water. The tablets must be dispersed in the dosing cup provided completely before ingesting them. Do not chew, cut, or crush the tablets. If the child in their care cannot use the dosing cup provided, they may also need an oral syringe to administer the medication. Consult with their doctor for advice.

The dose in children must be adjusted as they gain weight.

→Therefore, it is essential that children attend scheduled medical appointments.

Triumeq is available in film-coated tablets and dispersible tablets. Film-coated tablets and dispersible tablets are not the same. Therefore, do not switch between film-coated tablets and dispersible tablets without first consulting their doctor.

Do not give an antacidwithin 6 hours before administering Triumeq, or at least 2 hours after giving it. Other medications that reduce acidity, such as ranitidine and omeprazole, can be taken at the same time as Triumeq.

→Consult with their doctor for advice on which antacids they can use with Triumeq.

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

→Consult their doctor for advice on how to use supplements or multivitamins containing calcium, iron, or magnesium with Triumeq.

If you give moreTriumeq than you should

If you exceed the number of dispersible tablets of Triumeq,contact your doctor or pharmacist for advice.If possible, show them the Triumeq box.

If you forgot to giveTriumeq

If you forget to give a dose, do it as soon as you remember. However, if there are less than 4 hours until the next dose, omit the missed dose and wait to give the next dose at the usual time. Then continue the child's treatment as before.

→Do not give a double doseto compensate for missed doses.

If you have interrupted treatment with Triumeq

If for any reason, you have stopped giving Triumeq to the child — especially because you think it has side effects or because they have another illness:

→Consult your doctor before resuming treatment.Your doctor will check if the child's symptoms were related to an allergic reaction. If your doctor considers that they may have been related to an allergic reaction,they will advise you thatyou should never give Triumeq againor any other medication that contains abacavir or dolutegravir.It is essential that you follow this warning.

If your doctor advises you to have the child restart treatment withTriumeq, you can ask them to give the first doses in a place where the child has easy access to medical assistance if necessary.

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

When the child is on treatment for HIV, it may be difficult to distinguish whether a symptom is a side effect of Triumeq or of other medicines they 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 child's doctor about any change in their 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 importantthat 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.

The child is more likely to develop this reaction if they have a gene called HLA-B*5701 (but can suffer this reaction even if they do not have this gene). Before starting treatment with Triumeq, they should have had a test to detect this gene. If you know they 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, numbness or tingling in 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 to happen in the first 6 weeks of treatment.

Contact your doctor immediately:

1if the child has a skin rash, or

2if the child has symptoms included in at least 2 of the following groups:

- fever

- difficulty breathing, sore throat or cough

- nausea or vomiting, diarrhea or abdominal pain

- excessive fatigue or general aches and pains.

Your doctor may advise you to stop administering Triumeq.

If you have stopped giving Triumeq

If you have stopped giving Triumeq due to a hypersensitivity reaction,NEVER GIVE TRIUMEQ OR ANY OTHER MEDICINE CONTAINING ABACAVIR AGAIN.If you do, within hours, the child may experience a drop in blood pressure that could be potentially fatal or cause death. Do not give any other medicines containing dolutegravir either.

If for any reason, the child has interrupted treatment with Triumeq — especially because they think they have side effects or another illness:

Consult your doctor before resuming treatment.Your doctor will check if the child's symptoms were related to a hypersensitivity reaction. If your doctor considers it could have been related,they will advise youthatnever to give the child Triumeq or any other medicine containing abacavir again.Do not give any other medicines containing dolutegravir either. It is essential that you follow this warning.

Occasionally, hypersensitivity reactions have developed in people who take medicines containing abacavir again, after having had only one symptom of the Information 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 you to restart treatment with Triumeq, you can ask them to give the child the first doses in a place where they have easy access to medical assistance, in case it is necessary.

If the child is hypersensitive to Triumeq, return all unused Triumeq tablets to be disposed of safely. Consult your doctor or pharmacist.

The Triumeq packaging includes anInformation Cardto remind you and the medical staff of the possibility of suffering a hypersensitivity reaction.You must take 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" earlier in this section)
• loss of appetite
• skin rash
• itching(pruritus)
• vomiting
• abdominal pain(dyspepsia)
• stomach discomfort
• weight gain
• indigestion
• flatulence
• dizziness
• abnormal dreams
• nightmares
• depression(feeling of deep sadness and low self-esteem)
• anxiety
• fatigue
• feeling drowsy
• fever(elevated temperature)
• cough
• stuffy or runny nose
• hair loss
• muscle or joint pain
• weakness
• general feeling of being unwell.

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

• an increase in liver enzymes.
• an increase in muscle enzymes(creatine phosphokinase).

Uncommon side effects

These may affectup to 1 in 100people:

• inflammation of the liver(hepatitis)
• suicidal thoughts and behaviors (especially in patients who have had depression or mental health problems in the past)
• anxiety crisis.

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

• a decrease in the number of blood 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 levels
• an increase in triglyceride levels(a type of fat)in the blood.

Rare side effects

These may affectup to 1 in 10,000people:

• inflammation of the pancreas(pancreatitis)
• muscle tissue 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 had depression or mental health problems in the past).

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

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

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

Very rare side effects

These may affectup to 1 in 10,000people:

• numbness, tingling in the skin (pins and needles)

• weakness in the limbs
• skin rash, which may form blisters that look like small darts (a central dark spot surrounded by a lighter 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 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 the child in your care suffers any side effect

→Consult your doctor.This includes any possible side effect not mentioned in this leaflet.

Other possible side effects of combined HIV treatment

Combined treatments, like Triumeq, can cause other disorders todevelop 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). Such infections may have developed "silently", 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 monthsafter the child starts taking medicines to treat their 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 the child has any symptoms of infection and inflammationor if they notice any of the above symptoms:

→Consult your doctor immediately.Do not give any other medicines for the infection without consulting your doctor first.

Bone, joint, and muscle pain

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 systemis very weakened
• if they are overweight.

The signs of osteonecrosis include:

• joint stiffness
• aching or 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 blood lipid and glucose levels. 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 of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect not mentioned in this leaflet.You can also report them directly through the national notification 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 label of 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 dispose of the desiccant. Do not ingest the desiccant.

This medication does not require any special storage temperature.

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

Composition ofTriumeq

• The active ingredients aredolutegravir, abacavir and lamivudine.Each tablet containsdolutegravir sodium equivalent to 5mg of dolutegravir, 60mg of abacavir (as sulfate) and 30mg of lamivudine.
• The other components areacesulfame potassium, crospovidone, mannitol (E421), microcrystalline cellulose, povidone, microcrystalline cellulose silicified (microcrystalline cellulose; anhydrous colloidal silica), sodium glycolate starch, sodium stearate fumarate, strawberry cream flavor, sucralose, partially hydrolyzed polyvinyl alcohol, macrogol, talc, titanium dioxide (E171) and yellow iron oxide (E172).
• This medicine contains less than 1mmol of sodium (23mg) per dispersible tablet, which is essentially “sodium-free”.

Appearance of the product and contents of the pack

Triumeq dispersible tablets are yellow, biconvex, capsule-shaped tablets with "SV WTU" engraved on one side.

The bottles contain 90dispersible tablets.

The bottle contains a desiccant to reduce humidity. Once opened, keep the desiccant in the bottle, do not throw it away.

The pack includes a dosing cup.

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.

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

Last update date of this leaflet:

Other sources of information

The detailed information about this medicine is available on the website of the European Medicines Agency:https://www.ema.europa.eu.

Step-by-step instructions for use