Package leaflet: Information for the patient

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

dolutegravir/abacavir/lamivudine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Triumeq is and what it is used for
What you need to know before taking Triumeq
How to take Triumeq
Possible side effects
How to store Triumeq
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 substances used in the treatment of HIV infection:
abacavir, lamivudine and dolutegravir. Abacavir and lamivudine belong to a group of antiretroviral medicines
known as nucleoside reverse transcriptase inhibitors (NRTIs), while 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 weighing at least 25 kg.
Before prescribing Triumeq, your doctor will perform a test to determine whether you carry a particular gene called HLA-B*5701. Triumeq must not be used in patients known to carry the HLA-B*5701 gene. Patients with this gene are at 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, but it reduces the amount of virus in the body and keeps it at low levels. It also increases the number of CD4 cells in the blood. CD4 cells are a type of white blood cell important in helping the body fight infection.
Not everyone responds to treatment with Triumeq in the same way. Your doctor will monitor the effectiveness of the treatment.

2. What you need to know before taking Triumeq

Do not take Triumeq

if you are allergic (hypersensitive) to dolutegravir, abacavir (or any other medicine containing abacavir), or lamivudine, or to any of the other ingredients of this medicine (listed in section 6). Please read carefully all the information about hypersensitivity reactions in section 4.
if you are taking a medicine called fampridine (also known as dalfampridine, used for multiple sclerosis). → Consult your doctor if you think any of these conditions apply to you.

Warnings and precautions
IMPORTANT – Hypersensitivity reactions
Triumeq contains abacavir and dolutegravir. Both of these active substances can cause a serious
allergic reaction known as a hypersensitivity reaction. You must never take abacavir or any
medicines containing abacavir again if you have had a hypersensitivity reaction, as it could be life-threatening.
Please read carefully all the information in the section "Hypersensitivity reactions" in
section 4.
The Triumeq packaging includes an Alert card designed to remind you and healthcare professionals
that a hypersensitivity reaction may occur.
Remove this card and keep it with you at all times.
Be especially careful with Triumeq
Some people taking Triumeq or other combination therapies for the treatment of HIV are at higher risk of
serious side effects than others. You should be aware of these additional risks:

if you have moderate or severe liver disease
if you have had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop taking Triumeq without consulting your doctor, as hepatitis may worsen)
if you have kidney problems → Inform your doctor before using Triumeq if any of these conditions apply to you. You may need additional monitoring, including blood tests, while taking this medicine. See section 4 for further information.

Hypersensitivity reactions to abacavir
Even patients who do not carry the HLA-B*5701 gene may develop a hypersensitivity reaction (a severe allergic reaction).
→ Please 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 be associated with an increased risk of cardiovascular events.
→ Inform your doctor if you have cardiovascular problems, are a smoker, or suffer from conditions that may increase the risk of cardiovascular disease, such as high blood pressure or diabetes. Do not stop taking Triumeq unless your doctor advises you to do so.
Be aware of important symptoms
Some people taking medicines for HIV infection develop other conditions that may be serious. These include:

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

You should be aware of these important signs and symptoms so that you can recognize them while taking Triumeq.
→ Read the information in the section "Other possible side effects of combination therapy for HIV" in
section 4 of this leaflet.
Children
This medicine is not recommended for children weighing less than 25 kg, because the dose of each component of this medicine cannot be adjusted according to their body weight.
Other medicines and Triumeq
Inform your doctor if you are taking, have recently taken, or might take any other medicine.
Do not take Triumeq with the following medicine:

fampridine (also known as dalfampridine), used for multiple sclerosis.

Some medicines may affect the activity of Triumeq or make it more likely that you will experience side effects. Triumeq may also affect the activity of other medicines.
Inform your doctor if you are taking any of the medicines listed in the following list:

metformin, for the treatment of diabetes
medicines called antacids, for the treatment of indigestion and heartburn. Do not take an antacid within 6 hours before taking Triumeq or within at least 2 hours after taking it (see also section 3)
supplements or multivitamins containing calcium, iron, or magnesium. If you take Triumeq with food, you may take supplements or multivitamins containing calcium, iron, or magnesium at the same time as Triumeq. If you do not take Triumeq with food, do not take supplements or multivitamins containing calcium, iron, or magnesium within 6 hours before taking Triumeq or within at least 2 hours after taking it (see also section 3)
emtricitabine, etravirine, efavirenz, nevirapine, or tipranavir/ritonavir, for the treatment of HIV infection
medicines (usually liquids) containing sorbitol and other sweeteners (such as xylitol, mannitol, lactitol, or maltitol), if taken regularly
other medicines containing lamivudine used for the treatment of HIV infection or hepatitis B virus infection
cladribine, used for the treatment of hairy cell leukemia
rifampicin, for the treatment of tuberculosis (TB) and other bacterial infections
trimethoprim/sulfamethoxazole, an antibiotic for the treatment of bacterial infections
phenytoin and phenobarbital, for the treatment of epilepsy
oxcarbazepine and carbamazepine, for the treatment of epilepsy and bipolar disorders
St. John’s wort (Hypericum perforatum), a herbal remedy for the treatment of depression
methadone, used as a heroin substitute. Abacavir increases the rate at which methadone is eliminated from the body. If you are taking methadone, you will be monitored for any symptoms of withdrawal. It may be necessary to adjust your methadone dose.
riociguat, used for the treatment of high blood pressure in the blood vessels (pulmonary arteries) carrying blood from the heart to the lungs. Your doctor may need to reduce the dose of riociguat, as abacavir may increase riociguat blood levels. → Inform your doctor or pharmacist if you are taking any of these medicines. Your doctor may decide to adjust the dose or perform additional monitoring.
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to have a baby: → Talk to your doctor about the risks and benefits of taking Triumeq.

Inform your doctor immediately if you become pregnant or are planning a pregnancy. Your doctor will
review your treatment. Do not stop taking Triumeq without consulting your doctor, as this could harm you and your unborn child.
Breast-feeding
Breast-feeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the child through breast milk.
A small amount of the components in Triumeq may also pass into breast milk.
If you are breast-feeding or considering breast-feeding, you should discuss this with your doctor as soon as possible.
Driving and using machines
Triumeq may cause dizziness and other side effects that may reduce your level of alertness.
→ Do not drive or operate machinery if you are not sure that your ability to remain alert is not impaired.
Triumeq contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., essentially "sodium-free".

3. How to take Triumeq

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

The recommended dose is one tablet once daily.

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

Use in children and adolescents
Children and adolescents weighing at least 25 kg can take the adult dose of one tablet once daily.
If you weigh less than 25 kg, you must not take Triumeq film-coated tablets, because the dose of each component of this medicine cannot be adjusted according to body weight. Your doctor must prescribe you Triumeq dispersible tablets or the individual components separately.
Triumeq is available as film-coated tablets and dispersible tablets. Film-coated tablets and dispersible tablets are not interchangeable. Therefore, do not switch from a film-coated tablet to a dispersible tablet without first discussing it with your doctor.

Do not take an antacid within 6 hours before or at least 2 hours after taking Triumeq.
Other medicines that reduce acidity, such as ranitidine and omeprazole, may be taken at the same time as Triumeq.
→ Consult your doctor to find out which antacids you can take with Triumeq.

If you take Triumeq with food, you may take supplements or multivitamins containing calcium, iron, or magnesium at the same time as Triumeq. If you do not take Triumeq with food, do not take a supplement or multivitamin containing calcium, iron, or magnesium within the 6 hours before taking Triumeq, or for at least 2 hours after taking it.
→ Consult your doctor to find out which supplements or multivitamins containing calcium, iron, or magnesium you can take with Triumeq.

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

If you forget to take Triumeq
If you forget a dose, take it as soon as you remember. If your next dose is due within 4 hours, skip the missed dose and take the next dose at your usual time. Then continue as normal.
→ Do not take a double dose to make up for a forgotten dose.

If you have stopped taking Triumeq
If you have stopped taking Triumeq for any reason, especially because you thought you were experiencing side effects or other illnesses:
consult your doctor before restarting the medicine. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If your doctor suspects that your symptoms may have been due to a hypersensitivity reaction, you will be instructed never to take Triumeq or any other medicine containing abacavir or dolutegravir again. It is important that you follow this advice.
If your doctor advises you to restart Triumeq, you will be asked to take the first doses in a setting where you can receive immediate medical assistance if needed.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During HIV treatment, it may be difficult to determine whether a symptom is an unwanted effect of
Triumeq or of other medicines you are taking, or whether it is an effect of HIV disease itself. For this
reason, it is very important to inform your doctor about any changes in your health status.
Abacavir can cause a hypersensitivity reaction (a severe allergic reaction), especially in people who have a
particular gene called HLA-B*5701. Even patients who do not have the HLA-B*5701 gene may still develop
a hypersensitivity reaction , described in this leaflet in a section entitled "Hypersensitivity reactions". It is
very important to read and understand the information about this serious reaction.
During combination therapy for HIV, both the side effects listed below for Triumeq and other diseases may
occur.
It is important to read the information in the section entitled "Other possible side effects of combination
therapy for HIV".

Hypersensitivity reactions
Triumeq contains abacavir and dolutegravir. Both of these active substances can cause a serious allergic
reaction known as a hypersensitivity reaction.
These hypersensitivity reactions have been observed more frequently in people taking medicines containing
abacavir.

Who is at risk of these reactions?
Any person taking Triumeq may develop a hypersensitivity reaction, which can be life-threatening if you
continue taking Triumeq.
You are more likely to develop this reaction if you have a gene called HLA-B*5701 (but you may still
experience this reaction even if you do not have this gene). You will need to undergo a test to detect the
presence of this gene before Triumeq is prescribed. If you know you have this gene, inform your doctor.

What are the symptoms?
The most common symptoms are:
fever (high temperature) and rash.
Other common symptoms are:
nausea , vomiting, diarrhoea, abdominal pain (stomach pain), severe fatigue.
Other symptoms include:
muscle or joint pain, swelling of the neck, shortness of breath, sore throat, cough, occasional headache, eye
inflammation (conjunctivitis), mouth ulcers, low blood pressure, tingling or numbness in the hands or feet.

When do these reactions occur?
Hypersensitivity reactions can start at any time during treatment with Triumeq, but are more likely to occur
within the first 6 weeks of treatment.

Contact your doctor immediately:
1 if you develop a rash OR
2 if you develop 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 fatigue or body aches, or a general feeling of being unwell.

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, you must NEVER AGAIN take
Triumeq or any other medicine containing abacavir . If you do, your blood pressure may drop dangerously
within a few hours, possibly leading to death. You must also never take medicines containing dolutegravir
again.
If you have stopped taking Triumeq for any reason, especially because you thought you were experiencing side
effects or due to other illnesses:
inform your doctor before restarting the medicine. Your doctor will assess whether your symptoms were
related to a hypersensitivity reaction. If your doctor believes your symptoms may have been related to a
hypersensitivity reaction, you will be instructed never to take Triumeq or any other medicine containing
abacavir again. You will also be advised never to take any other medicine containing dolutegravir. It is
important that you follow this advice.
Sometimes, hypersensitivity reactions have occurred in people who restarted medicines containing abacavir
but who had previously experienced only one of the symptoms listed on the Warning Card before stopping the
medicine.
Very rarely, patients who previously took abacavir-containing medicines without any hypersensitivity
symptoms have later developed a hypersensitivity reaction when restarting these medicines.
If your doctor advises you to restart Triumeq, you will be asked to take the first doses in a place where you
can receive immediate medical assistance if needed.
If you are hypersensitive to Triumeq, return all unused Triumeq tablets so they can be safely disposed of. Ask
your doctor or pharmacist for advice.
The Triumeq package includes a Warning Card to remind you and healthcare professionals about
hypersensitivity reactions. Detach this card and keep it with you at all times.

Very common side effects
These may affect more than 1 in 10 people :

headache
diarrhoea
nausea
sleep disorders ( insomnia )
lack of energy ( fatigue )

Common side effects
These may affect up to 1 in 10 people :

hypersensitivity reaction (see "Hypersensitivity reactions" at the beginning of this section )
loss of appetite
rash
itching
vomiting
stomach ache ( abdominal pain )
stomach discomfort ( abdominal disturbances )
weight gain
indigestion
flatulence ( intestinal gas )
dizziness
abnormal dreams
nightmares
depression (feeling deeply sad and worthless)
anxiety
tiredness
drowsiness
fever ( high temperature )
cough
nasal irritation or runny nose
hair loss
muscle discomfort and pain
joint pain
feeling weak
general feeling of being unwell
Common side effects that may be detected by blood tests are:
increased liver enzyme levels
increased levels of muscle enzymes ( creatine phosphokinase )

Uncommon side effects
These may affect up to 1 in 100 people :

inflammation of the liver ( hepatitis )
suicidal thoughts and behaviour (particularly in patients who previously had depression or mental health problems)
panic attack

Uncommon side effects that may be detected by blood tests are:

reduced number of cells involved in blood clotting ( thrombocytopenia )
low number of red blood cells ( anaemia ) or low number of white blood cells ( neutropenia )
increased blood sugar ( glucose )
increased blood triglycerides (a type of fat)

Rare side effects
These may affect up to 1 in 1,000 people :

inflammation of the pancreas ( pancreatitis )
muscle tissue breakdown
liver failure (signs may include yellowing of the skin and whites of the eyes or unusually dark urine)
suicide (particularly in patients who previously had depression or mental health problems) → Inform your doctor immediately if you experience any mental health problems (see also other mental health issues listed above).

Rare side effects that may be detected by blood tests are:

increased bilirubin (a marker of liver function)
increased levels of an enzyme called amylase

Very rare side effects
These may affect up to 1 in 10,000 people :

sensation of numbness, tingling skin (pins and needles)
weakness in the limbs
rash with blister-like spots resembling small targets (a dark spot in the centre surrounded by a clear area with a black 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 causing skin peeling over more than 30% of the body surface ( toxic epidermal necrolysis )
lactic acidosis (excess lactic acid in the blood). A very rare side effect that may be detected by blood tests is:
bone marrow failure to produce new red blood cells ( pure red cell aplasia ).

If you experience any side effect:
→ consult your doctor. This includes any possible side effect not listed in this leaflet.

Other possible side effects of combination therapy for HIV
Combination therapy such as Triumeq may cause the development of other diseases 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 been "silent" and not detected by the
weakened immune system before starting treatment. After starting treatment, the immune system becomes
stronger and may react against these infections, causing symptoms of infection or inflammation. Symptoms
typically include fever together with:

headache
stomach pain
difficulty breathing

In rare cases, as the immune system strengthens, it may also attack healthy body tissues ( autoimmune disorders ). Symptoms of autoimmune disorders may develop many months after starting the medicine for HIV infection. Symptoms may include:

palpitations (rapid or irregular heartbeat) or tremor
hyperactivity (agitation and excessive movement)
weakness starting in the hands and feet and spreading towards the body trunk.

If you experience any symptoms of infection and inflammation or notice any of the symptoms listed above:
→ inform your doctor immediately. Do not take any other medicines for infection without consulting your doctor.

Joint pain, stiffness and bone problems
Some people taking combination therapy for HIV infection develop a condition called osteonecrosis . In this
condition, part of the bone tissue dies due to reduced blood flow to the bones. People may be more likely to
develop this condition:

if they have been on combination therapy for a long time
if they are also taking anti-inflammatory drugs called corticosteroids
if they consume alcoholic beverages
if their immune system is very weak
if they are overweight.

Signs of osteonecrosis include:

joint stiffness
pain and discomfort (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 therapy, an increase in weight and in blood lipid and glucose levels may occur. This is partly due
to improved health status and lifestyle, and sometimes to the HIV medicines themselves. Your doctor will
monitor these changes.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V . By reporting
side effects, you can help provide more information on the safety of this medicine.

5. How to store Triumeq

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after "Exp.".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. Keep the bottle tightly closed. Do not remove the desiccant.
This medicine does not require any special storage temperature.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Triumeq contains

The active substances 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 lamivudina.
The other ingredients are mannitol (E421), microcrystalline cellulose, povidone (K29/32), sodium starch glycolate, magnesium stearate, partially hydrolysed polyvinyl alcohol, titanium dioxide, macrogol/PEG, talc, black iron oxide and red iron oxide.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

Description of the appearance of Triumeq and contents of the pack
Triumeq film-coated tablets are purple, biconvex, oval tablets, with the code “572 Trı” engraved on one side.
The film-coated tablets are supplied in bottles containing 30 tablets.
The bottle contains a desiccant to reduce moisture. Once the bottle has been opened, keep the desiccant in the bottle and do not remove it.
Multiple packs containing 90 film-coated tablets (3 packs of 30 film-coated tablets) are also available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, The Netherlands

Manufacturer
Glaxo Wellcome, S.A., Avda. Extremadura 3, 09400 Aranda De Duero, Burgos, Spain
or
Delpharm Poznań Spółka Akcyjna, UL.Grunwaldzka 189, 60-322 Poznan, Poland.

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
ViiV Healthcare srl/bv ViiV Healthcare BV
Tél/Tel: + 32 (0) 10 85 65 00 Tel: + 370 80000334

България Luxembourg/Luxemburg
ViiV Healthcare BV ViiV Healthcare srl/bv
Teл.: + 359 80018205 Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 65 00

Česká republika Magyarország
GlaxoSmithKline, s.r.o. ViiV Healthcare BV
Tel: + 420 222 001 111 Tel.: + 36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S ViiV Healthcare BV
Tlf.: + 45 36 35 91 00 Tel: + 356 80065004
[email protected]

Deutschland Nederland
ViiV Healthcare GmbH ViiV Healthcare BV
Tel.: + 49 (0)89 203 0038-10 Tel: + 31 (0) 33 2081199
[email protected]

Eesti Norge
ViiV Healthcare BV GlaxoSmithKline AS
Tel: + 372 8002640 Tlf: + 47 22 70 20 00

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
Laboratorios ViiV Healthcare, S.L. GSK Services Sp. z o.o.
Tel: + 34 900 923 501 Tel.: + 48 (0)22 576 9000
[email protected]

France Portugal
ViiV Healthcare SAS VIIVHIV HEALTHCARE, UNIPESSOAL, LDA
Tél.: + 33 (0)1 39 17 69 69 Tel: + 351 21 094 08 01
[email protected] [email protected]

Hrvatska România
ViiV Healthcare BV ViiV Healthcare BV
Tel: + 385 800787089 Tel: + 40800672524

Ireland Slovenija
GlaxoSmithKline (Ireland) Limited ViiV Healthcare BV
Tel: + 353 (0)1 4955000 Tel: + 386 80688869

Ísland Slovenská republika
Vistor hf. ViiV Healthcare BV
Sími: +354 535 7000 Tel: + 421 800500589

Italia Suomi/Finland
ViiV Healthcare S.r.l GlaxoSmithKline Oy
Tel: + 39 (0)45 7741600 Puh/Tel: + 358 (0)10 30 30 30

Κύπρος Sverige
ViiV Healthcare BV GlaxoSmithKline AB
Τηλ: + 357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija United Kingdom (Northern Ireland)
ViiV Healthcare BV ViiV Healthcare BV
Tel: + 371 8020504 Tel: + 44 (0)800 221441
[email protected]

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

Instructions for the patient: package leaflet

Triumeq 5 mg/60 mg/30 mg dispersible tablets

dolutegravir/abacavir/lamivudine
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for a child you are caring for. Do not give it to other people, even if their symptoms are the same as those of the child you are caring for, as it could be harmful.
If the child experiences any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Triumeq is and what it is used for
What you need to know before using Triumeq
How to administer Triumeq
Possible side effects
How to store Triumeq
Contents of the pack and other information
Detailed instructions for use

1. What Triumeq is and what it is used for

Triumeq is a medicine that contains three active substances used in the treatment of HIV infection:
abacavir, lamivudine, and dolutegravir. Abacavir and lamivudine belong to a group of antiretroviral
medicines known as nucleoside reverse transcriptase inhibitors (NRTIs), while dolutegravir belongs to a
group of antiretroviral medicines called integrase inhibitors (INIs).
Triumeq is used to treat HIV infection (human immunodeficiency virus) in children aged 3 months or older
who weigh at least 6 kg but less than 25 kg.
Before Triumeq is prescribed for the child under your care, the doctor will perform a test to determine
whether the child carries a specific gene called HLA-B*5701. Triumeq must not be used in patients known
to carry the HLA-B*5701 gene. Patients with this gene are at 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, but it reduces the amount of virus in the body and keeps it at low
levels. It also increases the number of CD4 cells in the blood. CD4 cells are a type of white blood cell
important in helping the body fight infection.
Not everyone responds to treatment with Triumeq in the same way. Your doctor will monitor how well the
treatment is working for the child.

2. What you need to know before using Triumeq

Do not use Triumeq

If the child you are caring for is allergic (hypersensitive) to dolutegravir, abacavir (or any other medicine containing abacavir), or lamivudine, or to any of the other ingredients of this medicine (listed in section 6). Please read carefully all the information about hypersensitivity reactions in section 4
If the child you are caring for is taking a medicine called fampridine (also known as dalfampridine, used for multiple sclerosis). → Consult your doctor if you think either of these conditions applies to the child.

Warnings and precautions
IMPORTANT — Hypersensitivity reactions
Triumeq contains abacavir and dolutegravir. Both of these active substances can cause a severe
allergic reaction known as a hypersensitivity reaction.
The child you are caring for must never take abacavir or any medicines containing abacavir again if they have had a hypersensitivity reaction, as it could be life-threatening.
Please read carefully all the information in the section "Hypersensitivity reactions" in
section 4.
The Triumeq packaging includes an Alert card designed to remind you and healthcare professionals that a hypersensitivity reaction may occur.
Remove this card and keep it with you at all times.
Be especially careful with Triumeq
Some people taking Triumeq or other combination therapies for the treatment of HIV are at higher risk of serious side effects than others. You should be aware of these additional risks:

if the child you are caring for has moderate or severe liver disease
if the child you are caring for has had liver disease, including hepatitis B or C (if the child has hepatitis B infection, they must not stop taking Triumeq without medical advice, as hepatitis may flare up)
if the child you are caring for has kidney problems → Inform your doctor if any of these situations apply to the child before using Triumeq. Additional monitoring, including blood tests, may be required while taking the medicine. See section 4 for further information.

Hypersensitivity reactions to abacavir
Even patients who do not carry the HLA-B*5701 gene may develop a hypersensitivity reaction (a severe allergic reaction).
→ Please read carefully all the information about hypersensitivity reactions in section 4 of this
package leaflet.
Risk of cardiovascular events
It cannot be ruled out that abacavir may be associated with an increased risk of cardiovascular events.
→ Inform your doctor if the child you are caring for has cardiovascular problems, is a smoker,
or suffers from other conditions that may increase the risk of cardiovascular disease, such as high
blood pressure or diabetes. Do not stop administering Triumeq unless advised by your doctor.
Be alert to important symptoms
Some people taking medicines for HIV infection develop other conditions that may be serious. These include:

symptoms of infections and inflammation
joint pain, stiffness, and bone problems. You should be aware of these important signs and symptoms so that you can recognize them while administering Triumeq. → Read the information under "Other possible side effects of combination therapy for HIV" in section 4 of this leaflet.

Children
Triumeq is not indicated for use in children under 3 months of age or weighing less than 6 kg, as lower doses of this medicine have not been evaluated in these groups.
Children must attend all scheduled medical appointments (see section 3 How to take Triumeq for further information).
Other medicines and Triumeq
Inform your doctor if the child you are caring for is currently taking, has recently taken, or might take any other medicines.
Some medicines may affect the action of Triumeq or make side effects more likely. Triumeq may also affect the action of other medicines.
Inform your doctor if the child is taking any of the medicines listed in the following list:

metformin for the treatment of diabetes
medicines called antacids for the treatment of indigestion and heartburn. Do not take an antacid within 6 hours before or at least 2 hours after taking Triumeq (see also section 3)
supplements or multivitamins containing calcium, iron, or magnesium. If you take Triumeq with food, you may take supplements or multivitamins containing calcium, iron, or magnesium at the same time as Triumeq. If you do not take Triumeq with food, do not take supplements or multivitamins containing calcium, iron, or magnesium within 6 hours before or at least 2 hours after taking Triumeq (see also section 3)
emtricitabine, etravirine, efavirenz, nevirapine, or tipranavir/ritonavir, for the treatment of HIV infection
medicines (usually liquids) containing sorbitol and other sweeteners (such as xylitol, mannitol, lactitol, or maltitol), if taken regularly
other medicines containing lamivudine used for the treatment of HIV infection or hepatitis B virus infection
cladribine used for the treatment of hairy cell leukemia
rifampicin for the treatment of tuberculosis (TB) and other bacterial infections
trimethoprim/sulfamethoxazole, an antibiotic for the treatment of bacterial infections
phenytoin and phenobarbital for the treatment of epilepsy
oxcarbazepine and carbamazepine for the treatment of epilepsy and bipolar disorders
St. John’s wort (Hypericum perforatum), a herbal remedy for the treatment of depression
methadone used as a heroin substitute. Abacavir increases the rate at which methadone is eliminated from the body. If the child is taking methadone, they will be monitored for any withdrawal symptoms. It may be necessary to adjust the methadone dose.
riociguat, for the treatment of high blood pressure in the blood vessels (pulmonary arteries) carrying blood from the heart to the lungs. Your doctor may need to reduce the dose of riociguat, as abacavir may increase blood levels of riociguat.

→ Inform your doctor or pharmacist if the child you are caring for is taking any of these
medicines. Your doctor may decide to adjust the child’s dose or perform additional monitoring.
Pregnancy
Women who are pregnant, suspect they may be pregnant, or are planning to have a baby:
→ must speak with their doctor about the risks and benefits of taking Triumeq.
Inform your doctor immediately if you become pregnant or are planning a pregnancy. Your doctor will review your treatment. Do not stop taking Triumeq without consulting your doctor, as this could harm both you and your unborn child.
Breast-feeding
Breast-feeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the child through breast milk.
A small amount of the components in Triumeq may also pass into breast milk.
If you are breast-feeding or considering breast-feeding, you must speak with your doctor as soon as possible.
Driving and using machines
Triumeq may cause dizziness and other side effects that may impair attention.
→ Do not drive or operate machinery if you are not sure that your level of alertness is unaffected.
Triumeq contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dispersible tablet, i.e., essentially "sodium-free".

3. How to take Triumeq

Always take this medicine exactly as instructed by the doctor. If in doubt, consult your doctor or pharmacist.
The doctor will determine the correct dose of Triumeq for the child in your care based on their body weight.
If the child in your care is younger than 3 months of age or weighs less than 6 kg, Triumeq is not suitable, as it is not known whether Triumeq is safe and effective in such cases. The doctor will need to prescribe the individual components separately for the child.
Triumeq may be taken with or without food.
The dispersible tablets must be dispersed in drinking water. The tablets must be completely dispersed in the dosing cup provided before swallowing. Do not chew, cut, or crush the tablets. If the child in your care is unable to use the dosing cup provided, an oral syringe may also be used to administer the medicine. Speak with the doctor for advice.
The dose for children of Triumeq must be adjusted as body weight increases.
→ It is therefore important that children attend their scheduled medical appointments.
Triumeq is available as film-coated tablets and dispersible tablets. The film-coated tablets and dispersible tablets are not the same. Therefore, do not switch from a film-coated tablet to a dispersible tablet without first discussing it with the doctor.
Do not take an antacid within 6 hours before or at least 2 hours after taking Triumeq. Other medicines that reduce acidity, such as ranitidine and omeprazole, may be taken at the same time as Triumeq.
→ Consult your doctor to find out which antacids can be taken with Triumeq.
If you take Triumeq with food, you may take supplements or multivitamins containing calcium, iron, or
magnesium at the same time as Triumeq. If you do not take Triumeq with food, do not give a supplement or multivitamin containing calcium, iron, or magnesium within 6 hours before taking Triumeq, or for at least 2 hours after administration.
→ Consult your doctor to find out which supplements or multivitamins containing calcium, iron, or magnesium can be taken with Triumeq.
If you take more Triumeq than you should
If too many dispersible tablets of Triumeq have been taken, contact your doctor or pharmacist for advice. If possible, show them the Triumeq packaging.
If you forget to take Triumeq
If a dose is missed, take it as soon as you remember. However, if the next dose is due within 4 hours, skip the missed dose and take the next dose at the usual time. Then continue the child’s treatment as before.
→ Do not take a double dose to make up for a forgotten dose.
If you have stopped taking Triumeq
If you have stopped giving Triumeq to the child for any reason, particularly because you thought it was causing side effects or other illnesses:
consult your doctor before restarting the medicine. The doctor will check whether the child’s symptoms were related to a hypersensitivity reaction. If the doctor believes these symptoms may have been related to a hypersensitivity reaction, you will be told never to take Triumeq or any other medicine containing abacavir or
dolutegravir again. It is important that you follow this advice.
If the doctor advises restarting Triumeq, you will be asked to give the first doses in a setting where the child can receive prompt medical attention if needed.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During treatment of a child for HIV, it may be difficult to determine whether a symptom is a side effect of Triumeq, of other medicines the child is taking, or an effect of the HIV disease itself. For this reason, it is very important to inform the doctor of any changes in the child’s health status.

Abacavir may cause a hypersensitivity reaction (a serious allergic reaction), especially in people who carry a particular gene called HLA-B*5701. However, even patients who do not have the HLA-B*5701 gene can still develop a hypersensitivity reaction, described in this leaflet in a section titled "Hypersensitivity reactions". It is very important to read and understand the information about this serious reaction.

During combination therapy for HIV, both the side effects listed below for Triumeq and other illnesses may occur.

It is important to read the information in the section titled "Other possible side effects of combination therapy for HIV".

Hypersensitivity reactions

Triumeq contains abacavir and dolutegravir. Both of these active substances can cause a serious allergic reaction known as a hypersensitivity reaction.

These hypersensitivity reactions have been observed more frequently in people taking medicines containing abacavir.

Who is at risk of these reactions?

Any person taking Triumeq may develop a hypersensitivity reaction, which can be life-threatening if Triumeq is continued.

The child is more likely to develop this reaction if they carry a gene called HLA-B*5701 (but the reaction may still occur even if the child does not have this gene). The child in your care must be tested for the presence of this gene before Triumeq is prescribed. If you know the child has this gene, inform the doctor.

What are the symptoms?

The most common symptoms are:

fever (high temperature) and rash.

Other common symptoms are:

nausea, vomiting, diarrhoea, abdominal pain (stomach pain), severe fatigue.

Other symptoms include:

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

When do these reactions occur?

Hypersensitivity reactions may occur at any time during treatment with Triumeq, but are most likely to appear within the first 6 weeks of treatment.

Contact your doctor immediately:

1 if the child develops a rash OR

2 if the child develops 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 fatigue or body aches, or a general feeling of being unwell.

Your doctor may advise you to stop administering Triumeq.

If you have stopped administering Triumeq

If you have stopped giving Triumeq to the child due to a hypersensitivity reaction, the child must NEVER take Triumeq or any other medicine containing abacavir again. If this happens, blood pressure may drop dangerously within a few hours, potentially leading to death. The child must also never take medicines containing dolutegravir again.

If the child has stopped taking Triumeq for any reason, particularly because of suspected side effects or other illnesses:

inform the doctor before restarting the medicine. The doctor will assess whether the child’s symptoms were related to a hypersensitivity reaction. If the doctor suspects that the symptoms may have been due to a hypersensitivity reaction, you will be told never to administer Triumeq or any other medicine containing abacavir again. You will also be advised never to administer any medicine containing dolutegravir again. It is important to follow this advice.

Sometimes, hypersensitivity reactions have occurred in people who restarted abacavir-containing medicines after having experienced only one of the symptoms listed on the Warning Card before stopping the medicine.

Very rarely, patients who previously took abacavir-containing medicines without any hypersensitivity symptoms later developed a hypersensitivity reaction when restarting these medicines.

If your doctor advises restarting Triumeq, you will be asked to administer the first doses in a setting where the child can receive immediate medical assistance if needed.

If the child is hypersensitive to Triumeq, return all unused Triumeq tablets for safe disposal. Ask your doctor or pharmacist for advice.

The Triumeq package includes a Warning Card to remind you and medical staff about hypersensitivity reactions. Detach this card and keep it with you at all times.

Very common side effects

These may affect more than 1 in 10 people:

headache
diarrhoea
nausea
sleep disorders (insomnia)
lack of energy (fatigue)

Common side effects

These may affect up to 1 in 10 people:

hypersensitivity reaction (see "Hypersensitivity reactions" at the beginning of this section)
loss of appetite
rash
itching
vomiting
stomach ache (abdominal pain)
stomach discomfort (abdominal disturbances)
weight gain
indigestion
flatulence (intestinal gas)
dizziness
abnormal dreams
nightmares
depression (feeling of deep sadness and worthlessness)
anxiety
tiredness
drowsiness
fever (high temperature)
cough
nasal irritation or runny nose
hair loss
muscle discomfort and pain
joint pain
feeling of weakness
general feeling of being unwell

Common side effects that may be detected by blood tests include:

increased liver enzyme levels
increased levels of muscle enzymes (creatine phosphokinase)

Uncommon side effects

These may affect up to 1 in 100 people:

liver inflammation (hepatitis)
suicidal thoughts and behaviour (particularly in patients who have previously had depression or mental health problems)
panic attack

Uncommon side effects that may be detected by blood tests include:

reduced number of cells involved in blood clotting (thrombocytopenia)
low number of red blood cells (anaemia) or low number of white blood cells (neutropenia)
increased blood sugar (glucose) levels
increased blood triglycerides (a type of fat)

Rare side effects

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

inflammation of the pancreas (pancreatitis)
muscle tissue breakdown
liver failure (signs may include yellowing of the skin and whites of the eyes or unusually dark urine)
suicide (particularly in patients who have previously had depression or mental health problems) → Inform your doctor immediately if any mental health problems occur (see also other mental health problems listed above).

Rare side effects that may be detected by blood tests include:

increased bilirubin (a marker of liver function)
increased levels of an enzyme called amylase

Very rare side effects

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

sensation of numbness, tingling in the skin (pins and needles)
feeling of weakness in the limbs
rash with blister-like spots resembling small targets (a dark spot in the centre surrounded by a light 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 causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
lactic acidosis (excess lactic acid in the blood)

A very rare side effect that may be detected by blood tests is:

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

If the child in your care experiences any side effect:

→ consult the doctor. This includes any possible side effect not listed in this leaflet.

Other possible side effects of combination therapy for HIV

Combination therapy such as Triumeq may cause the development of other illnesses 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 be "silent" and not detected by the weakened immune system before starting treatment. After starting treatment, the immune system becomes stronger and may react against these infections, causing symptoms of infection or inflammation. Symptoms usually include fever together with:

headache
stomach ache
breathing difficulties

In rare cases, as the immune system strengthens, it may also attack the body's healthy tissues (autoimmune disorders). Symptoms of autoimmune disorders may develop many months after starting the medicine for HIV infection. Symptoms may include:

palpitations (fast or irregular heartbeat) or tremor
hyperactivity (agitation and excessive movement)
weakness starting in the hands and feet and spreading towards the body trunk.

If the child develops any symptoms of infection and inflammation or if you notice any of the symptoms listed above:

→ inform the doctor immediately. Do not administer other medicines for infection without consulting the doctor.

Joint pain, stiffness and bone problems

Some people taking combination therapy for HIV infection develop a condition called osteonecrosis. In this condition, part of the bone tissue dies due to reduced blood supply to the bones. People may be more likely to develop this condition if they:

have been on combination therapy for a long time
are also taking anti-inflammatory drugs called corticosteroids
consume alcoholic beverages
have a very weak immune system
are overweight.

Signs of osteonecrosis include:

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

If you notice any of these symptoms:

→ inform the doctor.

Effects on weight, lipids and blood glucose

During HIV therapy, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly due to improved health status and lifestyle, and sometimes due to the HIV medicines themselves. Your doctor will monitor these changes.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Triumeq

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the bottle after "Exp.".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. Keep the bottle tightly closed.
Do not remove the desiccant. Do not ingest the desiccant.
This medicine does not require any special storage temperature.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Triumeq contains

The active substances are dolutegravir, abacavir and lamivudine. Each tablet contains dolutegravir sodium equivalent to 5 mg of dolutegravir, 60 mg of abacavir (as sulfate) and 30 mg of lamivudine.
The other ingredients are potassium acesulfame, crospovidone, mannitol (E421), microcrystalline cellulose, povidone, silicified microcrystalline cellulose (microcrystalline cellulose, anhydrous colloidal silica), sodium starch glycolate, sodium stearil fumarate, strawberry cream flavour, sucralose, partially hydrolysed polyvinyl alcohol, macrogol, talc, titanium dioxide (E171) and yellow iron oxide (E172).
This medicine contains less than 1 mmol of sodium (23 mg) per dispersible tablet, i.e., essentially "sodium-free".

Description of the appearance of Triumeq and package contents
Triumeq dispersible tablets are yellow, capsule-shaped, biconvex tablets, with "SV WTU" engraved on one side.
The dispersible tablets are supplied in bottles containing 90 tablets.
The bottle contains a desiccant to reduce moisture. Once the bottle has been opened, keep the desiccant in the bottle and do not remove it.
The pack includes a dosing cup.

Marketing Authorisation Holder
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, The Netherlands

Manufacturer
Glaxo Wellcome, S.A., Avda. Extremadura 3, 09400 Aranda De Duero, Burgos, Spain

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder: