Triumeq 50 mg/600 mg/300 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Triumeq 50mg/600mg/300mg film-coated tablets
dolutegravir/abacavir/lamivudine
Read the entire 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the 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 to treat HIV infection: abacavir, lamivudine, and dolutegravir. Abacavir and lamivudine belong to a group of antiretroviral medicines (medicines used to treat HIV infection) known as nucleoside reverse transcriptase inhibitors (NRTIs), and dolutegravir belongs to a group of antiretroviral medicines called integrase inhibitors (INIs).
Triumeq is used to treat HIV infection (human immunodeficiency virus) in adults, adolescents, and children 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 this HLA-B*5701 gene. Patients with this gene have a high risk of developing a severe hypersensitivity (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 important in helping your body fight infections.
Not all people respond to treatment with Triumeq in the same way. Your doctor will monitor the effectiveness of your 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), lamivudine, or any of the other components of this medicine (listed in section 6).
Please read carefully all the information about hypersensitivity reactions in section 4.
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if you are taking a medicine called fampridine (also known as dalfampridine; used to treat multiple sclerosis).
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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 may 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: this could potentially be fatal.
Please read carefully the information on “Hypersensitivity reactions” in section 4.
The Triumeq packaging includes an Alert Card to remind you and healthcare professionals about the possibility of a hypersensitivity reaction. You must remove this card and carry it with you at all times.
Take special care with Triumeq
Some people taking Triumeq or other combination HIV treatments have a higher risk of developing serious side effects than others. You should be aware that there is an increased risk:
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if you have moderate or severe liver disease
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if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B, do not stop taking Triumeq without your doctor’s advice, as your condition could worsen)
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if you have kidney problems.
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Consult your doctor before starting Triumeq if any of these situations apply to you. You may need additional tests, including blood tests, while taking this medicine. For more information, see section 4.
Hypersensitivity reactions to abacavir
Even patients who do not have the HLA-B*5701 gene can develop a hypersensitivity reaction (serious 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 doctor if you have cardiovascular problems, if you smoke, or if you have any condition that may increase your risk of cardiovascular disease, such as high blood pressure or diabetes. Do not stop taking Triumeq unless advised by your doctor.
Be alert to important symptoms
Some people taking medicines for HIV infection develop other disorders, which may be serious. These include:
- symptoms of infections and inflammation
- joint pain, stiffness, and bone problems.
You need to know which important signs and symptoms to watch for while taking Triumeq.
- Read the information on “Other possible side effects of combination HIV treatment” in section 4 of this leaflet.
Children
This medicine is not recommended for children weighing less than 25 kg, as the dose of each component in this medicine cannot be adjusted according to their weight.
Other medicines and Triumeq
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.
Do not take Triumeq with the following medicine:
- fampridine (also known as dalfampridine), used to treat multiple sclerosis.
Some medicines may affect how Triumeq works, or increase the likelihood of side effects. Triumeq may also affect how other medicines work.
Tell your doctor if you are taking any of the following medicines:
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metformin, to treat diabetes
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medicines called antacids, to treat indigestion and heartburn. Do not take an antacid within 6 hours before taking Triumeq, or at least 2 hours after taking it (see also section 3)
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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 at least 2 hours after taking it (see also section 3)
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emtricitabine, etravirine, efavirenz, nevirapine, or tipranavir/ritonavir, to treat HIV infection
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medicines (usually liquids) containing sorbitol and other polyols (such as xylitol, mannitol, lactitol, or maltitol), if taken regularly
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other medicines containing lamivudine, used to treat HIV infection or hepatitis B
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cladribine, used to treat hairy cell leukemia
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rifampicin, to treat tuberculosis (TB) and other bacterial infections
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trimethoprim/sulfamethoxazole, an antibiotic to treat bacterial infections
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phenytoin and phenobarbital, to treat epilepsy
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oxcarbazepine and carbamazepine, to treat epilepsy or bipolar disorder
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St John’s wort (Hypericum perforatum), a herbal medicine used to treat depression
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methadone, used as a heroin substitute. Abacavir increases the rate at which methadone is eliminated from the body. If you are taking methadone, you should be monitored for withdrawal symptoms. Your methadone dose may need to be adjusted
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riociguat, to treat high blood pressure in the blood vessels (pulmonary arteries) carrying blood from the heart to the lungs. Your doctor may need to reduce your riociguat dose, as abacavir may increase blood levels of riociguat.
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Inform your doctor or pharmacist if you are taking any of these medicines. 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 doctor about the risks and benefits of taking Triumeq.
Inform your doctor immediately if you become pregnant or plan to become pregnant. Your doctor will review your treatment. Do not stop treatment with Triumeq without consulting your doctor, as this could harm you and your fetus.
Breast-feeding
Breast-feeding is not recommended for women living with HIV, as 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 breast-feeding or considering breast-feeding, you should consult your doctor as soon as possible.
Driving and use of machines
Triumeq may cause dizziness and may have other side effects that reduce your attention.
- Do not drive or operate machinery unless you are certain that your reflexes are not affected.
Triumeq contains sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; that is, essentially “sodium-free”.
3. How to take Triumeq
Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.
- The usual dose is one tablet once daily.
Swallow the tablet with some 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 should not take Triumeq film-coated tablets, as the dose of each component of this medicine cannot be adjusted according to your weight. Your doctor should prescribe 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 the same. Therefore, do not switch between film-coated tablets and dispersible tablets without first talking to your doctor.
Do not take an antacid within 6 hours before taking Triumeq, or at least 2 hours after taking it. Other medicines that reduce acidity, such as ranitidine and omeprazole, can be taken at the same time as Triumeq.
- Consult your doctor for advice on which acid-reducing medicines 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 any supplement or multivitamin containing calcium, iron, or magnesium within 6 hours before taking Triumeq, or at least 2 hours after taking it.
- Consult your doctor for advice on how to take multivitamin supplements containing calcium, iron, or magnesium with Triumeq.
If you take more Triumeq than you should
If you take more Triumeq tablets than prescribed, contact your doctor or pharmacist for advice. If possible, show them the Triumeq packaging.
If you forget to take Triumeq
If you miss a dose, take it as soon as you remember. However, if less than 4 hours remain before your next scheduled 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 dose to make up for a missed dose.
If you have stopped taking Triumeq
If for any reason you have stopped taking Triumeq — especially because you think you are experiencing adverse effects or because you have another illness:
Consult your doctor before restarting treatment. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If your doctor considers they may have been related to a hypersensitivity reaction, you will be advised never to take Triumeq or any other medicine containing abacavir or dolutegravir again. It is important that you follow this warning.
If your doctor advises restarting treatment with Triumeq, they may ask you to take the first doses in a place where you have easy access to medical assistance, if needed.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
While undergoing HIV treatment, it may be difficult to distinguish whether a symptom is an adverse effect of Triumeq or of other medicines you are taking, or whether it is due to the HIV disease itself. Therefore, it is very important that you inform your doctor about any changes in your health.
Abacavir may cause a hypersensitivity reaction (a serious allergic reaction), especially in people who have a specific gene type called HLA-B*5701. Even patients who do not have the HLA-B*5701 gene may develop a hypersensitivity reaction, described under the section "Hypersensitivity reactions". It is very important that you read and understand the information about this serious reaction.
In addition to the adverse effects listed below for Triumeq, other disorders may develop during combination antiretroviral therapy.
It is important that you read the information under the section “Other possible adverse effects of combination antiretroviral therapy” in this section.
Hypersensitivity reactions
Triumeq contains abacavir and dolutegravir. These two active substances may cause a serious allergic reaction known as a hypersensitivity reaction.
Such hypersensitivity reactions have occurred more frequently in people taking medicines containing abacavir.
Who experiences these reactions?
Any person taking Triumeq could develop a hypersensitivity reaction, which could potentially be fatal if you continue taking Triumeq.
Your risk of developing this reaction is higher if you have a gene called HLA-B*5701 (but you may still have this reaction even if you do not have this gene). Before starting treatment with Triumeq, you should have been tested for this gene. If you know you have this gene, inform your doctor.
What are the symptoms?
The most common symptoms are:
fever (elevated temperature) and rash.
Other common symptoms are:
nausea (feeling unwell), vomiting, diarrhoea, abdominal (stomach) pain, and excessive tiredness.
Other possible symptoms include:
joint or muscle pain, swelling of the neck, difficulty breathing, sore throat, cough, occasional headaches, eye inflammation (conjunctivitis), mouth ulcers, low blood pressure, tingling or numbness 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 occur within the first 6 weeks of treatment.
Contact your doctor immediately:
- if you develop a rash, OR
- if you have symptoms from at least 2 of the following groups:
- fever
- difficulty breathing, sore throat, or cough
- nausea or vomiting, diarrhoea, or abdominal pain
- excessive tiredness, aches and pains, or general malaise.
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 again or any other medicine containing abacavir. If you do, within hours you may experience a drop in blood pressure that could potentially be fatal or cause death. You must also never take medicines containing dolutegravir again.
If for any reason you have interrupted treatment with Triumeq — especially because you think you are experiencing adverse effects or due to another illness:
Consult your doctor before restarting treatment. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If your doctor suspects such a link, they will instruct you never to take Triumeq or any other medicine containing abacavir again. You must also never take medicines containing dolutegravir again. It is important that you follow this warning.
Occasionally, hypersensitivity reactions have occurred in people who restart abacavir-containing medicines after having experienced only one symptom listed on the Information Card before stopping.
Very rarely, patients who previously took abacavir-containing medicines without any hypersensitivity symptoms have developed a hypersensitivity reaction when restarting these medicines.
If your doctor advises restarting Triumeq, they may ask you to take the first doses in a place where you have easy access to medical care, in case it is needed.
If you are hypersensitive to Triumeq, you must return all unused Triumeq tablets so they can be safely disposed of. Consult your doctor or pharmacist.
The Triumeq packaging includes an Information Card to remind you and medical personnel of the possibility of a hypersensitivity reaction. You must remove the card and carry it with you at all times.
Very common adverse effects
These may affect more than 1 in 10 people:
- headache
- diarrhoea
- nausea
- difficulty sleeping (insomnia)
- lack of energy (fatigue).
Common adverse effects
These may affect up to 1 in 10 people:
- hypersensitivity reaction (see "Hypersensitivity reactions" above)
- loss of appetite
- rash
- itching (pruritus)
- vomiting
- stomach pain (abdominal pain)
- abdominal discomfort
- weight gain
- indigestion
- gas (flatulence)
- dizziness
- abnormal dreams
- nightmares
- depression (feeling deeply sad and lacking self-worth)
- anxiety
- tiredness
- drowsiness
- fever (elevated temperature)
- cough
- irritated or runny nose
- hair loss
- muscle pain and discomfort
- joint pain
- feeling weak
- general malaise.
Common adverse effects that may appear in blood tests include:
- increased levels of liver enzymes
- increased levels of muscle enzymes (creatine phosphokinase).
Uncommon adverse effects
These may affect up to 1 in 100 people:
- liver inflammation (hepatitis)
- suicidal thoughts and behaviour (especially in patients who previously had depression or mental health problems)
- panic attacks.
Uncommon adverse effects that may appear in blood tests include:
- a decrease in the number of cells involved in blood clotting (thrombocytopenia)
- low red blood cell count (anaemia) or low white blood cell count (neutropenia)
- increased blood sugar (glucose) levels
- increased blood triglyceride levels (a type of fat).
Rare adverse effects
These may affect up to 1 in 1,000 people:
- pancreatitis (inflammation of the pancreas)
- muscle tissue breakdown
- liver failure (signs may include yellowing of the skin and whites of the eyes, or unusually dark urine)
- suicide (especially in patients who previously had depression or mental health problems).
Contact your doctor immediately if you experience any mental health problems (see also other mental health issues listed above).
Rare adverse effects that may appear in blood tests include:
- increased bilirubin (liver function test)
- increased levels of an enzyme called amylase.
Very rare adverse effects
These may affect up to 1 in 10,000 people:
- numbness, skin tingling (pins and needles)
- weakness in the limbs
- skin rash that may form blisters resembling small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
- widespread blistering rash with 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).
Very rare adverse effects that may appear in blood tests include:
- failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
Frequency not known – cannot be estimated from available data:
- a condition in which red blood cells do not form correctly (sideroblastic anaemia).
If you experience any adverse effect
- Consult your doctor. This includes any possible adverse effect not mentioned in this leaflet.
Other possible adverse effects of combination antiretroviral therapy
Combination therapies, 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 been "silent," not detected by the weakened immune system before treatment began. After starting treatment, the immune system becomes stronger and may begin to fight these infections, causing symptoms of infection or inflammation. Symptoms usually include fever, along with some of the following:
- headache
- stomach pain
- difficulty breathing.
In rare cases, as the immune system becomes stronger, it may also attack healthy tissues (autoimmune disorders). Symptoms of autoimmune disorders may appear many months after starting HIV treatment. Symptoms may include:
- palpitations (irregular or rapid heartbeat) or tremor
- hyperactivity (excessive restlessness and movement)
- weakness starting in the hands and feet and moving upward toward the body trunk.
If you have any symptoms of infection or inflammation or notice any of the symptoms listed above:
- Contact your doctor immediately. Do not take other medicines for infection without first consulting your doctor.
Joint pain, stiffness, and bone problems
Some people receiving combination antiretroviral therapy develop osteonecrosis. In this condition, parts of the bone tissue die due to reduced blood supply. 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 medicines called corticosteroids
- drink alcohol
- have a severely weakened immune system
- are overweight.
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 in blood lipid and glucose levels. This is partly related to improved health and lifestyle, and sometimes to the HIV medicines themselves. Your doctor will assess these changes.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Triumeq
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after EXP. The expiry date is the last day of the month indicated.
Store in the original packaging to protect from moisture. Keep the bottle tightly closed. Do not discard the desiccant.
This medicine does not require any special storage temperature.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Triumeq
- The active substances are dolutegravir, abacavir and lamivudine. Each tablet contains dolutegravir sodium equivalent to 50 mg of dolutegravir, 600 mg of abacavir (as sulphate) and 300 mg of lamivudine.
- The other components are mannitol (E421), microcrystalline cellulose, povidone (K29/32), sodium carboxymethylstarch, magnesium stearate, poly(vinyl alcohol)-partially hydrolysed, 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, that is, essentially “sodium-free”.
Appearance of the product and contents of the container
Triumeq film-coated tablets are oval, biconvex, purple tablets with " 572 Tri " engraved on one side.
Bottles contain 30 film-coated tablets.
The bottle contains a desiccant to reduce moisture. Once opened, keep the desiccant in the bottle; do not discard it.
Clinical packs containing 90 film-coated tablets (3 packs of 30 film-coated tablets) are also available. Some pack sizes may not 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 Poznan Spólka Akcyjna, UL.Grunwaldzka 189, 60-322 Poznan, Poland.
More information about this medicine is available upon request to the local representative of the Marketing Authorisation Holder:
Belgium/Belgium/Belgium ViiV Healthcare srl/bv Tel/Tel: + 32 (0) 10 85 65 00 | Lithuania ViiV Healthcare BV Tel: + 370 80000334 |
| Luxembourg/Luxembourg ViiV Healthcare srl/bv Belgium/Belgium Tel/Tel: + 32 (0) 10 85 65 00 |
Czech Republic GlaxoSmithKline, s.r.o. Tel: + 420 222 001 111 | Hungary ViiV Healthcare BV Tel.: + 36 80088309 |
Denmark GlaxoSmithKline Pharma A/S Tlf.: + 45 36 35 91 00 | Malta ViiV Healthcare BV Tel: + 356 80065004 |
Germany ViiV Healthcare GmbH Tel.: + 49 (0)89 203 0038-10 | Netherlands ViiV Healthcare BV Tel: + 31 (0) 33 2081199 |
Estonia ViiV Healthcare BV Tel: + 372 8002640 | Norway GlaxoSmithKline AS Tlf: + 47 22 70 20 00 |
Greece GlaxoSmithKline Μονοπρóσωπη A.E.B.E. Tel: + 30 210 68 82 100 | Austria GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 |
Spain Laboratorios ViiV Healthcare, S.L. Tel: + 34 900 923 501 | Poland GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000 |
France ViiV Healthcare SAS Tél.: + 33 (0)1 39 17 69 69 | Portugal VIIVHIV HEALTHCARE, UNIPESSOAL, LDA Tel: + 351 21 094 08 01 |
Croatia ViiV Healthcare BV Tel: + 385 800787089 | Romania ViiV Healthcare BV Tel: + 40800672524 |
Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000 | Slovenia ViiV Healthcare BV Tel: + 386 80688869 |
Iceland Vistor ehf. Tel: +354 535 7000 | Slovakia ViiV Healthcare BV Tel: + 421 800500589 |
Italy ViiV Healthcare S.r.l Tel: + 39 (0)45 7741600 | Finland GlaxoSmithKline Oy Tel: + 358 (0)10 30 30 30 |
Cyprus ViiV Healthcare BV Tel: + 357 80070017 | Sweden GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 |
Latvia ViiV Healthcare BV Tel: + 371 80205045 | |
Date of the most recent review of this leaflet: (month YYYY).
Other sources of information
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.