Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - triumeq

Document Subject

Generated Narrative: MedicinalProductDefinition mp130bba2ea8da812c1b9f9db0b62fdb3a

identifier: http://ema.europa.eu/identifier/EU/1/14/940/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

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

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-130bba2ea8da812c1b9f9db0b62fdb3a

identifier: http://ema.europa.eu/identifier/EU/1/14/940/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - triumeq

Attesters

What is in this leaflet

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

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 anti-retroviral medicines (medicines used to treat HIV infection) called nucleoside analogue reverse transcriptase inhibitors (NRTIs), and dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs).

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

Before you are prescribed Triumeq your doctor will arrange a test to find out whether you carry a particular type of gene called HLA-B5701. Triumeq should not be used in patients who are known to carry the HLA-B5701 gene. Patients with this gene are at a high risk of developing a serious hypersensitivity (allergic) reaction if they use Triumeq (see hypersensitivity reactions in section 4).

Triumeq does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It also increases the number of CD4 cells in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection.

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

Do not take Triumeq

• if you are allergic (hypersensitive) to dolutegravir, abacavir (or any other medicine containing abacavir), or lamivudine, or any of the other ingredients of this medicine (listed in section 6). Carefully read all the information about hypersensitivity reactions in Section 4. * If you are taking a medicine called fampridine (also known as dalfampridine; used in multiple sclerosis). If you think any of these apply to you, tell your doctor.

Warnings and precautions
IMPORTANT Hypersensitivity reactions Triumeq contains abacavir and dolutegravir. Both of these active substances can cause a serious allergic reaction known as a hypersensitivity reaction. You should never take abacavir or abacavir- containing products again if you have a hypersensitivity reaction: it can be life threatening.

You must carefully read all the information under Hypersensitivity reactions in the panel in Section 4. The Triumeq pack includes an Alert Card to remind you and medical staff about hypersensitivity. Detach this card and keep it with you at all times.

Take special care with Triumeq

Some people taking Triumeq or other combination treatments for HIV are more at risk of serious side effects than others. You need to be aware of the extra risks:

• if you have moderate or severe liver disease
• if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, don t stop Triumeq without your doctor s advice, as your hepatitis may come back)
• if you have a kidney problem Talk to your doctor if any of these apply to you before using Triumeq. You may need extra check-ups, including blood tests, while you re taking your medicine. See Section 4 for more information.

Abacavir hypersensitivity reactions Even patients who don t have the HLA-B*5701 gene may still develop a hypersensitivity reaction (a serious allergic reaction). Carefully read all the information about hypersensitivity reactions in Section 4 of this leaflet.

Risk of cardiovascular events It cannot be excluded that abacavir may increase the risk of having cardiovascular events. Tell your doctor if you have cardiovascular problems, if you smoke, or have other illnesses that may increase your risk of cardiovascular diseases such as high blood pressure or diabetes. Don t stop taking Triumeq unless your doctor advises you to do so.

Look out for important symptoms
Some people taking medicines for HIV infection develop other conditions, which can be serious. These include:

• symptoms of infections and inflammation
• joint pain, stiffness and bone problems You need to know about important signs and symptoms to look out for while you re taking Triumeq.
  Read the information Other possible side effects of combination therapy for HIV in Section 4 of this leaflet.

Children This medicine is not for children weighing less than 25 kg because the dose of each component of this medicine cannot be adjusted to their weight.

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

Don't take Triumeq with the following medicine:

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

Some medicines can affect how Triumeq works, or make it more likely that you will have side effects.
Triumeq can also affect how some other medicines work.
Tell your doctor if you are taking any of the medicines in the following list:

• metformin, to treat diabetes

• medicines called antacids, to treat indigestion and heartburn. Do not take an antacid during the 6 hours before you take Triumeq, or for at least 2 hours after you take it. (See also Section 3).

• supplements or multivitamins containing calcium, iron or magnesium. If you take Triumeq with food, you can 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 during the 6 hours before you take Triumeq, or for at least 2 hours after you take it (see also Section 3).

• emtricitabine, etravirine, efavirenz, nevirapine or tipranavir/ritonavir, to treat HIV infection

• medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly

• other medicines containing lamivudine, used to treat HIV infection or hepatitis B infection

• cladribine, used to treat hairy cell leukaemia

• rifampicin, to treat tuberculosis (TB) and other bacterial infections

• trimethoprim/sulfamethoxazole, an antibiotic to treat bacterial infections

• phenytoin and phenobarbital, to treat epilepsy

• oxcarbazepine and carbamazepine, to treat epilepsy and bipolar disorder

• St. John s wort (Hypericum perforatum), a herbal remedy to treat depression

• methadone, used as a heroin substitute. Abacavir increases the rate at which methadone is removed from the body. If you are taking methadone, you will be checked for any withdrawal symptoms. Your methadone dose may need to be changed

• Riociguat, used to treat high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs. Your doctor may need to reduce your riociguat dose, as abacavir may increase riociguat blood levels.

  Tell your doctor or pharmacist if you are taking any of these. Your doctor may decide to adjust your dose or that you need extra checkups.

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

Talk to your doctor about the risks and benefits of taking Triumeq.

Taking Triumeq at the time of becoming pregnant or during the first six weeks of pregnancy, may increase the risk of a type of birth defect, called neural tube defect, such as spina bifida (malformed spinal cord).

If you could get pregnant while receiving Triumeq:

Talk to your doctor and discuss whether there is a need for contraception, such as condom or pills.

Tell your doctor immediately if you become pregnant or are planning to become pregnant. Your doctor will review your treatment. Do not stop taking Triumeq without consulting your doctor, as this may harm you and your unborn child.

Breast-feeding
Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.

A small amount of the ingredients in Triumeq can also pass into your breast milk. If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.

Driving and using machines
Triumeq can make you dizzy and have other side effects that make you less alert.

Don t drive or operate machinery unless you are sure your alertness has not been affected.

Triumeq contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially sodium-free .

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

• The usual dose is one tablet once a day

Swallow the tablet with 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 a day. If you weigh less than 25 kg, you cannot take Triumeq film-coated tablets, because the dose of each component of this medicine cannot be adjusted to your weight. Your doctor should prescribe Triumeq dispersible tablets or the components separately for you.

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

Do not take an antacid during the 6 hours before you take Triumeq, or for at least 2 hours after you take it. Other acid-lowering medicines like ranitidine and omeprazole can be taken at the same time as Triumeq.

Talk to your doctor for further advice on taking antacid medicines with Triumeq.

If you take Triumeq with food, you can 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 during the 6 hours before you take Triumeq, or for at least 2 hours after you take it.

Talk to your doctor for further advice on taking supplements or multivitamins containing calcium, iron or magnesium with Triumeq.

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

If you forget to take Triumeq
If you miss a dose, take it as soon as you remember. But if your next dose is due within 4 hours, skip the dose you missed and take the next one at the usual time. Then continue your treatment as before.

Don't take a double dose to make up for a missed dose.

If you have stopped taking Triumeq If you have stopped taking Triumeq for any reason especially because you think you are having side effects, or because you have another illness: Talk to your doctor before you start taking it again. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If the doctor thinks they may be related to a hypersensitivity reaction, you will be told never again to take Triumeq, or any other medicine containing abacavir or dolutegravir. It is important that you follow this advice. If your doctor advises that you can start taking Triumeq again, you may be asked to take your first doses in a place where you will have ready access to medical care if you need it.

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

When you re being treated for HIV, it can be hard to tell whether a symptom is a side effect of Triumeq or other medicines you are taking, or an effect of the HIV disease itself. So it is very important to talk to your doctor about any changes in your health.

Abacavir can cause a hypersensitivity reaction (a serious allergic reaction), especially in people who carry a particular type of gene called HLA-B5701. Even patients who don t have the HLA- B5701 gene may still develop a hypersensitivity reaction, described in this leaflet in the panel headed Hypersensitivity reactions . It is very important that you read and understand the information about this serious reaction.

As well as the side effects listed below for Triumeq, other conditions can develop during combination therapy for HIV.
It is important to read the information in this section under the heading 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 seen more frequently in people taking medicines that contain abacavir.

Who gets these reactions?

Anyone taking Triumeq could develop a hypersensitivity reaction, which could be life threatening if they continue to take Triumeq.

You are more likely to develop this reaction if you have a gene called HLA-B*5701 (but you can get a reaction even if you don t have this gene). You should have been tested for this gene before Triumeq was prescribed for you. If you know you have this gene, tell your doctor.

What are the symptoms?

The most common symptoms are: fever (high temperature) and skin rash. Other common symptoms are: nausea (feeling sick), vomiting (being sick), diarrhoea, abdominal (stomach) pain, severe tiredness.

Other symptoms include:

pains in the joints or muscles, swelling of the neck, shortness of breath, sore throat, cough, occasional headaches, inflammation of the eye (conjunctivitis), mouth ulcers, low blood pressure, tingling or numbness of the hands or feet.

When do these reactions happen?

Hypersensitivity reactions can start at any time during treatment with Triumeq, but are more likely during the first 6 weeks of treatment.

Contact your doctor immediately: 1 if you get a skin rash, OR 2 if you get 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 tiredness or aches and pains, or generally feeling ill.

Your doctor may advise you to stop taking Triumeq.

If you have stopped taking Triumeq

If you have stopped taking Triumeq because of a hypersensitivity reaction, you must NEVER AGAIN take Triumeq, or any other medicine containing abacavir. If you do, within hours, your blood pressure could fall dangerously low, which could result in death. You should also never again take medicines containing dolutegravir.

If you have stopped taking Triumeq for any reason especially because you think you are having side effects, or because you have other illness:

Talk to your doctor before you start again. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If the doctor thinks they may have been, you will then be told never again to take Triumeq, or any other medicine containing abacavir. You may also be told never again to take any other medicine containing dolutegravir. It is important that you follow this advice.

Occasionally, hypersensitivity reactions have developed in people who start taking abacavir containing products again, but who had only one symptom on the Alert 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 that you can start taking Triumeq again, you may be asked to take your first doses in a place where you will have ready access to medical care if you need it.

If you are hypersensitive to Triumeq, return all your unused Triumeq tablets for safe disposal. Ask your doctor or pharmacist for advice.

The Triumeq pack includes an Alert 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 feeling sick (nausea)
difficulty in sleeping (insomnia) lack of energy (fatigue)

Common side effects
These may affect up to 1 in 10 people: hypersensitivity reaction (see Hypersensitivity reactions earlier in this section) loss of appetite rash itching (pruritus) being sick (vomiting) stomach (abdominal) pain stomach (abdominal) discomfort weight gain indigestion wind (flatulence) dizziness abnormal dreams nightmares depression (feelings of deep sadness and unworthiness) anxiety tiredness feeling drowsy fever (high temperature) cough irritated or runny nose hair loss muscle pain and discomfort joint pain feeling weak general feeling of being unwell

Common side effects that may show up in blood tests are: an increase in the level of liver enzymes

Uncommon side effects
These may affect up to 1 in 100 people: inflammation of the liver (hepatitis)
suicidal thoughts and behaviours (particularly in patients who have had depression or mental health problems before) panic attack

Uncommon side effects that may show up in blood tests are: a decreased number of cells involved in blood clotting (thrombocytopenia). a low red blood cell count (anaemia) or low white blood cell count (neutropenia) an increase in sugar (glucose) in the blood an increase in triglycerides (type of fat) in the blood

Rare side effects These may affect up to 1 in 1000 people:

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

Rare side effects that may show up in blood tests are:

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

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

• numbness, tingly feelings in the skin (pins and needles)
• sensation of weakness in the limbs
• skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
• lactic acidosis (excess lactic acid in the blood).

Very rare side effects that may show up in blood tests are:

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

If you get any side effects Talk to your doctor. This includes any possible side effects not listed in this leaflet.

Other possible side effects of combination therapy for HIV Combination therapy such as Triumeq may cause other conditions to develop during HIV treatment.

Symptoms of infection and inflammation
People with advanced HIV infection or AIDS have weak immune systems, and are more likely to develop serious infections (opportunistic infections). Such infections may have been silent and not detected by the weak immune system before treatment was started. After starting treatment, the immune system becomes stronger, and may attack the infections, which can cause symptoms of infection or inflammation. Symptoms usually include fever, plus some of the following: headache stomach ache difficulty breathing In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders). The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection. Symptoms may include: palpitations (rapid or irregular heartbeat) or tremor hyperactivity (excessive restlessness and movement)
weakness beginning in the hands and feet and moving up towards the trunk of the body.

If you get any symptoms of infection and inflammation or if you notice any of the symptoms above:

Tell your doctor immediately. Don t take other medicines for the infection without your doctor s advice.

Joint pain, stiffness and bone problems Some people taking combination therapy for HIV develop a condition called osteonecrosis. In this condition, parts of the bone tissue die because of reduced blood supply to the bone. People may be more likely to get this condition: if they have been taking combination therapy for a long time if they are also taking anti-inflammatory medicines called corticosteroids if they drink alcohol if their immune systems are very weak if they are overweight. Signs of osteonecrosis include: stiffness in the joints aches and pains (especially in the hip, knee or shoulder) difficulty moving. If you notice any of these symptoms:

Tell your doctor.

Weight, blood lipid and blood glucose effects
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and lifestyle, and sometimes to the HIV medicines themselves. Your doctor will test for these changes.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 package in order to protect from moisture. Keep the bottle tightly closed. Do not remove the desiccant.

This medicine does not require any special temperature storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Triumeq contains

• The active substances are dolutegravir, abacavir and lamivudine. Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir, 600 mg abacavir (as sulfate) and 300 mg lamivudine.
• The other ingredients are mannitol (E421), microcrystalline cellulose, povidone (K29/32), sodium starch glycolate, magnesium stearate, poly(vinyl) alcohol partially hydrolysed, titanium dioxide, macrogol/PEG, talc, iron oxide black and iron oxide red).
• This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free . What Triumeq looks like and contents of the pack Triumeq film-coated tablets are purple, biconvex, oval tablets, debossed with 572 Tr on one side. The film-coated tablets are provided 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, do not remove it.
  Multipacks containing 90 film-coated tablets (3 packs of 30 film-coated tablets) are also available. Not all pack sizes may be available in your country.

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

Manufacturer
Glaxo Wellcome, S.A., Avda. Extremadura 3, 09400 Aranda De Duero, Burgos, Spain OR Delpharm Pozna Sp ka Akcyjna, UL.Grunwaldzka 189, 60-322 Poznan, Poland.

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

Belgi /Belgique/Belgien ViiV Healthcare srl/bv
T l/Tel: + 32 (0) 10 85 65 Lietuva ViiV Healthcare BV
Tel: + 370 80000
ViiV Healthcare BV
Te .: + 359 80018Luxembourg/Luxemburg ViiV Healthcare srl/bv
Belgique/Belgien T l/Tel: + 32 (0) 10 85 65 esk republika GlaxoSmithKline, s.r.o. Tel: + 420 222 001 cz.info@gsk.com

Magyarorsz g ViiV Healthcare BV Tel.: + 36 80088Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 dk-info@gsk.com

Malta ViiV Healthcare BV
Tel: + 356 80065Deutschland ViiV Healthcare GmbH
Tel.: + 49 (0)89 203 0038-viiv.med.info@viivhealthcare.com

Nederland ViiV Healthcare BV
Tel: + 31 (0)33 2081Eesti ViiV Healthcare BV
Tel: + 372 8002Norge GlaxoSmithKline AS Tlf: + 47 22 70 20
GlaxoSmithKline A.E.B.E. : + 30 210 68 82 sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com

Espa a Laboratorios ViiV Healthcare, S.L.
Tel: + 34 900 923 es-ci@viivhealthcare.com

Polska GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9France ViiV Healthcare SAS
T l.: + 33 (0)1 39 17 69 Infomed@viivhealthcare.com

Portugal VIIVHIV HEALTHCARE, UNIPESSOAL, LDA
Tel: + 351 21 094 08 viiv.fi.pt@viivhealthcare.com

Hrvatska ViiV Healthcare BV
Tel: + 385 800787Rom nia ViiV Healthcare BV
Tel: + 40800672Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955Slovenija ViiV Healthcare BV
Tel: + 386 80688 sland Vistor hf.
S mi: +354 535 7Slovensk republika ViiV Healthcare BV
Tel: + 421 800500Italia ViiV Healthcare S.r.l
Tel: + 39 (0)45 7741Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30
ViiV Healthcare BV
: + 357 80070Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 info.produkt@gsk.com

Latvija ViiV Healthcare BV
Tel: + 371 80205United Kingdom (Northern Ireland) ViiV Healthcare BV
Tel: + 44 (0)800 221customercontactuk@gsk.com

This leaflet was last revised in {month YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: