ABACAVIR 600 mg/300 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Abacavir+Lamivudine Accord, 600 mg + 300 mg, film-coated tablets
   1. Read all of this leaflet carefully before taking this medicine.
   2. IMPORTANT — Hypersensitivity Reactions
   3. It is essential to read all the information in the section "Hypersensitivity reactions" in section 4 carefully.
   4. Table of Contents
3. What Abacavir+Lamivudine Accord is and what it is used for
   1. Abacavir+Lamivudine Accord is used to treat HIV infection in adults, adolescents, and children weighing at least 25 kg.
4. Important information before taking Abacavir+Lamivudine Accord
   1. When not to take Abacavir+Lamivudine Accord:
   2. Read all the information about hypersensitivity reactions in section 4 carefully.
   3. When to be extra careful with Abacavir+Lamivudine Accord
   4. Before taking Abacavir+Lamivudine Accord, tell your doctor
   5. Hypersensitivity reactions to abacavir
   6. Read all the information about hypersensitivity reactions in section 4 of this leaflet carefully.
   7. Risk of cardiovascular events
   8. Looking out for serious signs
   9. Read the section "Other possible side effects of combination therapy for HIV" in section 4.
   10. Protecting others
   11. Abacavir+Lamivudine Accord with other medicines
   12. Tell your doctor or pharmacist about all the medicines you are taking
   13. The following medicines should not be taken with Abacavir+Lamivudine Accord:
   14. Some medicines interact with Abacavir+Lamivudine Accord
   15. Pregnancy
   16. Do not take Abacavir+Lamivudine Accord during pregnancy.
   17. Breast-feeding
   18. Consult your doctor.
   19. Driving and using machines
   20. Important information about some of the ingredients of Abacavir+Lamivudine Accord
5. How to take Abacavir+Lamivudine Accord
   1. The recommended dose of Abacavir+Lamivudine Accord for adults, adolescents, and children weighing at least 25 kg is one tablet once daily.
   2. Stay in regular contact with your doctor
   3. What to do if you take more Abacavir+Lamivudine Accord than you should
   4. What to do if you miss a dose of Abacavir+Lamivudine Accord
   5. What to do if you stop taking Abacavir+Lamivudine Accord
   6. Tell your doctor before you start taking Abacavir+Lamivudine Accord again.
6. Possible side effects
   1. Hypersensitivity reactions
   2. Who gets these reactions?
   3. What are the symptoms?
   4. If you continue to take Abacavir+Lamivudine Accord, these symptoms may get worse and can be life-threatening.
   5. When do these reactions occur?
   6. What to do if you develop any of the symptoms
8. 1. What to do if you stop taking Abacavir+Lamivudine Accord
   2. Talk to your doctor before you start taking Abacavir+Lamivudine Accord again.
   3. Disposal of unused medicinal products
   4. Common side effects
   5. Uncommon side effects
   6. Rare side effects
   7. Very rare side effects
   8. If you get any side effects, talk to your doctor or pharmacist
   9. Other possible side effects of combination therapy for HIV
   10. Infections and inflammation
   11. Old infections may come back
   12. Autoimmune problems
   13. Other side effects
   14. Reporting of side effects
9. How to store Abacavir+Lamivudine Accord
10. Contents of the pack and other information
    1. What Abacavir+Lamivudine Accord contains
    2. What Abacavir+Lamivudine Accord looks like and contents of the pack
    3. Marketing Authorisation Holder
    4. Manufacturer
    5. Date of last revision of the leaflet: September 2023

Package Leaflet: Information for the User

Abacavir+Lamivudine Accord, 600 mg + 300 mg, film-coated tablets

Abacavir + Lamivudine

Read all of this leaflet carefully before taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. See section 4.

IMPORTANT — Hypersensitivity Reactions

Abacavir+Lamivudine Accord contains abacavir(also found in other related medicines).
Some people taking abacavir may develop a hypersensitivity reaction(a severe allergic reaction) which can be life-threatening if they continue to take medicines containing abacavir.

It is essential to read all the information in the section "Hypersensitivity reactions" in section 4 carefully.

The packaging of Abacavir+Lamivudine Accord includes a Warning Cardto remind you and your healthcare provider of the risk of hypersensitivity reactions to abacavir. You should tear off the card and always carry it with you.

Table of Contents

• 1. What Abacavir+Lamivudine Accord is and what it is used for
• 2. Important information before taking Abacavir+Lamivudine Accord
• 3. How to take Abacavir+Lamivudine Accord
• 4. Possible side effects
• 5. How to store Abacavir+Lamivudine Accord
• 6. Contents of the pack and other information

1. What Abacavir+Lamivudine Accord is and what it is used for

Abacavir+Lamivudine Accord is used to treat HIV infection in adults, adolescents, and children weighing at least 25 kg.

Abacavir+Lamivudine Accord contains two active substances used to treat HIV infection: abacavir and lamivudine. They belong to a group of medicines called nucleoside reverse transcriptase inhibitors (NRTIs).
Abacavir+Lamivudine Accord does not cure HIV infection; it reduces the amount of HIV in your body and keeps it at a low level.
This helps to increase the number of CD4 cells in your blood. CD4 cells are a type of white blood cell that plays an important role in helping your body fight infection.
Not everyone responds to treatment with Abacavir+Lamivudine Accord in the same way.

2. Important information before taking Abacavir+Lamivudine Accord

When not to take Abacavir+Lamivudine Accord:

• If you are allergic (hypersensitive) to abacavir (or any other medicine containing abacavir, such as Trizivir, Triumeq, or Ziagen), lamivudine, or any of the other ingredients of this medicine (listed in section 6).

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

Talk to your doctorif you think any of the above applies to you. Do not take Abacavir+Lamivudine Accord.

When to be extra careful with Abacavir+Lamivudine Accord

Some people taking Abacavir+Lamivudine Accord or other combination treatments for HIV infection may be more likely to have serious side effects.
You should be aware of the additional risks:

• if you have moderate or severe liver disease
• if you have ever had liver disease, including viral hepatitis B or C (if you have hepatitis B, you should not stop taking Abacavir+Lamivudine Accord without your doctor's advice, as this may cause your hepatitis to come back)
• if you are overweight, especially if you are a woman
• if you have kidney problems.

Before taking Abacavir+Lamivudine Accord, tell your doctor

if any of the above apply to you. During treatment, your doctor may order additional tests, including blood tests. See section 4 for more information.

Hypersensitivity reactions to abacavir

Even if you do not have the HLA-B*5701 gene, you may still be at risk of a hypersensitivity reaction(a severe allergic reaction).

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

Risk of cardiovascular events

It is not known whether abacavir may increase the risk of cardiovascular events.
Tell your doctor if you have heart problems, if you smoke, or if you have other diseases that may increase your risk of heart disease, such as high blood pressure and diabetes. Do not stop taking Abacavir+Lamivudine Accord without your doctor's advice.

Looking out for serious signs

Some people taking medicines for HIV infection may develop other conditions, which can be serious.
You should look out for signs of:
— infections
— autoimmune disorders(where the immune system attacks healthy body tissue), such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body.

Read the section "Other possible side effects of combination therapy for HIV" in section 4.

Protecting others

HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing needles).
You can still pass on HIV when taking this medicine, although effective antiretroviral therapy has been shown to reduce the risk of transmission of HIV to others.
You must take precautions to avoid passing on the virus.
Talk to your doctor about the precautions you can take.

Abacavir+Lamivudine Accord with other medicines

Tell your doctor or pharmacist about all the medicines you are taking

now or have recently taken, including those you have bought without a prescription.
If you are about to start taking any new medicines, tell your doctor or pharmacist that you are taking Abacavir+Lamivudine Accord.

The following medicines should not be taken with Abacavir+Lamivudine Accord:

• emtricitabine, used to treat HIV infection
• other medicines containing lamivudine, used to treat HIV infectionor hepatitis B
• high doses of trimethoprim/sulfamethoxazole(an antibiotic)
• cladribine, used to treat hairy cell leukaemia. Tell your doctor if you are taking any of these medicines.

Some medicines interact with Abacavir+Lamivudine Accord

These include:

• phenytoin, used to treat epilepsy. If you are taking phenytoin, tell your doctor. Your doctor may need to monitor you while you are taking Abacavir+Lamivudine Accord.
• methadone, used as a heroin substitute. Abacavir speeds up the removal of methadone from the body. Patients taking methadone may be monitored for signs of withdrawal. A dose adjustment of methadone may be needed. If you are taking methadone, tell your doctor.
• medicines (usually liquids) containing sorbitol or other sugar alcohols(such as xylitol, mannitol, lactitol, or maltitol), if taken for a long time. If you are taking any of these medicines, tell your doctor or pharmacist.
• riociguat, used to treat high blood pressure in the blood vesselsthat transport blood from the heart to the lungs. Your doctor may need to reduce the dose of riociguat when taken with Abacavir+Lamivudine Accord, as abacavir may increase the levels of riociguat in your blood.

Pregnancy

Do not take Abacavir+Lamivudine Accord during pregnancy.

Abacavir+Lamivudine Accord and similar medicines may harm your unborn child. If you become pregnant while taking Abacavir+Lamivudine Accord, your doctor may order regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit of reducing the risk of passing on HIV to the child outweighs the risk of side effects.

Breast-feeding

Women with HIV infection should not breast-feed, as HIV can be passed on to the baby through breast milk. A small amount of the ingredients of Abacavir+Lamivudine Accord may also pass into breast milk.
If you are breast-feeding or thinking of breast-feeding:

Consult your doctor.

Driving and using machines

Abacavir+Lamivudine Accord can cause side effects that may affect your ability to drive or use machines.
Talk to your doctorabout driving or using machines while taking Abacavir+Lamivudine Accord.

Important information about some of the ingredients of Abacavir+Lamivudine Accord

Abacavir+Lamivudine Accord contains a coloring agent called sunset yellow F (E110), which may cause allergic reactions in some people.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially sodium-free.

3. How to take Abacavir+Lamivudine Accord

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose of Abacavir+Lamivudine Accord for adults, adolescents, and children weighing at least 25 kg is one tablet once daily.

Swallow the tablet whole with water. Abacavir+Lamivudine Accord can be taken with or without food.

Stay in regular contact with your doctor

Abacavir+Lamivudine Accord helps control your condition. You must take it every day to keep the HIV virus under control. You may still develop other infections and illnesses associated with HIV infection.
Keep in regular contact with your doctor and do not stop taking Abacavir+Lamivudine Accord without your doctor's advice.

What to do if you take more Abacavir+Lamivudine Accord than you should

If you accidentally take more than the recommended dose of Abacavir+Lamivudine Accord, tell your doctor or pharmacistor contact your nearest hospital emergency department for further advice.

What to do if you miss a dose of Abacavir+Lamivudine Accord

If you miss a dose, take it as soon as you remember. Then continue your treatment as before. Do not take a double dose to make up for a forgotten dose.
It is important to take Abacavir+Lamivudine Accord regularly to maintain its effectiveness.

What to do if you stop taking Abacavir+Lamivudine Accord

If you stop taking Abacavir+Lamivudine Accord for any reason — especially if you think you are having side effects or if you become ill:

Tell your doctor before you start taking Abacavir+Lamivudine Accord again.

Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If they were, your doctor will tell you not to take Abacavir+Lamivudine Accord againor any other medicine containing abacavir (such as Trizivir, Triumeq, or Ziagen).
It is essential to follow this advice.
Occasionally, reactions can occur when you restart abacavir in patients who have previously had only one symptom of a hypersensitivity reaction while taking abacavir.
Rarely, reactions can occur when you restart abacavir in patients who have previously not had any symptoms of a hypersensitivity reaction while taking abacavir.
If your doctor advises you to restart Abacavir+Lamivudine Accord, they may recommend that you take your first dose in a medical facility where you can be closely monitored for signs of a hypersensitivity reaction.

4. Possible side effects

During HIV treatment, weight gain and increases in blood levels of fats and sugars have been seen. This is partly due to the improvement in your condition and to the return to normal of the fat distribution in your body. Your doctor will monitor these factors.
As with all medicines, Abacavir+Lamivudine Accord can cause side effects, although not everybody gets them.
When treating HIV infection, it may still be difficult to tell whether some symptoms are due to the HIV disease or to the treatment.

Hypersensitivity reactions

Abacavir+Lamivudine Accord contains abacavir(also found in other related medicines). Abacavir can cause a hypersensitivity reaction(a severe allergic reaction), which can be life-threatening if you continue to take medicines containing abacavir.

Who gets these reactions?

Anyone taking Abacavir+Lamivudine Accord can develop a hypersensitivity reaction to abacavir, which can be life-threatening if you continue to take Abacavir+Lamivudine Accord.
The risk of developing a hypersensitivity reaction to abacavir is higher in people who have the HLA-B*5701 gene (but hypersensitivity reactions can occur in anyone, even if they do not have this gene).
Before your doctor prescribes Abacavir+Lamivudine Accord for you, they will check whether you have this gene. If you know you have this gene, tell your doctor before you start taking Abacavir+Lamivudine Accord.
A hypersensitivity reaction to abacavir occurred in about 3 to 4 out of every 100 patients who did not have the HLA-B*5701 gene and took abacavir in a clinical study.

What are the symptoms?

The most common symptoms are:

• fever(high temperature) and rash.

Other common symptoms include:

• nausea, vomiting, diarrhea, abdominal pain, and severe tiredness.

Other symptoms may include:

• joint or muscle pain, swelling of the neck, difficulty breathing, sore throat, cough, and occasionally headache, eye inflammation, mouth ulcers, low blood pressure, tingling or numbness of the hands and feet.

If you continue to take Abacavir+Lamivudine Accord, these symptoms may get worse and can be life-threatening.

When do these reactions occur?

Hypersensitivity reactions can occur at any time during treatment with Abacavir+Lamivudine Accord, but are more likely to occur in the first 6 weeks of treatment.

What to do if you develop any of the symptoms

1.

a rash

2.

or any of the following symptoms:

• fever
• respiratory symptoms such as cough, sore throat, or difficulty breathing
• gastrointestinal symptoms such as nausea, vomiting, diarrhea, or abdominal pain
• severe tiredness or a feeling of being generally unwell.

Tell your doctorwho will advise you to stop taking Abacavir+Lamivudine Accord.

What to do if you stop taking Abacavir+Lamivudine Accord

If you stop taking Abacavir+Lamivudine Accord because of a hypersensitivity reaction, you must never take Abacavir+Lamivudine Accord or any other medicine containing abacavir again(such as Trizivir, Triumeq, or Ziagen), as within hours of taking it again, you may experience a life-threatening reaction.
If you stop taking Abacavir+Lamivudine Accord for any reason — especially if you think you are having side effects or if you become ill:

Talk to your doctor before you start taking Abacavir+Lamivudine Accord again.

Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If they were, your doctor will tell you not to take Abacavir+Lamivudine Accord againor any other medicine containing abacavir (such as Trizivir, Triumeq, or Ziagen).
It is essential to follow this advice.
Occasionally, reactions can occur when you restart abacavir in patients who have previously had only one symptom of a hypersensitivity reaction while taking abacavir.
Rarely, reactions can occur when you restart abacavir in patients who have previously not had any symptoms of a hypersensitivity reaction while taking abacavir.
If your doctor advises you to restart Abacavir+Lamivudine Accord, they may recommend that you take your first dose in a medical facility where you can be closely monitored for signs of a hypersensitivity reaction.

Disposal of unused medicinal products

Return any unused Abacavir+Lamivudine Accord to a pharmacist for disposal. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

Common side effects

These may affect up to 1 in 10 people:

• hypersensitivity reactions
• headache
• vomiting
• nausea
• diarrhea
• abdominal pain
• loss of appetite
• feeling tired or lacking energy
• fever (high temperature)
• feeling generally unwell
• difficulty sleeping (insomnia)
• muscle pain and discomfort
• joint pain
• cough
• runny or stuffy nose
• skin rash
• hair loss.

Uncommon side effects

These may affect up to 1 in 100 people:

• low red blood cell count (anemia) or low white blood cell count (neutropenia)
• increased levels of liver enzymes in the blood
• reduced platelet count (thrombocytopenia).

Rare side effects

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

• liver damage, such as jaundice, enlarged liver, or fatty liver
• pancreatitis
• muscle breakdown (rhabdomyolysis).

Rare side effects that may show up in blood tests:

• increased levels of an enzyme called amylase.

Very rare side effects

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

• tingling or numbness of the hands and feet
• weakness of the limbs
• skin rash, which may form blisters and may be accompanied by fever (a condition known as erythema multiforme)
• widespread skin rash with blisters and peeling skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form called toxic epidermal necrolysis
• high levels of lactic acid in the blood (lactic acidosis).

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 the Yellow Card Scheme(for the UK) or to the FDA MedWatch(for the US). By reporting side effects, you can help provide more information on the safety of this medicine.

Other possible side effects of combination therapy for HIV

Combination therapy for HIV, such as Abacavir+Lamivudine Accord, can cause other conditions to occur.
These include:

Infections and inflammation

Old infections may come back

When people with advanced HIV infection start treatment, they may develop symptoms of infections that they already have (but were not apparent), called opportunistic infections. These symptoms may include:

• fever
• headache
• abdominal pain
• difficulty breathing.

And/or symptoms of more serious conditions such as:

• heart problems, such as inflammation of the heart muscleor myocarditis
• inflammation of the kidneys or kidney failure
• inflammation of the liver or liver failure
• severe anemiarequiring blood transfusions
• severe weakness of the bones(osteoporosis)

Autoimmune problems

Some people develop autoimmune problems (a condition where the immune system attacks healthy body tissue) when they take medicines for HIV. Symptoms may include:

• muscle weakness
• weakness beginning in the hands and feet and moving up towards the trunk of the body

Other side effects

Some people may experience:

• bone problems

These include:

• bone painor weakness
• osteonecrosis(a condition where the bone tissue dies due to lack of blood supply)

This condition can be caused by a problem with the blood supply to the bone or by taking corticosteroids or other medicines. If you experience bone pain or weakness, tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Abacavir+Lamivudine Accord

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 blister after EXP. The expiry date refers to the last day of that month.
There are no special storage requirements for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Abacavir+Lamivudine Accord contains

• Each film-coated tablet of Abacavir+Lamivudine Accord contains 600 mg of abacavir and 300 mg of lamivudine.
• The other ingredients are microcrystalline cellulose PH 102, microcrystalline cellulose PH 200, sodium starch glycolate (type A), povidone K 90, magnesium stearate, hypromellose cP 5, macrogol 400, titanium dioxide (E171), sunset yellow F (E110), and lak.

What Abacavir+Lamivudine Accord looks like and contents of the pack

Abacavir+Lamivudine Accord film-coated tablets are orange, film-coated tablets, capsule-shaped. The size of the tablet is 19.4 mm x 10.4 mm.
Abacavir+Lamivudine Accord is available in white, opaque blisters (Aluminum/PVC/PE/PVDC) in a cardboard box, containing 30 film-coated tablets.

Marketing Authorisation Holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7, 02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer

Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056, Limassol
Cyprus

Date of last revision of the leaflet: September 2023