ABACAVIR 300 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Abacavir Accord, 300 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. IMPORTANT – Hypersensitivity Reactions
   3. It is essential to read all the information about hypersensitivity reactions in section 4.
   4. Table of contents of the leaflet:
3. What is Abacavir Accord and what is it used for
   1. Abacavir Accord is used to treat human immunodeficiency virus (HIV) infections.
4. Important information before taking Abacavir Accord
   1. When not to take Abacavir Accord:
   2. Read all the information about hypersensitivity reactions in section 4 carefully.
   3. When to exercise special caution when taking Abacavir Accord
   4. Tell your doctor if any of the above circumstances apply to you.
   5. See section 4 for more information.
   6. Cardiovascular events risk
   7. Read the information 'Other possible side effects of combination therapy for HIV infection' in section 4 of this leaflet.
   8. Abacavir Accord and other medicines
   9. Tell your doctor or pharmacist about all the medicines you are taking
   10. Some medicines interact with Abacavir Accord.
   11. Pregnancy
   12. Breast-feeding
   13. Driving and using machines
   14. Abacavir Accord contains sodium
5. How to take Abacavir Accord
   1. Regular contact with your doctor
   2. Do not stop taking Abacavir Accord without your doctor's advice.
   3. What dose to take
   4. Adults, adolescents, and children weighing at least 25 kg
   5. Children from 1 year of age and weighing less than 25 kg
   6. Taking a higher dose of Abacavir Accord than recommended
   7. Missing a dose of Abacavir Accord
   8. Stopping Abacavir Accord treatment
   9. Tell your doctor before resuming Abacavir Accord treatment.
6. Possible side effects
   1. It is crucial to read and understand the information about this severe reaction.
   2. Hypersensitivity Reactions
   3. Who can experience these reactions?
   4. What are the symptoms?
   5. When can these reactions occur?
   6. For the caregivers of a child taking Abacavir Accord, it is essential to understand the information about hypersensitivity reactions. If the child experiences any of the symptoms described below, it is crucial to follow the instructions below.
   7. You must contact your doctor immediately if:
8. 1. Your doctor may advise you to stop taking Abacavir Accord.
   2. Stopping Abacavir Accord treatment
   3. If you are allergic to Abacavir Accord, return any unused Abacavir Accord to the pharmacy
   4. Common side effects
   5. Rare side effects
   6. Very rare side effects
   7. If you experience any of these symptoms, contact your doctor immediately.
   8. If you experience side effects
   9. Other possible side effects of combination therapy for HIV infection
   10. Infection and inflammation symptoms
   11. Previous infections may develop rapidly
   12. Bone disorders may occur
   13. Symptoms of osteonecrosis include:
   14. If you experience any of these symptoms:
   15. Tell your doctor.
   16. Reporting side effects
9. How to store Abacavir Accord
10. Contents of the packaging and other information
    1. What Abacavir Accord contains
    2. What Abacavir Accord looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer/Importer
    5. This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
    6. Date of last revision of the leaflet: October 2023

Leaflet accompanying the packaging: patient information

Abacavir Accord, 300 mg, film-coated tablets

Abacavirum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

IMPORTANT – Hypersensitivity Reactions

Abacavir Accord contains abacavir(which is also an active substance in medicines containing abacavir + lamivudine, abacavir + lamivudine + zidovudine, abacavir + dolutegravir + lamivudine).
In some patients taking abacavir, a hypersensitivity reaction(severe allergic reaction) may develop, which can be life-threatening if the use of medicines containing abacavir is continued.

It is essential to read all the information about hypersensitivity reactions in section 4.

The packaging of Abacavir Accord medicine contains a Warning Cardto remind the patient and medical staff about hypersensitivity to abacavir. The card should be removed from the packaging and carried with you at all times.

Table of contents of the leaflet:

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

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

Abacavir Accord is used to treat human immunodeficiency virus (HIV) infections.

Abacavir Accord contains the active substance abacavir. Abacavir belongs to a group of antiretroviral medicines called nucleoside reverse transcriptase inhibitors (NRTIs).
Abacavir Accord does not completely cure HIV infection; it reduces the amount of HIV in the patient's body and keeps it at a low level. It also increases the number of CD4 cells in the blood. CD4 cells are a type of white blood cell that plays an essential role in helping the body fight infections.
Not all patients respond to Abacavir Accord treatment in the same way. The effectiveness of the treatment will be monitored by the doctor.

2. Important information before taking Abacavir Accord

When not to take Abacavir Accord:

• if the patient is allergic(hypersensitive) to abacavir (or any other medicine containing abacavir
• e.g. abacavir + lamivudine, abacavir + lamivudine + zidovudine, abacavir + dolutegravir + 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.

Consult your doctorif you suspect that any of the above circumstances apply to you.

When to exercise special caution when taking Abacavir Accord

Some patients taking Abacavir Accord for HIV infection are more likely to experience severe side effects. The patient should be aware of this additional risk:

• if the patient has moderate or severe liver disease,
• if the patient has had liver diseasein the past, including viral hepatitis B or C,
• if the patient is overweight(especially in women),
• if the patient has severe kidney disease.

Tell your doctor if any of the above circumstances apply to you.

Your doctor may recommend additional monitoring tests, including blood tests, during treatment.

See section 4 for more information.

Hypersensitivity reactions to abacavir
Even in patients without the HLA-B*5701 gene, a hypersensitivity reaction(severe allergic reaction) may occur.
Read all the information about hypersensitivity reactions in section 4 of this leaflet carefully.

Cardiovascular events risk

It cannot be excluded that abacavir may increase the risk of cardiovascular events.
Tell your doctor if you have cardiovascular problems, if you smoke, or if you have other diseases that may increase the risk of cardiovascular disease, such as high blood pressure and diabetes. Do not stop taking Abacavir Accord unless your doctor advises you to.
Pay attention to important symptoms
Some patients taking HIV medicines may experience other complications that can be severe. The patient should be aware of the important signs and symptoms to look out for when taking Abacavir Accord.

Read the information 'Other possible side effects of combination therapy for HIV infection' in section 4 of this leaflet.

Abacavir Accord and other medicines

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

currentlyor recently, including herbal products and other medicines available without a prescription. If you start taking a new medicine while taking Abacavir Accord, remember to tell your doctor or pharmacist.

Some medicines interact with Abacavir Accord.

These include:

• phenytoin, used to treat epilepsy. If you are taking phenytoin, tell your doctor. Your doctor may recommend monitoring you while taking Abacavir Accord.
• methadone, used as a heroin substitute. Abacavir increases the rate at which methadone is removed from the body. Patients taking methadone will be monitored for signs of withdrawal. A dose adjustment of methadone may be necessary.
  If you are taking methadone, tell your doctor

and will be monitored for signs of withdrawal. A dose adjustment of methadone may be necessary.
If you are taking methadone, tell your doctor

• riociguat, used to treat high blood pressure in the blood vessels(in the pulmonary arteries) that carry blood from the heart to the lungs. It may be necessary to reduce the dose of riociguat by your doctor, as abacavir may increase the concentration of riociguat in the blood.

Pregnancy

Abacavir Accord should not be used during pregnancy. Abacavir Accord and similar medicines may cause side effects in the unborn child. If you have taken Abacavir Accord during pregnancy, your doctor may recommend regular blood tests and other diagnostic tests to monitor the development of the child. In children whose mothers took NRTIs during pregnancy, the benefit of reducing the risk of HIV infection outweighs the risk of side effects.

Breast-feeding

HIV-infected women should not breast-feedbecause HIV can be passed on to the baby through breast milk. A small amount of Abacavir Accord ingredients may also pass into breast milk.
If you are breast-feeding or plan to breast-feed, consult your doctor
immediately.

Driving and using machines

Do not drive or operate machineryunless you feel well.

Abacavir Accord contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially 'sodium-free'.

3. How to take Abacavir Accord

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Swallow the tablet with water. Abacavir Accord can be taken with or without food.
If you cannot swallow the tablet, you can crush it and add it to a small amount of semi-solid food or liquid, then take the whole dose immediately after preparation.

Regular contact with your doctor

Abacavir Accord helps control your condition. You must take it every day to keep your disease under control. You may still get other infections and illnesses related to HIV.

Do not stop taking Abacavir Accord without your doctor's advice.

Abacavir Accordwithout your doctor's advice.

What dose to take

Adults, adolescents, and children weighing at least 25 kg

The recommended dose of Abacavir Accord is 600 mg per day. It can be taken as one 300 mg tablet twice a day or two 300 mg tablets once a day.

Children from 1 year of age and weighing less than 25 kg

The dose depends on the child's weight. The recommended dosing is:

• Children weighing at least 20 kg and less than 25 kg:the usual dose of Abacavir Accord is 450 mg per day. According to your doctor's advice, the medicine can be taken as 150 mg (half a tablet) in the morning and 300 mg (one tablet) in the evening or as 450 mg (one and a half tablets) once a day.

The tablet can be divided into equal doses.
Abacavir is also available as an oral solution for the treatment of children over 3 months of age and weighing less than 14 kg, as well as for patients who require a dose reduction or are unable to take tablets.

Taking a higher dose of Abacavir Accord than recommended

If you accidentally take a higher dose of Abacavir Accord than recommended, tell your doctor or pharmacist or contact the nearest hospital emergency department for further advice.

Missing a dose of Abacavir Accord

If you miss a dose of Abacavir Accord, take it as soon as possible.
Continue with the treatment as before. Do not take a double dose to make up for the missed dose.
It is essential to take Abacavir Accord regularly, as irregular intake increases the risk of a hypersensitivity reaction.

Stopping Abacavir Accord treatment

If you stop taking Abacavir Accord for any reason - especially if you think you have experienced side effects or if another illness has occurred:

Tell your doctor before resuming Abacavir Accord treatment.

Abacavir Accordtreatment. Your doctor will check if the symptoms you experienced could be related to a hypersensitivity reaction. If they think it is possible, they will advise you never to take Abacavir Accord or any other medicine containing abacavir (e.g. abacavir + lamivudine, abacavir + lamivudine + zidovudine, abacavir + dolutegravir + lamivudine). It is crucial to follow this advice.
If your doctor advises you to start taking Abacavir Accord again, they may recommend that you take the first dose in a place where medical help is readily available.

4. Possible side effects

During HIV treatment, weight gain and increased lipid and glucose levels in the blood may occur. This is partly related to the improvement in health and lifestyle, and sometimes, in the case of lipid levels in the blood, to the effect of HIV medicines. Your doctor will recommend tests to detect these changes.
Like all medicines, Abacavir Accord can cause side effects, although not everybody gets them.
During HIV treatment, it is not always possible to determine whether a particular side effect is caused by Abacavir Accord, other medicines taken at the same time, or by the HIV infection itself. Therefore, it is essential to inform your doctor about any changes in your health. Even in patients without the HLA-B*5701 gene, a hypersensitivity reaction(severe allergic reaction) may occur, as described in this leaflet in the "Hypersensitivity Reactions" section.

It is crucial to read and understand the information about this severe reaction.

In addition to the side effects listed below, Abacavir Accordmay cause other side effects during combination therapy for HIV infection.
It is essential to read the information 'Other possible side effects of combination therapy for HIV infection' below.

Hypersensitivity Reactions

Abacavir Accordcontains abacavir(which is also an active substance in medicines containing abacavir + lamivudine, abacavir + lamivudine + zidovudine, abacavir + dolutegravir + lamivudine).
Abacavir may cause a severe allergic reaction known as a hypersensitivity reaction. These hypersensitivity reactions have been observed more frequently in patients taking abacavir-containing medicines.

Who can experience these reactions?

Any patient taking Abacavir Accord may experience a hypersensitivity reaction to abacavir, which can be life-threatening if Abacavir Accord treatment is continued.
The likelihood of such a reaction is higher in people with a gene called HLA-B*5701(however, even if the patient does not have this gene, a hypersensitivity reaction may occur). Before prescribing Abacavir Accord, your doctor should test you for this gene. If you know you have this gene, tell your doctor before starting Abacavir Accord treatment.A hypersensitivity reaction developed in about 3 to 4 out of every 100 patients without the HLA-B*5701 gene who received abacavir in a clinical trial.

What are the symptoms?

The most common symptoms of this reaction are:

• fever(high temperature) and skin rash.

Other common symptoms include:

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

Other symptoms may include:
joint or muscle pain, swelling of the neck, difficulty breathing, sore throat, cough, occasionally headache, eye inflammation (conjunctivitis), mouth ulcers, low blood pressure, tingling or numbness of the hands or feet.

When can these reactions occur?

Hypersensitivity reactions can occur at any time during Abacavir Accord treatment, but they most commonly occur within the first 6 weeks of treatment.

For the caregivers of a child taking Abacavir Accord, it is essential to understand the information about hypersensitivity reactions. If the child experiences any of the symptoms described below, it is crucial to follow the instructions below.

You must contact your doctor immediately if:

1.

a skin rash appears OR

2.

symptoms from at least 2 of the following groups occur:

• fever,
• difficulty breathing, sore throat, or cough,
• nausea or vomiting, diarrhea, or abdominal pain,
• severe fatigue or aching, or general feeling of being unwell.

Your doctor may advise you to stop taking Abacavir Accord.

Stopping Abacavir Accord treatment

If you stop taking Abacavir Accord due to a hypersensitivity reaction, NEVER TAKE ABACAVIR ACCORD OR ANY OTHER MEDICINE CONTAINING ABACAVIR (e.g. abacavir + lamivudine, abacavir + lamivudine + zidovudine, abacavir + dolutegravir + lamivudine)again, as blood pressure may drop dangerously, which can be fatal.
If you stop taking Abacavir Accord for any reason - especially if you think you have experienced side effects or if another illness has occurred:
Tell your doctor before resuming Abacavir Accord treatment.Your doctor will check if the symptoms you experienced could be related to a hypersensitivity reaction. If they think it is possible, they will advise you never to take Abacavir Accord or any other medicine containing abacavir (e.g. abacavir + lamivudine, abacavir + lamivudine + zidovudine, abacavir + dolutegravir + lamivudine). It is crucial to follow this advice.
If your doctor advises you to start taking Abacavir Accord again, they may recommend that you take the first dose in a place where medical help is readily available.

If you are allergic to Abacavir Accord, return any unused Abacavir Accord to the pharmacy

for proper disposal. Ask your doctor or pharmacist for advice.
The packaging of Abacavir Accord contains a Warning Cardthat reminds the patient and medical staff about hypersensitivity reactions. This card should be detached and carried with you at all times.

Common side effects

May affect up to 1 in 10patients:

• hypersensitivity reactions,
• nausea,
• headache,
• vomiting,
• diarrhea,
• loss of appetite,
• fatigue, weakness,
• fever (high temperature),
• skin rash.

Rare side effects

May affect up to 1 in 1000patients:

• pancreatitis.

Very rare side effects

May affect up to 1 in 10,000patients:

• skin rash with blisters, looking like small targets (darker spots in the center with a light ring around and a dark ring on the edge) ( erythema multiforme),
• widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome), and a more severe form with peeling of the skin on more than 30% of the body surface ( toxic epidermal necrolysis),
• lactic acidosis (excess of lactic acid in the blood).

If you experience any of these symptoms, contact your doctor immediately.

If you experience side effects

Tell your doctor or pharmacistif any side effect gets worse or if you notice any side effects not listed in this leaflet.

Other possible side effects of combination therapy for HIV infection

Combination therapy with Abacavir Accord may cause other illnesses during HIV treatment.

Infection and inflammation symptoms

Previous infections may develop rapidly

Patient with advanced HIV infection (AIDS) have a weakened immune system and are more likely to experience severe infections (opportunistic infections). In these patients, previously hidden infections may develop soon after starting treatment, causing the appearance of inflammation symptoms. The appearance of these symptoms is likely due to the strengthening of the immune system, which allows the body to fight these infections.
Symptoms usually include feverand some of the following symptoms:

• headache,
• abdominal pain,
• difficulty breathing.

In rare cases, when the immune system becomes stronger, it may also attack healthy tissues in the body ( autoimmune disorders). The symptoms of autoimmune disorders may develop months after starting treatment with HIV medicines. Symptoms may include:

• rapid or irregular heartbeat,
• hyperactivity (excessive psychomotor activity),
• weakness starting in the hands and feet and progressing towards the torso.

If you notice any symptoms of infection while taking Abacavir Accord:
Contact your doctor immediately. Do not take other medicines for infections without your doctor's advice.

Bone disorders may occur

In some patients taking combination HIV therapy, a bone disorder called osteonecrosismay develop. This occurs when a part of the bone tissue dies due to limited blood supply to the bone.
The risk of these disorders is higher in patients who:

• have been taking combination therapy for a long time,
• are also taking anti-inflammatory medicines called corticosteroids,
• drink alcohol,
• have a very weak immune system,
• are overweight.

Symptoms of osteonecrosis include:

• joint stiffness,
• pain (especially in the hip, knee, and shoulder),
• difficulty moving.

If you experience any of these symptoms:

Tell your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 201
Fax: +48 22 49 21 209
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Abacavir Accord

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month.
There are no special storage instructions 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. This will help protect the environment.

6. Contents of the packaging and other information

What Abacavir Accord contains

The active substance is abacavir.
Each tablet contains 300 mg of abacavir.
The other ingredients are: microcrystalline cellulose PH 102, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate, polyvinyl alcohol, titanium dioxide (E 171), talc, yellow iron oxide (E 172), macrogol 3350.

What Abacavir Accord looks like and contents of the pack

Abacavir Accord film-coated tablets are yellow, capsule-shaped with the letter 'H' embossed on one side and a line on the other side, separating the markings 'A' and '26'.
The tablets are available in white, non-transparent PVC/Aluminum or Aluminum/Aluminum blisters, each containing 30, 60, 90, or 120 tablets, in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer/Importer

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: October 2023