Abacavir accord

Package leaflet: Information for the user

Abacavir Accord, 300 mg, film-coated tablets
Abacavirum
Please read this entire leaflet carefully before 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

IMPORTANT – Hypersensitivity reactions
Abacavir Accord contains abacavir (which is also the active substance in medicines containing abacavir

• lamivudine, abacavir + lamivudine + zidovudine, abacavir + dolutegravir + lamivudine).
  In some patients taking abacavir, a hypersensitivity reaction (a severe allergic reaction) may develop,
  which may be life-threatening if treatment with abacavir-containing medicines is continued.
  It is essential to read carefully all the information provided in the box entitled 'Hypersensitivity reactions'
  in section 4.
  Each package of Abacavir Accord contains a Warning Card to remind the patient and healthcare
  professionals about abacavir hypersensitivity. The card should be removed from the package and carried
  at all times.

Contents of the leaflet:

1. What Abacavir Accord is and what it is 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 pack and other information

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

Abacavir Accord is used in the treatment of human immunodeficiency virus (HIV) infection.
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 cure HIV infection; however, it reduces the amount of HIV in the patient's body
and maintains it at a low level. It also increases the number of CD4 cells in the blood. CD4 cells are a type
of white blood cells that play an important role in helping the body fight infections.
Not all patients respond to treatment with Abacavir Accord in the same way. Your doctor will monitor the
effectiveness of your treatment.

2. Important information before using Abacavir Accord

When not to use Abacavir Accord:

• if the patient has a hypersensitivity (allergy) to abacavir (or any other medicine containing abacavir
  • e.g. abacavir + lamivudine, abacavir + lamivudine + zidovudine, abacavir + dolutegravir + lamivudine) or to any of the other ingredients of this medicine (listed in section 6). Carefully read all information about hypersensitivity reactions in section 4. Consult your doctor if you suspect any of the above circumstances apply.

When to take special care with Abacavir Accord
Some patients taking Abacavir Accord for HIV infection are at higher risk of developing serious adverse effects. You should be aware of this additional risk:

• if the patient has moderate or severe liver disease,
• if the patient has ever had liver problems in the past, including viral hepatitis B or C,
• if the patient has significant overweight (especially in women),
• if the patient has severe kidney disease. Inform your doctor if any of the above conditions apply to you. Your doctor may recommend additional monitoring tests during treatment, including blood tests. See section 4 for more information.

Hypersensitivity reactions to abacavir
Even in patients who do not carry the HLA-B*5701 gene, a hypersensitivity reaction (serious allergic reaction) may occur.
Carefully read all information about hypersensitivity reactions in section 4 of this leaflet.

Cardiovascular events risk
It cannot be ruled out that abacavir may increase the risk of cardiovascular events.
Inform your doctor if the patient has cardiovascular problems, smokes tobacco, or has other conditions that may increase the risk of cardiovascular disease, such as high blood pressure and diabetes. Do not stop taking Abacavir Accord unless instructed by your doctor.

Paying attention to important symptoms
Some patients receiving antiretroviral medicines for HIV infection may develop other complications, which can be serious. Patients should become familiar with the information about important signs and symptoms to watch for while taking Abacavir Accord.
Read the section 'Other possible adverse effects associated with HIV treatment' in section 4 of this leaflet.

Abacavir Accord and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including herbal remedies and other medicines available without a prescription. If the patient starts taking a new medicine while on Abacavir Accord, remember to inform the doctor or pharmacist.
Some medicines interact with Abacavir Accord.
These include:

• phenytoin, used to treat epilepsy. If the patient is taking phenytoin, inform your doctor. The doctor may recommend monitoring the patient during treatment with Abacavir Accord.

• methadone, used as a heroin substitute. Abacavir increases the rate at which methadone is eliminated from the body. Patients taking methadone will be monitored for withdrawal symptoms. A dose adjustment of methadone may be necessary.
  If the patient is taking methadone, inform your doctor.

• riociguat, used to treat high blood pressure in the blood vessels (pulmonary arterial hypertension) carrying blood from the heart to the lungs. Your doctor may need to reduce the dose of riociguat, as abacavir may increase riociguat levels in the blood.

Pregnancy
Abacavir Accord is not recommended during pregnancy. Abacavir Accord and similar medicines may cause adverse effects in the unborn child. If the patient has taken Abacavir Accord during pregnancy, the doctor may order regular blood tests and other diagnostic examinations to monitor the child's development. In children whose mothers took NRTIs during pregnancy, the benefit of reduced risk of HIV transmission outweighs the risk of adverse effects.

Breast-feeding
Women with HIV should not breast-feed, because HIV infection may be transmitted to the child via breast milk. A small amount of the components of Abacavir Accord may also pass into breast milk.
If the patient is breast-feeding or planning to breast-feed, she should consult her doctor immediately.

Driving and operating machinery
Do not drive or operate machinery unless the patient feels well.

Abacavir Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is considered "sodium-free".

3. How to use Abacavir Accord

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Swallow the tablet with water. Abacavir Accord may be taken with or without food.
If a patient is unable to swallow the tablet(s), they may crush it(them) and mix with a small amount of
soft food or liquid, then take the entire dose immediately after preparation.

Regular contact with your doctor
Abacavir Accord helps control the disease. It should be taken every day to prevent disease progression.
Other infections and HIV-related illnesses may still occur.
You must remain in regular contact with your doctor and must not stop taking Abacavir Accord
without your doctor's advice.

What dose should be taken
Adults, adolescents and children weighing at least 25 kg
The usual recommended dose of Abacavir Accord is 600 mg daily. This may be given either as one 300 mg tablet twice daily, or as two 300 mg tablets once daily.

Children aged one year and older, weighing less than 25 kg
The dose depends on the child's body weight. The following dosing is recommended:

• Children weighing at least 20 kg and less than 25 kg: The usual dose of Abacavir Accord is 450 mg daily. As directed by the doctor, the medicine may be taken as 150 mg (half a tablet) in the morning and 300 mg (one whole tablet) in the evening, or as 450 mg (one and a half tablets) once daily.

• Children weighing at least 14 kg and less than 20 kg: The usual dose of Abacavir Accord is 300 mg daily. As directed by the doctor, the medicine may be taken as 150 mg (half a tablet) twice daily or as 300 mg (one whole tablet) once daily.

The tablet may be divided into equal doses.
Abacavir is also available as an oral solution for the treatment of children over 3 months of age weighing less than 14 kg, and for patients who require dose adjustment or who cannot take tablets.

Taking more Abacavir Accord than prescribed
If a patient accidentally takes more Abacavir Accord than prescribed, inform your doctor or pharmacist immediately, or contact the nearest hospital emergency department for further advice.

Missing a dose of Abacavir Accord
If a dose of Abacavir Accord is missed, take it as soon as possible. Continue treatment as before. Do not take a double dose to make up for a missed dose.
It is important to take Abacavir Accord regularly, as irregular dosing increases the risk of hypersensitivity reactions.

Stopping Abacavir Accord
If a patient stops taking Abacavir Accord for any reason—especially if they think they have experienced side effects, or if another illness occurs:
Tell your doctor before restarting Abacavir Accord. The doctor will assess whether the symptoms may have been related to a hypersensitivity reaction.
If the doctor considers such a link possible, they will advise that Abacavir Accord, or any other medicine containing abacavir (e.g. abacavir + lamivudine, abacavir + lamivudine + zidovudine, abacavir + dolutegravir + lamivudine), must never be taken again. It is important to follow this advice.
If your doctor advises restarting Abacavir Accord, they may recommend taking the first dose in a place where immediate access to medical help is available, if needed.

4. Possible side effects

During treatment for HIV infection, increases in body weight and blood levels of lipids and glucose may occur. This is partly related to improved health and lifestyle, and sometimes, in the case of blood lipid levels, to the effect of anti-HIV drugs. Your doctor will recommend tests to detect these changes.
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
During treatment for HIV infection, it is not always possible to determine whether an adverse symptom is caused by the medicine Abacavir Accord, other medicines taken at the same time, or by the HIV infection itself. For this reason, it is very important to inform your doctor about any changes in your health. Even in patients who do not have the HLA-B*5701 gene, a hypersensitivity reaction (severe allergic reaction) may occur, described in this leaflet in the table "Hypersensitivity reactions".
It is very important to read and understand the information about this serious reaction.
In addition to the side effects listed below for Abacavir Accord, other symptoms may also occur during combination treatment for HIV infection.
It is important to read the information entitled 'Other possible side effects of combination HIV treatment' below.
Hypersensitivity reactions
Abacavir Accord contains abacavir (which is also the 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 medicines containing abacavir.
Who may experience these reactions?
A hypersensitivity reaction to abacavir, which may be life-threatening if treatment with Abacavir Accord is continued, may occur in any patient taking Abacavir Accord.
The likelihood of such a reaction is higher in individuals who have the HLA-B*5701 gene (however, even if a patient does not have this gene, a hypersensitivity reaction may still occur). Before prescribing Abacavir Accord, your doctor should test whether you have this gene. If you know you have this gene, you must inform your doctor before starting treatment with Abacavir Accord. A hypersensitivity reaction occurred in approximately 3 to 4 out of every 100 patients without the HLA-B*5701 gene who received abacavir in a clinical study.
What are the symptoms?
The most commonly observed symptoms of this reaction are:

• fever (high temperature) and rash.

Other commonly observed symptoms include:

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

Other possible symptoms may include:
joint or muscle pain, neck swelling, shortness of breath, sore throat, cough, occasional headache, eye inflammation (conjunctivitis), mouth ulcers, low blood pressure, tingling or numbness in hands or feet.
When may these reactions occur?
Hypersensitivity reactions may occur at any time during treatment with Abacavir Accord, but most commonly occur within the first 6 weeks of treatment.
For caregivers of a child being treated with Abacavir Accord, it is important to understand the information regarding hypersensitivity reactions. If the child develops any of the symptoms described below, it is important to follow the recommendations below.
Contact your doctor immediately if:
1. a rash develops OR
2. symptoms from at least 2 of the following groups occur:

• fever,
• shortness of breath, sore throat, or cough,
• nausea or vomiting, diarrhoea, or abdominal pain,
• severe fatigue, malaise, or general feeling of being unwell. Your doctor may advise stopping treatment with Abacavir Accord.

Stopping treatment with Abacavir Accord
If you stop taking Abacavir Accord due to a hypersensitivity reaction, you MUST NEVER TAKE Abacavir Accord again or any other medicine containing abacavir
(e.g. abacavir + lamivudine, abacavir + lamivudine + zidovudine, abacavir + dolutegravir + lamivudine), as within a few hours your blood pressure may drop dangerously, which could lead to death.
If you stop taking Abacavir Accord for any reason – especially due to suspected side effects or another illness:
Talk to your doctor before restarting treatment. Your doctor will assess whether your symptoms could have been related to a hypersensitivity reaction. If your doctor considers this 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) again. It is important to follow this advice.
Hypersensitivity reactions have occasionally occurred when abacavir was restarted in patients who previously had only one symptom listed in the Warning Card.
Very rarely, hypersensitivity reactions have been observed in patients restarting abacavir who had no prior symptoms of hypersensitivity before stopping treatment.
If your doctor advises restarting Abacavir Accord, they may recommend taking the first dose in a place where immediate medical help is available if needed.
If you are allergic to Abacavir Accord, return any unused supply of Abacavir Accord to a pharmacy for proper disposal. Consult your doctor or pharmacist.
The Abacavir Accord packaging contains a Warning Card reminding patients and healthcare professionals about hypersensitivity reactions. This card should be detached and carried at all times.
Common side effects
May occur in up to 1 in 10 patients:

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

Uncommon side effects
May occur in up to 1 in 1,000 patients:

• pancreatitis.

Rare side effects
May occur in up to 1 in 10,000 patients:

• skin rash, which may form blisters, appearing as small target-like lesions (darker spots in the centre with a pale ring around and a dark ring at the edge) ( erythema multiforme ),
• extensive rash with blistering and peeling of the skin, especially around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome ), and a more severe form with skin detachment over more than 30% of body surface area ( toxic epidermal necrolysis ),
• lactic acidosis (excess lactic acid in the blood).

If you experience any of these symptoms, contact your doctor urgently.
If you experience any side effects
Inform your doctor or pharmacist if any side effect worsens or if you experience any side effects not listed in this leaflet.
Other possible side effects of combination HIV treatment
Combination therapy including Abacavir Accord may lead to the development of other conditions during HIV treatment.
Infection and inflammatory symptoms
Old infections may flare up suddenly
Patients with advanced HIV infection (AIDS) have a weakened immune system and are more prone to severe infections (opportunistic infections). In these patients, previously hidden, dormant infections may flare up soon after starting treatment, causing symptoms of inflammation. These symptoms are likely due to immune reconstitution, whereby the strengthened immune system begins to fight these infections.
Symptoms usually include fever and one or more of the following:

• headache,
• abdominal pain,
• breathing difficulties.

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

• palpitations (fast or irregular heartbeat) or tremors,
• hyperactivity (excessive psychomotor agitation),
• weakness starting in hands and feet and progressing towards the trunk.

If you notice any signs of infection while taking Abacavir Accord:
Contact your doctor immediately. Do not take any other medicines for infections without your doctor's advice.
Bone problems may occur
Some patients receiving combination anti-HIV treatment may develop a bone disorder called osteonecrosis. This involves the death of bone tissue due to reduced blood supply to the bone.
The risk of developing this condition is higher in patients who:

• have been on combination treatment 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, or shoulder),
• difficulty moving. If you experience any of these symptoms: Inform your doctor.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Abacavir Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging and blister pack following:
EXP. The expiry date refers to the last day of the stated month.
There are no special storage conditions for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack 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 carboxymethyl starch (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 facilitating division on the other side, separating the markings 'A' and '26'.
The tablets are available in white, opaque PVC/Aluminium blisters and Aluminium/Aluminium blisters
containing 30, 60, 90 and 120 tablets, packed in a cardboard carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Poland
Tel: +48 22 577 28 00
Manufacturer/Importer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA3000
Malta
This medicinal product is authorised for supply in the European Economic Area and the United Kingdom (Northern Ireland)
under the following names: