Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Abacavir + Lamivudine Accord (Abacavir/Lamivudine Accord)
600 mg + 300 mg, film-coated tablets
Abacavirum + Lamivudinum
Abacavir + Lamivudine Accord and Abacavir/Lamivudine Accord are different trade names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any further questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

IMPORTANT — Hypersensitivity reactions
Abacavir + Lamivudine Accord contains abacavir (which is also the active substance in other related medicines).
Some patients taking abacavir may develop a hypersensitivity reaction (a severe allergic reaction), which may be life-threatening if treatment with abacavir-containing medicines is continued.
It is essential to read carefully all the information contained in the box titled "Hypersensitivity reactions" in section 4.
The Abacavir + Lamivudine Accord packaging contains a Warning Card to remind patients and healthcare professionals about abacavir hypersensitivity. The card should be removed from the packaging and carried at all times.

Contents of the leaflet

What Abacavir + Lamivudine Accord is and what it is used for
What you need to know before taking Abacavir + Lamivudine Accord
How to take Abacavir + Lamivudine Accord
Possible side effects
How to store Abacavir + Lamivudine Accord
Contents of the pack and other information

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

Abacavir + Lamivudine Accord is used in adults, adolescents, and children weighing at least 25 kg for the treatment of human immunodeficiency virus (HIV) infection.
Abacavir + Lamivudine Accord contains two active substances used in the treatment of HIV infection: abacavir and lamivudine. They belong to a group of antiretroviral medicines called nucleoside reverse transcriptase inhibitors (NRTIs).
Abacavir + Lamivudine Accord does not cure HIV infection completely; this medicine reduces the amount of HIV virus 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 play an important role in helping the body fight infections.
Not all patients respond to Abacavir + Lamivudine Accord therapy in the same way. The effectiveness of treatment will be monitored by your treating doctor.

2. Important information before taking Abacavir + Lamivudine Accord

When not to take Abacavir + Lamivudine Accord:

If the patient is allergic (hypersensitive) to abacavir (or any other medicine containing abacavir, e.g. Trizivir, Triumeq or Ziagen), lamivudine, or any of the other ingredients of this medicine (listed in section 6). Please read carefully all the information about hypersensitivity reactions in section 4. Consult your doctor if you suspect any of the circumstances described above. Do not take Abacavir + Lamivudine Accord.

When to be cautious when taking Abacavir + Lamivudine Accord
Some patients taking Abacavir + Lamivudine Accord or other combination treatments for HIV infection are at higher risk of developing serious side effects. Patients should be aware of these additional risks:

if the patient has moderate or severe liver disease,
if the patient has ever had liver problems, including viral hepatitis B or C (if the patient has hepatitis B, they should not stop taking Abacavir + Lamivudine Accord without medical advice, as hepatitis may worsen),
if the patient is overweight (particularly in women),
if the patient has kidney problems. Inform your doctor before taking Abacavir + Lamivudine Accord if any of the above apply to you. During treatment, your doctor may recommend additional monitoring tests, including blood tests. For more information, see section 4.

Hypersensitivity reactions to abacavir
Hypersensitivity reactions (severe allergic reactions) may occur even in patients who do not carry the HLA-B*5701 gene.
Please read carefully all the information about hypersensitivity reactions in section 4 of this leaflet.

Risk of cardiovascular events
It cannot be ruled out that abacavir may increase the risk of cardiovascular events.
Inform your doctor if you have cardiovascular problems, if you smoke, or if you have other conditions that may increase the risk of cardiovascular disease, such as high blood pressure and diabetes. Do not stop taking Abacavir + Lamivudine Accord unless advised by your doctor.

Be alert to important symptoms
Other complications, which may be serious, can occur in some patients taking medicines for HIV infection. Patients should become familiar with information about important subjective and objective symptoms to watch for during treatment with Abacavir + Lamivudine Accord.
Please read the information "Other possible side effects associated with HIV treatment" in section 4 of this leaflet.

Protecting others
HIV infection can be transmitted through sexual contact with infected individuals or through infected blood (e.g. by sharing needles). Patients may still transmit HIV while taking this medicine, although effective antiretroviral therapy can reduce this risk. Patients should discuss with their doctor the necessary precautions to avoid infecting others.

Abacavir + Lamivudine Accord and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken by the patient, including herbal medicines and other medicines purchased without a prescription.
If the patient starts taking a new medicine while on Abacavir + Lamivudine Accord, remember to inform the doctor or pharmacist.

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

emtricitabine, used in the treatment of HIV infection,
other medicines containing lamivudine, used in the treatment of HIV infection or chronic hepatitis B,
high-dose trimethoprim/sulfamethoxazole (an antibiotic),
cladribine, used in the treatment of hairy cell leukemia. Inform your doctor if you are being treated with any of these medicines.

Some medicines interact with Abacavir + Lamivudine Accord
These include:

phenytoin, used to treat epilepsy. If the patient is taking phenytoin, inform your doctor. Your doctor may recommend monitoring during treatment with Abacavir + Lamivudine Accord.
methadone, used as a heroin substitute. Abacavir increases the elimination of methadone from the body. Patients taking methadone will be monitored for signs of withdrawal. Dose adjustment of methadone may be necessary. If the patient is taking methadone, inform your doctor.
medicines (usually in liquid form) containing sorbitol or other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if used long-term. If the patient is taking any of these medicines, inform your doctor or pharmacist.
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 + Lamivudine Accord is not recommended during pregnancy.
Abacavir + Lamivudine Accord and similar medicines may cause side effects in the unborn child. If a patient has taken Abacavir + Lamivudine Accord during pregnancy, the doctor may recommend regular blood tests and other diagnostic tests 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 side effects.

Breast-feeding
Women infected with HIV must not breast-feed, as HIV infection may be transmitted to the child through breast milk. Small amounts of the active substances in Abacavir + Lamivudine Accord may also pass into breast milk.
If the patient is breast-feeding or intends to breast-feed:
She should consult her doctor immediately.

Driving and operating machinery
Abacavir + Lamivudine Accord may cause side effects that could affect the patient's ability to drive or operate machinery.
Talk to your doctor about whether it is safe to drive or operate machinery while taking Abacavir + Lamivudine Accord.

Important information about certain ingredients of Abacavir + Lamivudine Accord
Abacavir + Lamivudine Accord contains a colouring agent called Sunset Yellow FCF, aluminium lake (E 110), which may cause allergic reactions in some patients.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".

3. How to take Abacavir + Lamivudine Accord

This medicine should always be taken exactly as prescribed by your doctor. If you have any
doubts, consult your doctor or pharmacist.
The recommended dose of Abacavir + Lamivudine Accord for adults, adolescents, and children
weighing over 25 kg is one tablet once daily.
The tablet should be swallowed whole with water. Abacavir + Lamivudine Accord may be taken
with or without food.
It is important to maintain regular contact with your doctor.
Abacavir + Lamivudine Accord helps control the disease. It should be taken every day to prevent
disease progression. Other infections and HIV-related illnesses may still occur.
Maintain regular contact with your doctor and do not stop taking Abacavir + Lamivudine Accord
without your doctor's advice.
Taking more than the recommended dose of Abacavir + Lamivudine Accord
If you accidentally take more than the prescribed dose of Abacavir + Lamivudine Accord, inform
your doctor or pharmacist immediately, or contact the nearest hospital emergency department
for further advice.
Missing a dose of Abacavir + Lamivudine Accord
If you miss a dose, take it as soon as possible. Continue your treatment as before. Do not take a
double dose to make up for a missed dose.
Regular intake of Abacavir + Lamivudine Accord is important, as irregular dosing increases the
risk of hypersensitivity reactions.
Stopping treatment with Abacavir + Lamivudine Accord
If you stop taking Abacavir + Lamivudine Accord for any reason – especially if you suspect you are
experiencing adverse effects or have developed another illness:
Inform your doctor before restarting Abacavir + Lamivudine Accord. Your doctor will assess
whether your symptoms could be related to a hypersensitivity reaction. If such a connection is
considered possible, your doctor will advise you never to take Abacavir + Lamivudine Accord
again, or any other medicine containing abacavir (e.g. Trizivir, Triumeq, or Ziagen). It is very
important to follow this advice.
If your doctor decides that you should restart Abacavir + Lamivudine Accord, they may recommend
taking the first dose in a medical setting where immediate medical assistance is available if needed.

4. Possible adverse effects

During treatment for HIV infection, increases in body weight and in 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 adverse effects, although not everyone will experience them. During treatment for HIV infection, it is not always possible to determine whether unwanted symptoms have been caused by the medicine Abacavir + Lamivudine 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 carry the HLA-B*5701 gene, a hypersensitivity reaction (severe allergic reaction), described in the boxed section titled "Hypersensitivity reactions" in this leaflet, may occur.
It is very important to read and understand the information about this serious reaction.
In addition to the adverse effects listed below for Abacavir + Lamivudine Accord, other symptoms may also occur during combination treatment for HIV infection.
It is important to read the information below titled "Other possible adverse effects associated with combination HIV treatment".

Hypersensitivity reactions
The medicine Abacavir + Lamivudine Accord contains abacavir (which is also the active substance in other related medicines). Abacavir may cause a serious allergic reaction known as a hypersensitivity reaction. Hypersensitivity reactions have been observed more frequently in patients taking medicines containing abacavir (e.g. Trizivir, Triumeq or Ziagen).

Who may experience these reactions?
Any patient taking Abacavir + Lamivudine Accord may develop a hypersensitivity reaction to abacavir, which may be life-threatening if the medicine Abacavir + Lamivudine Accord is continued.
The likelihood of this reaction is higher in people who carry the HLA-B*5701 gene (however, hypersensitivity reactions may occur even in patients who do not carry this gene).
Before prescribing Abacavir + Lamivudine Accord, your doctor should test whether you carry this gene. If you know you are a carrier of this gene, you must inform your doctor before starting treatment with Abacavir + Lamivudine Accord.
In a clinical study, hypersensitivity reactions occurred in approximately 3 to 4 out of every 100 patients who did not carry the HLA-B*5701 gene and were receiving abacavir.

What are the symptoms?
The most commonly observed symptoms are:

fever (high temperature) and skin 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 the hands or feet.

If you continue taking Abacavir + Lamivudine Accord, symptoms will worsen and may become life-threatening.

When can these reactions occur?
Hypersensitivity reactions may occur at any time during treatment with Abacavir + Lamivudine Accord, but most commonly occur within the first 6 weeks of treatment.

Contact your doctor immediately if: 1. a skin rash develops OR 2. you experience 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 fatigue or joint pain or general malaise.

Your doctor may advise you to stop taking Abacavir + Lamivudine Accord.

Stopping treatment with Abacavir + Lamivudine Accord
If you stop taking Abacavir + Lamivudine Accord due to a hypersensitivity reaction, you MUST NEVER RESTART Abacavir + Lamivudine Accord or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Ziagen), because within a few hours there may be a dangerous drop in blood pressure, which could lead to death.

If you stop taking Abacavir + Lamivudine Accord for any reason—especially if you suspect you have experienced adverse symptoms or if you develop another illness:
Talk to your doctor before restarting the medicine. Your doctor will assess whether your symptoms could have been related to a hypersensitivity reaction. If such a link is considered possible, your doctor will advise you never to restart Abacavir + Lamivudine Accord or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Ziagen). It is important to follow this advice.

Hypersensitivity reactions have occasionally occurred after restarting abacavir in patients who previously experienced only one symptom listed in the Warning Card.

Very rarely, hypersensitivity reactions have been observed in patients restarting abacavir who did not experience any hypersensitivity symptoms before stopping treatment.

If your doctor decides to restart Abacavir + Lamivudine Accord, they may advise you to take the first dose in a medical facility where immediate medical help is available if needed.

If you are allergic to Abacavir + Lamivudine Accord, return any unused supply of Abacavir + Lamivudine Accord for proper disposal.
Ask your doctor or pharmacist for advice.

The packaging of Abacavir + Lamivudine Accord includes a Warning Card to remind patients and healthcare professionals about hypersensitivity reactions. Remove the card from the packaging and always carry it with you.

Common adverse effects
May occur in not more than 1 in 10 patients:

hypersensitivity reactions,
headache,
vomiting,
nausea,
diarrhoea,
abdominal pain,
loss of appetite,
fatigue, lack of energy,
fever (high temperature),
general malaise,
difficulty sleeping (insomnia),
muscle pain and discomfort,
joint pain,
cough,
nasal irritation or watery nasal discharge,
skin rash,
hair loss.

Uncommon adverse effects
May occur in not more than 1 in 100 patients and may be detected in blood tests:

low number of red blood cells in the blood (anaemia) or low number of white blood cells (neutropenia),
increased liver enzyme activity,
reduced number of platelets involved in blood clotting (thrombocytopenia).

Rare adverse effects
May occur in not more than 1 in 1000 patients:

liver function disorders, e.g. jaundice, enlarged liver or fatty liver, hepatitis,
pancreatitis,
muscle tissue breakdown.

Rare adverse effects that may be detected in blood tests:

increased activity of an enzyme called amylase.

Very rare adverse effects
May occur in not more than 1 in 10,000 patients:

numbness, tingling sensation,
feeling of limb weakness,
skin rash, which may form blister-like spots resembling small targets (darker in the centre, surrounded by a lighter area and a dark ring at the edge) (erythema multiforme),
extensive blistering rash with peeling of the skin, especially around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome) and a more severe form with skin detachment affecting more than 30% of the body surface (toxic epidermal necrolysis),
lactic acidosis (excess lactic acid in the blood).

If you experience any of these symptoms, contact your doctor urgently.
Very rare adverse effects detectable in blood tests:

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

If you experience any adverse effects
Inform your doctor or pharmacist if any adverse effect worsens or if you experience any adverse effects not listed in this leaflet.

Other possible adverse effects associated with combination HIV treatment
Combination therapy, such as using Abacavir + Lamivudine Accord, may lead to other conditions during treatment for HIV infection.

Symptoms of infection and inflammatory conditions
Dormant infections may suddenly become active
In people with advanced HIV infection (AIDS), the immune system is weakened, making them more susceptible to developing serious infections (opportunistic infections). Such infections may be "dormant" and undetected by the weakened immune system until treatment begins. After starting treatment, the immune system becomes stronger and may react against these infections, leading to symptoms of infection or inflammation. Typical symptoms include fever and one or more of the following:

headache,
abdominal pain,
breathing difficulties.

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

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

If you experience any symptoms of infection or inflammation, or notice any of the symptoms listed above:
Inform your doctor immediately. Do not take other medicines for infections without your doctor's advice.

Bone disorders may occur
Some patients receiving combination HIV treatment may develop a condition called osteonecrosis. This involves the death of bone tissue due to reduced blood flow to the bone. The risk of this condition is higher in people who:

have been on combination treatment for a long time,
are also taking anti-inflammatory medicines called corticosteroids,
drink alcohol,
have a severely weakened immune system,
are overweight.

Symptoms of osteonecrosis include:

joint stiffness,
pain (especially in the hip, knee or shoulder joints),
difficulty moving.

If you experience any of these symptoms:
Inform your doctor.

Reporting of adverse effects
If you experience any adverse effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse effects can also 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 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

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 stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
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 packaging and other information

What Abacavir + Lamivudine Accord contains

Each coated tablet of Abacavir + Lamivudine Accord contains 600 mg of abacavir and 300 mg of lamivudine.
Other components: microcrystalline cellulose PH 102, microcrystalline cellulose PH 200, sodium carboxymethyl starch (type A), povidone K 90, magnesium stearate; coating: hypromellose cP 5, polyethylene glycol 400, titanium dioxide (E 171), sunset yellow FCF, aluminium lake (E 110).

What Abacavir + Lamivudine Accord looks like and contents of the pack
Abacavir + Lamivudine Accord is an orange, film-coated tablet in a capsule-shaped form. The tablet dimensions are 19.4 mm x 10.4 mm.
Abacavir + Lamivudine Accord is available in white, opaque aluminium-PVC/PE/PVDC blisters packed in a cardboard box containing 30 film-coated tablets.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Lithuania, country of export:
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
The Netherlands
Manufacturer:
Remedica Ltd.
Aharnon Street, Limassol Industrial Estate
Limassol 3056
Cyprus
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Lithuania, country of export: LT/1/16/3900/001
LT/1/16/3900/002
Parallel import authorization number: 358/25

Abacavir + lamivudine accord