Abacavir + lamivudine accord

Package leaflet: Information for the user

Abacavir + Lamivudine Accord, 600 mg + 300 mg, film-coated tablets
Abacavirum + Lamivudinum
Please read all of this 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, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell 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).
In some patients, treatment with abacavir may lead to 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 package includes a Warning Card to remind the patient and
healthcare professionals about abacavir hypersensitivity. This card should be detached from the
package and always carried on your person.

Contents of the leaflet

1. What Abacavir + Lamivudine Accord is and what it is used for
2. What you need to know 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 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 to treat 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 treatment with Abacavir + Lamivudine Accord in the same way.
The effectiveness of treatment will be monitored by your doctor.

2. Important information before taking Abacavir + Lamivudine Accord

When not to take Abacavir + Lamivudine Accord:

• If the patient has an allergy ( hypersensitivity ) 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 information regarding hypersensitivity reactions in section 4. Consult your doctor if the patient suspects any of the above circumstances apply. Do not take Abacavir + Lamivudine Accord.

When to exercise special caution when taking Abacavir + Lamivudine Accord
Some patients taking Abacavir + Lamivudine Accord or other types of combination therapy for HIV infection are at higher risk of developing severe adverse effects.
The patient 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, treatment with Abacavir + Lamivudine Accord should not be stopped without medical advice, as hepatitis may flare up)
• if the patient is overweight (especially in women)
• if the patient has kidney problems. Inform your doctor before taking Abacavir + Lamivudine Accord if any of the above conditions 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
Even in patients who do not carry the HLA-B*5701 gene, a hypersensitivity reaction (serious allergic reaction) may occur.
Please read carefully all 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 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 + Lamivudine Accord unless instructed by your doctor.

Be alert to important symptoms
Other complications, which may be serious, can occur in some patients taking medicines for HIV infection. The patient 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 adverse 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). The patient may still transmit HIV while taking this medicine, although effective antiretroviral therapy can reduce this risk. The patient 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 the patient is currently taking or has recently taken, 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 their doctor or pharmacist.

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

• emtricitabine, used to treat HIV infection
• other medicines containing lamivudine, used to treat HIV infection or hepatitis B virus infection
• high doses of trimethoprim/sulfamethoxazole (an antibiotic)
• cladribine, used to treat hairy cell leukemia. Inform your doctor if the patient is 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. The doctor may recommend monitoring the patient 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 withdrawal symptoms. A 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 (in the pulmonary arteries) carrying blood from the heart to the lungs. Your doctor may need to reduce the dose of riociguat, as abacavir may increase the concentration of riociguat in the blood.

Pregnancy
Abacavir + Lamivudine Accord is not recommended during pregnancy.
Abacavir + Lamivudine Accord and similar medicines may cause adverse effects in the unborn child. If the patient has taken Abacavir + Lamivudine 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 infected with HIV must not breast-feed, as HIV infection may be transmitted to the child through breast milk. A small amount of the active ingredients of Abacavir + Lamivudine 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
Abacavir + Lamivudine Accord may cause adverse effects that could affect the patient's ability to drive or operate machinery.
Talk to your doctor about the possibility of driving or operating 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 (E110), which may cause allergic reactions in some patients.
This medicine contains less than 1 mmol (23 mg) of sodium per dose unit, 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 in doubt,
consult your doctor or pharmacist.
The recommended dose of Abacavir + Lamivudine Accord in 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 daily 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 Abacavir + Lamivudine Accord than recommended
If a patient accidentally takes more than the recommended 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 a dose is missed, take it as soon as possible. Continue with the regular dosing schedule.
Do not take a double dose to make up for a missed dose.
It is important to take Abacavir + Lamivudine Accord regularly, as irregular dosing increases
the risk of hypersensitivity reactions.
Stopping treatment with Abacavir + Lamivudine Accord
If a patient stops taking Abacavir + Lamivudine Accord for any reason – especially if they think
they have experienced adverse effects or have developed another illness:
They must inform their doctor before restarting Abacavir + Lamivudine Accord.
The doctor will assess whether the symptoms could have been related to a hypersensitivity
reaction. If such a link is considered possible, the doctor will advise that the patient must never
again take Abacavir + Lamivudine Accord or any other medicine containing abacavir
(e.g. Trizivir, Triumeq or Ziagen). It is essential to follow this advice.
If the doctor decides that treatment with Abacavir + Lamivudine Accord should be restarted,
they may recommend taking the first dose in a medical setting where immediate access to
medical assistance is available, if needed.

4. Possible side effects

During treatment for HIV infection, increases in body weight, as well as blood lipid and glucose levels, 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 everyone will experience them. During treatment for HIV infection, it is not always possible to determine whether any adverse symptoms are 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 (a severe allergic reaction) may occur, as described in the boxed section titled "Hypersensitivity reactions" in this leaflet.

It is very important to read and understand the information about this serious reaction.

In addition to the side effects listed below for Abacavir + Lamivudine Accord, other symptoms may occur during combination treatment for HIV infection. It is important to read the information below entitled "Other possible side effects of combination HIV treatment."

Hypersensitivity reactions

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 experience a hypersensitivity reaction to abacavir, which may be life-threatening if the medicine is continued.

The likelihood of this reaction is higher in individuals who carry the HLA-B*5701 gene (however, hypersensitivity reactions may still occur even in patients who do not have 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.

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 in a clinical trial.

What are the symptoms?

The most commonly observed symptoms are:

• Fever (high temperature) and skin rash.

Other frequently 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.

If the patient continues taking Abacavir + Lamivudine Accord, symptoms may worsen and become life-threatening.

When may these reactions occur?

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

Contact your doctor immediately if:

1. A skin 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 or joint pain or general malaise.

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

Stopping treatment with Abacavir + Lamivudine Accord

If a patient stops taking Abacavir + Lamivudine Accord due to a hypersensitivity reaction, they MUST NEVER RESTART taking Abacavir + Lamivudine Accord or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Ziagen), as a dangerous drop in blood pressure may occur within hours, which could lead to death.

If a patient stops taking Abacavir + Lamivudine Accord for any reason – especially if they suspect they have experienced adverse symptoms or have developed another illness:

Talk to your doctor before restarting the medicine. Your doctor will assess whether the symptoms could have been related to a hypersensitivity reaction. If such a link is possible, your doctor will advise you to never 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 had no prior symptoms of hypersensitivity before stopping treatment.

If your doctor considers restarting Abacavir + Lamivudine Accord, they may advise taking the first dose in a medical setting where immediate medical assistance is available if needed.

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

The Abacavir + Lamivudine Accord packaging includes a Warning Card to remind patients and healthcare professionals about hypersensitivity reactions. The card should be detached from the packaging and carried at all times.

Common side 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 side effects
May occur in not more than 1 in 100 patients and may be evident in blood test results:

• Low number of red blood cells in the blood (anaemia) or low number of white blood cells (neutropenia)
• Increased liver enzyme activity
• Decreased number of platelets involved in blood clotting (thrombocytopenia)

Rare side 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 side effects that may appear in blood test results:

• Increased activity of an enzyme called amylase

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

• Numbness, tingling sensation
• Weakness in limbs
• Skin rash, which may form blister-like lesions resembling small targets (darker in the centre with a lighter ring and a dark edge) (erythema multiforme)
• Widespread blistering rash with skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form with skin detachment affecting more than 30% of body surface (toxic epidermal necrolysis)
• Lactic acidosis (excess lactic acid in the blood)

If any of these symptoms occur, contact your doctor urgently.

Very rare side effects that may be evident in blood test results:

• Bone marrow failure to produce new red blood cells (pure red cell aplasia)

If you experience any side effects

Inform your doctor or pharmacist if any of the side effects worsen or if you experience any side effects not listed in this leaflet.

Other possible side effects of combination HIV treatment

Combination therapy, such as using Abacavir + Lamivudine Accord, may lead to other conditions during HIV treatment.

Infection and inflammatory symptoms

Old infections may flare up suddenly

In people with advanced HIV infection (AIDS), the immune system is weakened, making them more susceptible to severe infections (opportunistic infections). These infections may be "hidden" and not detected by the weakened immune system until treatment begins. After starting treatment, the immune system becomes stronger and may begin to fight these infections, leading to the appearance of infection or inflammatory symptoms. Symptoms usually include fever, and one or more of the following:

• Headache
• Abdominal pain
• Breathing difficulties

In rare cases, as the immune system strengthens, 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 any infection or inflammatory symptoms occur, or if you notice any of the symptoms listed above:

Contact your doctor immediately. Do not take any other medicines for infections without medical advice.

Bone disorders may occur

In some patients receiving combination HIV treatment, a condition called osteonecrosis may develop. This involves the death of bone tissue due to reduced blood supply to the bone. The risk of this condition is higher in people who:

• Have been on combination therapy 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 side effects

If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring 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, e-mail: [email protected].

Side effects can also be reported to the marketing authorisation holder. Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Abacavir + Lamivudine Accord

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

6. Contents of the package 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 carboxymethyl starch (type A), povidone K 90, magnesium stearate, hypromellose cP 5, macrogol 400, titanium dioxide (E171), sunset yellow (E110), lac.

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 tablet dimensions are 19.4 mm x 10.4 mm.
Abacavir+Lamivudine Accord is available in white, opaque blisters made of Aluminium/PVC/PE/PVDC, packed in a cardboard box containing 30 film-coated tablets.
Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7, 02-677 Warsaw
Tel: +48 22 577 28 00
Manufacturer
Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056, Limassol
Cyprus