Abacavir/lamivudine Macleods 600 mg/300 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Abacavir/Lamivudine Macleods 600 mg/300 mg film-coated tablets EFG

abacavir/lamivudine

Read the entire leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

IMPORTANT — Hypersensitivity Reactions

This medicine contains abacavir. Some people taking abacavir may develop a hypersensitivity reaction (a serious allergic reaction), which could be life-threatening if treatment with abacavir-containing medicines is continued. You must read the information on “Hypersensitivity reactions” carefully in section 4 of this leaflet.

The packaging of this medicine includes an Information Card to remind you and healthcare professionals about abacavir hypersensitivity. You must remove this card and carry it with you at all times.

Contents of the leaflet

1. What Abacavir/Lamivudine Macleods is and what it is used for
2. What you need to know before taking Abacavir/Lamivudine Macleods
3. How to take Abacavir/Lamivudine Macleods
4. Possible side effects
5. Storage of Abacavir/Lamivudine Macleods
6. Contents of the pack and other information

1. What Abacavir/Lamivudina Macleods is and what it is used for

This medicine is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents, and children weighing at least 25 kg.

This medicine contains two active substances used to treat HIV infection: abacavir and lamivudina. Both belong to a group of antiretroviral medicines called nucleoside reverse transcriptase inhibitors (NRTIs).

This medicine does not completely cure HIV infection; it reduces the amount of virus in the 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 cell that play an important role in helping your body fight infection.

Not everyone responds to treatment with this medicine in the same way. Your doctor will monitor the effectiveness of your treatment.

2. What you need to know before starting to take Abacavir/Lamivudina Macleods

Do not take this medicine:

• if you are allergic (hypersensitive) to abacavir (or to any other medicine containing abacavir — e.g. Trizivir, Triumeq or Ziagen), lamivudina, or to any of the other ingredients of this medicine (listed in section 6).

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

Talk to your doctor if you think any of the following apply to you. Do not take this medicine.

Take special care with this medicine

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Abacavir/Lamivudina Macleods.

Some people taking this medicine or other combination treatments for HIV are at higher risk of serious side effects. You should be aware that the risk is greater:

• if you have moderate or severe liver disease
• if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B, do not stop taking this medicine without your doctor’s advice, as your condition may worsen)
• if you are significantly overweight (especially if you are female)
• if you have any kidney problems.

Talk to your doctor before starting this medicine if any of these apply to you. You may need additional tests, including blood tests, while taking this medicine. For more information, see section 4.

Hypersensitivity reactions to abacavir

Even patients who do not carry the HLA-B*5701 gene can develop a hypersensitivity reaction (a serious allergic reaction).

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

It cannot be ruled out that abacavir may increase the risk of cardiovascular events.

Tell your doctor if you have cardiovascular problems, if you smoke, or if you have conditions that may increase your risk of cardiovascular disease, such as high blood pressure or diabetes. Do not stop taking this medicine unless your doctor advises you to do so.

Be alert to important symptoms

Some people taking medicines for HIV infection develop other disorders, which may be serious. You need to know which important signs and symptoms to watch for while taking this medicine.

Read the information on “Other possible side effects of combination HIV treatment” in section 4 of this leaflet.

Other medicines and Abacavir/Lamivudina Macleods

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Remember to inform your doctor or pharmacist if you start taking a new medicine while on this treatment.

The following medicines must not be used together with Abacavir/Lamivudina Macleods:

• emtricitabine, used to treat HIV infection
• other medicines containing lamivudina, used to treat HIV infection or hepatitis B
• high doses of trimethoprim/sulfamethoxazole, an antibiotic
• cladribine, used to treat hairy cell leukemia.

Tell your doctor if you are being treated with any of these medicines.

Some medicines interact with this medicine, including:

• phenytoin, used to treat epilepsy. Tell your doctor if you are taking phenytoin. Your doctor may need to monitor you while you are taking this medicine.
• methadone, used as a heroin substitute. Abacavir increases the rate at which methadone is eliminated from the body. If you are taking methadone, you should be monitored for symptoms of withdrawal. Your methadone dose may need to be adjusted. Tell your doctor if you are taking methadone.
• medicines (usually liquids) containing sorbitol and other polyols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly. Tell your doctor or pharmacist if you are being treated with any of these.
• riociguat, used to treat high blood pressure in the blood vessels (pulmonary arteries) carrying blood from the heart to the lungs. Your doctor may need to reduce your dose of riociguat, as abacavir may increase blood levels of riociguat.

Pregnancy

Use of this medicine during pregnancy is not recommended. This medicine and similar medicines may cause adverse effects in babies during pregnancy.

If you have taken this medicine during pregnancy, your doctor may recommend regular blood tests and other diagnostic tests to monitor your child’s development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV was greater than the risk of adverse effects occurring.

Breast-feeding

Breast-feeding is not recommended for women living with HIV because HIV infection can be passed to the baby through breast milk. A small amount of the components of this medicine may also pass into breast milk.

If you are breast-feeding or considering breast-feeding, you must consult your doctor as soon as possible.

Driving and using machines

This medicine may cause side effects that could affect your ability to drive or operate machinery.

Consult your doctor regarding your ability to drive or operate machinery while taking this medicine.

Important information about some of the ingredients of this medicine

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially “sodium-free”.

3. How to take Abacavir/Lamivudina Macleods

Follow exactly the instructions for using this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose of this medicine for adults, adolescents, and children weighing at least 25 kg or more is one tablet once daily.

Swallow the tablets whole with some water. This medicine can be taken with or without food.

Keep regular contact with your doctor. This medicine helps control your condition. You will need to take it every day to prevent your disease from worsening. You may still develop other infections and illnesses associated with HIV infection. Stay in contact with your doctor and do not stop taking this medicine without first talking to your doctor.

If you take more Abacavir/Lamivudina Macleods than you should

If you accidentally take more Abacavir/Lamivudina Macleods than you should, inform your doctor or pharmacist, or contact the nearest hospital emergency department for further advice.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take this medicine

If you forget to take a dose, take it as soon as you remember, and then continue with your regular dosing schedule.

Do not take a double dose to make up for forgotten doses.

It is important to take this medicine regularly, as irregular intake may increase the risk of developing a hypersensitivity reaction.

If you stop taking Abacavir/Lamivudina Macleods

If for any reason you have stopped taking this medicine, especially because you think you are experiencing adverse effects or due to another illness:

• Consult your doctor before restarting treatment. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If your doctor considers there may have been a connection, you will be advised never to take this medicine again, or any other medicine containing abacavir (e.g., Trizivir, Triumeq or Ziagen). It is important that you follow this warning.
• If your doctor advises restarting treatment with this medicine, they may ask you to take the first doses in a place where you have easy access to medical assistance, if needed.

4. Possible adverse effects

During HIV treatment, there may be an increase in weight and in blood glucose and lipid levels. This may be partly related to the recovery of health, lifestyle, and, in the case of blood lipids, sometimes to the anti-HIV medications themselves. Your doctor will monitor these changes.

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

When undergoing HIV treatment, it may be difficult to distinguish whether a symptom is an adverse effect of this medicine, of other medicines you are taking, or due to the HIV-related illness itself. Therefore, it is very important that you inform your doctor about any changes in your health.

Even patients who do not carry the HLA-B*5701 gene may develop a hypersensitivity reaction (a serious allergic reaction), described in this leaflet in the box entitled "Hypersensitivity reactions".

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

In addition to the adverse effects listed below for this medicine, other disorders may occur during combination antiretroviral therapy.

It is important that you read the information under the section "Other possible adverse effects of combination antiretroviral therapy".

Hypersensitivity Reactions This medicine contains abacavir (an active ingredient also present in Trizivir, Triumeq, and Ziagen). Abacavir may cause a serious allergic reaction known as a hypersensitivity reaction. These hypersensitivity reactions have been observed more frequently in people taking medicines containing abacavir. Who experiences these reactions? Any person taking Abacavir/Lamivudine could develop a hypersensitivity reaction to abacavir, which could be life-threatening if you continue taking this medicine. You are more likely to develop this reaction if you have a gene called HLA-B*5701 (but you may still experience this reaction even if you do not have this gene). Before starting treatment with Abacavir/Lamivudine, you should have been tested for this gene. If you know you carry this gene, tell your doctor before taking Abacavir/Lamivudine. Approximately 3 to 4 out of every 100 patients treated with abacavir in a clinical trial who did not have the HLA-B*5701 gene developed a hypersensitivity reaction. What are the symptoms? The most common symptoms are: fever (high temperature) and skin rash. Other commonly observed signs include: nausea (feeling unwell), vomiting, diarrhea, abdominal (stomach) pain, and excessive fatigue. Other possible symptoms may include: Joint or muscle pain, swelling of the neck, difficulty breathing, sore throat, cough, occasional headache, eye inflammation (conjunctivitis), mouth ulcers, low blood pressure, and tingling or numbness in the hands or feet. When do these reactions occur? Hypersensitivity reactions may occur at any time during treatment with Abacavir/Lamivudine, but are most likely to occur within the first 6 weeks of treatment. Contact your doctor immediately: if you develop a skin rash OR if you have symptoms from at least 2 of the following groups: fever difficulty breathing, sore throat, or cough nausea or vomiting, diarrhea, or abdominal pain excessive fatigue or general aches and discomfort. Your doctor may advise you to stop taking this medicine. If you have stopped taking this medicine due to a hypersensitivity reaction, never take this medicine again or any other medicine containing abacavir (e.g., Trizivir, Triumeq, or Ziagen). If you do, you may experience a drop in blood pressure within hours, which could be life-threatening or fatal. If for any reason you have interrupted treatment with this medicine—especially because you think you are experiencing side effects or due to another illness: Consult your doctor before restarting treatment. Your doctor will assess whether your symptoms were related to a hypersensitivity reaction. If your doctor suspects such a reaction, you will be instructed never to take this medicine or any other medicine containing abacavir again. It is important that you follow this warning. Occasionally, hypersensitivity reactions have occurred in people who restart abacavir after having experienced only one symptom listed on the Warning Card before stopping the medicine. Very rarely, reactions have occurred in people restarting abacavir treatment who had no prior symptoms of hypersensitivity before stopping the medicine. If your doctor advises restarting treatment with this medicine, they may ask you to take the first doses in a setting where immediate medical assistance is available, if needed. If you are hypersensitive to this medicine, you must return all unused tablets of this medicine so they can be safely disposed of. Speak with your doctor or pharmacist. The packaging of this medicine includes a Warning Card to remind you and healthcare professionals about hypersensitivity reactions. Remove the card from the package and carry it with you at all times.

Frequent adverse effects:

May affect up to 1 in 10 people:

• hypersensitivity reaction
• headache
• vomiting
• discomfort (nausea)
• diarrhoea
• stomach pain
• loss of appetite
• fatigue, lack of energy
• fever (high temperature)
• general feeling of malaise
• difficulty falling asleep (insomnia)
• muscle pains and aches
• joint pain
• cough
• irritated nose or excessive nasal discharge
• skin rash
• hair loss.

Uncommon adverse effects:

May affect up to 1 in 100 people and may be reflected in blood tests:

• low red blood cell count (anaemia) or low white blood cell count (neutropenia)
• increased levels of liver enzymes
• a decrease in the number of cells involved in blood clotting (thrombocytopenia).

Rare adverse effects:

May affect up to 1 in 1,000 people:

• liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis)
• inflammation of the pancreas (pancreatitis)
• muscle tissue rupture.

Rare adverse effects that may appear in blood tests include:

• increase in an enzyme called amylase.

Very rare adverse effects:

May affect up to 1 in 10,000 people:

• numbness, tingling sensation in the skin (pricking sensations)
• feeling of weakness in the limbs
• skin rash, which may form blisters resembling small targets (dark center surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens–Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
• lactic acidosis (excess lactic acid in the blood).

If you notice any of these symptoms, contact a doctor urgently.

A very rare adverse effect that may appear in blood tests is:

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

If you experience adverse effects

Inform your doctor or pharmacist if you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet.

Other possible adverse effects of combination HIV treatment

Combination treatments, such as this medicine, may cause other disorders to develop during HIV treatment.

Symptoms of infection and inflammation

Exacerbation of prior infections

People with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop serious infections (opportunistic infections). Such infections may have been "latent" and undetected by the weakened immune system before treatment began. After starting treatment, the immune system becomes stronger, so it begins to fight these infections, which may cause symptoms of infection or inflammation. Symptoms usually include fever, along with some of the following:

• headache
• stomach pain
• difficulty breathing.

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

• palpitations (rapid or irregular heartbeat) or tremor
• hyperactivity (excessive restlessness and movement)
• weakness starting in the hands and feet and progressing upward toward the trunk of the body.

If you notice any symptoms of infection or inflammation, or any of the symptoms listed above: Inform your doctor immediately. Do not take any other medication for infection without medical advice.

You may have problems with your bones

Some patients receiving combination HIV treatment develop a bone disease called osteonecrosis. In this condition, part of the bone tissue dies due to reduced blood supply to the bone. People are more likely to develop this disease:

• if they have been on combination treatment for a long time
• if they also take anti-inflammatory medicines called corticosteroids
• if they drink alcohol
• if their immune system is severely weakened
• if they are overweight.

Signs of osteonecrosis include:

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

If you notice any of these symptoms:

Inform your doctor

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Abacavir/Lamivudine Macleods

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 month indicated.

Use this medicine within 30 days after opening the bottle.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE collection point at your pharmacy. If you are in doubt, please consult your pharmacist on how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition Abacavir/Lamivudine Macleods

• The active substances are Abacavir and Lamivudine. Each film-coated tablet contains 600 mg of abacavir (as sulfate) and 300 mg of lamivudine.

• The other components are:

Microcrystalline cellulose

Sodium starch glycolate Type A (Potato starch)

Povidone

Isopropyl alcohol

Colloidal silicon dioxide

Low-substituted hydroxypropyl cellulose

Magnesium stearate

• The tablets are coated with:

Hypromellose 3cPs (E464)

Polyethylene glycol 400 (E1521)

Polysorbate 80 (E433)

Titanium dioxide (E171)

Appearance of the product and contents of the container

Film-coated tablets, white to off-white, capsule-shaped, biconvex, engraved with “300” on one side and “600” on the other.

Blister pack: The blister pack consists of aluminum foil and cold-form laminated foil.

Pack size: 30 tablets. Single-dose blister pack containing 30 tablets.

Bottle container: The bottle container consists of a white, round high-density polyethylene (HDPE) bottle with a child-resistant closure.

Pack size: 30 tablets

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona, Spain

Manufacturer

Synoptis Industrial SP.Z.O.O.

ul. Rabowicka 15

62020 Swarzedz

Poland

Date of the most recent review of this package leaflet: November 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)