ABACAVIR/LAMIVUDINE AUROVITAS 600 mg/300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

IMPORTANT — Hypersensitivity Reactions

Abacavir/Lamivudine Aurovitascontains abacavir(which is also an active substance in medicines such as Trizivir, Triumeq, and Ziagen). Some people who take abacavir may develop a hypersensitivity reaction(a severe allergic reaction), which can be life-threatening if they continue to take medicines containing abacavir.

You must read the information on “Hypersensitivity reactions” in section 4 of this leaflet carefully.

The packaging of Abacavir/Lamivudine Aurovitas includes an Alert Cardto remind you and your medical staff of abacavir hypersensitivity. You must take out this card and always carry it with you.

Contents of the pack

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

1. What Abacavir/Lamivudine Aurovitas is and what it is used for

Abacavir/lamivudine is used to treat HIV infection in adults, adolescents, and children weighing at least 25 kg.

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

Abacavir/Lamivudine Aurovitas does not completely cure HIV infection; it reduces the amount of virus in your body and keeps it at a low level. It also increases the number of CD4 cells in your blood. CD4 cells are a type of white blood cell that helps your body fight infection.

Not everyone responds to treatment with abacavir/lamivudine in the same way. Your doctor will monitor the effectiveness of your treatment.

2. What you need to know before you take Abacavir/Lamivudine Aurovitas

Do not take Abacavir/Lamivudine Aurovitas

• If you are allergic 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).

Read the information on “Hypersensitivity reactions” in section 4 of this leaflet carefully.

Consult your doctorif you think any of these conditions apply to you. Do not take Abacavir/Lamivudine Aurovitas.

Warnings and precautions

Consult your doctor or pharmacist before starting Abacavir/Lamivudine Aurovitas.

Some people who take abacavir/lamivudine or other anti-HIV combination therapies have a higher risk of serious side effects. You need to know that there is a higher risk:

• 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 abacavir/lamivudine without your doctor's advice, as it may get worse).
• if you are significantly overweight (especially if you are a woman).
• if you have kidney problems.

Consult your doctor before starting abacavir/lamivudine if you have any of these conditions. 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 have the HLA-B*5701 gene may develop a hypersensitivity reaction(a severe allergic reaction).

Read the information on “Hypersensitivity reactions” in section 4 of this leaflet carefully.

Risk of cardiovascular events

It cannot be excluded that abacavir increases the risk of cardiovascular events.

Tell your doctorif you have cardiovascular problems, smoke, or suffer from diseases that may increase your risk of cardiovascular disease, such as high blood pressure and diabetes. Do not stop taking abacavir/lamivudine unless your doctor advises you to.

Be aware of important symptoms

Some people who take medicines for HIV infection develop other conditions, which can be serious. You need to know what important signs and symptoms to look out for while taking abacavir/lamivudine.

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

Other medicines and Abacavir/Lamivudine Aurovitas

Tell your doctor or pharmacistif you are taking, have recently taken, or might take any other medicines.

Remember to tell your doctor or pharmacist if you start taking a new medicine while taking abacavir/lamivudine.

The following medicines must not be used with abacavir/lamivudine:

• emtricitabine, to treat HIV infection.
• other medicines containing lamivudine, used to treat HIV infection or hepatitis B.
• high doses of cotrimoxazole (a combination of trimethoprim and sulfamethoxazole), an antibiotic.
• cladribine, used to treat hairy cell leukemia.

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

Some medicines interact with abacavir/lamivudine

These include:

• phenytoin, to treat epilepsy.

Tell your doctorif you are taking phenytoin. Your doctor may need to monitor you while you are taking abacavir/lamivudine.

• methadone, used as a substitute for heroin. Abacavir increases the rate at which methadone is removed from the body. If you are taking methadone, you may need to be monitored for signs of withdrawal. You may need your methadone dose to be changed.

Tell your doctorif you are taking methadone.

• medicines (usually liquids) that contain sorbitol and other polyalcohols (such as xylitol, mannitol, lactitol, or maltitol), if taken regularly.

Tell your doctor or pharmacistif you are being treated with any of these.

• riociguat, to treat high blood pressure in the blood vessels (arteries) that carry blood from the heart to the lungs. Your doctor may need to reduce your dose of riociguat, as abacavir may increase the levels of riociguat in your blood.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Abacavir/lamivudine is not recommended during pregnancy.

Abacavir/lamivudine and similar medicines may cause side effects in babies during pregnancy. If you have taken abacavir/lamivudine during your pregnancy, your doctor may ask for 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 side effects.

Breast-feeding

It is recommended that HIV-infected women do not breast-feed their babiesbecause HIV can be passed to the baby through breast milk. A small amount of the components of abacavir/lamivudine may also pass into breast milk.

If you are breast-feeding or thinking of breast-feeding, consult your doctor as soon as possible.

Driving and using machines

Abacavir/lamivudine may cause side effects that can affect your ability to drive or use machines.

Consult your doctorabout your ability to drive or use machines while taking abacavir/lamivudine.

Abacavir/Lamivudine Aurovitas contains orange yellow S

This medicine may cause allergic reactions because it contains orange yellow S (E110).

It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Abacavir/Lamivudine Aurovitas contains sodium

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

3. How to take Abacavir/Lamivudine Aurovitas

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose of abacavir/lamivudine for adults, adolescents, and children weighing at least 25 kg or more is one tablet once a day.

Swallow the tablets whole, with a little water. Abacavir/lamivudine can be taken with or without food.

Stay in regular contact with your doctor

Abacavir/lamivudine helps control your condition. You need to take it every day to control your HIV infection. You may still develop other infections and illnesses associated with HIV.

Stay in contact with your doctor and do not stop taking abacavir/lamivudinewithout discussing it with your doctor first.

If you take more Abacavir/Lamivudine Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Abacavir/Lamivudine Aurovitas

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

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

It is important to take abacavir/lamivudine regularly, as irregular intake of abacavir/lamivudine can increase the risk of a hypersensitivity reaction.

If you stop taking Abacavir/Lamivudine Aurovitas

If for any reason you have stopped taking abacavir/lamivudine, especially because you think you have had side effects or because of another illness:

Consult your doctor before restarting treatment. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If your doctor thinks they were, they will tell you that you must never take abacavir/lamivudine or any other medicine containing abacavir (e.g., Trizivir, Triumeq, or Ziagen) again. It is important that you follow this advice.

If your doctor advises you to restart treatment with abacavir/lamivudine, they may ask you to take the first doses in a place where you can easily get medical help if needed.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

When you are being treated for HIV, it can be difficult to distinguish whether a symptom is an adverse effect of abacavir/lamivudine or of other medications you are taking, or is due to an effect of the disease caused by HIV. Therefore, it is very important that you inform your doctor about any change in your health.

Even patients who do not have the HLA-B*5701 gene can develop a hypersensitivity reaction (a severe allergic reaction), described in this prospectus in the box called "Hypersensitivity Reactions".

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

In addition to the adverse effects listed below for abacavir/lamivudine, other disorders can develop during combined treatment for HIV.

It is important that you read the information under the heading "Other Possible Adverse Effects of Combined Treatment for HIV".

Frequent Adverse Effects

May affect up to 1 in 10people:

• hypersensitivity reaction.
• headache.
• vomiting.
• discomfort (nausea).
• diarrhea.
• stomach pain.
• loss of appetite.
• fatigue, lack of energy.
• fever (high temperature).
• general feeling of discomfort.
• difficulty sleeping (insomnia).
• muscle pain or discomfort.
• joint pain.
• cough.
• irritated or runny nose.
• skin rash.
• hair loss.

Uncommon Adverse Effects

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

• low red blood cell count (anemia) 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 1,000people:

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

Rare adverse effects that may appear in blood tests are:

• increased levels of an enzyme called amylase.

Very Rare Adverse Effects

May affect up to 1 in 10,000people:

• numbness, tingling sensation in the skin (pins and needles).
• weakness in the limbs.
• skin rash that can form blisters resembling small targets (central dark spot 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 that causes 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 suffer from adverse effects

Tell your doctor or pharmacistif you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus.

Other Possible Adverse Effects of Combined Treatment for HIV

Combined treatments, such as abacavir/lamivudine, can cause other disorders to develop during treatment for HIV.

Symptoms of Infection and Inflammation

Exacerbation of Old Infections

People with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop serious infections (opportunistic infections). These infections may have been "latent" and not detected by the weakened immune system before starting treatment. After starting treatment, the immune system becomes stronger, so it starts fighting these infections, which can cause symptoms of infection or inflammation. The symptoms usually include fever, as well as some of the following:

• headache.
• stomach pain.
• difficulty breathing.

In rare cases, as the immune system becomes stronger, it can also attack healthy tissues (autoimmune disorders). The symptoms of autoimmune disorders can appear many months after starting to take medications to treat HIV infection. The symptoms can include:

• palpitations (rapid or irregular heartbeats) or tremors.
• hyperactivity (excessive restlessness and movement).
• weakness starting in the hands and feet and moving up to the trunk of the body.

If you observe any symptoms of infectionand inflammation or if you notice any of the above symptoms:

Tell your doctor immediately.Do not take any other medication for the infection without your doctor's advice.

You may have bone problems

Some patients receiving combined treatment for HIV develop a bone disease called osteonecrosis. With this disease, part of the bone tissue dies due to a reduction in blood supply to the bone. People are more likely to suffer from this disease:

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

Signs of osteonecrosis include:

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

If you notice any of these symptoms:

Tell your doctor.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Abacavir/Lamivudina Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date shown on the label, carton, and blister after CAD. The expiration date is the last day of the month indicated.

Blister:Store below 30°C.

HDPE Bottle:No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Abacavir/Lamivudina Aurovitas

• The active ingredients are abacavir and lamivudine. Each film-coated tablet contains 600 mg of abacavir (as sulfate) and 300 mg of lamivudine.
• The other ingredients are:

Tablet core:microcrystalline cellulose, sodium carboxymethyl starch (type A) (potato), magnesium stearate.

Tablet coating:hypromellose 2910 (3cP), hypromellose 2910 (6cP), titanium dioxide (E171), polysorbate 80, macrogol 400, orange yellow S (E110).

Appearance of the Product and Package Contents

Film-coated tablets are orange, modified capsule-shaped, with the mark "H" on one side and "27" on the other. The size is 20.7 mm × 9.2 mm.

Abacavir/Lamivudina Aurovitas film-coated tablets are available in transparent PVC/PVdC-Aluminum blister packs and white opaque HDPE bottles with polypropylene closures.

Package sizes:

Blister:30, 50, 60, and 90 film-coated tablets.

HDPE Bottles:30 and 100 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this prospectus: December 2023

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