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

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

IMPORTANT — Hypersensitivity reactions

Abacavir/Lamivudine Aurovitas contains abacavir (which is also the active substance in medicines such as Trizivir, Triumeq, and Ziagen). 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 carefully the information on “Hypersensitivity reactions” in section 4 of this leaflet.

The Abacavir/Lamivudine Aurovitas package includes an Alert 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 this leaflet

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

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

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

Abacavir/lamivudina 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).

Abacavir/lamivudina 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 the body fight infection.

Not everyone responds to treatment with abacavir/lamivudina in the same way. Your doctor will monitor how well your treatment is working.

2. What you need to know before taking Abacavir/Lamivudina Aurovitas

Do not take Abacavir/Lamivudina Aurovitas

• If you are allergic to abacavir (or to any other medicine containing abacavir, e.g. Trizivir, Triumeq or Ziagen), to 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.

Consult your doctor if you think any of these situations apply to you. Do not take Abacavir/Lamivudina Aurovitas.

Warnings and precautions

Talk to your doctor or pharmacist before taking Abacavir/Lamivudina Aurovitas.

Some people taking abacavir/lamivudina or other combination treatments for HIV are at higher risk of serious side effects. You need to know that the risk is higher:

• 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/lamivudina 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 abacavir/lamivudina if any of these situations 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 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.

Tell your doctor if you have cardiovascular problems, smoke, or have conditions that may increase your risk of cardiovascular disease, such as high blood pressure and diabetes. Do not stop taking abacavir/lamivudina 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 abacavir/lamivudina.

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

Other medicines and Abacavir/Lamivudina Aurovitas

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 abacavir/lamivudina.

The following medicines must not be used together with abacavir/lamivudina:

• emtricitabine, used to treat HIV infection.
• other medicines containing lamivudina, 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 doctor if you are being treated with any of these medicines.

Some medicines interact with abacavir/lamivudina

These include:

• phenytoin, used to treat epilepsy.

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

• 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. You may need to have your methadone dose 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 and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Abacavir/lamivudina is not recommended during pregnancy.

Abacavir/lamivudina and similar medicines may cause adverse effects in babies during pregnancy. If you have taken abacavir/lamivudina during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your baby'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.

Breastfeeding

It is not recommended that women living with HIV breastfeed, because HIV infection can be transmitted to the baby through breast milk. A small amount of the components of abacavir/lamivudina may also pass into breast milk.

If you are breastfeeding or considering breastfeeding, you must consult your doctor as soon as possible.

Driving and using machines

Abacavir/lamivudina may cause side effects that could affect your ability to drive or operate machinery.

Consult your doctor about your ability to drive or operate machinery while taking abacavir/lamivudina.

Abacavir/Lamivudina Aurovitas contains sunset yellow FCF

This medicine may cause allergic reactions as it contains sunset yellow FCF (E110).

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

Abacavir/Lamivudina Aurovitas contains sodium

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

3. How to take Abacavir/Lamivudine Aurovitas

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

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

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

Maintain regular contact with your doctor

Abacavir/lamivudine helps control your condition. You 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 abacavir/lamivudine without first speaking to your doctor.

If you take more Abacavir/Lamivudine Aurovitas than you should

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

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 usual 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 may increase the risk of experiencing a hypersensitivity reaction.

If you interrupt treatment with Abacavir/Lamivudine Aurovitas

If for any reason you have stopped taking abacavir/lamivudine, 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 that there may have been a connection, you will be advised never to take abacavir/lamivudine or any other medicine containing abacavir again (e.g., Trizivir, Triumeq or Ziagen). It is important that you follow this warning.

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 have easy access to medical assistance, if needed.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.

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

When receiving HIV treatment, it may be difficult to determine whether a symptom is an adverse effect of abacavir/lamivudina or of other medicines you are taking, or is due to the HIV disease itself. Therefore, it is very important that you inform your doctor of 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 section titled “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 abacavir/lamivudina, other disorders may occur during combination HIV treatment.

It is important that you read the information under the section “Other possible adverse effects of combination HIV treatment”.

Hypersensitivity Reactions Abacavir/lamivudine contains abacavir (the 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 individuals taking medications containing abacavir. Who experiences these reactions? Any person taking abacavir/lamivudine could develop a hypersensitivity reaction to abacavir, which could be life-threatening if they continue taking abacavir/lamivudine. Your risk of developing this reaction is higher if you have a gene called HLA-B*5701 (although you may still have this reaction even if you do not have this gene). Before starting treatment with abacavir/lamivudine, you should be tested for this gene. If you know you have this gene, inform your doctor before taking abacavir/lamivudine. In a clinical trial, approximately 3 to 4 out of every 100 patients treated with abacavir who did not have the HLA-B*5701 gene developed a hypersensitivity reaction. What are the symptoms? The most common symptoms are: fever (elevated 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, neck swelling, 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 can 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: 1if you develop a skin rash OR 2if 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 body aches and malaise. Your doctor may advise you to stop taking abacavir/lamivudine. If you have stopped taking abacavir/lamivudine If you have stopped taking abacavir/lamivudine due to a hypersensitivity reaction, NEVER restart abacavir/lamivudine or any other medicine containing abacavir (e.g., Trizivir, Triumeq, or Ziagen). If you do, within hours you may experience a drop in blood pressure that could be life-threatening or fatal. If for any reason you have interrupted treatment with abacavir/lamivudine, especially because you suspect 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 abacavir/lamivudine or any other medicine containing abacavir again (e.g., Trizivir, Triumeq, or Ziagen). It is important that you follow this warning. Occasionally, hypersensitivity reactions have occurred in individuals who restart abacavir after having experienced only one symptom listed on the Alert Card before stopping treatment. Very rarely, reactions have occurred in individuals restarting abacavir treatment who had no prior symptoms of hypersensitivity before stopping. If your doctor advises restarting abacavir/lamivudine, 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 abacavir/lamivudine, you must return all unused abacavir/lamivudine tablets for safe disposal. Consult your doctor or pharmacist. The packaging of Abacavir/Lamivudine Aurovitas includes an Alert 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).
• diarrhea.
• stomach pain.
• loss of appetite.
• tiredness, lack of energy.
• fever (elevated temperature).
• general feeling of malaise.
• difficulty falling asleep (insomnia).
• muscle aches and pains.
• 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 (anemia) or low white blood cell count (neutropenia).
• increased levels of liver-produced enzymes.
• decrease in the number of cells involved in blood clotting (thrombocytopenia).

Rare adverse effects

May affect up to 1 in 1,000 people:

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

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, skin tingling sensations (pricking).
• feeling of weakness in the limbs.
• skin rash, which may form blisters resembling small targets (a 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 abacavir/lamivudine, may cause other disorders to develop during HIV treatment.

Symptoms of infection and inflammation

Exacerbation of previous 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 treatment began. After starting treatment, the immune system becomes stronger and 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 toward the body trunk.

If you notice any symptoms of infection and inflammation, or if you experience any of the symptoms listed above:

?Inform your doctor immediately. Do not take any other medication for infection without your doctor's 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 drugs 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 they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Abacavir/Lamivudine Aurovitas

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

Do not use this medicine after the expiry date which is stated on the label, the carton, and the blister after EXP. The expiration date refers to the last day of the month indicated.

Blister: Store below 30°C.

HDPE bottle: No special storage conditions required.

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

6. Contents of the pack and other information

Composition of Abacavir/Lamivudine Aurovitas

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

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

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

Appearance of the product and contents of the pack

Film-coated orange-colored, modified capsule-shaped tablets, marked with “H” on one side and “27” on the other. Size: 20.7 mm × 9.2 mm.

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

Pack sizes:

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

HDPE bottles: 30 and 100 film-coated tablets.

Not all pack 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 medicinal product is authorized in the European Economic Area member states under the following names:

Germany:	Abacavir/Lamivudin Aurobindo 600 mg/300 mg Filmtabletten
Belgium:	Abacavir/Lamivudine AB 600 mg/300 mg film-coated tablets
Spain:	Abacavir/Lamivudina Aurovitas 600 mg/300 mg film-coated tablets EFG
France:	Abacavir/Lamivudine Arrow 600 mg/300 mg film-coated tablets
Italy:	Abacavir e Lamivudina Aurobindo
Netherlands:	Abacavir/Lamivudine Aurobindo 600 /300 mg, film-coated tablets
Portugal:	Abacavir + Lamivudina Aurovitas

Date of the most recent review of this leaflet: December 2023

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