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

Introduction

Patient Information: Summary of Product Characteristics

Abacavir/LamivudineViatris600 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 Viatris contains abacavir. 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 that contain abacavir. You must read the information on “Hypersensitivity reactions” in section 4 of this leaflet carefully.

The packaging of Abacavir/Lamivudine Viatris includes an Information Cardto remind you and your healthcare provider of abacavir hypersensitivity. You must take out this card and always carry it with you.

Contents of the pack

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

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

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

Abacavir/lamivudine contains two active substances that are 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 does not completely cure HIV infection; it reduces the amount of virus in the 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 plays an important role in helping 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 Viatris

Do not takeAbacavir/Lamivudine Viatris

• If you are allergic(hypersensitive) to abacavir (or any other medicine that contains abacavir, such as abacavir/lamivudine, abacavir/lamivudine/zidovudine, abacavir/dolutegravir/lamivudine), lamivudine, or any of the other ingredients of this medicine (listed in section 6).

Read the information on hypersensitivity reactions in section 4 carefully.

Consult your doctorif you think any of these conditions apply to you. Do not take this medicine.

Warnings and precautions

Be especially careful with Abacavir/Lamivudine Viatris

Some people who take abacavir/lamivudine or other anti-HIV combination therapies have a higher risk of serious side effects. You should be aware of the additional risks:

• 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 hepatitis may come back).
• If you have significant overweight(especially if you are a woman).
• If you have any 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. See section 4 for more information.

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 or 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 Viatris

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal medicines and those bought without a prescription.

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 that contain lamivudine, used to treat HIV infection or hepatitis B.
• High doses of trimethoprim/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 heroin substitute. 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 methadone withdrawal. You may need to have your methadone dose changed.

Tell your doctorif you are taking methadone.

• Medicines (usually liquids) that contain sorbitol and other sugar alcohols(such as xylitol, mannitol, lactitol, maltitol), if taken regularly.

Tell your doctor or pharmacistif you are taking any of these.

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

Pregnancy and breastfeeding

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

Pregnancy

Abacavir/lamivudine is not recommended during pregnancy. This medicine 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 regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV was greater than the risk of side effects.

Breastfeeding

It is not recommendedthat women with HIV breastfeed their babies because HIV infection can pass to the baby through breast milk. A small amount of the components of abacavir/lamivudine may also pass into breast milk.

If you are breastfeeding or thinking of breastfeeding, 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 this medicine.

3. How to take Abacavir/Lamivudine Viatris

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 who weigh at least 25 kg or more is one tablet once a day.

Swallow the tablets whole, with a little water. This medicine can be taken with or without food.

Stay in regular contact with your doctor

Abacavir/lamivudine helps to 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 touch with your doctor and do not stop taking this medicine without discussing it with your doctor first.

If you take more Abacavir/Lamivudine Viatris than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, contact the emergency department of the nearest hospital, 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 Viatris

If you forget to take a dose, take it as soon as you remember and then continue with your regular treatment. Do not take a double dose to make up for forgotten doses.

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

If you stop taking Abacavir/Lamivudine Viatris

If for any reason you have stopped taking this medicine - especially because you think you have side effects or because of another illness:

Consult your doctor before restarting treatment.Your doctor will check if your symptoms were related to a hypersensitivity reaction. If your doctor thinks that there may have been a connection, they will advise you to never take this medicine or any other medicine that contains abacavir (such as abacavir/lamivudine, abacavir/lamivudine/zidovudine, abacavir/dolutegravir/lamivudine) 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 have easy access to medical care, in case it is 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 is related, in part, to the recovery of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications themselves. Your doctor will monitor these changes.

When you are undergoing treatment 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 if it 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 section 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".

STOP taking this medicine and contact a doctor immediately if you experience any of the following adverse effects:

Frequent(may affect up to 1 in 10 people)

• hypersensitivity reactions (allergic). Consult the table "Hypersensitivity Reactions" below for important information about these symptoms.

Rare(may affect up to 1 in 1,000 people):

• swelling of the eyelids, face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing.

Inform your doctor as soon as possible if you experience any of the following adverse effects:

Uncommon(may affect up to 1 in 100 people):

• reduction in the number of white blood cells, shown in blood tests, which increases the risk of infections (neutropenia, lymphopenia)
• reduced number of platelets, shown in blood tests, which causes unexpected bruising or bleeding for longer than usual (thrombocytopenia).

Rare(may affect up to 1 in 1,000 people):

• liver disorders such as jaundice, enlarged liver, or fatty liver, inflammation (hepatitis). You may feel unwell, notice yellowing of the skin and whites of the eyes, have pale stools, dark urine, and severe stomach pain
• inflammation of the pancreas (pancreatitis). You may experience severe stomach pain that radiates to the back, have a swollen and soft stomach, and feel unwell and generally ill
• rupture of muscle tissue (rhabdomyolysis). You may have muscle pain, especially in the shoulders, thighs, or lower back, weakness or difficulty moving your arms or legs, dark urine, or little or no urine.

Very Rare(may affect up to 1 in 10,000 people):

• rapid, deep, and difficult breathing, drowsiness, numbness or weakness in the limbs, discomfort (nausea), vomiting, and stomach pain. These can be symptoms of an excess of lactic acid in the blood (lactic acidosis), as shown in blood tests
• failure of the bone marrow to produce new red blood cells (pure red cell aplasia), as shown in blood tests. You may feel tired, lethargic, and notice abnormal paleness of the skin
• skin rash, which can form blisters that look like small targets (a dark center surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form that causes peeling of the skin over more than 30% of the body surface (toxic epidermal necrolysis)
• numbness, tingling sensation in the skin (pins and needles).

Other Possible Adverse Effects:

Frequent(may affect up to 1 in 10 people):

• 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 and discomfort
• joint pain
• cough
• irritated or runny nose
• skin rash
• hair loss.

Uncommon(may affect up to 1 in 100 people):

• low red blood cell count (anemia), shown in blood tests
• an increase in liver enzyme levels, shown in blood tests.

Rare(may affect up to 1 in 1,000 people):

• an increase in an enzyme called amylase, shown in blood tests

If you suffer from adverse effects

Inform 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 severe infections (opportunistic infections). Such infections may have been "latent" and not detected by the weakened immune system before treatment began. After starting treatment, the immune system becomes stronger, so it starts to fight these infections, which can cause symptoms of infection or inflammation. The symptoms usually include fever, in addition to some of the following:

• headache
• stomach pain
• breathing difficulties.

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 for HIV treatment. The symptoms may include:

• palpitations (rapid or irregular heartbeats) or tremors
• hyperactivity (excessive restlessness and movement)
• weakness that starts in the hands and feet and moves up to the torso.

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

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

You may have problems with your bones

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.

The 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:

Inform 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 Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Abacavir/Lamivudine Viatris

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the box, label on the bottle, or blister pack after EXP. The expiration date is the last day of the month indicated.

Bottle only: Write the date the bottle was opened in the space provided on the label and/or in the case. Do not use this medicine after 90 days of opening.

This medicine does not require any special storage temperature. Store in the original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Container contents and additional information

Composition of Abacavir/Lamivudine Viatris

The active ingredients of each film-coated tablet are abacavir sulfate equivalent to 600 mg of abacavir and 300 mg of lamivudine.

The other ingredients are microcrystalline cellulose, crospovidone, magnesium stearate, anhydrous colloidal silica, and talc. The coating contains hypromellose, titanium dioxide (E-171), macrogol, and polysorbate 80.

Appearance of Abacavir/Lamivudine Viatris and container contents

White, rectangular, biconvex, film-coated tablet, engraved with "AL12" on one side and "M" on the other.

It is available in plastic bottles with a white, opaque, child-resistant closure containing 30 tablets and in packs containing 30, 30x1 (perforated unit-dose blisters) or 90 tablets, or in multi-packs of 90 tablets, consisting of 3 packs, each with 30 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturers:

Mylan Hungary Kft

Mylan utca 1.

Komárom, 2900

Hungary

Or

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Hoehe

Benzstrasse 1, Bad Homburg v. d. Hoehe

Hessen, 61352, Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany Abacavir/Lamivudin Mylan Pharma 600 mg/300 mg Filmtabletten

Austria Abacavir/Lamivudin Viatris 600 mg/300 mg Filmtabletten

Belgium Abacavir/Lamivudine Viatris 600 mg/300 mg filmomhulde tabletten

Bulgaria Abacavir/Lamivudine Viatris 600 mg/300 mg film-coated tablets

Denmark Abacavir/Lamivudine Viatris

Spain Abacavir/Lamivudina Viatris 600 mg/300 mg comprimidos EFG

Estonia Abacavir/Lamivudine Viatris

Finland Abakavir/Lamivudin Viatris

France ABACAVIR/LAMIVUDINE VIATRIS 600 mg/300 mg comprimé pelliculé

Greece Abacavir/Lamivudine Mylan Pharma 600 mg/300 mg film-coated tablets

Ireland Abacavir/Lamivudine Viatris 600 mg/300 mg Film-coated Tablets

Latvia Abacavir/Lamivudine Viatris 600 mg/300 mg apvalkotas tabletes

Lithuania Abacavir/Lamivudine Viatris 600 mg/300 mg plevele dengtos tabletes

Luxembourg Abacavir/Lamivudine Viatris 600 mg/300 mg comprimés pelliculés

Norway Abacavir/Lamivudine Viatris

Netherlands Abacavir/Lamivudine Viatris 600 mg/300 mg filmomhulde tabletten

Portugal Abacavir/Lamivudina Mylan 600 mg/300 mg comprimidos revestidos por película

United Kingdom (Northern Ireland) Abacavir/Lamivudine Viatris 600 mg/300 mg Film-coated Tablets

Romania Abacavir/Lamivudina Viatris 600 mg/300 mg comprimate filmate

Sweden Abakavir/Lamivudin Viatris

Date of the last revision of this leaflet:December 2024

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