Patient Information Leaflet

Abacavir/LamivudineViatris600 mg/300 mg Film-Coated Tablets

Read this 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

IMPORTANT --- Hypersensitivity Reactions

Abacavir/Lamivudine Viatris contains abacavir. Some people who take abacavir may develop ahypersensitivity reaction(severe allergic reaction), which can be life-threatening if you continue taking medicines that contain abacavir.You must read the information about “Hypersensitivity Reactions” carefully in section 4 of this leaflet.

The packaging of Abacavir/Lamivudine Viatris includes aWarning Cardto remind you and healthcare professionals about your hypersensitivity to abacavir.You must remove this card and carry it with you at all times..

1. What isAbacavir/Lamivudine Viatrisand what is it used for

2. What you need to know before takingAbacavir/Lamivudine Viatris

3. How to takeAbacavir/Lamivudine Viatris

4. Possible side effects

5. Storage ofAbacavir/Lamivudine Viatris

6. Contents of the pack and additional information

Abacavir/lamivudina is used in the treatment of infection caused by the HIV (human immunodeficiency virus) in adults, adolescents, and children who weigh at least 25 kg.

Abacavir/lamivudina contains two active ingredients that are used for the treatment of infection caused by the HIV: abacavir and lamivudina. Both belong to a group of antiretroviral medications called nucleoside reverse transcriptase inhibitors (NRTIs).

Abacavir/lamivudina 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 the body fight infection.

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

Do not takeAbacavir/Lamivudina Viatris

• If you areallergic(hypersensitive) to abacavir (or to any other medication that contains abacavir --- for example, abacavir/lamivudina, abacavir/lamivudina/zidovudina, abacavir/dolutegravir/lamivudina), lamivudina or to any of the other components of this medication (including those listed in section 6).

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

Consult your doctorif you think you are affected by any of these circumstances.Do not take this medication.

Warnings and precautions

Be especially careful with Abacavir/Lamivudina Viatris

Some people taking abacavir/lamivudina or other combination treatments for HIV are at a higher risk of experiencing severe side effects.You should be aware of the additional risks:

• If you havemoderate or severe liver disease.
• If you have ever hadliver disease, including hepatitis B or C (if you have hepatitis B do not stop taking this medication without consulting your doctor, as your hepatitis may recur).
• If you havesignificant obesity(especially if you are a woman).
• If you have anykidney problems.

Consult your doctor before starting to take abacavir/lamivudina if you have any of these circumstances.You may need additional tests, including blood tests, while taking this medication.For more information see section 4.

Abacavir hypersensitivity reactions

Even patients who do not have the HLA-B*5701 gene can develop ahypersensitivity reaction(a severe 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 ofexperiencing cardiovascular events.

Inform your doctorif you have cardiovascular problems, smoke or have conditions that may increase your risk of cardiovascular disease such as high blood pressure or diabetes. Do not stop taking abacavir/lamivudina unless your doctor advises you to.

Be aware of important symptoms

Some people taking HIV medications develop other conditions, which can be serious. You need to know what signs and symptoms to be aware of while taking abacavir/lamivudina.

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

Other medications and Abacavir/Lamivudina Viatris

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including medications based on plants and those obtained without a prescription.

Remember to inform your doctor or pharmacist if you start taking a new medication while taking abacavir/lamivudina.

The following medications should not be used with abacavir/lamivudina:

• Emtricitabine, to treatHIV infection.
• Other medications that contain lamivudina, used to treatHIV infection or hepatitis B.
• High doses oftrimethoprim/sulfamethoxazole, an antibiotic.
• Cladribine, used to treatacute myeloid leukemia.

Inform your doctorif you are being treated with any of these medications.

Some medications interact with abacavir/lamivudina

These include:

• Phenytoin, to treatepilepsy.

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

• Methadone, used as asubstitute for heroin. Abacavir increases the rate at which methadone is eliminated from the body. If you are taking methadone, you will need to be monitored for signs of withdrawal. You may need your methadone dose to be adjusted.

Inform your doctorif you are taking methadone.

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

Inform your doctor or pharmacistif you are taking any of them.

• Riociguat, to treathigh blood pressure in the blood vessels(pulmonary arteries) that carry blood from the heart to the lungs.
• It may be necessary for your doctor to reduce your dose of riociguat, as abacavir may increase the levels of riociguat in the blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before taking this medication.

Pregnancy

Abacavir/lamivudina is not recommended during pregnancy. This medicationand similar medicationsmay cause adverse effects in babies during pregnancy. If you have been taking abacavir/lamivudina during your pregnancy, your doctor may request that you have periodic blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took antiretroviral drugs during pregnancy, the benefit of HIV protection was greater than the risk of adverse effects.

Breastfeeding

It is not recommendedfor women with HIV to breastfeed,as the HIV infection can be passed 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 orplan to breastfeed,you should consultyour doctoras soon as possible.

Driving and operating machinery

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

Consult your doctorabout your ability to drive or operate machinery while taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of 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 a day.

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

Maintain regular contact with your doctor

Abacavir/lamivudine helps control your condition. You will need to take it every day to prevent your disease from worsening. You may continue to develop other infections and diseases associated with HIV infection.

Remain in contact with your doctor and do not stop taking this medication without first speaking with your doctor.

If you take more Abacavir/Lamivudina Viatris than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately,contact the nearest hospital emergency serviceor call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Abacavir/Lamivudina Viatris

If you forget to take a dose, take it as soon as you remember and then continue with your usual treatment. Do not take a double dose to compensate for the missed doses.

It is essential to take this medication regularly, as irregular intake may increase the risk of experiencing a hypersensitivity reaction.

If you interrupt treatment with Abacavir/Lamivudina Viatris

If for any reason, you have stopped taking this medication - especially because you think it has side effects or due to another illness:

Consult your doctor before resuming treatment.Your doctor will check if your symptoms were related to a hypersensitivity reaction. If your doctor considers it related,he will instruct you never to take this medication again or any other medication that contains abacavir (for example, abacavir/lamivudine, abacavir/lamivudine/zidovudine, abacavir/dolutegravir/lamivudine).It is essential that you follow this warning.

If your doctor advises you to restart treatment with abacavir/lamivudine, you can ask him to take the first doses in a place where you have easy access to medical assistance if necessary.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

When you are on treatment for HIV, it may be difficult to distinguish whether a symptom is a side effect of abacavir/lamivudine or of other medicines you are taking, or is due to an effect of the HIV disease itself.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 ahypersensitivity reaction(a severe allergic reaction), described in this leaflet in the box called “Hypersensitivity reactions”.

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

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

It is important that you read the information under the heading “Other possible side effects of combined HIV treatment”.

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

Frequent(may affect up to 1 in 10 people)

• hypersensitivity reactions (allergic). See the box “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 side effects:

Infrequent(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)
• reduction in the number of platelets, shown in blood tests, which causes unexpected bleeding or bleeding for longer than usual (thrombocytopenia).

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

• liver problems 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, 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, feeling unwell (nausea), vomiting, and stomach pain. These may 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 pale skin
• skin rash, which may form blisters that look like small darts (respiratory difficulty, drowsiness, numbness or weakness in the limbs, feeling unwell (nausea), vomiting, and stomach pain. These may 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 pale skin
• skin rash, which may form blisters that look like small darts (erythema multiforme)
• a generalised 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 on more than 30% of the body surface (toxic epidermal necrolysis)
• numbness, tingling in the skin (pins and needles).

Other possible side effects:

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

• headache
• vomiting
• feeling unwell (nausea)
• diarrhea
• abdominal pain
• loss of appetite
• tiredness, lack of energy
• fever (high temperature)
• general feeling of illness
• difficulty falling asleep (insomnia)
• muscle pain and discomfort
• joint pain
• cough
• irritated or runny nose
• skin rash
• hair loss.

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

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

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

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

If you experience side effects

Inform your doctor or pharmacistif you consider that any of the side effects you experience are serious or if you notice any side effect not mentioned in this leaflet.

Other possible side effects of combined HIV treatment

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

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 treatment began. After treatment begins, the immune system becomes stronger, and it starts to fight these infections, which can cause symptoms of infection or inflammation. The symptoms usually includefever, as well as some of the following:

• headache
• abdominal pain
• difficulty breathing.

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

• palpitations (rapid or irregular heartbeats) or tremor
• hyperactivity (excessive restlessness and movement)
• weakness that starts in the hands and feet and ascends to the trunk of the body.

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

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

You may have problems with your bones

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

• if they have been taking a combined treatment for a long time
• if they are also taking anti-inflammatory medicines 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box, bottle label or blister pack after CAD. 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 case. Do not use this medication after 90 days of its opening.

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

Medicines should not be thrown down the drains or in the trash. If in doubt, ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Abacavir/LamivudineViatris

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

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

Appearance of Abacavir/LamivudineViatrisand packaging contents

White, rectangular, biconvex film-coated tablet, engraved with “AL12” on one face and “M” on the other.

It is presented 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 containing 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

O

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Hoehe

Benzstrasse 1, Bad Homburg v. d. Hoehe

Hessen, 61352, Germany

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

GermanyAbacavir/LamivudinMylan Pharma600 mg/300 mg Filmtabletten

AustriaAbacavir/LamivudinViatris600 mg/300 mg Filmtabletten

BelgiumAbacavir/LamivudineViatris600 mg/300 mg filmomhuldetabletten

BulgariaAbacavir/Lamivudine Viatris 600 mg/300 mg film-coated tablets

DenmarkAbacavir/LamivudineViatris

SpainAbacavir/LamivudinaViatris600 mg/300 mg comprimidos EFG

EstoniaAbacavir/LamivudineViatris

FinlandAbakavir/LamivudinViatris

FranceABACAVIR/LAMIVUDINE VIATRIS 600 mg/300 mg comprimé pelliculé

GreeceAbacavir/LamivudineMylan Pharma600 mg/300 mg film-coated tablets

IrelandAbacavir/LamivudineViatris600 mg/300 mg Film-coated Tablets

LatviaAbacavir/LamivudineViatris600 mg/300 mg apvalkotas tabletes

LithuaniaAbacavir/LamivudineViatris600 mg/300 mg plevele dengtos tabletes

LuxembourgAbacavir/LamivudineViatris600 mg/300 mg comprimés pelliculés

NorwayAbacavir/Lamivudine Viatris

NetherlandsAbacavir/Lamivudine Viatris 600 mg/300 mg filmomhulde tabletten

PortugalAbacavir/LamivudinaMylan600 mg/300 mg comprimidos revestidos por película

United Kingdom (Northern Ireland)Abacavir/LamivudineViatris600 mg/300 mg Film-coated Tablets

RomaniaAbacavir/LamivudinaViatris600 mg/300 mg comprimate filmate

SwedenAbakavir/LamivudinViatris

Last review date of this leaflet:December 2024

For detailed and updated information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/