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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

Read the entire leaflet carefully before you start taking this medicine, as 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

IMPORTANT — Hypersensitivity reactions

Abacavir/Lamivudine Viatris contains abacavir. Some people taking abacavir may develop a hypersensitivity reaction (a serious allergic reaction), which may 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 packaging of Abacavir/Lamivudine Viatris 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 the leaflet

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

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

Abacavir/lamivudine is used in the treatment of human immunodeficiency virus (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 known as nucleoside reverse transcriptase inhibitors (NRTIs).

Abacavir/lamivudine 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/lamivudine in the same way. Your doctor will monitor the effectiveness of your treatment.

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

Do not take Abacavir/Lamivudina Viatris

• If you are allergic (hypersensitive) to abacavir (or to any other medicine containing abacavir — (for example, abacavir/lamivudina, abacavir/lamivudina/zidovudine, abacavir/dolutegravir/lamivudina), 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.

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

Warnings and precautions

Be especially careful with Abacavir/Lamivudina Viatris

Some people taking abacavir/lamivudina or other combination treatments for HIV have a higher risk of developing 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 return).
• If you are significantly overweight (especially if you are a woman).
• If you have any kidney problems.

Consult your doctor before starting abacavir/lamivudina 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 carry the HLA-B*5701 gene can develop a hypersensitivity reaction (a severe allergic reaction).

Read carefully the information on 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 or 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 treatment for HIV” in section 4 of this leaflet.

Other medicines and Abacavir/Lamivudina Viatris

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

Remember to inform your doctor or pharmacist if you start taking a new medicine while taking 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 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 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 withdrawal symptoms. Your methadone dose may need to be adjusted.

Tell your doctor if you are taking methadone.

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

Tell your doctor or pharmacist if you are taking 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 before taking this medicine.

Pregnancy

The use of abacavir/lamivudina during pregnancy is not recommended. This medicine and similar medicines may cause adverse effects in babies during pregnancy. If you have taken abacavir/lamivudina during your pregnancy, your doctor may request periodic 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.

Breastfeeding

Breastfeeding 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 abacavir/lamivudina may also pass into breast milk.

If you are breastfeeding or planning to breastfeed, 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 regarding your ability to drive or operate machinery while taking this medicine.

3. How to take Abacavir/Lamivudina Viatris

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

The recommended dose of abacavir/lamivudina 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. This medicine can be taken with or without food.

Maintain regular contact with your doctor

Abacavir/lamivudina 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 Viatris than you should

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

If you forget 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 dosing schedule. Do not take a double dose to make up for a missed dose.

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

If you stop taking Abacavir/Lamivudina Viatris

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 assess whether your symptoms were related to a hypersensitivity reaction. If your doctor considers that there may have been a connection, you will be instructed never to take this medicine again, or any other medicine containing abacavir (for example, abacavir/lamivudina, abacavir/lamivudina/zidovudine, abacavir/dolutegravir/lamivudina). It is important that you follow this warning.

If your doctor advises restarting treatment with abacavir/lamivudina, they may ask you to take the first doses in a place where you have easy access to medical assistance, should it be 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 can cause adverse effects, although not everyone will experience them.

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

While undergoing HIV treatment, it may be difficult to determine whether a symptom is an adverse effect of abacavir/lamivudine, of other medicines you are taking, or is due to the HIV disease 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 the box below 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 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.”

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

Common (may affect up to 1 in 10 people)

• hypersensitivity (allergic) reactions. See the “Hypersensitivity reactions” box below for important information about these symptoms.

Hypersensitivity Reactions Abacavir/Lamivudine Viatris contains abacavir (active ingredient also present in abacavir/lamivudine, abacavir/lamivudine/zidovudine, abacavir/dolutegravir/lamivudine). 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 such a reaction even if you do not have this gene). Before starting treatment with Abacavir/Lamivudine Viatris, you should have been tested for this gene. If you know you carry this gene, tell your doctor before taking this medicine. 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 rash. Other commonly observed signs include: nausea (feeling unwell), vomiting, diarrhea, abdominal (stomach) pain, shortness of breath, cough, excessive fatigue, general malaise, headache, muscle pain. Other possible symptoms may include: Joint pain, mouth ulcers, sore throat, chest pain, breathing difficulties (respiratory problems), swelling of arms or legs, swollen glands (in neck, armpits or groin), low blood pressure, eye inflammation (conjunctivitis), tingling or numbness in hands or feet. Signs of liver problems include yellowing of the skin or whites of the eyes, dark urine, pale stools; signs of kidney problems include little or no urine production or lower back pain. Kidney or liver problems may also be detected through blood tests. When do these reactions occur? Hypersensitivity reactions can occur at any time during treatment with this medicine, but are most likely to occur within the first 6 weeks of treatment. Contact your doctor immediately: 1if you develop a 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 this medicine If you have stopped taking abacavir/lamivudine due to a hypersensitivity reaction, NEVER restart abacavir/lamivudine or any other medicine containing abacavir (e.g., abacavir/lamivudine, abacavir/lamivudine/zidovudine, abacavir/dolutegravir/lamivudine). If you do, within hours you may experience a severe 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 adverse 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 link, you will be instructed never to restart abacavir/lamivudine or any medicine containing abacavir (e.g., abacavir/lamivudine, abacavir/lamivudine/zidovudine, abacavir/dolutegravir/lamivudine). It is important to follow this warning. Occasionally, hypersensitivity reactions have occurred in people restarting abacavir after having experienced only one symptom listed on the Warning Card prior to stopping. Very rarely, reactions have occurred in people who restarted abacavir therapy but 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 this medicine, you must return all unused tablets for safe disposal. Consult your doctor or pharmacist. The packaging of Abacavir/Lamivudine Viatris includes an Information Card to remind you and healthcare professionals about hypersensitivity reactions. Separate the card from the package and carry it with you at all times.

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

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

Contact your doctor as soon as possible if you experience any of the following side effects:

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

• reduced number of white blood cells, shown in blood tests, increasing the risk of infections (neutropenia, lymphopenia)
• reduced number of platelets, shown in blood tests, causing unexpected bruising or bleeding longer than normal (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 radiating to the back, have a swollen and tender abdomen, and feel unwell and generally ill
• breakdown of muscle tissue (rhabdomyolysis). You may have muscle pain, especially in the shoulders, thighs, or lower back, weakness or difficulty moving arms or legs, dark urine, or little to 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, malaise (nausea), vomiting, and stomach pain. These may be symptoms of excess 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 may form blisters resembling small targets (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 causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
• numbness, tingling sensation in the skin (pins and needles).

Other possible side effects:

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

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

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

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

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

• increased levels of an enzyme called amylase, shown in blood tests.

If you experience side effects

Tell your doctor or pharmacist if you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet.

Other possible side 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 undetected 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. Symptoms may include:

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

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

Contact your doctor immediately. Do not take any other medication for infection without consulting your doctor.

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 condition:

• 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:

• 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 of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if they are possible side effects 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 side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abacavir/Lamivudine Viatris

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

Do not use this medicine after the expiry date stated on the carton, bottle label, or blister pack after EXP. The expiry date refers to 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 carton. Do not use this medicine after 90 days from the date of opening.

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

Medicines must not be disposed of via wastewater or household waste. If you are unsure how to dispose of unused medicines and their packaging, ask your pharmacist. This will help protect the environment.

6. Contents of the container and other information

Composition of Abacavir/Lamivudine Viatris

The active substances in 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 polysorbate 80.

Appearance of Abacavir/Lamivudine Viatris and contents of the container

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

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

Only certain pack sizes may be commercially available.

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 most recent review of this leaflet: December 2024

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