ABACAVIR/LAMIVUDINE KERN PHARMA 600 mg/300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Abacavir/Lamivudine Kern Pharma 600mg/300mg 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

IMPORTANT—Hypersensitivity Reactions

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

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

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

Contents of the package leaflet

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

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

Abacavir/Lamivudine Kern Pharma is used in the treatment of HIV (Human Immunodeficiency Virus) infection in adults, adolescents, and children who weigh at least 25 kg.

This medicine 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 Kern Pharma 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 start taking Abacavir/Lamivudine Kern Pharma

Do not take Abacavir/Lamivudine Kern Pharma

• if you are allergic (hypersensitive) to abacavir (or to any other medicine that contains abacavir – such as Trizivir, Triumeqor Ziagen), lamivudine, or to any of the other ingredients of this medicine (listed in section 6).

Read the information about hypersensitivity reactions in section 4 of this leaflet carefully.

Consult your doctorif you think you may be affected by any of these conditions. Do not take Abacavir/Lamivudine.

Warnings and precautions

Some people who take abacavir/lamivudine or other HIV treatments 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 your hepatitis may get worse)
• if you have significant overweight(especially if you are a woman)
• if you have any kidney problems.

Consult your doctor before starting abacavir/lamivudineif 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 about 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 this medicine unless your doctor advises you to.

Be aware of important symptoms

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

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

Other medicines and Abacavir/Lamivudine Kern Pharma

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/lamivudina.

The following medicines MUST NOT be used with Abacavir/Lamivudine:

• Emtricitabine, to treat HIV infection
• other medicines that contain lamivudine, used to treat HIV infectionor hepatitis B
• high doses of cotrimoxazole (a combination 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 Kern Pharma

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 eliminated from the body. If you are taking methadone, you may need to be monitored for signs of 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 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

This medicine is not recommended during pregnancy.Abacavir/Lamivudine Kern Pharma and similar medicines may cause side effects in babies during pregnancy.

If you have taken this medicine during pregnancy, your doctor may request regular 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

Women with HIV infection should not breast-feed their babiesbecause HIV infection can pass to the baby through breast milk. A small amount of the components of this medicine may also pass into breast milk.

If you are breast-feeding, or have doubts about breast-feeding: Consult your doctor immediately.

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/lamivudina.

Important information about some components of Abacavir/Lamivudine Kern Pharma

This medicine may cause allergic reactions because it contains orange yellow S (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Abacavir/Lamivudine Kern Pharma

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose of Abacavir/Lamivudine Kern Pharma 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 control your condition. You will need to take it every day to avoid your disease getting worse. You may still develop other infections and diseases associated with HIV infection.

Stay in contact with your doctor and do not stop taking this medicinewithout talking to your doctor first.

If you take more Abacavir/Lamivudine Kern Pharma than you should

If you accidentally take more abacavir/lamivudine than you should, tell your doctor or pharmacist, or contact the emergency department of the nearest hospital for more information.

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

If you forget to take Abacavir/Lamivudine Kern Pharma

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 make up for forgotten doses.

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

If you stop taking Abacavir/Lamivudine Kern Pharma

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 they were, they will tell you that you should never take abacavir/lamivudina or any other medicine that contains abacavir again(such as Trizivir, Triumeq, or Ziagen). 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 assistance if needed.

4. Possible Adverse Effects

During HIV treatment, 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 to HIV medications themselves. Your doctor will monitor these changes.

Like all medications, this medication may produce adverse effects, although not all people suffer from them.

When you are being treated for HIV, it may 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/lamivudina, other disorders can develop during combined treatment for HIV.

It is essential that you read the information under the heading “Other Possible Adverse Effects of Combined HIV Treatment”.

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 and 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)
• pancreas inflammation (pancreatitis)
• muscle tissue rupture.

Rare adverse effects that may appear in blood tests are:

• an increase in 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 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 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 fighting these infections, which can cause symptoms of infection or inflammation. The 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 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 starting in the hands and feet and ascending towards the body trunk.

If you observe any symptom 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 HIV treatment 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 Medications: https://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 Kern Pharma

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Store below 25°C

Medications should not be thrown away through drains or into the trash. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Abacavir/Lamivudina Kern Pharma

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

• The other components are microcrystalline cellulose, crospovidone (type A), povidone K-30, magnesium stearate, and yellow iron oxide (E-172) and Opadry YS-1-13065A (containing orange-yellow S (E-110)).

Appearance of Abacavir/Lamivudina Kern Pharma and Packaging Content

Film-coated tablets with a capsule shape, biconvex, orange in color, and engraved with “300” on one side and “600” on the other.

Abacavir/Lamivudina Kern Pharma is presented in blisters containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Date of the last revision of this prospectus:November 2023

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