Package Leaflet: Information for the User

Abacavir/Lamivudine Kern Pharma 600mg/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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

IMPORTANT—Hypersensitivity Reactions

Abacavir/Lamivudine Kern Pharma contains abacavir(which is also an active ingredient in medicines such asTrizivir, TriumeqandZiagen). Some people who take abacavir may develop ahypersensitivity reaction(severe allergic reaction), which can be life-threatening if you continue to take medicines that contain abacavir.

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

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

1. What isAbacavir/Lamivudine Kern Pharmaand what is it used for

2. What you need to know before you start takingAbacavir/Lamivudine Kern Pharma

3. How to takeAbacavir/Lamivudine Kern Pharma

4. Possible side effects

5. Storage ofAbacavir/Lamivudine Kern Pharma

6. Contents of the pack and additional information

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

This medication contains two active principles that are used for the treatment of the infection caused by the HIV: abacavir and lamivudina. Both belong to a group of antiretroviral medications calledinhibitors of reverse transcriptase analogs of nucleosides(NRTIs).

Abacavir/Lamivudina Kern Pharma does not completely cure the 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 treatment with Abacavir/Lamivudina in the same way. Your doctor will monitor the effectiveness of your treatment.

Do not take Abacavir/Lamivudina Kern Pharma

• if you areallergic (hypersensitive)to abacavir (or to any other medicine that contains abacavir – (such asTrizivir, TriumeqorZiagen), lamivudina or to any of the other components of this medicine (listed in section 6).

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

Consult your doctorif you think you are affected by any of these circumstances.Do not take Abacavir/Lamivudina.

Warnings and precautions

Some people taking abacavir/lamivudina or other combined HIV treatments have a higher risk of severe side effects. You need to know that there is a higher risk:

• 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 Abacavir/Lamivudina without consulting your doctor, as your hepatitis may worsen)
• if you have asignificant overweight(especially if you are a woman)
• if you have anykidney problems.

Consult your doctor before starting to take abacavir/lamivudinaif you have any of these circumstances. 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 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

Abacavir cannot be ruled out from increasing the risk of cardiovascular events.

Inform your doctorif you have cardiovascular problems, smoke or have diseases that may increase your risk of cardiovascular diseases 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 taking HIV medicines develop other disorders, which can be severe. 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 combined HIV treatment” in section 4 of this leaflet.

Other medicines and Abacavir/Lamivudina Kern Pharma

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

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

The following medicinesshould not be used with Abacavir/Lamivudina:

• Emtricitabina, to treatHIV infection,
• other medicines that contain lamivudina, used to treatHIV infectionorhepatitis B,
• high doses of cotrimoxazol (association oftrimetoprim/sulfametoxazol), an antibiotic,
• cladribina, used to treatleukemia of hairy cells.

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

Some medicines interact with Abacavir/Lamivudina Kern Pharma

These include:

• Fenitoína, to treatepilepsy.

Inform your doctorif you are taking fenitoína. Your doctor may need to monitor you while you are taking Abacavir/Lamivudina.

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

Inform your doctorif you are taking metadona.

• Medicines (usually liquids) that contain sorbitol and other polyols (such as xilitol, manitol, lactitol or maltitol), if taken regularly.

Inform your doctor or pharmacistif you are being treated with any of these.

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

Pregnancy

This medicine is not recommended for use during pregnancy.Abacavir /Lamivudina Kern Pharma and similar medicines may cause adverse effects in babies during pregnancy.

If you have taken this medicine during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took INTIs during pregnancy, the benefit of protection against HIV was greater than the risk of adverse effects.

Breastfeeding

Women infected with HIV should not breastfeed their babies, as 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 breastfeeding, or have doubts about breastfeeding:Consult your doctor immediately.

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 abacavir/lamivudina.

Important information about some components of Abacavir/Lamivudina Kern Pharma

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

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/Lamivudina Kern Pharma 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/Lamivudina 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 medicationwithout first speaking with your doctor.

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

If you accidentally take more abacavir/lamivudina than you should, inform your doctor or pharmacist, or contact the nearest hospital's emergency service for further information.

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

If you forgot to take Abacavir/Lamivudina Kern Pharma

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 compensate for the missed doses.

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

If you interrupt treatment with Abacavir/Lamivudina Kern Pharma

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 abacavir/lamivudina again or any other medication that contains abacavir(such as Trizivir, Triumeq, or Ziagen). It is essential that you follow this warning.

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

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

Like all medications, this medication can produce side effects, although not everyone will experience them.

When you are on HIV treatment, it may be difficult to distinguish whether a symptom is a side effect of abacavir/lamivudine or of other medications you are taking, or is due to an effect of the disease caused by HIV 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 severe 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”.

Common side effects

They can affect up to1 in 10people:

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

Rare side effects

They can affect up to1 in 100people and may be reflected in blood tests:

• low red blood cell count(anemia)or low white blood cell count(neutropenia)
• an increase in enzymes produced by the liver
• a decrease in the number of cells involved in blood clotting (thrombocytopenia).

Very rare side effects

They can affect up to1 in 1,000people:

• liver damage, such as jaundice, liver enlargement or fatty liver, inflammation (hepatitis)
• pancreatitis (inflammation of the pancreas)
• muscle rupture.

Rare side effects that may appear in blood tests are:

• an increase in an enzyme calledamylase.

Very rare side effects

They can affect up to1 in 10,000people:

• tingling, numbness in the skin (pins and needles)
• weakness in the limbs
• skin rash, which may form blisters that look like small darts (central dark spot surrounded by a lighter 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 on 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 side 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 side effects

• Inform your doctor or pharmacistif you consider that any of the side effects you are experiencing 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). Such infections may have been "latent" and not detected by the weakened immune system before treatment began. After treatment began, 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 to take medications to treat HIV infection. 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 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 medication for the infection without your doctor's advice.

You may have bone problems

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 suffer from this disease:

• if they have been taking a combined treatment for a long time
• if they are also taking 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 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 Medications for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

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

Store below 25°C

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Abacavir/Lamivudina Kern Pharma

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

• 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 yellow-orange S (E-110)).

Appearance of Abacavir/Lamivudina Kern Pharma and contents of the packaging

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

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

Holder of the marketing authorization and Responsible for manufacturing

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Date of the last review of this leaflet: November 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/