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

2. What you need to know before you take Abacavir/Lamivudina Macleods

Do not takethis medicine:

• if you are allergic(hypersensitive)to abacavir (or to any other medicine that contains abacavir — e.g., Trizivir, Triumeqor Ziagen), lamivudine, 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 doctor if you think any of these circumstances apply to you. Do not take this medicine.

Be especially careful with this medicine

Warnings and precautions

Consult your doctor or pharmacist before starting to take Abacavir/Lamivudina Macleods.

Some people who take this medicine or other combination treatments for HIV have a higher risk of suffering from 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 this medicine without your doctor's advice, as it may get worse)
• if you are significantly overweight (especially if you are a woman)
• if you have kidney problems.

Consult your doctor before starting to take this medicine if you have any of these circumstances.You may need to have 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 carefully the information about hypersensitivity reactions in section 4 of this leaflet.

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 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 who take medicines for HIV infection develop other disorders, which can be serious. You need to know what signs and symptoms to look out for while taking this medicine.

Read the information on “Other possible side effects of combination therapy for HIV” in section 4 of this leaflet.

Other medicines and Abacavir/Lamivudina Macleods

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

The following medicines must not be used with Abacavir/Lamivudina Macleods:

• 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 doctor if you are being treated with any of these medicines.

Some medicines interact with this medicine, these include:

• phenytoin, to treat epilepsy. Tell your doctor if you are taking phenytoin. Your doctor may need to monitor you while you are taking this medicine.
• methadone, used as a substitute for heroin. 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 doctor if 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 pharmacist if 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.This medicine and similar medicines may cause side effects in babies during pregnancy.

If you have been taking this medicine 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.

Breast-feeding

It is not recommendedthat women living with HIV breast-feed because the 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 think you may want to breast-feed, you must consult your doctor as soon as possible.

Driving and using machines

This medicine 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.

Important information about some of the ingredients ofthis medicine

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

3. How to take Abacavir/Lamivudina Macleods

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

The recommended dose of this medicine 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 medicine can be taken with or without food.

Keep in regular contact with your doctor.This medicine helps to control your condition. You will need to take it every day to prevent your disease from getting worse. You may continue to develop other infections and illnesses associated with HIV infection. Stay in touch with your doctor and do not stop taking this medicinewithout talking to your doctor first.

If you take more Abacavir/Lamivudina Macleodsthan you should

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

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

If you forget to take this medicine

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 this medicine regularly, as irregular intake can increase the risk of a hypersensitivity reaction.

If you stop taking Abacavir/Lamivudina Macleods

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 never to take this medicine or any other medicine that containsabacavir (e.g.,Trizivir, Triumeq, or Ziagen). It is important that you follow this advice.
• If your doctor advises you to restart treatment with this medicine, 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 blood glucose and lipid levels. 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 will experience them.

When you are undergoing HIV treatment, it can be difficult to distinguish whether a symptom is an adverse effect of this medication or other medications you are taking, or if it 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 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 this medication, , other disorders can develop during combined HIV treatment.

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 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)
• pancreatitis (pancreatitis)
• muscle tissue rupture.

Rare adverse effects that may appear in blood tests are:

• increased levels of an enzyme called amylase.

Very Rare Adverse Effects

May affect up to 1 in 10,000 people:

• numbness, tingling sensation in the skin (pinpricks)
• weakness in the limbs
• skin rash that can form blisters resembling small targets (dark central 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 experience adverse effects

Inform your doctor or pharmacist if you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus.

Other Possible Adverse Effects of Combined HIV Treatment

Combined treatments, such as this medication, 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 starting treatment. After starting treatment, the immune system becomes stronger, so it begins to fight 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 can 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 observe any symptoms of infection and 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 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 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/Lamivudine Macleods

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the box. The expiration date is the last day of the month indicated.

Use this medication within 30 days after opening the bottle.

Do not store above 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medications. This way, you will help protect the environment.

6. Package Contents and Additional Information

Abacavir/Lamivudine Macleods Composition

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

• Other components are:

Microcrystalline cellulose

Sodium starch glycolate Type A (Potato starch)

Povidone

Isopropyl alcohol

Colloidal silicon dioxide

Low-substituted hydroxypropyl cellulose

Magnesium stearate

• The tablets are coated with

Hypromellose 3cPs (E464)

Polyethylene glycol 400 (E1521)

Polysorbate 80 (E433)

Titanium dioxide (E171)

Product Appearance and Package Contents

White to off-white, capsule-shaped, biconvex film-coated tablets, engraved with “300” on one side and “600” on the other.

Blister Pack:The blister pack consists of an aluminum foil and cold-forming laminate

Package size: 30 tablets. Single-dose blister pack of 30 tablets.

Container:The container consists of a round, high-density polyethylene (HDPE) bottle with a child-resistant closure.

Package size: 30 tablets

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona, Spain

Manufacturer

Synoptis Industrial SP.Z.O.O.

ul. Rabowicka 15

62020 Swarzedz

Poland

Date of the last revision of this prospectus: November 2024

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