Leaflet:Information for the user

Abacavir/Lamivudina Macleods 600 mg/300 mg Film-coated Tablets EFG

abacavir/lamivudina

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 pass it on to others even if they have similar symptoms, as it may harm them.

-If you experience any side effects, talk to your doctor or pharmacist. See section 4.

IMPORTANT — Hypersensitivity reactions

This medicine 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” in section 4of this leaflet carefully.

The packaging ofthis medicineincludes aMedication Information 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/Lamivudina Macleodsand what is it used for

2.What you need to knowbeforestarting totakeAbacavir/Lamivudina Macleods

3.How to takeAbacavir/Lamivudina Macleods

4.Possible side effects

5Storage ofAbacavir/Lamivudina Macleods

6.Contents of the pack and additional information

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

This medicationcontains 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 callednucleoside reverse transcriptase inhibitors (NRTIs).

This medicationdoes 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 withthis medicationin the same way. Your doctor will monitor the effectiveness of your treatment.

Do not take this medication:

• if you areallergic(hypersensitive)to abacavir(or to any other medication that contains abacavir — e.g.Trizivir, TriumeqorZiagen), lamivudine or to any of the other components of this medication (listed in section 6).

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

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

Be especially careful with this medication

Warnings and precautions

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

Some people taking this medication or other combined treatments for HIV have a higher risk of severe 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 medication without consulting your doctor, as it may worsen)
• if you have significant overweight (especially if you are a woman)
• if you have any kidney problems.

Consult your doctor before starting to take this medication 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.

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 on hypersensitivity reactions in section 4 of this leaflet.

You cannot rule out that abacavir may increase 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 medication unless your doctor advises you to.

Be aware of important symptoms

Some people taking HIV medications develop other disorders, which can be severe. You need to know what signs and symptoms to look out for while taking this medication.

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

Other medications and Abacavir/Lamivudina Macleods

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

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

The following medications should not be used with Abacavir/Lamivudina Macleods:

• emtricitabine, to treat HIV infection
• other medications containing lamivudine, used to treat HIV infection or hepatitis B
• high doses of trimethoprim/sulfamethoxazole), an antibiotic
• cladribine, used to treat hairy cell leukemia.

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

Some medications interact with this medication, including:

• phenytoin, to treat epilepsy.Inform your doctorif you are taking phenytoin. Your doctor may need to monitor you while you are takingthis medication.
• methadone, used as a heroin substitute.Abacavir increases the rate at which methadone is eliminated from the body. If you are taking methadone, you will need to be monitored for symptoms of withdrawal. You may need your methadone dose to be adjusted.Inform your doctorif you are taking methadone.
• medications (usually liquids) containingsorbitol and other polyols(such as xylitol, mannitol, 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 carry 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 medication is not recommended for use during pregnancy.This medicationand similar medications may cause adverse effects in babies during pregnancy.

If you have been takingthis medicationduring your pregnancy, your doctor may request that you have periodic blood tests and other diagnostic tests to monitor the development of your baby. In children whose mothers took INTIs during pregnancy, the benefit of HIV protection was greater than the risk of adverse effects.

Breastfeeding

This medication is not recommended for women with HIV to breastfeedbecause the HIV infection can pass to the baby through breast milk. A small amount of the components ofthis medicationmay also pass into breast milk.

If you are breastfeeding or plan to breastfeed,you should consult your doctor as soon as possible.

Driving and operating machines

This medication may cause side effects that can affect your ability to drive or operate machines.

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

Important information about some of the components ofthis medication

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

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 this medication 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 medicationcan be taken with or without food.

Maintain regular contact with your doctor.This medicationhelps control your condition. You will need to take it every day to prevent your condition 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 Macleodsthan you should

If you accidentally take moreAbacavir/Lamivudina Macleodsthan you should, inform your doctor or pharmacist, or contact the nearest hospital 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 this medication

If you forgot 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 this medication regularly, as irregular intake may increase the risk of experiencing a hypersensitivity reaction.

If you interrupt treatment with Abacavir/Lamivudina Macleods

If for any reason, you have stopped takingthis 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 not to take this medication or any other containingabacavir (e.g.Trizivir, Triumeq, or Ziagen)again. It is essential that you follow this warning.
• If your doctor advises you to resume treatment withthis medication, 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 health recovery 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 may produce side effects, although not all people will experience them.

When you are on HIV treatment, it may be difficult to distinguish whether a symptom is a side effect of this medication or of other medications you are taking, or is due to an effect of the disease caused by HIV.Therefore, it is very important that you inform your doctor about any changes 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 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 this medication,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:

May affectup to1 in 10people:

• hypersensitivity reaction
• headache
• vomiting
• discomfort(nausea)
• diarrhea
• abdominal pain (stomach)
• 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:

May affectup to1 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 enzymes produced by the liver
• a decrease in the number of cells involved in blood clotting (thrombocytopenia).

Rare side effects:

May affectup to1 in 1,000people:

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

Rare side effects that may appear in blood tests are:

• increased levels of an enzyme calledamylase.

Very rare side effects:

May affect up to 1 in 10,000 people:

• numbness, tingling sensation in the skin (pinpricks)
• sensation of weakness in the limbs
• skin rash, which may form blisters that appear as small dots (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 severe or if you notice any side effect not mentioned in this prospectus.

Other possible side effects of combined HIV treatment

Combined treatments, like this medication, may 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 may cause symptoms of infection or inflammation. The symptoms usually includefever, as well as some of the following:

• headache
• abdominal pain (stomach)
• 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 body trunk.

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 develop 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 prospectus. 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 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 at a temperature above 30°C.

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

Composition Abacavir/Lamivudina Macleods

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

- The other components are:

Microcrystalline cellulose

Sodium glycolate starch Type A (Potato starch)

Povidone

Isopropyl alcohol

Colloidal silicon dioxide

Low-substitution hydroxypropyl cellulose

Magnesium stearate

- The tablets are coated with

Hypromellose 3cPs (E464)

Polyethylene glycol 400 (E1521)

Polysorbate 80(E433)

Titanium dioxide (E171)

Appearance of the product and content of the container

Film-coated tablets of white to off-white color, capsule-shaped, biconvex, engraved on one face with “300” and “600” on the other.

Blister pack: The blister pack consists ofaluminum foil and cold-formed laminated material

Container size: 30 tablets. Blister pack unit dose of 30 tablets.

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

Container size: 30 tablets

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona, Spain

Responsible manufacturer

Synoptis Industrial SP.Z.O.O.

ul. Rabowicka 15

62020 Swarzedz

Poland

Last review date of this leaflet: November 2024

The detailed information of this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS) (http://www.aemps.gob.es/)