Prospect: Information for the User

Abacavir/Lamivudine Aurovitas 600 mg/300 mg Film-Coated Tablets

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

IMPORTANT — Hypersensitivity Reactions

Abacavir/Lamivudine Aurovitascontains abacavir(which is also the active ingredient in medicines such asTrizivir,TriumeqandZiagen). Some people taking abacavir may develop ahypersensitivity reaction(severe allergic reaction), which can be life-threatening if abacavir-containing medicines are continued.

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

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

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

2.What you need to know before starting to take Abacavir/Lamivudine Aurovitas

3.How to take Abacavir/Lamivudine Aurovitas

4.Possible adverse effects

5.Storage of Abacavir/Lamivudine Aurovitas

6.Contents of the pack and additional information

Abacavir/lamivudina is 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.

Abacavir/lamivudina 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 medicationsdenominated inhibitors of reverse transcriptase analogs of nucleosides(ITIANs).

Abacavir/Lamivudina 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 to 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 Aurovitas

•If you areallergicto abacavir (or to any other medicine that contains abacavir, e.g.Trizivir, Triumeq or Ziagen), to lamivudine or to any of the other components of this medicine (listed in section 6).

Read carefully the information on 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 Aurovitas.

Warnings and precautions

Consult your doctor orpharmacist before starting to take Abacavir/Lamivudina Aurovitas.

Some people taking abacavir/lamivudine or other combination treatments for HIV 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/lamivudine without consulting your doctor, as it may worsen).

•If you havesignificant obesity(especially if you are a woman).

•If you have anykidney problems.

Consult your doctor before starting to take abacavir/lamivudine if 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 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.

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 abacavir/lamivudine 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 look out for while taking abacavir/lamivudine.

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

Other medicines and Abacavir/Lamivudina Aurovitas

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

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

The following medicines should not be used withabacavir/lamivudine:

•emtricitabine, to treatHIV infection.

•other medicines that contain lamivudine, used to treatHIV infectionorhepatitis B.

•high doses ofco-trimoxazole(a combination of trimethoprim and sulfamethoxazole), an antibiotic.

•cladribine, used to treatleukaemia.

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

Some medicines interact with abacavir/lamivudine

These include:

•phenytoin, to treatepilepsy.

Inform your doctorif you are taking phenytoin. Your doctor may need to monitor you while you are takingabacavir/lamivudine.

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

Inform your doctorif you are taking methadone.

•medicines (usually liquids) that containsorbitol 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 treathigh 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 the levels of riociguat in the blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Abacavir/Lamivudina Aurovitas is not recommended for use during pregnancy.

Abacavir/lamivudineand similar medicines may cause adverse effects in babies during pregnancy. If you have been takingabacavir/lamivudineduring your pregnancy, your doctor may ask you to have regular blood tests and other diagnostic tests to monitor the development of your baby. In babies whose mothers took ITIANs during pregnancy, the benefit of HIV protection was greater than the risk of adverse effects.

Breastfeeding

Abacavir/Lamivudina Aurovitas is not recommendedfor women with HIV to breastfeed, as the infection can be transmitted to the baby through breast milk. A small amount of the components ofabacavir/lamivudinemay 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

Abacavir/lamivudine 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 abacavir/lamivudine.

Abacavir/Lamivudina Aurovitas contains yellow orange S

This medicine may cause allergic reactions because it contains yellow orange S (E110).

It may cause asthma, especially in patients allergic to aspirin.

Abacavir/Lamivudina Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; that is, it 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 abacavir/lamivudine 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. Abacavir/lamivudine can be taken with or without food.

Maintain regular contact with your doctor

Abacavir/lamivudine helps control your condition. You need to take it every day to avoid 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 abacavir/lamivudinewithout first speaking with your doctor.

If you take more Abacavir/Lamivudine Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Abacavir/Lamivudine Aurovitas

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/lamivudine regularly, as irregular intake of abacavir/lamivudine may increase the risk of experiencing a hypersensitivity reaction.

If you interrupt treatment with Abacavir/Lamivudine Aurovitas

If for any reason, you have stopped takingabacavir/lamivudine,especially because you think you have side effects or 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 takeabacavir/lamivudineor any other medication containing abacavir (e.g., Trizivir, Triumeq, or Ziagen)again. It is essential that you follow this warning.

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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 HIV medications themselves. Your doctor will monitor these changes.

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 changes 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 leaflet in the box called “Hypersensitivity reactions”.

It is very important that you read and understand the information about this serious 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

May affectup to 1 in 10people:

•hypersensitivity reaction.

•headache.

•vomiting.

•discomfort (nausea).

•diarrhea.

•abdominal pain.

•loss of appetite.

•fatigue, lack of energy.

•fever (high temperature).

•general feeling of discomfort.

•difficulty falling asleep (insomnia).

•muscle and joint pain.

•arthralgia.

•cough.

•irritated or runny nose.

•skin rash.

•hair loss.

May affectup to 1 in 100people and may be reflected in blood tests:

•low red blood cell count (anemia) or low white blood cell count (neutropenia).

•increase in liver enzymes.

•decrease in the number of cells involved in blood clotting (trombocytopenia).

May affectup to 1 in 1,000people:

•liver damage, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis).

•pancreatitis (inflammation of the pancreas).

•muscle rupture.

Rare side effects that may appear in blood tests are:

•increase in an enzyme called amylase.

May affectup to 1 in 10,000people:

•numbness, tingling sensation in the skin (pinpricks).

•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 experience 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, 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). These 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 treatment for HIV infection. The symptoms may include:

•palpitations (rapid or irregular heartbeat) or tremor.

•hyperactivity (excessive restlessness and movement).

•weakness that starts in the hands and feet and ascends to the trunk of the body.

If you observe 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 problems with your bones

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 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 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 Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label, in the box, and in the blister pack after CAD. The expiration date is the last day of the month indicated.

Blister pack:Store below 86°F (30°C).

HDPE Bottle:No special storage conditions are required.

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. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Abacavir/Lamivudina Aurovitas

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

-The other components are:

Core of the tablet:microcrystalline cellulose, sodium carboxymethyl starch (type A) (from potato), magnesium stearate.

Coating of the tablet:hypromellose 2910 (3cP), hypromellose 2910 (6cP), titanium dioxide (E171), polysorbate 80, macrogol 400, yellow-orange S (E110).

Appearance of the product and contents of the package

Film-coated tablets of orange color, with a modified capsule shape, with the mark “H” on one side and “27” on the other. The size is 20.7 mm × 9.2 mm.

Abacavir/Lamivudina Aurovitas film-coated tabletsare available in PVC/PVdC transparent-Aluminum blisters and HDPE white opaque bottles with polypropylene closures.

Package sizes:

Blister:30, 50, 60, and 90 film-coated tablets.

HDPE bottles:30 and 100 film-coated tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: December 2023

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