Label: Information for the User

Abacavir/LamivudineDr. Reddys600 mg/300 mg Film-Coated Tablets

Read this label carefully before starting to take the medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

IMPORTANT — Hypersensitivity Reactions

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

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

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

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

Abacavir/Lamivudina Dr. Reddys contains two active ingredients used for the treatment of the infection caused by HIV: abacavir and lamivudina. Both belong to a group of antiretroviral medications calledinhibitors of reverse transcriptase analogs of nucleosides(NRTIs).

Abacavir/Lamivudina Dr. Reddys 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 the body fight infection.

Not everyone responds to treatment with Abacavir/Lamivudina Dr. Reddys in the same way. Your doctor will monitor the effectiveness of your treatment.

Do not take Abacavir/LamivudinaDr. Reddys

• if you areallergic(hypersensitive)to abacavir (or to any other medicine that contains abacavir, e.g. Trizivir, Triumeq or Ziagen), 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 have any of these circumstances.Do not take Abacavir/Lamivudina Dr. Reddys

Be especially careful with Abacavir/LamivudinaDr. Reddys

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 it may worsen)
• if you havesignificant overweight(especially if you are a woman)
• if you have anykidney problems.

Consult your doctor before starting to take Abacavir/LamivudinaDr. Reddysif 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 effects

You cannot rule out that abacavir may increase the risk of cardiovascular effects.

Inform your doctorif you have cardiovascular problems, smoke or have diseases that may increase your risk of cardiovascular diseases such as high blood pressure or 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 serious. You need to know what signs and symptoms to look out for while taking Abacavir/Lamivudina.

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

Use of Abacavir/LamivudinaDr. Reddyswith other medicines

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 this medicine.

The following medicines should not be used with Abacavir/LamivudinaDr. Reddys:

• Emtricitabine, to treatHIV infection
• other medicines containing lamivudine, used to treatHIV infectionorhepatitis B
• high doses ofco-trimoxazole(a combination of trimethoprim and sulfamethoxazole), an antibiotic
• cladribine, used to treatcutaneous T-cell lymphoma.

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

Some medicines interact with Abacavir/LamivudinaDr. Reddys

These include:

• phenytoin, to treatepilepsy.

Inform your doctorif you are taking phenytoin. Your doctor may need to monitor you while you are taking this medicine.

• 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.

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

• Riociguat, to treatpulmonary arterial hypertension. Your doctor may need to reduce your dose of riociguat, as abacavir may increase your riociguat blood levels.

Pregnancy, breastfeeding and fertility

Pregnancy

Abacavir/Lamivudina Dr. Reddys is not recommended during pregnancy.Abacavir/Lamivudina and similar medicines may cause adverse effects in babies during pregnancy.

If you have been taking Abacavir/Lamivudina Dr. Reddysduring your pregnancy, your doctor may request that you have regular blood tests and other diagnostic tests to monitor the development of your baby. In babies whose mothers took HIV medicines during pregnancy, the benefit of HIV protection was greater than the risk of adverse effects.

Breastfeeding

Abacavir/Lamivudina is not recommended for breastfeeding mothers because HIV infection can be transmitted to the baby through breast milk.A small amount of the components of Abacavir/Lamivudina may pass into breast milk.

If you are breastfeeding, or have doubts about breastfeeding, you should consult your doctor as soon as possible.

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 this medicine

Abacavir/LamivudinaDr. Reddys containsamarillo anaranjado (E110)

This medicine may cause allergic reactions because it contains a colourant called amarillo anaranjado (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication 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 medication can be taken with or without food.

Maintain regular contact with your doctor.

Abacavir/Lamivudine 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 Abacavir/Lamivudinewithout first speaking with your doctor.

If you take more Abacavir/LamivudineDr. Reddysthan you should

If you accidentally take more Abacavir/Lamivudine Dr. Reddys 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/LamivudineDr. Reddys

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/LamivudineDr. Reddys

If for any reason, you have stopped taking Abacavir/Lamivudine, 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 Abacavir/Lamivudine or any other medication containing abacavir again.It is essential that you follow this warning.

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

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

When you are being treated for HIV, it may be difficult to distinguish whether a symptom is a side effect of this medicine or of other medicines 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 serious reaction.

In addition to the side effects listed below for this medicine, 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”.

Frequent side effects

May affectup to 1 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 and joint pain
• arthralgia (joint pain)
• cough
• irritated or runny nose
• skin rash
• hair loss.

Rare side effects

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)
• 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 to 1 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:

• increased levels of an enzyme calledamylase.

Very rare side effects

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 appear as small dianas (a central dark area 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).

Report side effects to 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 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). These infections may have been "latent" and not detected by the weakened immune system before treatment began. After starting treatment, the immune system becomes stronger, and it begins 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). Symptoms of autoimmune disorders can appear many months after starting treatment for 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 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 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 medicines 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 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 box. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Composition of Abacavir/LamivudinaDr. Reddys

The active ingredients of each film-coated tablet of this medication are 600 mg of abacavir and 300 mg of lamivudina.

The other components are microcrystalline cellulose (E460), sodium carboxymethyl starch (Type A) from potato, povidone K90 (E1201), magnesium stearate (E470b), hypromellose 5 (E464), macrogol 400 (E1521), titanium dioxide (E171), and yellow-orange S (E110).

Appearance of Abacavir/LamivudinaDr. Reddysand contents of the packaging

The tablets are orange in color, film-coated, and capsule-shaped. The dimensions of the tablets are 19.4 mm x 10.4 mm ± 5%.

They are presented in blisters containing 30 tablets and multi-blisters containing 90 (3x30) tablets.

Only some sizes of packaging may be commercially available.

Marketing Authorization Holder

Reddy Pharma Iberia, S.A.

Avda Josep Tarradellas, nº 38

08029 Barcelona

Spain

Telephone: 93 355 49 16

Fax: 93 355 49 61

Responsible for Manufacturing

Remedica Limited

Aharnon Street, Limassol Industrial Estate

Limassol, 3056 Cyprus

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

Spain:Abacavir/LamivudinaDr. Reddys600 mg/300mg film-coated tablets EFG

Date of the last review of this leaflet:January 2024

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