ABACAVIR/LAMIVUDINE Dr. Reddy's 600 mg/300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Abacavir/LamivudineDr. Reddys600 mg/300 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

IMPORTANT — Hypersensitivity Reactions

Abacavir/LamivudineDr. Reddyscontains abacavir(which is also an active substance in related medicines). Some people who take abacavir may develop a hypersensitivity reaction(a severe allergic reaction), which can be life-threatening if they continue to take medicines containing abacavir.

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

The packaging of Abacavir/Lamivudine Dr. Reddys includes a Warning Cardto remind you and your medical staff of the hypersensitivity to abacavir. You must take out this card and always carry it with you.

Contents of the pack

1. What Abacavir/Lamivudine Dr. Reddys is and what it is used for
2. What you need to know before you take Abacavir/Lamivudine Dr. Reddys
3. How to take Abacavir/Lamivudine Dr. Reddys
4. Possible side effects
5. Storing Abacavir/Lamivudine Dr. Reddys
6. Contents of the pack and further information

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

Abacavir/LamivudineDr. Reddysis used to treat HIV infection in adults, adolescents, and children who weigh at least 25 kg.

Abacavir/Lamivudine Dr. Reddys contains two active substances used to treat HIV infection: abacavir and lamivudine. Both belong to a group of antiretroviral medicines called nucleoside analogue reverse transcriptase inhibitors(NRTIs).

Abacavir/Lamivudine 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 your body fight infection.

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

2. What you need to know before you take Abacavir/Lamivudine Dr. Reddys

Do not take Abacavir/LamivudineDr. Reddys

• if you are allergic(hypersensitive)to abacavir (or to any other medicine that contains abacavir, e.g. Trizivir, Triumeq, or Ziagen), lamivudine, or to any of the other ingredients of this medicine (listed in section 6).

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

Consult your doctorif you think you have any of these conditions. Do not take Abacavir/Lamivudine Dr. Reddys

Be especially careful with Abacavir/LamivudineDr. Reddys

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

Consult your doctor before taking Abacavir/LamivudineDr. Reddysif you have any of these conditions.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 may develop a hypersensitivity reaction(a severe allergic reaction).

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

Risk of cardiovascular effects

It cannot be excluded that abacavir increases the risk of cardiovascular effects.

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 or 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 important signs and symptoms to look out for while taking Abacavir/Lamivudine.

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

Using Abacavir/LamivudineDr. Reddyswith other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,including herbal medicines and those bought without a prescription.

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

The following medicines must not be used with Abacavir/LamivudineDr. Reddys:

• Emtricitabine, to treat HIV infection
• other medicines that contain lamivudine, used to treat HIV infectionor hepatitis B
• high doses of co-trimoxazole(a combination of trimethoprim and sulfamethoxazole), an antibiotic
• cladribine, used to treat hairy cell leukemia.

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

Some medicines interact with Abacavir/LamivudineDr. Reddys

These include:

• phenytoin, to treat epilepsy.

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

• methadone, used as a heroin substitute. 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 your methadone dose to be changed.

Tell your doctorif you are taking methadone.

• medicines (usually liquids) that contain sorbitol and other polyols (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, for the treatment of high blood pressure in the blood vessels (the 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, breastfeeding, and fertility

Pregnancy

Abacavir/LamivudineDr. Reddysis not recommended during pregnancy. Abacavir/Lamivudine and similar medicines may cause side effects in babies during pregnancy.

If you have taken Abacavir/Lamivudine Dr. Reddysduring 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.

Breastfeeding

Breastfeeding is not recommended in women with HIV because HIV infection can be passed to the baby through breast milk. A small amount of the components of Abacavir/Lamivudine may also pass into breast milk.

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

Driving and using machines

Abacavir/Lamivudine 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

Abacavir/LamivudineDr. Reddyscontainsorange yellow S (E110)

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

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

3. How to take Abacavir/Lamivudine Dr. Reddys

Follow exactly the instructions of your doctor for taking this medicine. If you are not sure, ask your doctor or pharmacist again.

The recommended dose of this medicine for adults, adolescents, and children who weigh 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.

Stay in regular contact with your doctor.

Abacavir/Lamivudine helps control your condition. You need to take it every day to avoid your disease getting worse. You may still develop other infections and illnesses associated with HIV infection.

Stay in contact with your doctor and do not stop taking Abacavir/Lamivudinewithout talking to your doctor first.

If you take more Abacavir/LamivudineDr. Reddysthan you should

If you accidentally take more Abacavir/Lamivudine Dr. Reddys 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, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Abacavir/LamivudineDr. Reddys

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 Abacavir/Lamivudine regularly, as irregular intake of Abacavir/Lamivudine can increase the risk of a hypersensitivity reaction.

If you stop taking Abacavir/LamivudineDr. Reddys

If for any reason you have stopped taking Abacavir/Lamivudine, 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 they may be related, they will advise you to never take Abacavir/Lamivudine or any other medicine that contains abacavir again. It is important that you follow this advice.

If your doctor advises you to restart treatment with Abacavir/Lamivudine, 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

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

When you are being treated for HIV, it can be difficult to distinguish whether a symptom is an adverse effect of this medicine or of other medicines you are taking, or if it is due to an effect of the disease caused by HIV. 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 serious reaction.

In addition to the adverse effects listed below for this medicine, other disorders can develop during combined treatment for HIV.

It is important 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 feeling of 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)
• pancreas inflammation (pancreatitis)
• muscle tissue rupture.

Rare adverse effects that may appear in blood tests are:

• increase in an enzyme called amylase.

Very Rare Adverse Effects

May affect up to 1 in 10,000people:

• numbness, tingling sensation in the skin (pins and needles)
• weakness in the limbs
• skin rash that can form blisters resembling small targets (central dark 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 pharmacistif you consider that any of the adverse effects you are experiencing are serious or if you notice any adverse effect not mentioned in this prospectus.

Other Possible Adverse Effects of Combined HIV Treatment

Combined treatments, such as Abacavir/Lamivudine, can cause other disorders to develop during HIV treatment.

Infection and Inflammation Symptoms

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 starts fighting 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 medicines for HIV treatment. The symptoms may include:

• palpitations (rapid or irregular heartbeats) or tremors
• hyperactivity (excessive restlessness and movement)
• weakness starting in the hands and feet and moving up to the torso.

If you observe any symptom of infectionand inflammation or if you notice any of the above symptoms:

Inform your doctor immediately. Do not take any other medicine 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 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 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 Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Abacavir/Lamivudine Dr. Reddys

Keep this medicine out of sight and reach of children.

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

This medicine does not require special storage conditions.

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

6. Package Contents and Additional Information

Composition of Abacavir/LamivudineDr. Reddys

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

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

Appearance of Abacavir/LamivudineDr. Reddysand Package Contents

The tablets are orange, film-coated, and have a modified capsule shape. 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 package sizes may be marketed.

Marketing Authorization Holder

Reddy Pharma Iberia, S.A.

Avda Josep Tarradellas, nº 38

08029 Barcelona

Spain

Phone: 93 355 49 16

Fax: 93 355 49 61

Manufacturer

Remedica Limited

Aharnon Street, Limassol Industrial Estate

Limassol, 3056 Cyprus

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

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

Date of the last revision of this prospectus:January 2024

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