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

Introduction

Package Leaflet: Information for the User

Abacavir/Lamivudine Glenmark 600 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/Lamivudine Glenmark contains abacavir(which is also an active substance in medicines such as Trizivir,Triumeqand Ziagen). 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 about “Hypersensitivity reactions” in section 4 of this leaflet carefully.

The packaging of Abacavir/Lamivudina Glenmark includes an Information Cardto remind you and your healthcare provider of abacavir hypersensitivity. You must take out this card and always carry it with you.

Contents of the pack and other information

1. What is Abacavir/Lamivudina Glenmark and what is it used for
2. What you need to know before you take Abacavir/Lamivudina Glenmark
3. How to take Abacavir/Lamivudina Glenmark
4. Possible side effects
5. Storing Abacavir/Lamivudina Glenmark

Contents of the pack and other information

1. What is Abacavir/Lamivudina Glenmark and what is it used for

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

Abacavir/lamivudine 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 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 helps your body fight infection.

Not everyone responds to treatment with abacavir/lamivudine in the same way. Your doctor will monitor the effectiveness of your treatment.

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

Do not take Abacavir/Lamivudina Glenmark

• 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 ingredients of this medicine (listed in section 6). Read the information about hypersensitivity reactions in section 4 of this leaflet carefully.
• Consult your doctorif you think any of these apply to you. Do not take Abacavir/Lamivudina Glenmark

Be especially careful with Abacavir/Lamivudina Glenmark

Some people who take Abacavir/Lamivudina 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/Lamivudina Glenmark 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 taking Abacavir/Lamivudina Glenmark if you have any of these conditions.You may need to have additional tests, including blood tests, while taking this medicine. See section 4 for more information.

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 about hypersensitivity reactions in section 4 of this leaflet carefully.

Risk of cardiovascular events

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 conditions, which can be serious. You need to know what important signs and symptoms to look out for while taking Abacavir/Lamivudina Glenmark.

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

Other medicines and Abacavir/Lamivudina Glenmark

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 Abacavir/Lamivudina Glenmark.

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

• 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 doctorif you are being treated with any of these medicines.

Some medicines interact with Abacavir/Lamivudina Glenmark

These include:

• Phenytoin, to treat epilepsy. Tell your doctorif you are taking phenytoin. Your doctor may need to monitor you while you are taking Abacavir/Lamivudina Glenmark.
• Methadone, used as a heroin substitute. Abacavir increases the rate at which methadone is removed 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 doctorif 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 pharmacistif 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

Abacavir/Lamivudina Glenmark is not recommended during pregnancy.Abacavir/Lamivudina and similar medicines may cause side effects in the fetus during pregnancy.

If you have been taking Abacavir/lamivudine 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 recommended that HIV-infected women do not breast-feed their babies because HIV infection can be passed to the baby through breast milk. A small amount of the components of Abacavir/Lamivudina Glenmark may also pass into breast milk.

If you are breast-feeding or think you may want to, consult your doctor as soon as possible.

Driving and using machines

Abacavir/Lamivudina Glenmark 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 of Abacavir/Lamivudina Glenmark.

This medicine contains a colorant called orange yellow (E110), which may cause allergic reactions in some people.

3. How to take Abacavir/Lamivudina Glenmark

Always take this medicine exactly as your doctor has told you.

If you are not sure, consult your doctor or pharmacist.

The recommended dose of abacavir/lamivudine 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. Abacavir/lamivudine can be taken with or without food.

Stay in regular contact with your doctor.

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

Stay in touch with your doctor and do not stop taking abacavir/lamivudinawithout discussing it with your doctor first.

If you take more Abacavir/Lamivudina Glenmark than you should

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

If you forget to take Abacavir/Lamivudina Glenmark

If you forget to take a dose, take it as soon as you remember and then continue with your normal treatment schedule.

Do not take a double dose to make up for a forgotten dose.

It is important to take abacavir/lamivudine regularly, as irregular intake of abacavir/lamivudine can increase the risk of a hypersensitivity reaction.

If you have stopped taking Abacavir/Lamivudina Glenmark

If, for any reason, you have stopped taking abacavir/lamivudine, especially because you think you have had side effects or because of another illness:

Consult your doctor before restarting treatment.Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If your doctor thinks that they were, you should never take abacavir/lamivudina or any other medicine that contains abacavir(e.g. Trizivir,Triumeqor Ziagen) 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 can easily get medical help if you need it.

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 health recovery 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 can cause adverse effects, although not all people will experience them.

When undergoing HIV treatment, it can be difficult to distinguish whether a symptom is an adverse effect of Abacavir/Lamivudina Glenmark or other medications being taken, or is due to an effect of the HIV disease itself. Therefore, it is very important that you inform your doctor aboutany change 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 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 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 10patients:

• 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 100patients 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 1,000patients:

• liver disorders, such as jaundice, liver enlargement or fatty liver, inflammation (hepatitis)
• pancreas inflammation (pancreatitis)
• muscle tissue rupture

The 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 10,000patients:

• numbness, tingling sensation in the skin (pinpricks)
• sensation of 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 on more than 30% of the body surface (toxic epidermal necrolysis).

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

Tell your doctor or pharmacistif you consider that any of the adverse effects you are experiencing is 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/Lamivudina, 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 begins to fight these infections, which can cause symptoms of infection or inflammation. The symptoms usually include fever, in addition to 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 to treat HIV infection. 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 infectionand inflammation or if you notice any of the above symptoms:

Tell 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. In 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:

Tell 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 not listed in this prospectus. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Abacavir/Lamivudina Glenmark

Keep this medication out of sight and reach of children.

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

Store below 25 °C.

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

6. Package contents and additional information

Composition of Abacavir/Lamivudina Glenmark

• The active ingredients of this medication are 600 mg of abacavir and 300 mg of lamivudine.
• The other components are: microcrystalline cellulose, crospovidone, povidone, yellow iron oxide (E172) and magnesium stearate in the tablet core. The tablet coating contains: hypromelose, titanium dioxide (E171), macrogol, polysorbate 80 and orange-yellow lake FCF (E110).

Appearance of the product and package contents

Abacavir/Lamivudina Glenmark film-coated tablets are film-coated tablets with a modified capsule shape, orange in color and biconvex. The tablet dimensions are 20.6 mm x 9.1 mm, with a “300” engraved on one face and a “600” on the other face.

This medication is available in packages containing 30, 60 or 90 tablets, in unit dose blisters in packages containing 30 x 1 or 90 x 1 film-coated tablets or in multiple packages containing 60 or 90 film-coated tablets.

The 30-tablet bottles contain an activated carbon and oxygen absorbent packet for humidity control in the bottle.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibíchova 143

566 17 Vysoké Mýto

Czech Republic

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Estate Paola

PLA 3000

Malta

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

This medication is authorized in EEA member states with the following names:

Date of the last revision of this prospectus:April 2023.

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