Abacavir/lamivudine Glenmark 600 mg/300 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Abacavir/Lamivudina Glenmark 600 mg/300 mg film-coated tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

IMPORTANT — Hypersensitivity reactions

Abacavir/Lamivudina Glenmark contains abacavir (which is also the active substance in medicines such as Trizivir, Triumeq, and Ziagen). Some people taking abacavir may develop a hypersensitivity reaction (a serious allergic reaction), which could be life-threatening if treatment with abacavir-containing medicines is continued.

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

The packaging of Abacavir/Lamivudina Glenmark includes an Information Card to remind you and healthcare professionals about abacavir hypersensitivity. You must remove this card and always carry it with you.

Leaflet contents

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

Pack contents and additional information

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

Abacavir/lamivudina is used in the treatment of human immunodeficiency virus (HIV) infection in adults, adolescents, and children weighing at least 25 kg.

Abacavir/lamivudina contains two active substances used to treat HIV infection: abacavir and lamivudina. Both belong to a group of antiretroviral medicines known as nucleoside reverse transcriptase inhibitors (NRTIs).

Abacavir/lamivudina does not completely cure HIV infection; it reduces the amount of virus in the body and maintains 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 play an important role in helping the body fight infection.

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

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

Do not take Abacavir/Lamivudina Glenmark

• if you are allergic (hypersensitive) to abacavir (or to any other medicine containing abacavir (e.g. Trizivir, Triumeq or Ziagen), lamivudine, or to any of the other ingredients of this medicine (listed in section 6).** Read carefully all the information about hypersensitivity reactions in section 4 of this leaflet.
• Consult your doctor if you think any of these situations apply to you. Do not take Abacavir/Lamivudina Glenmark

Take special care with Abacavir/Lamivudina Glenmark

Some people who take Abacavir/Lamivudina or other combination treatments for HIV are at higher risk of experiencing serious adverse effects. You should be aware that the risk is greater:

• 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 consulting your doctor, as your condition may worsen)
• if you are significantly overweight (especially if you are female)
• if you have any kidney problems.

Consult your doctor before starting Abacavir/Lamivudina Glenmark if 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 carry the HLA-B*5701 gene can develop a hypersensitivity reaction (a severe allergic reaction).

Read carefully the information about 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 doctor if you have cardiovascular problems, smoke, or suffer from conditions that may increase your risk of cardiovascular disease, such as high blood pressure and diabetes. Do not stop taking this medicine unless your doctor advises you to do so.

Be alert to important symptoms

Some people who take medicines for HIV infection develop other disorders, which may be serious. You need to know which important signs and symptoms to watch for while taking Abacavir/Lamivudina Glenmark.

Read the information on “Other possible adverse effects of combination treatment for HIV” 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 medicine, including herbal medicines and those obtained without a prescription.

Remember to inform your doctor or pharmacist if you start taking a new medicine while taking Abacavir/Lamivudina Glenmark.

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

• Emtricitabine, used to treat HIV infection
• Other medicines 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 doctor if you are being treated with any of these medicines.

Some medicines interact with Abacavir/Lamivudina Glenmark

These include:

• Phenytoin, used to treat epilepsy. Inform your doctor if 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 eliminated from the body. If you are taking methadone, you should be monitored for symptoms of withdrawal. You may need an adjustment of your methadone dose. Inform your doctor if you are taking methadone.
• Medicines (usually liquids) containing sorbitol and other polyols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly.

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

• Riociguat, used to treat high blood pressure in the blood vessels (pulmonary arteries) carrying blood from the heart to the lungs. Your doctor may need to reduce your dose of riociguat, as abacavir may increase blood levels of riociguat.

Pregnancy

The use of Abacavir/Lamivudina Glenmark during pregnancy is not recommended. Abacavir/Lamivudina and similar medicines may cause adverse effects in fetuses during pregnancy.

If you have taken Abacavir/lamivudina during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV was greater than the risk of adverse effects occurring.

Breast-feeding

Breast-feeding 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/Lamivudina Glenmark may also pass into breast milk.

If you are breast-feeding, or have any doubts about breast-feeding, contact your doctor as soon as possible.

Driving and use of machines

Abacavir/Lamivudina Glenmark may cause adverse effects that could affect your ability to drive or operate machinery. Consult your doctor regarding your ability to drive or operate machinery while taking this medicine.

Important information about some of the ingredients of Abacavir/Lamivudina Glenmark.

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

3. How to take Abacavir/Lamivudina Glenmark

Follow exactly the instructions for use of this medicine given by your doctor.

If in 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 daily.

Swallow the tablets whole with a little water. Abacavir/lamivudine can be taken with or without food.

Keep in 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 still develop other infections and illnesses associated with HIV infection.

Stay in contact with your doctor and do not stop taking abacavir/lamivudine without first speaking to your doctor.

If you take more Abacavir/Lamivudina Glenmark than you should

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

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 regular treatment schedule.

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 may increase the risk of experiencing 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 are experiencing adverse effects or due to another illness:

Consult your doctor before restarting treatment. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If your doctor considers that there may have been a connection, you will be instructed never to take abacavir/lamivudine or any other medicine containing abacavir again (e.g. Trizivir, Triumeq or Ziagen). It is important that you follow this warning.

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

During HIV treatment, there may be an increase in weight and in blood glucose and lipid levels. This may be partly related to improved health, lifestyle, and, in the case of blood lipids, sometimes to HIV medicines themselves. Your doctor will monitor these changes.

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

When undergoing HIV treatment, it may be difficult to determine whether a symptom is an adverse effect of Abacavir/Lamivudina Glenmark, of other medicines you are taking, or due to the HIV disease itself. Therefore, it is very important that you inform your doctor of any changes in your health.

Even patients who do not carry the HLA-B*5701 gene may develop a hypersensitivity reaction (a serious allergic reaction), described in this leaflet in the box titled "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 may occur during combination HIV treatment.

It is important that you read the information under the section "Other possible adverse effects of combination HIV treatment".

Common side effects

May affect up to 1 in 10 patients:

• hypersensitivity reaction
• headache
• vomiting
• malaise (nausea)
• diarrhea
• stomach pain
• loss of appetite
• fatigue, lack of energy
• fever (high temperature)
• general feeling of being unwell
• difficulty falling asleep (insomnia)
• muscle pains and discomfort
• joint pain
• cough
• irritated nose or excessive nasal discharge
• skin rash
• hair loss

Uncommon side effects

May affect up to 1 in 100 patients and may be reflected in blood tests:

• low red blood cell count (anemia) or low white blood cell count (neutropenia)
• increased levels of liver-produced enzymes
• decrease in the number of cells involved in blood clotting (thrombocytopenia)

Rare side effects

May affect up to 1 in 1,000 patients:

• liver problems, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis)
• inflammation of the pancreas (pancreatitis)
• breakdown of muscle tissue

Rare side effects that may appear in blood tests include:

• increase in an enzyme called amylase

Very rare side effects

May affect up to 1 in 10,000 patients:

• numbness, tingling sensation in the skin (pins and needles)
• feeling of weakness in the limbs
• skin rash that may form blisters resembling small targets (dark center surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens–Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)

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 pharmacist if you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet.

Other possible side effects of combination HIV treatment

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

Symptoms of infection and inflammation

Exacerbation of previous 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 was started. After starting treatment, the immune system becomes stronger and begins to fight these infections, which may cause symptoms of infection or inflammation. 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 may also attack healthy tissues (autoimmune disorders). Symptoms of autoimmune disorders may appear many months after starting HIV treatment medications. Symptoms may include:

• palpitations (fast or irregular heartbeat) or tremor
• hyperactivity (excessive restlessness and movement)
• weakness starting in the hands and feet and moving upward toward the trunk of the body

If you notice any symptoms of infection and inflammation, or if you experience any of the symptoms listed above:

Inform your doctor immediately. Do not take any other medication for infection without your doctor’s advice.

You may have problems with your bones

Some patients receiving combination HIV treatment develop a bone disease called osteonecrosis. In this condition, part of the bone tissue dies due to reduced blood supply to the bone. The likelihood of developing this disease is higher in people who:

• have been receiving combination treatment for a long time
• are also taking anti-inflammatory medicines called corticosteroids
• drink alcohol
• have a severely weakened immune system
• are overweight

Signs of osteonecrosis include:

• joint stiffness
• pain and discomfort (especially in the hip, knee, or shoulder)
• difficulty moving

If you notice any of these symptoms:

Inform your doctor.

Reporting of adverse reactions

If you experience any adverse reactions, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Abacavir/Lamivudina Glenmark

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store below 25 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point of your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Abacavir/Lamivudina Glenmark

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

Appearance of the product and contents of the container

Abacavir/Lamivudina Glenmark film-coated tablets are modified capsule-shaped, biconvex, orange film-coated tablets. The tablets measure 20.6 mm x 9.1 mm, with "300" engraved on one side and "600" on the other.

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

The 30-tablet bottles contain an activated carbon sachet and an oxygen absorber to control moisture within the bottle.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Responsible

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany

Manufacturer Responsible:

Glenmark Pharmaceuticals s.r.o.
Fibíchova 143
566 17 Vysoké Mýto
Czech Republic

Pharmadox Healthcare Ltd
KW20A Kordin Industrial Estate
Paola
PLA 3000
Malta

Further information on this medicine can be requested from the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
28045 Madrid
Spain

This medicine is authorized in the EEA member states under the following names:

Date of the most recent review of this leaflet: April 2023.

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