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

Patient Information Leaflet

Introduction

Patient Information Leaflet

Abacavir/Lamivudine Teva 600 mg/300 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 others, 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/Lamivudine Teva contains abacavir. Some people taking abacavir may develop a hypersensitivity reaction (a serious allergic reaction), which may 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/Lamivudine Teva includes an Information Card to remind you and healthcare professionals about abacavir hypersensitivity. You must remove this card and carry it with you at all times.

Leaflet Contents

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

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

Abacavir/Lamivudina Teva is used to treat 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 class of antiretroviral medicines called nucleoside reverse transcriptase inhibitors (NRTIs).

Abacavir/Lamivudina 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 in the same way. Your doctor will monitor the effectiveness of your treatment.

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

Do not take Abacavir/Lamivudina

• if you are allergic to abacavir (or to any other medicine containing abacavir), 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 you have any of these conditions. Do not take Abacavir/Lamivudina.

Warnings and precautions

Some people who take Abacavir/Lamivudina or other combination treatments for HIV are at higher risk of serious side 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 without medical advice, as your condition may worsen)
• if you are significantly overweight (especially if you are a woman)
• if you have any kidney problems.

Consult your doctor before starting Abacavir/Lamivudina 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 may develop a hypersensitivity reaction (a severe allergic reaction).

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

Cardiovascular risks

An association between abacavir treatment and an increased risk of cardiovascular events cannot be ruled out.

Inform your doctor if you have cardiovascular problems, smoke, or have conditions that may increase your risk of cardiovascular disease, such as high blood pressure and diabetes. Do not stop taking this medicine unless advised by your doctor.

Be alert to important symptoms

Some people taking 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.

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

Other medicines and Abacavir/Lamivudina Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including herbal products and those obtained without a prescription.

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

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

• 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

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.

• 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. Your methadone dose may need to be adjusted.

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 taking any of these medicines.

• 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 riociguat blood levels.

Pregnancy

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

If you have taken Abacavir/Lamivudina Teva during pregnancy, your doctor should arrange regular blood tests and other diagnostic tests to monitor your baby'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.

Breastfeeding

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

If you are breastfeeding, or have questions about breastfeeding, you should discuss this with your doctor as soon as possible.

Driving and using machines

Abacavir/Lamivudina may cause side effects that could affect your ability to drive or operate machinery. Consult your doctor about your ability to drive or operate machines while taking this medicine.

Abacavir/Lamivudina Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Abacavir/Lamivudina Teva

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Abacavir/Lamivudina for adults, adolescents, and children weighing at least 25 kg or more is one tablet once daily.

Swallow the tablets whole with some water. Abacavir/Lamivudina may be taken with or without food.

Keep regular contact with your doctor

Abacavir/Lamivudina 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/Lamivudina without first talking to your doctor.

If you take more Abacavir/Lamivudina than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Abacavir/Lamivudina

If you forget to take a dose, take it as soon as you remember, and then continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

It is important to take Abacavir/Lamivudina regularly, as irregular intake of this medicine may increase the risk of experiencing a hypersensitivity reaction.

If you have stopped treatment with Abacavir/Lamivudina

If, for any reason, you have stopped taking Abacavir/Lamivudina — especially because you think you are experiencing side 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/Lamivudina or any other medicine containing abacavir again. It is important that you follow this warning.

If your doctor advises restarting treatment with Abacavir/Lamivudina, 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 the recovery of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medications 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 differentiate whether a symptom is an adverse effect of Abacavir/Lamivudina or of other medications you are taking, or is due to the HIV disease itself. Therefore, it is very important that you inform your doctor about any change in your health.

Even patients who do not carry the HLA-B*5701 gene may develop a hypersensitivity reaction (a severe 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 Abacavir/Lamivudina, other disorders may develop during combination antiretroviral therapy.

It is important that you read the information under the section “Other possible adverse effects of combination antiretroviral therapy for HIV”.

Hypersensitivity reactions

This medicine contains abacavir. Abacavir may cause a serious allergic reaction known as a hypersensitivity reaction. These hypersensitivity reactions have been observed more frequently in people taking medications containing abacavir.

Who experiences these reactions?

Any person taking Abacavir/Lamivudina could develop a hypersensitivity reaction to abacavir, which could be life-threatening if you continue taking this medicine.

Your likelihood of developing this reaction is higher if you carry a gene called HLA-B*5701 (but you may still experience this reaction even if you do not carry this gene). Before starting treatment with Abacavir/Lamivudina, you should have been tested for this gene. If you know you carry this gene, tell your doctor before taking this medicine.

Approximately 3 to 4 out of every 100 patients treated with abacavir in a clinical trial who did not carry the HLA-B*5701 gene developed a hypersensitivity reaction.

What are the symptoms?

The most common symptoms are:

fever (high temperature) and rash.

Other commonly observed signs are:

nausea (feeling unwell), vomiting, diarrhea, abdominal pain (stomach), and excessive fatigue.

Other possible symptoms may include:

Joint or muscle pain, neck swelling, difficulty breathing, sore throat, cough, occasional headache, eye inflammation (conjunctivitis), mouth ulcers, low blood pressure, and tingling or numbness in the hands or feet.

When do these reactions occur?

Hypersensitivity reactions can occur at any time during treatment with Abacavir/Lamivudina, but are most likely to occur within the first 6 weeks of treatment.

Contact your doctor immediately:

1if you develop a rash OR

2if you have symptoms from at least 2 of the following groups:

• fever
• difficulty breathing, sore throat, or cough
• nausea or vomiting, diarrhea, or abdominal pain
• excessive fatigue or general aches and discomfort.

Your doctor may advise you to stop taking Abacavir/Lamivudina.

If you have stopped taking Abacavir/Lamivudina

If you have stopped taking this medicine due to a hypersensitivity reaction, NEVER restart Abacavir/Lamivudina or any other medicine containing abacavir. If you do, within hours you may experience a drop in blood pressure that could be life-threatening or fatal.

If for any reason you have interrupted treatment with Abacavir/Lamivudina — especially because you think you are experiencing adverse effects or due to another illness:

Consult your doctor before restarting treatment. Your doctor will assess whether your symptoms were related to a hypersensitivity reaction. If your doctor considers there may have been a link**, they will instruct you never to take Abacavir/Lamivudina or any other medicine containing abacavir again**. It is important that you follow this warning.

Occasionally, hypersensitivity reactions have occurred in people who restart abacavir after having experienced only one symptom listed on the Warning Card before stopping the medicine.

Very rarely, such reactions have occurred in people restarting abacavir treatment who had no prior symptoms of hypersensitivity before stopping.

If your doctor advises restarting treatment with Abacavir/Lamivudina, they may ask you to take the first doses in a place where you have easy access to medical care if needed.

If you are hypersensitive to Abacavir/Lamivudina, you must return all unused tablets of this medicine so they can be safely disposed of. Consult your doctor or pharmacist.

The Abacavir/Lamivudina Teva packaging includes a Warning Card to remind you and healthcare professionals about hypersensitivity reactions. Separate the card from the packaging and always carry it with you.

Frequent adverse effects

May affect up to 1 in 10 people:

• hypersensitivity reaction
• headache
• vomiting
• 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 nose or excessive nasal discharge
• rash
• hair loss.

Uncommon adverse effects

May affect up to 1 in 100 people and may be detected in blood tests:

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

Rare adverse effects

May affect up to 1 in 1,000 people:

• swelling of the face, lips, tongue, or throat, difficulty breathing and/or swallowing, blisters (angioedema)
• liver problems, such as jaundice, enlarged liver, fatty liver, inflammation (hepatitis)
• inflammation of the pancreas (pancreatitis)
• muscle tissue breakdown.

Rare adverse effects that may appear in blood tests include:

• increase in an enzyme called amylase.

Very rare adverse effects

May affect up to 1 in 10,000 people:

• numbness, skin tingling (pins and needles)
• feeling of weakness in the limbs
• skin rash, which may blister and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• widespread blistering rash with skin peeling, 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)
• 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 pharmacist if you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet.

Other possible adverse effects of combination antiretroviral therapy for HIV

Combination therapies, such as Abacavir/Lamivudina Teva, 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). These infections may have been "latent" and undetected by the weakened immune system before treatment began. 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. Symptoms may include:

• palpitations (rapid or irregular heartbeat) or tremors
• hyperactivity (excessive restlessness and movement)
• weakness starting in the hands and feet and moving upward toward the body trunk.

If you notice any symptoms of infection and inflammation or 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 antiretroviral therapy develop a bone disease called osteonecrosis. In this disease, part of the bone tissue dies due to reduced blood supply to the bone. People are more likely to develop this condition:

• if they have been on combination therapy for a long time
• if they also take anti-inflammatory drugs called corticosteroids
• if they drink alcohol
• if their immune system is severely weakened
• if they 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 effects

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

5. Storage of Abacavir/Lamivudina Teva

Keep this medicine out of sight and reach of children.

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

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Abacavir/Lamivudina Teva

• The active substances are abacavir and lamivudine.

Each film-coated tablet contains 600 mg of abacavir and 300 mg of lamivudine.

• The other components are:
  • Tablet core: microcrystalline cellulose, hydroxypropylcellulose (E-463), sodium starch glycolate (type A) from potato, magnesium stearate
  • Tablet coating: hypromellose, polyethylene glycol 4000, titanium dioxide (E171), polysorbate 80, yellow iron oxide (E172), red iron oxide (E172)

What Abacavir/Lamivudina Teva looks like and contents of the pack

Abacavir/Lamivudina Teva 600 / 300 mg film-coated tablets are orange, oblong, biconvex film-coated tablets, engraved with "600" on one side and "300" on the other, with approximate dimensions of ~20.5 mm x 9 mm.

Abacavir/Lamivudina Teva is available in packs of 10, 30 and 90 film-coated tablets in blister packs, or in unit-dose blisters of 10x1, 30x1 and 90x1.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B 1st floor

28108 Alcobendas (Madrid)

Spain

Manufacturer responsible

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25, Zagreb

10000

Croatia

or

Merckle GmbH

Graf-Arco-Str. 3, Ulm

89079 Germany

Date of the most recent revision of this leaflet: March 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/