Introduction

Label: Information for the User

Abacavir/Lamivudina Teva 600mg/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 doubts, consult your doctor or pharmacist.
This medicine has been prescribed only for you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

IMPORTANT—Hypersensitivity Reactions

Abacavir / Lamivudina Teva contains abacavir. Some people who take abacavir may develop ahypersensitivity reaction(severe allergic reaction), which can be life-threatening if you continue taking medicines that contain abacavir.

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

The packaging of Abacavir / Lamivudina Teva includes aReminder Cardto remind you and healthcare professionals about your hypersensitivity to abacavir.You must remove this card and carry it with you at all times.

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

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

3. How to take Abacavir/Lamivudina Teva

4. Possible side effects

5. Storage of Abacavir/Lamivudina Teva

6. Contents of the pack and additional information

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

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

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

Abacavir/Lamivudina does not completely cure the 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 starting to take Abacavir/Lamivudina Teva

Do not take Abacavir/Lamivudina

if you areallergicto abacavir (or to any other medicine that contains abacavir), 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 these circumstances.Do not take Abacavir/Lamivudina.

Warnings and precautions

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 have moderate 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 could worsen)
if you have asignificant overweight(especially if you are a woman)
if you have anykidney problems.

Consult your doctor before starting to take Abacavir/Lamivudinaif you have any of these circumstances. You may need additional tests, including blood tests, while taking this medicine.For more information see section 4.

Abacavir hypersensitivity reactions

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.

CARDIOVASCULAR RISKS

You cannot rule out an association between abacavir treatment and an increased risk of cardiovascular events.

Inform your doctorif 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 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 HIV combination treatment” in section 4 of this leaflet.

Other medicines and Abacavir/Lamivudina Teva

Inform your doctor or pharmacist if you are taking, have recently taken or may need to take 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 Abacavir/Lamivudina.

The following medicines should not be used with Abacavir/Lamivudina:

emtricitabine, to treatHIV infection

other medicines that contain lamivudine, used to treatHIV infectionorhepatitis B
high doses oftrimetoprim/sulfamethoxazole, an antibiotic
cladribine, used to treatacute myeloid leukemia.

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

Some medicines interact with Abacavir/Lamivudina

These include:

phenytoin, to treatepilepsy.

Inform your doctorif you are taking phenytoin. Your doctor may need to monitor you while you are taking Abacavir/Lamivudina.

methadone, used as aheroin substitute. 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.

medicines (usually liquids) that containsorbitol and other polyols(such as xylitol, mannitol, lactitol or maltitol), if taken regularly.

Inform your doctor or pharmacist if you are taking some of these medicines.

riociguat, to treathigh blood pressure in the blood vessels(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 your blood levels of riociguat.

Pregnancy

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

If you have taken Abacavir/Lamivudina Teva during your pregnancy, your doctor should ask for regular blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took antiretrovirals during pregnancy, the benefit of HIV protection was greater than the risk of adverse effects.

Breastfeeding

Breastfeedingis not recommended in 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 doubts about breastfeeding, you should discuss itwith 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/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 administration instructions for this medication as indicated by your doctor.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 a day.

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

Maintain regular contact with your doctor

Abacavir/Lamivudina helps control your condition. You will need to take it every day to prevent your condition 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/Lamivudinawithout first speaking with 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 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 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 treatment. Do not take a double dose to compensate for the missed doses.

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

If you have interrupted treatment with Abacavir/Lamivudina

If for any reason, you have stopped taking Abacavir/Lamivudina — 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,they will instruct you never to take Abacavir/Lamivudina 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/Lamivudina, you can ask them to take the first doses in a place where you have easy access to medical assistance if necessary.

4. Possible Adverse Effects

During HIV treatment, there may be an increase in weight and levels of glucose and lipids in the blood. This may be partly related to 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 medications, this medication may produce side effects, although not everyone will experience them.

When you are on HIV treatment, it may be difficult to distinguish whether a symptom is a side effect of Abacavir/Lamivudine or of other medications 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 Abacavir/Lamivudine, 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”.

Hypersensitivity reactions

This medicationcontainsabacavir. Abacavir can cause a severe allergic reaction known as a hypersensitivity reaction. These hypersensitivity reactions have been observed more frequently in people taking medications containing abacavir.

Who suffers these reactions?

Anyone taking Abacavir/Lamivudine could develop a hypersensitivity reaction to abacavir, which could put their life at risk if they continue to take this medication.

You are more likely to develop this reaction if you have a gene calledHLA-B*5701(but you can suffer this reaction even if you do not have this gene). Before starting treatment with Abacavir/Lamivudine, you should have had a test to detect this gene.If you know you have this gene, tell your doctor before taking this medication.

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

What are the symptoms?

The most common symptoms are:

fever(elevated temperature) andskin rash.

Othersigns frequently observed are:

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

Other symptoms may include:

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

When do these reactions occur?

Hypersensitivity reactions may appear at any timeduring treatment with Abacavir/Lamivudine, but it is more likely to happen in the first 6 weeks of treatment.

Contact your doctor immediately:

1if you have a skin rash or

2if you have symptoms including 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 pain or discomfort.

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

If you have stopped taking Abacavir/Lamivudine

If you have stopped taking this medication due to a hypersensitivity reaction,NEVER TAKE Abacavir/Lamivudine or any other medication containing abacavir again.If you do, within hours, you may experience a drop in blood pressure that can put your life at risk or cause death.

If for any reason, you have interrupted treatment with Abacavir/Lamivudine — especially because you think you have side effects or another illness:

Consult your doctor before restarting treatment. Your doctor will check if your symptoms were related to a hypersensitivity reaction. If your doctor considers it could have been related, they will advise you that you should never take Abacavir/Lamivudine or any other medication containing abacavir again.

Occasionally, hypersensitivity reactions have developed in people who have taken abacavir again after having only one symptom included in the Information Card before they stopped taking it.

Very rarely, reactions have developed in people who restart treatment with abacavir, but who did not have any symptoms of hypersensitivity before they stopped taking it.

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

If you are hypersensitive to Abacavir/Lamivudine, you must return all your unused tablets of this medication for safe disposal.Consult your doctor or pharmacist.

The packaging of Abacavir/Lamivudine Teva includes an Information Card to remind you and healthcare staff about hypersensitivity reactions.Separate the card from the packaging and always carry it with you.

Frequent side effects

May affect up to1 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 sleeping (insomnia)
muscle and joint pain
arthralgia (joint pain)
cough
irritated or runny nose
skin rash
hair loss.

Rare side effects

May affect up to1 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 affect up to1 in 1,000people:

swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, and/or hives (angioedema)
liver damage, such as jaundice, enlarged liver 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 affect up to1 in 10,000people:

tingling, numbness in the skin (pins and needles)
weakness in the limbs
skin rash, which may form blisters that look like small darts (central dark spot surrounded by a lighter 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 that causes peeling of the skin 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).

If you experience side effects

Inform your doctor or pharmacistif you consider that any of the side effects you are experiencing are serious 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 Teva, may 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 treatment begins, the immune system becomes stronger, and it starts to fight these infections, which can cause symptoms of infection or inflammation. The symptoms usually include fever, 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). The symptoms of autoimmune disorders may appear many months after starting to take medications to treat 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 problems with your bones

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 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:

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 Medications for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

5. Conservation of Abacavir/Lamivudina Teva

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, after CAD. 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.

6. Contents of the packaging and additional information

Composition ofAbacavir/Lamivudina Teva

The active principles are abacavir and lamivudina.

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

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

Appearance ofAbacavir/Lamivudina Tevaand contents of the packaging

Abacavir/Lamivudina Teva600 / 300 mg film-coated tablets are orange film-coated, oblong, and biconvex tablets engraved on one face with 600 and 300 on the other with an approximate dimension of ~20.5 mm x 9mm.

Abacavir/Lamivudina Tevais available in packaging of 10, 30, and 90 film-coated tablets in blisters or packaging of10x1, 30x1, and 90x1 in single-dose blisters

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and Manufacturer

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

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

Prilaz baruna Filipovica 25, Zagreb

10000

Croatia

Merckle GmbH

Graf-Arco-Str. 3, Ulm

89079 Germany

Revision date of this leaflet:March 2023

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