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

Introduction

Package Leaflet: Information for the User

Abacavir/Lamivudine Tarbis 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 Tarbis contains abacavir(which is also the active substance in medicines such as abacavir, dolutegravir/abacavir/lamivudine or abacavir/lamivudine/zidovudine). 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 under “Hypersensitivity reactions” in section 4 of this leaflet carefully.

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

1. What Abacavir/Lamivudine Tarbis is and what it is 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 that are 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 plays an important role in helping 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/Lamivudine Tarbis

Do not take Abacavir/Lamivudine Tarbis

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

Read the information under “Hypersensitivity reactions” in section 4 of this leaflet carefully.

Tell your doctorif you think any of these situations apply to you.

Be especially careful with Abacavir/Lamivudine Tarbis

Some people who take abacavir/lamivudine or other anti-HIV treatments 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 are significantly overweight(especially if you are a woman)
• if you have any kidney problems.

Tell your doctor before you start taking abacavir/lamivudine if you have any of these conditions.You may need to have extra checks, including blood tests, while you are 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 under “Hypersensitivity reactions” in section 4 of this leaflet carefully.

Risk of cardiovascular eventsIt cannot be excluded that there is an association between treatment with abacavir and an increased 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 abacavir/lamivudine 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 you are taking abacavir/lamivudine.

Read the information under “Other possible side effects of anti-HIV therapy” in section 4 of this leaflet.

Other medicines and Abacavir/Lamivudine Tarbis

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

Remember to tell your doctor or pharmacist if you start taking any new medicines while you are taking abacavir/lamivudine.

The following medicines must not be used with Abacavir/Lamivudine Tarbis:

• Emtricitabine, for treating HIV infection
• other medicines that contain lamivudine, used for treating HIV infection or hepatitis B
• high doses of trimethoprim/sulfamethoxazole, an antibiotic
• cladribine, used for treating hairy cell leukemia.

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

Some medicines interact with Abacavir/Lamivudine Tarbis

These include:

• phenytoin, for treating epilepsy.

Tell your doctorif you are taking phenytoin. Your doctor may need to monitor you while you are taking abacavir/lamivudine.

• 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, for treating high 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 the levels of riociguat in your blood.

Pregnancy

Abacavir/Lamivudine Tarbis is not recommended during pregnancy. Abacavir/lamivudine and similar medicines may cause side effects in babies 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

Breast-feeding is not recommended in women with HIV, as HIV infection can pass to the baby through breast milk. A small amount of the components of abacavir/lamivudine may also pass into breast milk.

If you are breast-feeding, or think you might want to, consult your doctor immediately.

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 abacavir/lamivudine.

Important information about some of the ingredients of Abacavir/Lamivudine Tarbis

Abacavir/lamivudine contains a colorant called orange yellow (E110), which may cause allergic reactions in some people.

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

3. How to take Abacavir/Lamivudine Tarbis

Always take this medicine exactly as your doctor has told you.If you are not sure, check with 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. This medicine 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 continue to develop other infections and illnesses associated with HIV.

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

If you take more Abacavir/Lamivudine Tarbis than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediatelyor call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Abacavir/Lamivudine Tarbis

If you miss 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 stop taking Abacavir/Lamivudine Tarbis

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 you start taking abacavir/lamivudine again. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If your doctor thinks that they may have been, you should never take abacavir/lamivudine or any other medicine that contains abacavir (e.g. abacavir, dolutegravir/abacavir/lamivudine or abacavir/lamivudine/zidovudine) 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 glucose and lipid levels in the blood. This may be partly related to the recovery of health 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 may produce adverse effects, although not all people suffer from them.

When you are undergoing HIV treatment, it may be difficult to distinguish whether a symptom is an adverse effect of abacavir/lamivudine or other medications you are taking, or if it is due to an effect of 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 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 Abacavir/Lamivudina Tarbis, other disorders can develop during combined HIV treatment.

It is essential 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
• nausea (discomfort)
• 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.

Infrequent 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:

• increased levels of 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:

• bone marrow failure 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 is severe 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.

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 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 generally include fever, as well as 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 for HIV treatment. The symptoms can include:

• palpitations (rapid or irregular heartbeats) or tremors
• hyperactivity (excessive restlessness and movement)
• weakness starting in the hands and feet and ascending to the trunk of the body.

If you observe any symptoms of infectionand 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 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 medications called corticosteroids
• if they drink alcohol
• if their immune system is severely weakened
• if they are overweight.

The 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 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 directly through the Spanish Pharmacovigilance System for Human Use 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 Tarbis

Keep this medication out of sight and reach of children.

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

For PVC/PVDC-Aluminum blister packs: Store below 30°C.

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

6. Package Contents and Additional Information

Composition of Abacavir/Lamivudina Tarbis

The active ingredients are abacavir and lamivudine.

The other components are:

Core of the tablet: Microcrystalline cellulose (E460), sodium starch glycolate (E468), Colloidal anhydrous silica (E551), and magnesium stearate (E470b).

Tablet coating: Opadry Orange containing hypromellose (E464), titanium dioxide (E171), macrogol (E1521), yellow-orange aluminum lake (E110), and polysorbate 80 (E433).

Appearance of Abacavir/Lamivudina Tarbis and Package Contents

Abacavir/Lamivudina Tarbis is a film-coated, biconvex, modified capsule-shaped tablet, orange in color (approximately 20.6 x 8.6 mm) with the inscription “H” on one side and “A1” on the other.

Abacavir/Lamivudina Tarbis is available in OPA-Aluminum-PVC/Aluminum or PVC-PVDC/Aluminum blister packs containing 30, 60, 90, or 120 tablets or 30x1, 60x1, 90x1, and 120x1 tablets in single-dose blister packs.

Abacavir/Lamivudina Tarbis is also available in a white HDPE plastic bottle with a child-resistant white plastic cap containing 30 or 90 (3 bottles of 30) tablets. Each bottle contains a desiccant gel silica container that should be kept in the bottle to help protect your tablets and should not be swallowed.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany: Abacavir/Lamivudin Amarox 600 mg/300 mg Filmtabletten

Netherlands: Abacavir/Lamivudine Amarox 600 mg/300 mg filmomhulde tabletten

Spain: Abacavir/Lamivudina Tarbis 600 mg/300 mg comprimidos recubiertos con película EFG

United Kingdom: Abacavir/Lamivudine Amarox 600 mg/300 mg film-coated tablets

Date of the last revision of this prospectus:01/2024

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