ABACAVIR TARBIS 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Abacavir Tarbis 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, as 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

This medicine contains abacavir(which is also an active substance in medicines such as Kivexa, Triumeq, and Trizivir). Some people who take abacavir may develop a hypersensitivity reaction(a serious 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 Tarbis 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 package leaflet

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

1. What is Abacavir Tarbis and what is it used for

Abacavir Tarbis is used to treat HIV infection.

Abacavir Tarbis contains the active substance abacavir. Abacavir belongs to a group of antiretroviral medicines called nucleoside analogue reverse transcriptase inhibitors(NRTIs).

Abacavir Tarbis does not completely cure HIV infection; it reduces the amount of virus in your body and keeps it at a low level. It also increases the number of CD4 cells in your 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 Tarbis in the same way. Your doctor will monitor the effectiveness of your treatment.

2. What you need to know before you take Abacavir Tarbis

Do not take Abacavir Tarbis

• if you are allergic(hypersensitive)to abacavir (or to any other medicine that contains abacavir — such as Triumeq, Trizivir, or Kivexa) 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.

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

Be especially careful with Abacavir Tarbis

Some people who take Abacavir Tarbis 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 are significantly overweight(especially if you are a woman)
• if you have severe kidney disease.

Talk to your doctorif 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 still develop a hypersensitivity reaction(a serious 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 may increase the risk of cardiovascular events.

Tell your doctorif you have cardiovascular problems, if you smoke, or if you have diseases that may increase the risk of cardiovascular disease, such as high blood pressure and diabetes. Do not stop taking Abacavir Tarbis 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 Tarbis.

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

Protect others

HIV infection is spread by sexual contact with someone who has the infection or by transfer of infected blood (for example, by sharing needles). While you are taking this medicine, you can still pass HIV to others, although effective antiretroviral therapy reduces the risk. Ask your doctor about the precautions you need to take to avoid infecting others.

Taking Abacavir Tarbis with other medicines

Tell your doctor or pharmacistif you are taking or have recently takenany other medicines, including those obtained without a prescription, including herbal medicines. Remember to tell your doctor or pharmacist if you start taking any new medicine while you are taking Abacavir Tarbis.

Some medicines interact with Abacavir Tarbis

These include:

• phenytoin, used to treat epilepsy.

Tell your doctorif you are taking phenytoin. Your doctor may need to monitor you while you are taking Abacavir Tarbis.

• methadone, used as a heroin substitute. Abacavir increases the rate at which methadone is removed from the body. If you are taking methadone, you will need to be checked for signs of withdrawal. You may need to have your methadone dose changed.

Tell your doctorif you are taking methadone.

Pregnancy

Abacavir Tarbis is not recommended during pregnancy. Abacavir Tarbis and similar medicines may cause side effects in babies during pregnancy. If you have taken Abacavir Tarbis during your pregnancy, your doctor may ask for 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 side effects.

Breast-feeding

Women with HIV infection should not breast-feed their babies, because HIV infection can be passed to the baby through breast milk. A small amount of the ingredients of Abacavir Tarbis can also pass into breast milk.

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

Driving and using machines

Do not drive or operate machinesunless you feel well.

Abacavir Tarbis contains sodium

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

3. How to take Abacavir Tarbis

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets with a little water. Abacavir Tarbis can be taken with or without food.

If you cannot swallow the tablets whole, you can break them and mix them with a small amount of food or liquid; take the whole dose immediately.

Keep in regular contact with your doctor

Abacavir Tarbis 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 Tarbiswithout talking to your doctor first.

How much to take

Adults, adolescents, and children weighing at least 25 kg:

The usual dose of Abacavir Tarbis is 600 mg a day. This can be taken either as one 300 mg tablet twice a day or two 300 mg tablets once a day.

Children from 1 year of age and weighing less than 25 kg

The dose depends on your child's weight. The recommended dose is:

• Children weighing between 20 kg and less than 25 kg:The usual dose of Abacavir Tarbis is 450 mg a day. This can be given as 150 mg (half a tablet) in the morning and 300 mg (one tablet) in the evening, or 450 mg (one and a half tablets) once a day, as advised by your doctor.

• Children weighing between 14 kg and less than 20 kg:The usual dose of Abacavir Tarbis is 300 mg a day. This can be given as 150 mg (half a tablet) twice a day or 300 mg (one tablet) once a day, as advised by your doctor.

The tablet can be divided into equal doses.

A liquid solution (20 mg of abacavir per ml) is available for the treatment of children over 3 months of age and weighing less than 14 kg, as well as for patients who require a reduction in the usual dose or who are unable to take tablets.

If you take more Abacavir Tarbis than you should

If you accidentally take more Abacavir Tarbis than you should, talk to 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, stating the medicine and the amount taken.

If you forget to take Abacavir 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 Tarbis regularly, as irregular intake of Abacavir Tarbis can increase the risk of a hypersensitivity reaction.

If you have stopped taking Abacavir Tarbis

If for any reason you have stopped taking Abacavir Tarbis — especially because you think you have had side effects or because of another illness:

Talk to your doctor before you start taking it again. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If your doctor thinks that they may have been, they will tell you that you must never take Abacavir Tarbis again or take any other medicine that contains abacavir (e.g., Triumeq, Trizivir, or Kivexa). It is very important that you follow this advice.

If your doctor advises you to start taking Abacavir Tarbis again, they may ask you to take the first doses in a place where you can get immediate 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 can produce adverse effects, although not all people suffer from them.

When you are undergoing HIV treatment, it can be difficult to distinguish whether a symptom is an adverse effect of Abacavir Tarbis or other medications you are taking, or is due to an effect of the disease caused by HIV. 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 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”.

Hypersensitivity Reactions

Abacavir Tarbiscontains abacavir(the active ingredient also present in Trizivir, Triumeq, and Kivexa).

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 from these reactions?

Anyone taking Abacavir Tarbis could develop a hypersensitivity reaction to abacavir, which can be life-threatening if they continue taking Abacavir Tarbis.

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

About 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 frequent symptoms are:

• fever (high temperature) and skin rash.

Other signs frequently observed are:

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

Other symptoms may include:

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

When do these reactions occur?

Allergic reactions can appear at any time during treatment with Abacavir Tarbis, but it is more likely that they will occur in the first 6 weeks of treatment.

If you are caring for a child who is being treated with Abacavir Tarbis, it is essential that you understand the information about this hypersensitivity reaction. If the child experiences the symptoms described below, it is crucialthat you follow the indicated instructions.

Contact your doctor immediately:

1if you have a skin rash OR

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

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

Your doctor may advise you to stop taking Abacavir Tarbis.

While taking Abacavir Tarbis, always carry the Patient Information Card with you.

If you have stopped taking Abacavir Tarbis

If you have stopped taking Abacavir Tarbis due to a hypersensitivity reaction, NEVER AGAINtake Abacavir Tarbis or any other medication containing abacavir (e.g., Trizivir, Triumeq, or Kivexa). If you do, you may experience a drop in blood pressure that can be life-threatening or cause death within hours.

If you have interrupted treatment with Abacavir Tarbis — especially because you think you have adverse 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 that there may have been a relationship, they will indicatethat you should never againtake Abacavir Tarbis or any other medication containing abacavir (e.g., Trizivir, Triumeq, or Kivexa). It is essential that you follow this warning.

Occasionally, hypersensitivity reactions have developed in people who restart abacavir after having had a single symptom of those included in the Patient Information Card before they stopped taking it.

Very rarely, patients who have taken medications containing abacavir in the past without symptoms of hypersensitivity have developed a hypersensitivity reaction when restarting it.

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

If you are hypersensitive to Abacavir Tarbis, you must return all unused Abacavir Tarbis tablets to be safely disposed of. Consult your doctor or pharmacist.

The packaging of Abacavir Tarbis includes a Patient Information Cardto remind you and healthcare personnel about hypersensitivity reactions. Separate the card from the packaging and always carry it with you.

Common Adverse Effects

May affect up to 1 in 10patients:

• hypersensitivity reaction
• discomfort (nausea)
• headache
• vomiting
• diarrhea
• loss of appetite
• fatigue, lack of energy
• fever (high temperature)
• skin rash.

Rare Adverse Effects

May affect up to 1 in 1,000patients:

• pancreatitis (inflammation of the pancreas).

Very Rare Adverse Effects

May affect up to 1 in 10,000patients:

• skin rash that can form blisters resembling small targets (a 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 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.

If you experience adverse effects

Consult your doctor or pharmacistif you experience adverse effects, even if they are not listed in this prospectus.

Other Possible Adverse Effects of Combined HIV Treatment

Combined treatments, including Abacavir Tarbis, can cause other diseases 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). When these people start treatment, they may find that old infections, which were hidden, flare up, causing signs and symptoms of inflammation. These symptoms are probably due to an improvement in the body's immune response, which allows it to fight these infections. The symptoms usually include fever, plus any of the following:

• headache
• stomach pain
• difficulty breathing.

In rare cases, since the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders). The symptoms of autoimmune disorders can appear many months after starting HIV treatment. The symptoms may include:

• palpitations (rapid or irregular heartbeats) or tremors
• hyperactivity (excessive movement or agitation)
• weakness starting in the hands and feet and moving towards the trunk of the body.

If you notice any symptoms of infection while taking Abacavir Tarbis:

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. 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.

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

5. Storage of Abacavir 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.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Abacavir Tarbis

The active ingredient is abacavir. Each tablet contains 300 mg of abacavir.

The other ingredients are: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, and anhydrous colloidal silica in the tablet core. The coating contains poly(vinyl) alcohol-partially hydrolyzed (E1203), titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), and macrogol (E1521).

Appearance of Abacavir Tarbis and Package Contents

Abacavir Tarbis film-coated tablets are yellow, biconvex, capsule-shaped, and marked with “H” on one side and with "A" and "26" on either side of the score line on the other side, and are available in blister packs containing 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Via Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

2252 TR Voorschoten

Netherlands

Date of the Last Revision of this Prospectus: November 2023

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.gob.es/