Label: Information for the User

Abacavir Tarbis 300 mg Film-Coated Tablets

Read this label carefully before starting to take this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribedonly for you, and you should notgive it to other people even if they have the same symptomsas you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

IMPORTANT — Hypersensitivity Reactions

This medicine contains abacavir(which is also the active ingredient in medicines such asKivexa, Triumeq, and Trizivir). Some people who take abacavir may develop ahypersensitivity reaction(severe allergic reaction), which can be life-threatening if they continue to take medicines that contain abacavir.

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

The Abacavir Tarbis packaging includes aInformation Cardto remind you and healthcare professionals of your hypersensitivity to abacavir.You must remove this card and carry it with you at all times.

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

2.What you need to knowbefore starting to take Abacavir Tarbis

3.How to take Abacavir Tarbis

4.Possible side effects

5.Storage of Abacavir Tarbis

6.Contents of the pack and additional information

Abacavir Tarbis is used in the treatment of the infection caused by the HIV (human immunodeficiency virus).

Abacavir Tarbis contains abacavir as its active ingredient. Abacavir belongs to a group of antiretroviral medications calledinhibitors of reverse transcriptase analogs of nucleosides(NRTIs).

Abacavir Tarbis 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 cellsare a type of white blood cell that plays an important role in helping the body fight infection.

Not everyone responds to treatment with Abacavir Tarbis in the same way. Your doctor will monitor the effectiveness of your treatment.

Do not take AbacavirTarbis

• if you areallergic(hypersensitive)to abacavir (or to any other medication that contains abacavir — such asTriumeq,TrizivirorKivexa) or to any of the other components ofthis medication(listed in section 6).

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

Consult your doctorif you think you are affected by any of these circumstances.

Be especially careful with AbacavirTarbis

Some people taking Abacavir Tarbis for HIV have a higher risk of severe side effects. You need to know that there is a higher risk:

• if you havemoderate or severe liver disease
• if you have ever hadliver disease, including hepatitis B or C
• if you havesignificant overweight(especially if you are a woman)
• if you havesevere kidney disease.

Consult your doctor ifyou suffer from any of these circumstances.You may need additional tests, including blood tests, while taking this medication.For more information see section 4.

Hypersensitivity reactions to abacavir

Even patients who do not have the HLA-B*5701 gene can develophypersensitivity reactions(a severe allergic reaction).

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

Risk of cardiovascular events

You cannot rule out that abacavir may increase the risk of cardiovascular events.

Inform your doctorif you have cardiovascular problems, if you smoke or if you have diseases that may increase the risk of cardiovascular diseases, 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 taking HIV medications develop other diseases, which can be serious. You need to know about the important signs and symptoms to look out for while taking Abacavir Tarbis.

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

Protect others

HIV is transmitted through sexual contact with someone who has the infection or by blood transfer (for example, by sharing needles). While taking this medication, you can still transmit HIV to others, although effective antiretroviral treatment reduces the risk.Consult your doctor about what precautions are necessary to avoid infecting others.

Taking AbacavirTarbiswith other medications

Inform your doctor or pharmacist if you aretakingor have recently takenother medications,including over-the-counter medications and herbal remedies.Remember to inform your doctor or pharmacist if you start taking a new medication while taking Abacavir Tarbis.

Some medications interact with AbacavirTarbis

These include:

• phenytoin, for treatingepilepsy.

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

• 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 withdrawal symptoms. You may need your methadone dose to be adjusted.

Informyour doctorif you are taking methadone.

Pregnancy

Abacavir Tarbis is not recommended during pregnancy. Abacavir Tarbis and similar medications may cause adverse effects in babies during pregnancy.If you have been takingAbacavirTarbisduring your pregnancy, your doctor may request that you have regular blood tests and other diagnostic tests to monitor the development of your baby. In children whose mothers took INTIs during pregnancy, the benefit of HIV protection was greater than the risk of adverse effects.

Breastfeeding

Women infected with HIV should not breastfeed their babies, because HIV can be passed to the baby through breast milk. A small amount of the components of Abacavir Tarbis may also pass into breast milk.

If you are breastfeeding, or have doubts about breastfeeding:

Consult your doctor immediately.

Driving and operating machinery

Do not drive or operate machineryunless you are feeling well.

Abacavir Tarbis contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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 drink; take the entire dose immediately.

Maintain regular contact with your doctor

Abacavir Tarbis helps control your condition. You will need to take it every day to prevent your disease 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 Tarbis without first speaking with your doctor.Tarbis

How much to take

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

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

Children from one year of age weighing less than 25 kg

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

• Children weighing at least 20 kg and less than 25 kg:The usual dose of Abacavir Tarbis is 450 mg per day. They can be given 150 mg (half a tablet) in the morning and 300 mg (one whole tablet) in the afternoon, or 450 mg (one and a half tablets) once a day, as indicated by your doctor.

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

The tablet can be divided into equal doses.

A oral solution (20 mg of abacavir/ml) is available for the treatment of children over three months 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, inform your doctor or pharmacist, or contact the nearest hospital emergency service for more 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 forgot to take Abacavir Tarbis

If you forget to take a dose, take it as soon as you remember and then continue with your usual treatment.

Do not take a double dose to compensate for the missed doses.

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

If you have interrupted treatment with Abacavir Tarbis

If for any reason, you have stopped taking Abacavir Tarbis — 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 that you should never take Abacavir Tarbis again or any other medication containing abacavir (e.g. Triumeq, Trizivir, or Kivexa).It is essential that you follow this warning.

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

During treatment for HIV, 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 lipids in the blood, sometimes to the HIV medications themselves. Your doctor will monitor these changes.

Like all medications, this medication can produce side effects, although not all people will experience them.

When you are being treated for HIV, it may be difficult to distinguish whether a symptom is a side effect of Abacavir Tarbis 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 of any change in your health.

Even patients who do not have the HLA-B*5701 gene can developahypersensitivity reaction(a severe allergic reaction), described in this prospectus 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 AbacavirTarbis, other disorders can develop during combined HIV treatment.

It is important that you read the information under the heading “Other possible side effects of combined HIV treatment”.

If you have stopped taking Abacavir Tarbis due to a hypersensitivity reaction,NEVER TAKEAbacavirTarbisor any other medication that contains abacavir (e.g. Trizivir, Triumeq or Kivexa)again. If you do, within hours, you may experience a drop in blood pressure that can put your life at risk or cause death.

Common side effects

May affectup to 1 in 10patients:

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

Rare side effects

May affectup to 1 in 1,000patients:

• pancreatitis (inflammation of the pancreas)(pancreatitis).

Very rare side effects

May affectup to 1 in 10,000patients:

• skin eruption, which can form blisters that appear as small dianas (a central dark area surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• widespread eruption 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 on more than 30% of the body surface (toxic epidermal necrolysis)
• lactic acidosis (excess of lactic acid in the blood).

If you notice any of these symptoms, contact a doctor urgently.

If you experience side effects

Consult your doctor or pharmacistif you experience side effects,including any side effects that do not appear in this prospectus..

Other possible side 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 latent, 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 includefever, and possibly one or more of the following:

• headache
• abdominal 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 treatment for HIV infection. The symptoms can include:

• palpitations (rapid or irregular heartbeat) or tremors
• hyperactivity (excessive movement or agitation)
• weakness that starts in the hands and feet and spreads to the body trunk.

If you notice any of these 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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Reporting of Adverse Reactions to Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

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.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 the packaging and the

medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medications you no longer need. By doing so, you will help protect the environment.

Composition of Abacavir Tarbis

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

The other components 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 contents of the container

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 groove on the other side, and are presented in blister packs containing 60 tablets.

Marketing authorization holder and manufacturer(s)

Marketing authorization holder

Tarbis Farma S.L.

Gran Via Carlos III, 94

08028 Barcelona

Spain

Manufacturer(s)

Pharmadox HeaIthcare Ltd.

KW20A Kordin Industrial Park, Paola, PLA 3000

Malta.

Amarox Pharma B.V.

Rouboslaan 32

2252 TR Voorschoten

Netherlands

Last review date of this leaflet: November 2023

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