ABACAVIR Zentiva 300 mg FILM-COATED TABLETS

Introduction

Prospective: information for the user

Abacavir Zentiva 300 mg film-coated tablets EFG

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again. If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

IMPORTANT — Hypersensitivity Reactions

This medication contains abacavir(which is also the active ingredient in medications such as Kivexa, Triumeq, and Trizivir). Some people who take abacavir may develop a hypersensitivity reaction(severe allergic reaction), which can be life-threatening if they continue to take medications containing abacavir.

You must read the information about "Hypersensitivity Reactions" in section 4 of this prospectus carefully.

The packaging of this medication includes an Information Cardto remind you and medical personnel of hypersensitivity to abacavir. You must remove this card and always carry it with you.

Contents of the prospectus

1. What is Abacavir Zentiva and what is it used for
2. What you need to know before starting to take Abacavir Zentiva
3. How to take Abacavir Zentiva
4. Possible adverse effects
5. Storage of Abacavir Zentiva
6. Contents of the packaging and additional information

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

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

This medication contains abacavir as its active ingredient. Abacavir belongs to a group of antiretroviral medications called nucleoside analog reverse transcriptase inhibitors(NRTIs).

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

2. What you need to know before starting to take Abacavir Zentiva

Do not take Abacavir Zentiva

• if you are allergic(hypersensitive)to abacavir (or to any other medication that contains abacavir — such as Triumeq, Trizivir, or Kivexa) or to any of the other components of this medication (listed in section 6).

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

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

Be careful with Abacavir Zentiva

Some people who take abacavir for HIV are at a higher risk of experiencing serious adverse 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 significant overweight(especially if you are a woman)
• if you have severe kidney disease.

Consult your doctorif you have any of these conditions. You may need additional tests, including blood tests, while taking this medication. See section 4 for more information.

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 about hypersensitivity reactions in section 4 of this prospectus carefully.

Risk of heart attack

A link between treatment with abacavir and a higher risk of having a heart attack cannot be ruled out.

Tell your doctorif you have heart problems, if you smoke, or if you have diseases that may increase the risk of heart disease, such as high blood pressure and diabetes. Do not stop taking abacavir unless your doctor advises you to do so.

Be aware of important symptoms

Some people who take medications for HIV infection develop other diseases, which can be serious. You need to know what signs and symptoms to look out for while taking abacavir.

Read the information about "Other possible adverse effects of combination therapy for HIV" in section 4 of this prospectus.

Protect others

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

Taking Abacavir Zentiva with other medications

Tell your doctor or pharmacistif you are taking or have recently taken other medications, including herbal medicines and those purchased without a prescription. Remember to inform your doctor or pharmacist if you start taking a new medication while taking abacavir.

Some medications interact with abacavir

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.

• methadone, used as a heroin substitute. Abacavir increases the rate at which methadone is eliminated from the body. If you are taking methadone, you may need to be monitored for symptoms of withdrawal. You may need to have your methadone dose adjusted.

Tell your doctorif you are taking methadone.

• riociguat, used to treat 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 is not recommended during pregnancy. Abacavir and similar medications may cause adverse effects in babies during pregnancy. If you have been taking abacavirduring your pregnancy, your doctor may request that you have regular 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 adverse effects.

Breastfeeding

Women with HIV infection should not breastfeed their children, as HIV infection can be transmitted through breast milk. A small amount of the components of abacavir may also pass into breast milk.

If you are breastfeeding, or have doubts about breastfeeding:

Consult your doctor immediately.

Driving and using machines

Do not drive or operate machinesunless you feel well.

This medication contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per dose; it is essentially "sodium-free).

3. How to take Abacavir Zentiva

Follow the instructions for administration of this medication indicated by your doctor or pharmacist exactly. If you are in doubt, consult your doctor or pharmacist again.

Swallow the tablets with a little water. Abacavir 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 entire dose immediately.

Stay in regular contact with your doctor

Abacavir 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.

Stay in contact with your doctor and do not stop taking abacavirwithout talking to your doctor first.

How much to take

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

The usual dose of abacavir 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 1 year of age weighing less than 25 kg

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

• Children weighing between 20 kg and less than 25 kg:The usual dose of abacavir is 450 mg per day. It can be administered as 150 mg (half a tablet) in the morning and 300 mg (one whole tablet) in the evening, or 450 mg (one and a half tablets) once a day, as indicated by your doctor.
• Children weighing between 14 kg and less than 20 kg:The usual dose of abacavir is 300 mg per day. It can be administered as 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.

An oral solution (20 mg of abacavir/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 than you should

If you accidentally take more abacavir than you should, inform your doctor or pharmacist, or contact the emergency department of the nearest hospital for more information. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take abacavir

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 make up for forgotten doses.

It is important to take abacavir regularly, as irregular intake of abacavir may increase the risk of experiencing a hypersensitivity reaction.

If you have stopped treatment with abacavir

If, for any reason, you have stopped taking abacavir — especially because you think you have adverse effects or because of 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 advise you never to take this medication or any other medication that contains abacavir (e.g., Triumeq, Trizivir, or Kivexa) again. It is essential that you follow this warning.

If your doctor advises you to restart treatment with abacavir, 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 blood glucose and lipid levels. This may be partly related to health recovery and lifestyle, and in the case of blood lipids, sometimes to HIV medications themselves. Your doctor will monitor these changes.

Like all medicines, this medicine can cause 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 or other medications you are taking, or 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, other disorders can develop during combined HIV treatment.

It is important 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 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 (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 that include abacavir 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, hidden infections 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 one or more 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 that starts in the hands and feet and moves towards the trunk of the body.

If you notice any symptoms of infection while taking abacavir:

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. In 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Abacavir Zentiva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the carton after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the (SIGRE Collection Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Abacavir Zentiva

• The active ingredient of each film-coated tablet is 300 mg of abacavir.

• Other components are:

Core:microcrystalline cellulose (ph 102), sodium starch glycolate (type A) (E1450), magnesium stearate, and anhydrous colloidal silica.

Coating:partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, and yellow iron oxide.

Appearance and Packaging of the Product

The film-coated tablets are scored, yellow, biconvex, and capsule-shaped with an “H” engraved on one face and an “A” and “26” separated by a break line on the other face.

The tablets are presented in opaque PVC/Alu white blisters, unit-dose Alu/Alu blisters, and HDPE bottles with 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zentiva k.s.,

U kabelovny 130,

Dolní Mecholupy,

102 37 Prague 10

Czech Republic

Manufacturer

Pharmadox Healthcare Limited

Luqa

LQA9040, Malta

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

Date of the Last Revision of this Prospectus:July 2021

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