Abacavir/lamivudine Tarbis 600 mg/300 mg film-coated tablets EFG

Package leaflet: Information for the user

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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are 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 taking abacavir may develop a hypersensitivity reaction (a serious allergic reaction), which could be life-threatening if treatment with abacavir-containing medicines is continued.

You must read carefully the information on “Hypersensitivity reactions” in section 4 of this leaflet.

The packaging of Abacavir/Lamivudine Tarbis includes an Information Card to remind you and healthcare professionals about abacavir hypersensitivity. You must remove this card and carry it with you at all times.

Contents of the leaflet

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

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

Abacavir/lamivudina is used in the treatment of HIV (human immunodeficiency virus) infection in adults, adolescents, and children weighing at least 25 kg.

Abacavir/lamivudina contains two active substances used to treat HIV infection: abacavir and lamivudina. Both belong to a class of antiretroviral medicines known as nucleoside reverse transcriptase inhibitors (NRTIs).

Abacavir/lamivudina does not completely cure HIV infection; it reduces the amount of virus in the body and maintains 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 play an important role in helping your body fight infection.

Not everyone responds to treatment with abacavir/lamivudina in the same way. Your doctor will monitor how well your treatment is working.

2. What you need to know before taking Abacavir/Lamivudina Tarbis

Do not take Abacavir/Lamivudina Tarbis

• if you are allergic (hypersensitive) to abacavir (or to any other medicine containing 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 carefully all the information about hypersensitivity reactions in section 4 of this leaflet.

Consult your doctor if you think any of these circumstances apply to you.

Take special care with Abacavir/Lamivudina Tarbis

Some people taking abacavir/lamivudine or other combination treatments for HIV are at higher risk of experiencing serious side effects. You should be aware that the risk is higher:

• 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 your condition may worsen)
• if you are significantly overweight (particularly if you are female)
• if you have any kidney problems.

Consult your doctor before starting abacavir/lamivudine if any of these circumstances apply to you. You may need additional tests, including blood tests, while taking this medicine. For more information, see section 4.

Hypersensitivity reactions to abacavir

Even patients who do not carry the HLA-B*5701 gene may develop a hypersensitivity reaction (a serious allergic reaction).

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

Risk of cardiovascular events A possible association between abacavir treatment and an increased risk of cardiovascular events cannot be ruled out.

Tell your doctor if you have cardiovascular problems, smoke, or have conditions that may increase your risk of cardiovascular disease, such as high blood pressure or diabetes. Do not stop taking abacavir/lamivudine unless your doctor advises you to do so.

Be alert to important symptoms

Some people taking medicines for HIV infection develop other disorders, which may be serious. You need to know which important signs and symptoms to watch for while taking abacavir/lamivudine.

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

Other medicines and Abacavir/Lamivudina Tarbis

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

Remember to inform your doctor or pharmacist if you start taking a new medicine while taking abacavir/lamivudine.

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

• Emtricitabine, used to treat HIV infection
• other medicines containing lamivudine, used to treat HIV infection or hepatitis B
• high doses of trimethoprim and sulfamethoxazole, an antibiotic
• cladribine, used to treat hairy cell leukemia.

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

Some medicines interact with Abacavir/Lamivudina Tarbis

These include:

• Phenytoin, used to treat epilepsy.

Tell your doctor if 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 eliminated from the body. If you are taking methadone, you should be monitored for symptoms of withdrawal. Your methadone dose may need to be adjusted.

Tell your doctor if you are taking methadone.

• Medicines (usually liquids) containing sorbitol and other polyols (such as xylitol, mannitol, lactitol, or maltitol), if taken regularly.

Tell your doctor or pharmacist if you are being treated with any of these.

• Riociguat, used to treat high blood pressure in the blood vessels (pulmonary arteries) carrying blood from the heart to the lungs. Your doctor may need to reduce your dose of riociguat, as abacavir may increase blood levels of riociguat.

Pregnancy

Use of Abacavir/Lamivudina Tarbis during pregnancy is not recommended. Abacavir/lamivudine and similar medicines may cause adverse effects in babies during pregnancy.

If you have taken abacavir/lamivudine during pregnancy, your doctor may request periodic 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 outweighed the risk of adverse effects.

Breast-feeding

Breast-feeding is not recommended in women with HIV, because HIV infection can be passed 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 have any doubts about breast-feeding: consult your doctor immediately.

Driving and use of machines

Abacavir/lamivudine may cause side effects that could affect your ability to drive or operate machinery.

Consult your doctor regarding your ability to drive or operate machinery while taking abacavir/lamivudine.

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

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

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

3. How to take Abacavir/Lamivudina Tarbis

Follow exactly the instructions given by your doctor for taking this medicine. 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 daily.

Swallow the tablets whole with a little water. This medicine 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 disease from worsening. You may still develop other infections and illnesses associated with HIV infection.

Stay in contact with your doctor and do not stop taking abacavir/lamivudina without first talking to your doctor.

If you take more Abacavir/Lamivudina Tarbis than you should

If you accidentally take more abacavir/lamivudina than you should, inform your doctor or pharmacist, or contact the nearest hospital emergency department for advice.

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

If you forget to take Abacavir/Lamivudina Tarbis

If you forget to take a dose, take it as soon as you remember, and then continue with your usual dosing schedule. Do not take a double dose to make up for a missed dose.

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

If you interrupt treatment with Abacavir/Lamivudina Tarbis

If for any reason you have stopped taking abacavir/lamivudina — especially because you think you are experiencing adverse effects or due to another illness:

Consult your doctor before restarting treatment. Your doctor will assess whether your symptoms were related to a hypersensitivity reaction. If your doctor considers that there may have been a connection, you will be instructed never to take abacavir/lamivudina or any other medicine containing abacavir again (e.g., abacavir, dolutegravir/abacavir/lamivudina, or abacavir/lamivudina/zidovudine). It is important that you follow this warning.

If your doctor advises restarting treatment with abacavir/lamivudina, 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 in blood glucose and lipid levels. This may be partly related to improved health, lifestyle factors, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

When receiving HIV treatment, it may be difficult to determine whether a symptom is an adverse effect of abacavir/lamivudine or of other medicines you are taking, or is due to the HIV disease itself. Therefore, it is very important that you inform your doctor about any changes in your health.

Even patients who do not carry the HLA-B*5701 gene may develop a hypersensitivity reaction (a serious allergic reaction), described in the warning box in this leaflet entitled “Hypersensitivity reactions”.

It is very important that you read and understand the information about this serious reaction.

In addition to the adverse effects listed below for Abacavir/Lamivudina Tarbis, other disorders may occur during combination HIV treatment.

It is important that you read the information under the section “Other possible adverse effects of combination HIV treatment”.

Hypersensitivity reactions Abacavir/Lamivudine Tarbis contains abacavir (active ingredient also present in abacavir, dolutegravir/abacavir/lamivudine or abacavir/lamivudine/zidovudine). Abacavir may cause a serious allergic reaction known as a hypersensitivity reaction. These hypersensitivity reactions have been observed more frequently in individuals taking medications containing abacavir. Who experiences these reactions? Any person taking abacavir/lamivudine may develop a hypersensitivity reaction to abacavir, which could be life-threatening if treatment with abacavir/lamivudine is continued. Your risk of developing this reaction is higher if you carry a gene called HLA-B*5701 (although you may still experience this reaction even if you do not have this gene). Before starting treatment with abacavir/lamivudine, you should have been tested for this gene. If you know you carry this gene, inform your doctor before taking abacavir/lamivudine. In a clinical trial, approximately 3 to 4 out of every 100 patients treated with abacavir who did not carry the HLA-B*5701 gene developed a hypersensitivity reaction. What are the symptoms? The most common symptoms are: fever (elevated temperature) and skin rash. Other commonly observed signs include: nausea (feeling unwell), vomiting, diarrhoea, abdominal (stomach) pain, and excessive fatigue. Other possible symptoms may include: joint or muscle pain, swelling of the neck, difficulty breathing, sore throat, cough, occasional headache, eye inflammation (conjunctivitis), mouth ulcers, low blood pressure, and tingling or numbness in the hands or feet. When do these reactions occur? Hypersensitivity reactions may occur at any time during treatment with abacavir/lamivudine, but are most likely to occur within the first 6 weeks of treatment. Contact your doctor immediately: 1 if you develop a skin rash OR 2 if you experience symptoms from at least 2 of the following groups: fever difficulty breathing, sore throat, or cough nausea or vomiting, diarrhoea, or abdominal pain excessive fatigue or generalised aches and discomfort. Your doctor may advise you to stop taking Abacavir/Lamivudine Tarbis. If you have stopped taking Abacavir/Lamivudine Tarbis If you have stopped taking abacavir/lamivudine due to a hypersensitivity reaction, NEVER take abacavir/lamivudine or any other medicine containing abacavir again (e.g. abacavir, dolutegravir/abacavir/lamivudine or abacavir/lamivudine/zidovudine). If you do, within hours you may experience a drop in blood pressure that could be life-threatening or fatal. If for any reason you have interrupted treatment with abacavir/lamivudine — especially because you think you are experiencing adverse effects or due to another illness: Consult your doctor before restarting treatment. Your doctor will assess whether your symptoms were related to a hypersensitivity reaction. If your doctor suspects such a link, you will be instructed never to take abacavir/lamivudine or any other medicine containing abacavir again (e.g. abacavir, dolutegravir/abacavir/lamivudine or abacavir/lamivudine/zidovudine). It is important that you follow this warning. Occasionally, hypersensitivity reactions have occurred in individuals who restart abacavir after having experienced only one symptom listed on the Information Card prior to stopping treatment. Very rarely, reactions have occurred in individuals restarting abacavir who had no prior symptoms of hypersensitivity before stopping treatment. If your doctor advises restarting treatment with abacavir/lamivudine, they may ask you to take the first doses in a setting where immediate medical assistance is available, if needed. If you are hypersensitive to abacavir/lamivudine, you must return all unused abacavir/lamivudine tablets for safe disposal. Speak to your doctor or pharmacist. The abacavir/lamivudine packaging includes an Information Card to remind you and healthcare professionals about hypersensitivity reactions. Remove the card from the pack and carry it with you at all times.

Common side effects

May affect up to 1 in 10 people:

• hypersensitivity reaction
• headache
• vomiting
• malaise (nausea)
• diarrhea
• stomach pain
• loss of appetite
• fatigue, lack of energy
• fever (elevated temperature)
• general feeling of discomfort
• difficulty falling asleep (insomnia)
• muscle pain and discomfort
• joint pain
• cough
• irritated nose or excessive nasal discharge
• skin rash
• hair loss.

Uncommon side effects

May affect up to 1 in 100 people and may be detected in blood tests:

• low red blood cell count (anemia) or low white blood cell count (neutropenia)
• increased levels of liver enzymes
• decreased number of blood clotting cells (thrombocytopenia).

Rare side effects

May affect up to 1 in 1,000 people:

• liver problems, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis)
• inflammation of the pancreas (pancreatitis)
• muscle tissue breakdown.

Rare side effects that may appear in blood tests include:

• increased levels of an enzyme called amylase.

Very rare side effects

May affect up to 1 in 10,000 people:

• numbness, tingling sensation in the skin (pricking)
• feeling of weakness in the limbs
• skin rash that may form blisters resembling small targets (a dark center spot surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• widespread blistering rash with skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens–Johnson syndrome), and a more severe form causing 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 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 pharmacist if you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet.

Other possible side effects of combination HIV treatment

Combination treatments, such as abacavir/lamivudine, may cause other disorders to emerge during HIV treatment.

Symptoms of infection and inflammation

Exacerbation of previous 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 undetected by the weakened immune system before treatment began. After starting treatment, the immune system becomes stronger and begins to fight these infections, which may cause symptoms of infection or inflammation. Symptoms generally include fever, along with some of the following:

• headache
• stomach pain
• difficulty breathing.

In rare cases, as the immune system becomes stronger, it may also attack healthy tissues (autoimmune disorders). Symptoms of autoimmune disorders may appear many months after starting HIV treatment. Symptoms may include:

• palpitations (rapid or irregular heartbeat) or tremor
• hyperactivity (excessive restlessness and movement)
• weakness starting in the hands and feet and moving upward toward the body trunk.

If you notice any symptoms of infection and inflammation or any of the symptoms listed above:

Inform your doctor immediately. Do not take any other medication for infection without your doctor's advice.

You may have bone problems

Some patients receiving combination HIV treatment develop a bone disease called osteonecrosis. In this condition, part of the bone tissue dies due to reduced blood supply to the bone. People are more likely to develop this condition:

• if they have been on combination 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:

• 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 of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. They can also be reported directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abacavir/Lamivudine Tarbis

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

Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Abacavir/Lamivudine Tarbis

The active substances are abacavir and lamivudine.

The other components are:

Tablet core: Microcrystalline cellulose (E460), sodium carboxymethyl starch from potato (E468), colloidal anhydrous silica (E551) and magnesium stearate (E470b).

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

Appearance of Abacavir/Lamivudine Tarbis and contents of the pack

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

Abacavir/Lamivudine Tarbis is available in OPA-Aluminium-PVC/Aluminium or PVC-PVDC/Aluminium blisters containing 30, 60, 90 or 120 tablets, or 30x1, 60x1, 90x1 and 120x1 tablets in perforated unit-dose blisters.

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

Only certain pack sizes may be marketed.

Marketing Authorisation 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

The Netherlands

This medicinal product is authorised in the European Economic Area (EEA) member states 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 most recent review of this leaflet: 01/2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/