Ficha técnica de Abacavir/lamivudina tarbis 600 mg/300 mg comprimidos recubiertos con pelicula efg – Espanha

Como usar Abacavir/lamivudina tarbis 600 mg/300 mg comprimidos recubiertos con pelicula efg

Introduction

Prospect: information for the user

Abacavir/Lamivudina Tarbis 600 mg/300 mg film-coated tablets

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

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

IMPORTANT — Hypersensitivity reactions

Abacavir/Lamivudina Tarbis contains abacavir(which is also the active ingredient in medicines such asabacavir, dolutegravir/abacavir/lamivudina or abacavir/lamivudina/zidovudina). Some people who take abacavir may develop ahypersensitivity reaction(severe allergic reaction), which can be life-threatening if medicines containing abacavir are continued.

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

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

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

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

Abacavir/lamivudina contains two active ingredients used for the treatment of infection caused by the HIV: abacavir and lamivudina. Both belong to a group of antiretroviral medications calledinhibitors of reverse transcriptase analogs of nucleosides(NRTIs).

Abacavir/lamivudina 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 the body fight infection.

Not everyone responds to abacavir/lamivudina treatment in the same way. Your doctor will monitor the effectiveness of your treatment.

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

Do not take Abacavir/Lamivudina Tarbis

if you areallergic(hypersensitive)to abacavir (or to any other medication that contains abacavir, e.g. abacavir, dolutegravir/abacavir/lamivudina or abacavir/lamivudina/zidovudina), lamivudine or to any of the other components of this 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 Abacavir/Lamivudina Tarbis

Some people taking abacavir/lamivudine or other combination treatments 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 have hepatitis B do not stop taking abacavir/lamivudine without consulting your doctor, as it may worsen)
if you havesignificant overweight(especially if you are a woman)
if you have anykidney problems.

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

Abacavir hypersensitivity reactions

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

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

Risk of cardiovascular eventsNo association between abacavir treatment and an increased risk of cardiovascular events can be ruled out.

Inform your doctorif you have cardiovascular problems, smoke or have conditions that may increase your risk of cardiovascular diseases such as high blood pressure and diabetes. Do notstoptaking abacavir/lamivudine unless your doctor advises you to.

Be aware of important symptoms

Some people taking HIV medications develop other conditions, which can be severe. You need to know what signs and symptoms to be aware of while taking abacavir/lamivudine.

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

Other medications and Abacavir/Lamivudina Tarbis

Inform your doctor or pharmacist if you are taking or have recently taken any other medication,including medications based on plants and those acquired without a prescription.

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

The following medications should not be used with Abacavir/Lamivudina Tarbis:

Emtricitabine, to treatHIV infection
other medications containing lamivudine, used to treatHIV infection or hepatitis B
high doses oftrimethoprim and sulfamethoxazole, an antibiotic
cladribine, used to treatacute lymphoblastic leukemia.

Inform your doctorif you are being treated with any of these medications.

Some medications interact with Abacavir/Lamivudina Tarbis

These include:

phenytoin, to treat epilepsy.

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

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.

Inform your doctorif you are taking methadone.

medications(usually liquids) containingsorbitol and other polyols(such as xylitol, mannitol, lactitol or maltitol), if taken regularly.

Inform your doctor or pharmacistif you are being treated with any of these.

riociguat, to treathigh blood pressure in the blood vessels(pulmonary arteries) that transport blood from the heart to the lungs. Your doctor may need to reduce your dose of riociguat, as abacavir may increase your riociguat blood levels.

Pregnancy

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

If you have been taking abacavir/lamivudineduring 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 antiretrovirals during pregnancy, the benefit of HIV protection was greater than the risk of adverse effects.

Breastfeeding

Breastfeeding is not recommended in women with HIV, as the 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 breastfeeding, or have doubts about breastfeeding:consult your doctor immediately.

Driving and operating machines

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

Consult your doctorabout your ability to drive or operate machines while taking abacavir/lamivudine.

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

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

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

3. How to Take Abacavir/Lamivudine Tarbis

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of 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 a day.

Swallow the tablets whole with a little water. This medication 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 continue to develop other infections and diseases associated with HIV infection.

Remain in contact with your doctor and do not stop taking abacavir/lamivudinawithout first speaking with 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's emergency service for further 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/Lamivudina Tarbis

If you forget to take a dose, take it as soon as you remember and then continue with your regular treatment. Do not take a double dose to compensate for the missed doses.

It is essential to take abacavir/lamivudina regularly, as irregular intake of abacavir/lamivudina may increase the risk of experiencing 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 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,he will instruct you not to take abacavir/lamivudina or any other medication that contains abacavir (e.g. abacavir, dolutegravir/abacavir/lamivudina, or abacavir/lamivudina/zidovudine).It is essential that you follow this warning.

If your doctor advises you to resume treatment with abacavir/lamivudina, you can ask him to take the first doses in a place where you have easy access to medical assistance if necessary.

4. Possible Adverse Effects

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/lamivudina or of 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 ahypersensitivity reaction(a severe allergic reaction), described in this leaflet in the box called “Hypersensitivity reactions”.

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

In addition to the side effects listed below for Abacavir/Lamivudina Tarbis, other disorders may develop during combined HIV treatment.

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

Hypersensitivity reactions

Abacavir/Lamivudina Tarbiscontainsabacavir(an active ingredient that is also present inabacavir, dolutegravir/abacavir/lamivudina or abacavir/lamivudina/zidovudine).

Abacavir can produce 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 these reactions?

Anyone taking abacavir/lamivudina could develop a hypersensitivity reaction to abacavir, which could put their life at risk if they continue taking abacavir/lamivudina.

You are more likely to develop this reaction if you have a gene calledHLA-B*5701(but you can still develop the reaction even if you do not have this gene). Before starting treatment with abacavir/lamivudina, you should have had a test to detect this gene.If you know you have this gene, tell your doctor before taking abacavir/lamivudina.

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 common symptoms are:

fever(elevated temperature) andskin rash.

Other frequently observed signs include:

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

Other symptoms may include:

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

When do these reactions occur?

Hypersensitivity reactions can appear at any time during treatment with abacavir/lamivudina, but it is more likely to happen in the first 6 weeks of treatment.

Contact your doctor immediately:

1 if you have a skin rash

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

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

Your doctor may advise you to stop taking Abacavir/Lamivudina Tarbis.

If you have stopped taking Abacavir/Lamivudina Tarbis

If you have stopped taking abacavir/lamivudina due to a hypersensitivity reaction,NEVER TAKE ABACAVIR/LAMIVUDINA AGAIN OR ANY OTHER MEDICINE CONTAINING ABACAVIR (E.G. ABACAVIR, DOLUTEGRAVIR/ABACAVIR/LAMIVUDINA OR ABACAVIR/LAMIVUDINA/ZIDOVUDINE).If you do, within hours, you may experience a drop in blood pressure that can put your life at risk or cause death.

If for any reason, you have interrupted treatment with abacavir/lamivudina — especially because you think you are experiencing side effects or 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 could have been related,they will advise you that you should never take abacavir/lamivudina again or any other medicine containing abacavir (e.g. abacavir, dolutegravir/abacavir/lamivudina or abacavir/lamivudina/zidovudine).It is important that you follow this warning.

Occasionally, hypersensitivity reactions have developed in people who take abacavir again after having had only one symptom of those included in the Information Card before they stopped taking it.

Very rarely, reactions have developed in people who restart treatment with abacavir, but who did not have any symptoms of hypersensitivity before they stopped taking it.

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

If you are hypersensitive to abacavir/lamivudina, you must return all your abacavir/lamivudina tablets without using them, so that they can be disposed of safely.Consult your doctor or pharmacist.

The packaging of abacavir/lamivudina includes anInformation Cardto remind you and healthcare staff about hypersensitivity reactions.Separate the card from the packaging and always carry it with you.

Frequent side effects

They can affectup to 1 in 10people:

hypersensitivity reaction
headache
vomiting
discomfort (nausea)
diarrhea
abdominal pain
loss of appetite
fatigue, lack of energy
fever (elevated temperature)
general feeling of discomfort
difficulty sleeping (insomnia)
muscle and joint pain
arthralgia
cough
irritated or runny nose
skin rash
hair loss.

Rare side effects

They can affectup 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 enzymes produced by the liver
decrease in the number of cells involved in blood clotting (thrombocytopenia).

Rare side effects

They can affectup to 1 in 1,000people:

liver damage, such as jaundice, liver enlargement or fatty liver, inflammation (hepatitis)
pancreatitis (inflammation of the pancreas)
muscle rupture.

Rare side effects that may appear in blood tests are:

increaseof an enzyme calledamylase.

Very rare side effects

They can affectup to 1 in 10,000people:

numbness, tingling sensation in the skin (pins and needles)
sensation of weakness in the limbs
skin eruption, which can form blisters that look like small darts (a central dark spot 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 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 pharmacistif you consider that any of the side effects you are experiencing are serious or if you notice any side effect not mentioned in this leaflet.

Other possible side effects of combined HIV treatment

Combined treatments, such as abacavir/lamivudina, 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 serious infections (opportunistic infections). Such infections may have been "latent" and not detected by the weakened immune system before treatment began. After treatment began, the immune system becomes stronger, and it starts to fight these infections, which can cause symptoms of infection or inflammation. The symptoms usually includefever, as well as some of the following:

headache
abdominal pain
difficulty breathing.

In rare cases, as the immune system becomes stronger, it may also attack healthy tissues (autoimmune disorders). The symptoms of autoimmune disorders can appear many months after starting to take medications to treat HIV infection. The symptoms can include:

palpitations (rapid or irregular heartbeats) or tremors
hyperactivity (excessive restlessness and movement)
weakness that starts in the hands and feet and ascends to the body trunk.

If you notice any symptoms of infectione 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 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 suffer from 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 not mentioned in this leaflet.You can also report directly through the Spanish System for the Vigilance of Medicinal Products for Human Use website:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

5. Conservation of Abacavir/Lamivudina Tarbis

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.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications.This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Abacavir/Lamivudina Tarbis

The active principles are abacavir and lamivudina.

The other components are:

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

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

Appearance of Abacavir/Lamivudina Tarbis and contents of the package

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

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicine is authorized in the member states of the European Economic Area with 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

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

Last review date of this leaflet:01/2024

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.es/