Abacavir Tarbis 300 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Abacavir Tarbis 300 mg film-coated tablets EFG
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, 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 they are effects not listed in this leaflet. See section 4.
IMPORTANT — Hypersensitivity reactions
This medicine contains abacavir (which is also the active substance in medicines such as Kivexa, Triumeq and Trizivir). Some people taking abacavir may develop a hypersensitivity reaction (a serious allergic reaction), which may be life-threatening if they continue taking medicines containing abacavir.
You must read carefully the information on “Hypersensitivity reactions” in section 4 of this leaflet.
The Abacavir Tarbis package includes an Information Card to remind you and medical personnel about abacavir hypersensitivity. You must remove this card and always carry it with you.
Contents of the leaflet
- What Abacavir Tarbis is and what it is used for
- What you need to know before taking Abacavir Tarbis
- How to take Abacavir Tarbis
- Possible side effects
- How to store Abacavir Tarbis
- Contents of the pack and other information
1. What Abacavir Tarbis is and what it is used for
Abacavir Tarbis is used in the treatment of HIV (human immunodeficiency virus) infection.
Abacavir Tarbis contains the active substance abacavir. Abacavir belongs to a group of antiretroviral medicines known as nucleoside reverse transcriptase inhibitors (NRTIs).
Abacavir Tarbis 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 Tarbis in the same way. Your doctor will monitor the effectiveness of your treatment.
2. What you need to know before taking Abacavir Tarbis
Do not take Abacavir Tarbis
- if you are allergic (hypersensitive) to abacavir (or to any other medicine containing abacavir — such as Triumeq, Trizivir or Kivexa) or to any of the other ingredients of this medicine (listed in section 6).
Please read carefully all the information about hypersensitivity reactions in section 4 of this leaflet.
Consult your doctor if you think any of the following circumstances apply to you.
Take special care with Abacavir Tarbis
Some people taking Abacavir Tarbis for HIV have a higher risk of developing serious side effects. You should be aware that the risk is greater:
- 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.
Consult your doctor 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 severe allergic reaction).
Please read carefully the information on hypersensitivity reactions in section 4 of this leaflet.
Risk of cardiovascular events
It cannot be ruled out that abacavir may increase the risk of cardiovascular events.
Inform your doctor if you have cardiovascular problems, if you smoke, or if you have conditions 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 do so.
Be alert to important symptoms
Some people taking medicines for HIV infection develop other illnesses, which may be serious. You need to know which important signs and symptoms to watch for while taking Abacavir Tarbis.
Read the information on “Other possible side effects of combination HIV treatment” in section 4 of this leaflet.
Protect others
HIV infection is transmitted through sexual contact with someone who has the infection or through transfer of infected blood (for example, by sharing needles). While taking this medicine, you may still transmit HIV to others, although effective antiretroviral treatment reduces the risk. Consult your doctor about which precautions are necessary to avoid infecting others.
Taking Abacavir Tarbis with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might take 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 on Abacavir Tarbis.
Some medicines interact with Abacavir Tarbis
These include:
- phenytoin, used to treat epilepsy.
Inform your doctor if 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 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.
Inform your doctor if you are taking methadone.
Pregnancy
The use of Abacavir Tarbis during pregnancy is not recommended. Abacavir Tarbis and similar medicines may cause adverse effects in babies during pregnancy. If you have taken Abacavir Tarbis during your 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 was greater than the risk of adverse effects occurring.
Breast-feeding
Women infected with HIV must not breast-feed their children, because HIV infection can pass to the baby through breast milk. A small amount of the components of Abacavir Tarbis 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
Do not drive or operate machinery unless 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
Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, please consult your doctor or pharmacist again.
Swallow the tablets with a little water. Abacavir Tarbis can be taken with or without food.
If you are unable to swallow the tablets whole, you may 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 still develop other infections and illnesses associated with HIV infection.
Stay in contact with your doctor and do not stop taking Abacavir Tarbis without first speaking to your doctor.
Dosage
Adults, adolescents, and children weighing at least 25 kg:
The usual dose of Abacavir Tarbis is 600 mg daily. This may be taken as one 300 mg tablet twice daily, or two 300 mg tablets once daily.
Children aged one year and older weighing less than 25 kg
The dose depends on your child's body weight. The recommended dose is:
-
Children weighing at least 20 kg up to less than 25 kg: The usual dose of Abacavir Tarbis is 450 mg daily. This may 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 daily, as directed by your doctor.
-
Children weighing at least 14 kg up to less than 20 kg: The usual dose of Abacavir Tarbis is 300 mg daily. This may be administered as 150 mg (half a tablet) twice daily, or 300 mg (one whole tablet) once daily, as directed by your doctor.
The tablet may be divided into equal doses.
An oral solution (20 mg abacavir/mL) is available for the treatment of children older than three months and weighing less than 14 kg, as well as for patients requiring 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 department for further advice.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Abacavir Tarbis
If you forget to take a dose, take it as soon as you remember, and then continue with your regular dosing schedule.
Do not take a double dose to make up for missed doses.
It is important to take Abacavir Tarbis regularly, as irregular intake of Abacavir Tarbis may increase the risk of developing a hypersensitivity reaction.
If you have stopped treatment with Abacavir Tarbis
If for any reason you have stopped taking Abacavir Tarbis — especially because you think you are experiencing side 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 advised that you must never take Abacavir Tarbis or any other medicine containing abacavir (e.g. Triumeq, Trizivir or Kivexa) again. It is important that you follow this warning.
If your doctor advises restarting 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.
4. Possible adverse effects
During HIV treatment, there may be an increase in body weight and in blood glucose and lipid levels. This may be partly related to the recovery of health and lifestyle, and in the case of blood lipids, sometimes to the anti-HIV medications themselves. Your doctor will monitor these changes.
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
When undergoing HIV treatment, it may be difficult to distinguish whether a symptom is an adverse effect of Abacavir Tarbis or of other medicines you are taking, or is due to the disease itself caused by HIV. Therefore, it is very important that you inform your doctor about any change in your health.
Even patients who do not carry the HLA-B*5701 gene may develop a hypersensitivity reaction (a severe allergic reaction), described in this leaflet in the section called “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 AbacavirTarbis, other disorders may develop during combination antiretroviral therapy.
It is important that you read the information under the section “Other possible adverse effects of combination antiretroviral therapy”.
Hypersensitivity reactions
AbacavirTarbis contains abacavir (the active substance also present in Trizivir, Triumeq and Kivexa).
Abacavir may cause a serious allergic reaction known as a hypersensitivity reaction. These hypersensitivity reactions have been observed more frequently in people taking medications containing abacavir.
Who experiences these reactions?
Any person taking Abacavir Tarbis could develop a hypersensitivity reaction to abacavir, which could be life-threatening if you continue taking AbacavirTarbis.
Your risk of developing this reaction is higher if you carry a gene called HLA-B*5701 (but you may still have this reaction even if you do not carry this gene). Before starting treatment with Abacavir Tarbis, you should have been tested for this gene. If you know you carry this gene, tell your doctor before taking AbacavirTarbis.
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 rash.
Other commonly observed signs include:
•nausea (feeling unwell), vomiting, diarrhea, abdominal pain (stomach), and excessive fatigue.
Other possible symptoms may include:
J oint or muscle aches, 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?
Allergic reactions may occur at any time during treatment with Abacavir Tarbis, but are most likely to occur within the first 6 weeks of treatment.
If you are caring for a child being treated with AbacavirTarbis, it is important that you understand the information about this hypersensitivity reaction. If the child develops the symptoms described below, it is essential that you follow the instructions provided.
Contact your doctor immediately:
1if you develop a 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 general aches and discomfort.
Your doctor may advise you to stop taking AbacavirTarbis.
While taking AbacavirTarbis, always carry your Patient Information Card with you.
If you have stopped taking AbacavirTarbis
If you have stopped taking Abacavir Tarbis due to a hypersensitivity reaction, NEVER take AbacavirTarbis or any other medicine containing abacavir again (e.g., Trizivir, Triumeq or Kivexa). 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 Tarbis — 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 link, you will be advised never to take AbacavirTarbis or any other medicine containing abacavir again (e.g., Trizivir, Triumeq or Kivexa). It is important that you follow this warning.
Occasionally, hypersensitivity reactions have occurred in people who restart abacavir after having experienced only one symptom listed on the Patient Information Card before stopping.
Very rarely, patients who previously took abacavir-containing medicines without hypersensitivity symptoms have developed a hypersensitivity reaction upon re-exposure.
If your doctor advises restarting treatment with Abacavir Tarbis, you may be asked to take the first doses in a setting where immediate medical assistance is available, if needed.
If you are hypersensitive to AbacavirTarbis, you must return all unused AbacavirTarbis tablets for safe disposal. Consult your doctor or pharmacist.
The Abacavir Tarbis packaging includes a Patient Information Card to remind you and healthcare professionals about hypersensitivity reactions. Separate the card from the packaging and always carry it with you.
Frequent adverse effects
May affect up to 1 in 10 patients:
- hypersensitivity reaction
- nausea
- headache
- vomiting
- diarrhea
- loss of appetite
- fatigue, lack of energy
- fever (elevated temperature)
- rash.
Rare adverse effects
May affect up to 1 in 1,000 patients:
- inflammation of the pancreas (pancreatitis).
Very rare adverse effects
May affect up to 1 in 10,000 patients:
- skin rash that may blister and resemble small targets (a dark center surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
- widespread blistering rash with peeling of the skin, 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.
If you experience adverse effects
Consult your doctor or pharmacist if you experience adverse effects, even if they are not listed in this leaflet.
Other possible adverse effects of combination antiretroviral therapy
Combination treatments, including Abacavir Tarbis, may cause other conditions to develop 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). When these individuals start treatment, previously hidden infections may flare up, causing signs and symptoms of inflammation. These symptoms are likely due to an improved immune response, enabling the body to fight these infections. Symptoms usually include fever, along with one or more of the following:
- headache
- stomach pain
- difficulty breathing.
In rare cases, as the immune system becomes stronger, it may also attack healthy body tissue (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 movement or agitation)
- weakness starting in the hands and feet and moving toward the body trunk.
If you notice any signs of infection while taking Abacavir Tarbis:
Inform your doctor immediately. Do not take any other medication for infection without your doctor's advice.
You may have problems with your bones
Some patients receiving combination antiretroviral therapy develop a bone disease called osteonecrosis. In this condition, part of the bone tissue dies due to reduced blood supply to the bone. The risk of developing this disease is higher in people who:
- have been on combination therapy for a long time
- also take anti-inflammatory medicines called corticosteroids
- drink alcohol
- have a severely weakened immune system
- 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 adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Abacavir 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 refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to a SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of AbacavirTarbis
The active substance is abacavir. Each tablet contains 300 mg of abacavir.
The other components are: microcrystalline cellulose, sodium starch glycolate from potato, magnesium stearate and anhydrous colloidal silica in the tablet core. The coating contains poly(vinyl alcohol)-partially hydrolysed (E1203), titanium dioxide (E171), talc (E553b), yellow iron oxide (E172) and macrogol (E1521).
Appearance of AbacavirTarbis and contents of the pack
Film-coated tablets of AbacavirTarbis are yellow, biconvex, capsule-shaped, marked with "H" on one side and with "A" and "26" on either side of the breakline on the other side. They are supplied in blister packs containing 60 tablets.
Marketing Authorisation Holder and Manufacturer(s)
Marketing Authorisation 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
The Netherlands
Date of the most recent review of this leaflet: November 2023
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/