Abacavir/lamivudine Dr. Reddy's 600 mg/300 mg film-coated tablets EFG
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Abacavir/Lamivudina Dr. Reddys is and what it is used for
- 2. What you need to know before taking Abacavir/Lamivudina Dr. Reddys
- 3. How to take Abacavir/Lamivudina Dr. Reddys
- 4. Possible adverse effects
- 5. Storage of Abacavir/Lamivudine Dr. Reddy's
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Abacavir/Lamivudine Dr. Reddy's 600 mg/300 mg film-coated tablets EFG
Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. 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. 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
Abacavir/Lamivudine Dr. Reddy's contains abacavir (which is also the active substance in related medicines). 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 Dr. Reddy's 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
- What Abacavir/Lamivudine Dr. Reddy's is and what it is used for
- What you need to know before taking Abacavir/Lamivudine Dr. Reddy's
- How to take Abacavir/Lamivudine Dr. Reddy's
- Possible side effects
- How to store Abacavir/Lamivudine Dr. Reddy's
- Contents of the pack and other information
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1. What Abacavir/Lamivudina Dr. Reddys is and what it is used for
Abacavir/Lamivudina Dr. Reddys is used in the treatment of HIV (human immunodeficiency virus) infection in adults, adolescents, and children weighing at least 25 kg.
Abacavir/Lamivudina Dr. Reddys contains two active substances used to treat HIV infection: abacavir and lamivudina. Both belong to a group of antiretroviral medicines known as nucleoside reverse transcriptase inhibitors (NRTIs).
Abacavir/Lamivudina Dr. Reddys 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 cells that play an important role in helping the body fight infection.
Not everyone responds to treatment with Abacavir/Lamivudina Dr. Reddys in the same way. Your doctor will monitor the effectiveness of your treatment.
2. What you need to know before taking Abacavir/Lamivudina Dr. Reddys
Do not take Abacavir/Lamivudina Dr. Reddys
- if you are allergic (hypersensitive) to abacavir (or to any other medicine containing abacavir, e.g. Trizivir, Triumeq or Ziagen), 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.
Talk to your doctor if you think you have any of these conditions. Do not take Abacavir/Lamivudina Dr. Reddys
Be especially careful with Abacavir/Lamivudina Dr. Reddys
Some people taking Abacavir/Lamivudina or other combination treatments for HIV are at higher risk of serious side effects. You should be aware that the risk is greater:
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if you have moderate or severe liver disease
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if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B, do not stop taking Abacavir/Lamivudina without your doctor's advice, as your condition may worsen)
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if you are significantly overweight (especially if you are female)
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if you have any kidney problems.
Talk to your doctor before starting Abacavir/Lamivudina Dr. Reddys if you have any of these conditions. 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 have the HLA-B*5701 gene can develop a hypersensitivity reaction (a serious allergic reaction).
Read carefully the information on hypersensitivity reactions in section 4 of this leaflet.
Risk of cardiovascular effects
It cannot be ruled out that abacavir may increase the risk of cardiovascular events.
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 this medicine 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/Lamivudina.
Read the information on “Other possible side effects of combination HIV treatment” in section 4 of this leaflet.
Use of Abacavir/Lamivudina Dr. Reddys with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal medicines and those purchased without a prescription.
Remember to inform your doctor or pharmacist if you start taking a new medicine while taking this one.
The following medicines must not be used together with Abacavir/Lamivudina Dr. Reddys:
- Emtricitabine, used to treat HIV infection
- other medicines containing lamivudine, used to treat HIV infection or hepatitis B
- high doses of cotrimoxazole (a combination 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 Dr. Reddys
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 this medicine.
- 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) that carry 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, breastfeeding and fertility
Pregnancy
Use of Abacavir/Lamivudina Dr. Reddys during pregnancy is not recommended. Abacavir/Lamivudina and similar medicines may cause adverse effects in babies during pregnancy.
If you have taken Abacavir/Lamivudina Dr. Reddys during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your baby'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
Breastfeeding is not recommended for women with HIV because HIV infection can be transmitted to the baby through breast milk. A small amount of the components of Abacavir/Lamivudina may also pass into breast milk.
If you are breastfeeding, or have any doubts about breastfeeding, you should discuss this with your doctor as soon as possible.
Driving and using machines
Abacavir/Lamivudina may cause side effects that could affect your ability to drive or operate machinery.
Consult your doctor regarding your ability to drive or operate machines while taking this medicine.
Abacavir/Lamivudina Dr. Reddys contains sunset yellow (E110)
This medicine may cause allergic reactions because it contains a colouring agent called sunset yellow (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially "sodium-free".
3. How to take Abacavir/Lamivudina Dr. Reddys
Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose of this medicine 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 may be taken with or without food.
Keep 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 speaking to your doctor.
If you take more Abacavir/Lamivudina Dr. Reddys than you should
If you accidentally take more Abacavir/Lamivudina Dr. Reddys 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/Lamivudina Dr. Reddys
If you forget to take a dose, take it as soon as you remember, and then continue with your usual treatment schedule. Do not take a double dose to make up for forgotten doses.
It is important to take Abacavir/Lamivudina regularly, as irregular intake of Abacavir/Lamivudina may increase the risk of experiencing a hypersensitivity reaction.
If you stop treatment with Abacavir/Lamivudina Dr. Reddys
If for any reason you have stopped taking Abacavir/Lamivudina, especially because you think you are experiencing side effects or due to another illness:
Consult your doctor before restarting treatment. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If your doctor considers that there may have been a connection, you will be advised never to take Abacavir/Lamivudina or any other medicine containing abacavir again. 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
Like all medicines, this medicine can have adverse effects, although not everyone will experience them.
When undergoing treatment for HIV, it may be difficult to determine whether a symptom is an adverse effect of this medicine, of other medicines you are taking, or 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 this leaflet in the box 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 this medicine, other disorders may develop during combination treatment for HIV.
It is important that you read the information under the section “Other possible adverse effects of combination HIV treatment”.
Hypersensitivity reactions Abacavir/Lamivudine Dr. Reddys contains abacavir (the active ingredient also present in other related medicines). Abacavir can cause a serious allergic reaction known as a hypersensitivity reaction. These hypersensitivity reactions have been observed more frequently in people taking medicines containing abacavir. Who experiences these reactions? Any person taking Abacavir/Lamivudine could develop a hypersensitivity reaction to abacavir, which could be life-threatening if you continue taking Abacavir/Lamivudine. You are more likely to develop this reaction if you have a gene called HLA-B*5701 (but 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 have this gene, tell your doctor before taking Abacavir/Lamivudine. 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:
Other commonly observed signs include:
Other symptoms may include: Joint or muscle pain, swelling of the neck, difficulty breathing, sore throat, cough, occasional headache, eye swelling (conjunctivitis), mouth ulcers, low blood pressure, and tingling or numbness in the hands or feet. When do these reactions occur? Hypersensitivity reactions can 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:
Your doctor may advise you to stop taking Abacavir/Lamivudine Dr. Reddys. If you have stopped taking Abacavir/Lamivudine Dr. Reddys If you have stopped taking Abacavir/Lamivudine due to a hypersensitivity reaction, NEVER take this medicine again or any other medicine containing abacavir. 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 side effects or due to another illness: Consult your doctor before restarting treatment. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If your doctor suspects such a link, you will be advised never to take this medicine or any other medicine containing abacavir again. 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 Information Card before stopping the medicine. Very rarely, reactions have occurred in people who restart abacavir treatment but who had no symptoms of hypersensitivity before stopping the medicine. If your doctor advises restarting treatment with Abacavir/Lamivudine Dr. Reddys, they may ask you to take the first doses in a place where you have immediate access to medical assistance if needed. If you are hypersensitive to Abacavir/Lamivudine, you must return all unused Abacavir/Lamivudine tablets for safe disposal. Speak with your doctor or pharmacist. The packaging of this medicine includes an Information Card to remind you and healthcare professionals about hypersensitivity reactions. Separate the card from the packaging 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)
- diarrhoea
- stomach pain
- loss of appetite
- tiredness, lack of energy
- fever (elevated temperature)
- general feeling of discomfort
- difficulty falling asleep (insomnia)
- muscle pains 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 (anaemia) 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 rupture.
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, skin tingling sensation (pricking)
- feeling of weakness in the limbs
- skin rash, which may form blisters resembling small targets (dark center 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 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 effect not mentioned in this leaflet.
Other possible side effects of combination HIV treatment
Combination treatments, such as Abacavir/Lamivudina, may cause other disorders 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). 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 usually 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 medications to treat HIV infection. Symptoms may include:
- palpitations (fast or irregular heartbeat) or tremor
- hyperactivity (excessive restlessness and movement)
- weakness starting in the hands and feet and moving upwards towards the trunk of the body.
If you notice any symptoms of infection and inflammation or if you notice any of the symptoms listed above:
Inform your doctor immediately. Do not take any other medication for the infection without medical advice.
You may have problems with your bones
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 disease:
- if they have been on combination treatment for a long time
- if they also take anti-inflammatory medicines 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:
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. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Abacavir/Lamivudine Dr. Reddy's
Keep this medicine out of 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. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Abacavir/Lamivudina Dr. Reddys
The active substances in each film-coated tablet of this medicine are 600 mg of abacavir and 300 mg of lamivudina.
The other components are microcrystalline cellulose (E460), sodium carboxymethyl starch (potato Type A), povidone K90 (E1201), magnesium stearate (E470b), hypromellose 5 (E464), macrogol 400 (E1521), titanium dioxide (E171) and sunset yellow FCF (E110).
Appearance of Abacavir/Lamivudina Dr. Reddys and contents of the pack
The tablets are orange-coloured, film-coated, modified capsule-shaped tablets. The dimensions of the tablets are 19.4 mm x 10.4 mm ± 5%.
They are presented in blisters containing 30 tablets and in multi-blister packs containing 90 (3x30) tablets.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder
Reddy Pharma Iberia, S.A.
Avda Josep Tarradellas, nº 38
08029 Barcelona
Spain
Telephone: 93 355 49 16
Fax: 93 355 49 61
Manufacturer
Remedica Limited
Aharnon Street, Limassol Industrial Estate
Limassol, 3056 Cyprus
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Spain: Abacavir/Lamivudina Dr. Reddys 600 mg/300 mg film-coated tablets EFG
Date of the most recent review of this leaflet: January 2024
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/