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Abacavir/Lamivudine SUN 600 mg/300 mg film-coated tablets
Abacavir/Lamivudine 600 mg/300 mg film-coated tablets
abacavir/lamivudine
Abacavir/Lamivudine contains abacavir (which is also an active substance in medicines such as Kivexa, Trizivir, Triumeq and Ziagen). Some people who take abacavir may develop a hypersensitivity reaction (a serious allergic reaction), which can be life-threatening if they continue to take abacavir containing products.
You must carefully read all the information under ‘Hypersensitivity reactions’ in the panel in Section 4.
The Abacavir/Lamivudine pack includes an Alert Card, to remind you and medical staff about abacavir hypersensitivity. Detach this card and keep it with you at all times.
1. What Abacavir/Lamivudine is and what it is used for
2. What you need to know before you take Abacavir/Lamivudine
3. How to take Abacavir/Lamivudine
4. Possible side effects
5. How to store Abacavir/Lamivudine
6. Contents of the pack and other information
Abacavir/Lamivudine is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents and in children weighing at least 25 kg.
Abacavir/Lamivudine contains two active ingredients that are used to treat HIV infection: abacavir and lamivudine. These belong to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Abacavir/Lamivudine does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection.
Not everyone responds to treatment with Abacavir/Lamivudine in the same way. Your doctor will monitor the effectiveness of your treatment.
Some people taking Abacavir/Lamivudine or other combination treatments for HIV are more at risk of serious side effects. You need to be aware of the extra risks:
Talk to your doctor if any of these apply to you before using Abacavir/Lamivudine. You may need extra check-ups, including blood tests, while you are taking your medicine. See Section 4 for more information.
Abacavir hypersensitivity reactions
Even patients who don’t have the HLA-B*5701 gene may still develop a hypersensitivity reaction (a serious allergic reaction).
Carefully read all the information about hypersensitivity reactions in Section 4 of this leaflet.
It cannot be excluded that abacavir may increase the risk of having cardiovascular events.
Tell your doctor if you have cardiovascular problems, if you smoke, or have other illnesses that may increase your risk of cardiovascular diseases such as high blood pressure, or diabetes. Do not stop taking Abacavir/Lamivudine unless your doctor advises you to do so.
Some people taking medicines for HIV infection develop other conditions, which can be serious. You need to know about important signs and symptoms to look out for while you are taking Abacavir/Lamivudine.
Read the information ‘Other possible side effects of combination therapy for HIV’ in Section 4 of this leaflet.
Tell your doctor or pharmacist if you are taking any other medicines, or if you have taken any recently, including herbal medicines or other medicines you bought without a prescription.
Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Abacavir/Lamivudine.
These medicines should not be used with Abacavir/Lamivudine:
Tell your doctor if you are being treated with any of these.
Some medicines interact with Abacavir/Lamivudine
These include:
Abacavir/Lamivudine is not recommended for use during pregnancy. Abacavir/Lamivudine and similar medicines may cause side effects in unborn babies.
If you have taken Abacavir/Lamivudine during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Breast-feeding
Breast-feeding is not recommended in women living with HIV, because HIV infection can be passed on to the baby in breast milk. A small amount of the ingredients in Abacavir/Lamivudine can also pass into your breast milk.
If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.
Abacavir/Lamivudine may cause side effects which could affect your ability to drive or use machines.
Talk to your doctor about your ability to drive or operate machines while taking Abacavir/Lamivudine.
Abacavir/Lamivudine contains a colouring called sunset yellow (E110), this may cause allergic reactions in some people.
This medicine contains less than 1 mmol sodium (23 mg) per film coated tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose of Abacavir/Lamivudine for adults, adolescents and children weighing 25 kg or more is one tablet once a day.
Swallow the tablets whole, with some water. Abacavir/Lamivudine can be taken with or without food.
Abacavir/Lamivudine helps to control your condition. You need to keep taking it every day to stop your illness getting worse. You may still develop other infections and illnesses linked to HIV infection.
Keep in touch with your doctor, and do not stop taking Abacavir/Lamivudine without your doctor’s advice.
If you accidentally take too much Abacavir/Lamivudine, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before.
Do not take a double dose to make up for a forgotten dose.
It is important to take Abacavir/Lamivudine regularly, because if you take it at irregular intervals, you may be more likely to have a hypersensitivity reaction.
If you have stopped taking Abacavir/Lamivudine for any reason —especially because you think you are having side effects, or because you have other illness:
Talk to your doctor before you start taking it again. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If the doctor thinks they may have been related, you will be told never again to take Abacavir/Lamivudine, or any other medicine containing abacavir (e.g. Kivexa, Trizivir, Triumeq or Ziagen). It is important that you follow this advice.
If your doctor advises that you can start taking Abacavir/Lamivudine again, you may be asked to take your first doses in a place where you will have ready access to medical care if you need it.
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.
Like all medicines, this medicine can cause side effects, although not everyone gets them.
When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Abacavir/Lamivudine or other medicines you are taking, or an effect of the HIV disease itself. So it is very important to talk to your doctor about any changes in your health.
Even patients who don’t have the HLA-B*5701 gene may still develop a hypersensitivity reaction (a serious allergic reaction), described in this leaflet in the panel headed ‘Hypersensitivity reactions’.
It is very important that you read and understand the information about this serious reaction.
As well as the side effects listed below for Abacavir/Lamivudine, other conditions can develop during combination therapy for HIV.
It is important to read the information later in this section under ‘Other possible side effects of combination therapy for HIV’.
Abacavir/Lamivudine contains abacavir (which is also an active substance in medicines such as Kivexa, Trizivir, Triumeq and Ziagen). Abacavir can cause a serious allergic reaction known as a hypersensitivity reaction. These hypersensitivity reactions have been seen more frequently in people taking medicines that contain abacavir.
Who gets these reactions?
Anyone taking Abacavir/Lamivudine could develop a hypersensitivity reaction to abacavir, which could be life threatening if they continue to take Abacavir/Lamivudine.
You are more likely to develop this reaction if you have a gene called HLA-B*5701 (but you can get a reaction even if you do not have this gene). You should have been tested for this gene before Abacavir/Lamivudine was prescribed for you. If you know you have this gene, tell your doctor before you take Abacavir/Lamivudine.
About 3 to 4 in 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 common symptoms are:
Other symptoms include:
Pains in the joints or muscles, swelling of the neck, shortness of breath, sore throat, cough, occasional headaches, inflammation of the eye (conjunctivitis), mouth ulcers, low blood pressure, tingling or numbness of the hands or feet.
When do these reactions happen?
Hypersensitivity reactions can start at any time during treatment with Abacavir/Lamivudine, but are more likely during the first 6 weeks of treatment.
Contact your doctor immediately:
1. if you get a skin rash, OR
2. if you get symptoms from at least 2 of the following groups:
Your doctor may advise you to stop taking Abacavir/Lamivudine.
If you have stopped taking Abacavir/Lamivudine
If you have stopped taking Abacavir/Lamivudine because of a hypersensitivity reaction, you must NEVER AGAIN take Abacavir/Lamivudine, or any other medicine containing abacavir (e.g. Kivexa, Trizivir, Triumeq or Ziagen). If you do, within hours, your blood pressure could fall dangerously low, which could result in death.
If you have stopped taking Abacavir/Lamivudine for any reason —especially because you think you are having side effects, or because you have other illness:
Talk to your doctor before you start again. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If the doctor thinks they may have been, you will then be told never again to take Abacavir/Lamivudine, or any other medicine containing abacavir (e.g. Kivexa, Trizivir, Triumeq or Ziagen). It is important that you follow this advice.
Occasionally hypersensitivity reactions have developed in people who start taking abacavir containing products again, but who had only one symptom on the Alert Card before they stopped taking it.
Very rarely patients who have taken medicines containing abacavir in the past without any symptoms of hypersensitivity have developed a hypersensitivity reaction when they start taking these medicines again.
If your doctor advises that you can start taking Abacavir/Lamivudine again, you may be asked to take your first doses in a place where you will have ready access to medical care if you need it.
If you are hypersensitive to Abacavir/Lamivudine, return all your unused Abacavir/Lamivudine tablets for safe disposal. Ask your doctor or pharmacist for advice.
The Abacavir/Lamivudine pack includes an Alert Card, to remind you and medical staff about hypersensitivity reactions. Detach this card and keep it with you at all times.
Common side effects
These may affect up to 1 in 10 people:
Uncommon side effects
These may affect up to 1 in 100 people and may show up in blood tests:
Rare side effects
These may affect up to 1 in 1000 people:
Rare side effects that may show up in blood tests are:
Very rare side effects
These may affect up to 1 in 10,000 people:
Very rare side effects that may show up in blood tests are:
Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.
Combination therapy such as Abacavir/Lamivudine may cause other conditions to develop during HIV treatment.
Symptoms of infection and inflammation
Old infections may flare up
People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections). Such infections may have been “silent” and not detected by the weak immune system before treatment was started. After starting treatment, the immune system becomes stronger, and may attack the infections, which can cause symptoms of infection or inflammation. Symptoms usually include fever, plus some of the following:
In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders). The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection. Symptoms may include:
If you get any symptoms of infection and inflammation or if you notice any of the symptoms above:
Tell your doctor immediately. Do not take other medicines for the infection without your doctor’s advice.
Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone. People may be more likely to get this condition:
Signs of osteonecrosis include:
If you notice any of these symptoms:
Tell your doctor.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date shown on the carton, bottle and blister, after “EXP”. The expiry date refers to the last day of that month.
Bottles: After the first opening of the bottle, use within 100 days.
Do not store above 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Abacavir/Lamivudine film-coated tablets are orange coloured, capsule shaped tablets, of about 21.4 mm length and 8.3 mm width, debossed with “RF-90” on one side and plain on the other side.
Pack sizes:
Triplex blister pack: PVC/PE/PVDC/Al blister pack containing 30 tablets.
Cold form blister pack: PVC/PA/Al blister pack containing 30 tablets.
HDPE Bottle packs: HDPE bottle with polypropylene screw cap or with child-resistant closure, containing 30 or 90 tablets.
Not all pack sizes may be marketed.
Manufacturer
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
United Kingdom (Northern Ireland) Abacavir/Lamivudine 600 mg/300 mg film-coated tablets
Spain Abacavir/Lamivudina SUN 600 mg/300 mg comprimidos recubiertos con pelicula EFG
Italy Abacavir e Lamivudina SUN
Germany Abacavir/Lamivudin Basics 600 mg/300 mg Filmtabletten
France Abacavir/Lamivudine SUN 600 mg/300 mg comprimé pelliculé
Romania Abacavir/ Lamivudină Terapia 600 mg/300 mg comprimate filmate
This leaflet was last revised in December 2023.
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