Contains abacavir (as sulfate) and lamivudine
CONSUMER MEDICINE INFORMATION
PATIENTS TAKING ABACAVIR/LAMIVUDINE MYLAN, WHICH CONTAINS ABACAVIR, MAY DEVELOP A HYPERSENSITIVITY REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF TREATMENT WITH ABACAVIR/LAMIVUDINE MYLAN IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE ON WHETHER YOU SHOULD STOP TAKING ABACAVIR/LAMIVUDINE MYLAN IF:
1) YOU GET A SKIN RASH OR
2) YOU GET ONE OR MORE SYMPTOMS FROM AT LEAST TWO OF THE FOLLOWING GROUPS:
FEVER
SHORTNESS OF BREATH, SORE THROAT OR COUGH
NAUSEA OR VOMITING OR DIARRHOEA OR ABDOMINAL PAIN
SEVERE TIREDNESS OR ACHINESS OR GENERALLY ILL FEELING
IF YOU HAVE HAD A HYPERSENSITIVITY (ALLERGIC) REACTION TO ABACAVIR/LAMIVUDINE MYLAN TABLETS, NEVER TAKE ABACAVIR/LAMIVUDINE MYLAN, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR AGAIN AS YOU MAY DEVELOP A LIFE THREATENING REACTION WHICH CAN BE FATAL.
THERE IS AN ALERT CARD INCLUDED IN THE ABACAVIR/LAMIVUDINE MYLAN PACK, TO REMIND YOU AND MEDICAL STAFF ABOUT ABACAVIR HYPERSENSITIVITY. THIS CARD SHOULD BE REMOVED FROM THE PACK AND KEPT WITH YOU AT ALL TIMES. SEE MORE DETAILS UNDER BEFORE YOU TAKE ABACAVIR/LAMIVUDINE MYLAN.
What is in this leaflet
Please read this leaflet carefully before you start ABACAVIR/LAMIVUDINE MYLAN tablets.
This leaflet answers some common questions about ABACAVIR/LAMIVUDINE MYLAN tablets. It does not contain all of the available information.
It does not take the place of talking to your doctor or pharmacist (also known as a chemist).
All medicines have benefits and risks. Your doctor has weighed the expected benefits of you taking ABACAVIR/LAMIVUDINE MYLAN tablets against the risks this medicine could have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the tablets.
You may need to read it again.
What ABACAVIR/LAMIVUDINE MYLAN tablets are used for
ABACAVIR/LAMIVUDINE MYLAN tablets contain abacavir and lamivudine which belong to a group of medicines called antiretrovirals.
These are also available as separate medicinal products.
ABACAVIR/LAMIVUDINE MYLAN tablets are used together with other antiretrovirals to slow down the progression of human immunodeficiency virus (HIV) infection, which can lead to Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses (e.g. AIDS-related Complex or ARC).
ABACAVIR/LAMIVUDINE MYLAN tablets do not cure AIDS or kill the HIV virus, but delays further damage to the immune system by stopping production of new viruses.
ABACAVIR/LAMIVUDINE MYLAN tablets do not reduce the risk of passing the infection to others. You will still be able to pass on the HIV virus by sexual activity or by contamination with infected blood. You should still use proper precautions to prevent this.
While taking ABACAVIR/LAMIVUDINE MYLAN tablets and/or any other therapy for HIV disease, you may continue to develop other infections and other complications of HIV infection. You should keep in regular contact with the doctor who is looking after you.
ABACAVIR/LAMIVUDINE MYLAN tablets are not addictive.
Before you take ABACAVIR/LAMIVUDINE MYLAN tablets
Do not take if:
You must not take ABACAVIR/LAMIVUDINE MYLAN tablets if:
you have ever had an allergic reaction to abacavir
you are allergic to the active ingredient lamivudine or any of the other ingredients listed toward the end of this leaflet.
you have a serious liver disease ABACAVIR/LAMIVUDINE MYLAN may not be suitable for you.
Special Warning
ABACAVIR/LAMIVUDINE MYLAN contains abacavir. Abacavir can cause a serious allergic reaction known as a hypersensitivity reaction, which can be life-threatening if treatment with abacavir containing products is not stopped.
Research has found that people with a gene called HLA-B (type 5701) are more likely to have a hypersensitivity reaction to abacavir. However, even if you do not have this gene type it is still possible for you to get this reaction. If you know you have this gene type, be sure to tell your doctor before you take abacavir.
The most common symptoms of this reaction include high temperature (fever) and a skin rash. Other most frequently seen symptoms include nausea, vomiting, diarrhoea or abdominal pain; severe tiredness or body aches or generally feeling ill; headache; shortness of breath, sore throat or cough. If you develop any of these symptoms call your doctor IMMEDIATELY WHO WILL ADVISE YOU WHETHER YOU SHOULD STOP TAKING ABACAVIR/LAMIVUDINE MYLAN tablets. If your doctor is not available you must urgently seek other medical advice (e.g. the Accident and Emergency unit of the nearest hospital) before taking the next dose.
Other symptoms may include joint or muscle pain, swelling of the neck or itchy skin. Occasionally inflammation of the eye (conjunctivitis), ulcers in the mouth, tingling or numbness of the hands or feet or low blood pressure may occur. The symptoms of this allergic reaction can occur at any time during treatment with ABACAVIR/LAMIVUDINE MYLAN tablets. However they usually occur in the first six weeks of treatment, and get worse with continued treatment.
If you have had this serious reaction to ABACAVIR/LAMIVUDINE MYLAN tablets, NEVER take ABACAVIR/LAMIVUDINE MYLAN or any other medicinal product containing abacavir again as within hours you may experience a life-threatening lowering of your blood pressure or death.
Occasionally life threatening hypersensitivity reactions have occurred when ABACAVIR/LAMIVUDINE MYLAN tablets was restarted in patients who reported only one of the symptoms on the Alert Card before stopping.
On very rare occasions, hypersensitivity has been reported when ABACAVIR/LAMIVUDINE MYLAN tablets were restarted in patients who had no symptoms of hypersensitivity before stopping.
If you have stopped taking ABACAVIR/LAMIVUDINE MYLAN tablets for any reason it is important that you contact your doctor before restarting. This is especially so if you think you are having side-effects from other medicines or have another illness. Your doctor will check whether any symptoms you had before stopping may be related to this hypersensitivity reaction. If your doctor thinks there is a possibility that they were related, you may be told never to take ABACAVIR/LAMIVUDINE MYLAN tablets again. It is important that you follow this advice.
If you are hypersensitive to ABACAVIR/LAMIVUDINE MYLAN tablets you should return all of your unused ABACAVIR/LAMIVUDINE MYLAN tablets to your doctor or pharmacist for proper disposal.
You must not take ABACAVIR/LAMIVUDINE MYLAN tablets if:
you had a previous allergic reaction to ABACAVIR/LAMIVUDINE MYLAN tablets or other abacavir containing products
you are pregnant, think you may be pregnant or are breastfeeding, unless your doctor tells you to
the expiry date (EXP.) printed on the pack has passed
the packaging is torn or shows signs of tampering.
You must tell your doctor if:
you are allergic to foods, dyes, preservatives or any other medicines
you have any other illness
you are taking any other medicines, including medicines you buy without a prescription from a supermarket or health food shop.
Abacavir or lamivudine in ABACAVIR/LAMIVUDINE MYLAN tablets may interact with certain other medicines. ABACAVIR/LAMIVUDINE MYLAN tablets should not be taken with zalcitabine or emtricitabine.
Some medicines may affect how ABACAVIR/LAMIVUDINE MYLAN works, or make it more likely that you'll have side effects. These medicines include:
trimethoprim-sulphamethoxazole (also known as co-trimoxazole), (an antibiotic used to treat PCP - Pneumocystis carinii pneumonia or toxoplasmosis).
If you are taking methadone, your doctor may need to adjust your methadone dose, as abacavir increases the rate at which methadone leaves your body. This is unlikely to affect most methadone users.
How do I take ABACAVIR/LAMIVUDINE MYLAN tablets?
How much to take
Take ABACAVIR/LAMIVUDINE MYLAN tablets as directed by your doctor or pharmacist. The normal dose for adults and adolescents is one tablet once a day. Your doctor may prescribe a different dosage.
How to take them
ABACAVIR/LAMIVUDINE MYLAN tablets should be swallowed whole with water. ABACAVIR/LAMIVUDINE MYLAN tablets do not have to be taken with food.
How long to take them for
Because your medicine helps to control your condition, but does not cure it, you will need to take the tablets every day. Do not stop taking ABACAVIR/LAMIVUDINE MYLAN tablets or change the dose without first talking to your doctor.
What do I do if I take too much? (Overdose)
If you think you or anyone else may have taken too many ABACAVIR/LAMIVUDINE MYLAN tablets, immediately telephone your doctor.
If you are not sure what to do, contact your doctor or pharmacist.
While you are taking ABACAVIR/LAMIVUDINE MYLAN tablets
Things you must do
Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.
Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
If you forget to take them
It is important to take this medicine as prescribed to ensure you get maximum benefit. If you forget to take a dose, take it as soon as you remember, and then continue as before.
Do not take more than one tablet to make up for the doses you have missed.
If you have stopped taking them
If you have stopped taking ABACAVIR/LAMIVUDINE MYLAN tablets for any reason, it is important that you contact your doctor before restarting. This is especially so if you think you are having side-effects or have another illness. In some cases your doctor will ask you to restart ABACAVIR/LAMIVUDINE MYLAN tablets where medical care can be readily accessed by yourself or others.
Things you must not do
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not use ABACAVIR/LAMIVUDINE MYLAN tablets to treat any other complaints unless your doctor tells you to.
If you have hepatitis B infection, you should not stop ABACAVIR/LAMIVUDINE MYLAN tablets without instructions from your doctor, as you may have a recurrence of your hepatitis. This may occur due to you suddenly stopping lamivudine.
Things to be careful of
Be careful driving or operating machinery until you know how ABACAVIR/LAMIVUDINE MYLAN tablets affect you.
No studies on the effects of ABACAVIR/LAMIVUDINE MYLAN tablets on the ability to drive and use machines have been performed. However, you should take into account the state of your health and the possible side effects of ABACAVIR/LAMIVUDINE MYLAN tablets before considering driving or using machines.
What are the side-effects?
Check with your doctor as soon as possible if you think you are experiencing any side-effects or allergic reactions while taking ABACAVIR/LAMIVUDINE MYLAN tablets, even if the problem is not listed in this leaflet.
Like all medicines, ABACAVIR/LAMIVUDINE MYLAN tablets can cause some side-effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and may need medical attention.
Hypersensitivity Reaction
ABACAVIR/LAMIVUDINE MYLAN contains abacavir.
Abacavir can cause a serious allergic reaction known as a hypersensitivity reaction, which can be life-threatening if treatment with abacavir containing products is not stopped. This is described in the section "Special warning" under "Before you take ABACAVIR/LAMIVUDINE MYLAN tablets", of this leaflet.
It is important that you read and understand the information about this serious reaction.
As ABACAVIR/LAMIVUDINE MYLAN tablets contains both abacavir and lamivudine, the side effects reported for each of these have been combined.
The most common side-effects (could affect at least one to ten in every 100 people) are:
nausea, vomiting
diarrhoea
upper abdominal pain
headache
high temperature
lethargy, fatigue, loss of appetite
hair loss
joint and muscle pain
abacavir hypersensitivity
skin rash (without any other illness).
Uncommon side-effects (could affect less than one in every 100 people) are:
increases in enzymes produced by the liver
anaemia (low red blood cell count)
neutropenia (low white blood cell count)
reduction in the number of platelets (blood cells important for blood clotting).
If the production of red blood cells is reduced, you may have symptoms of tiredness or breathlessness.
A reduction in your white blood cell count can make you more prone to infection. If you have a low platelet count, you may notice that you bruise more easily.
Rare side-effects (could affect less than one in every 1,000 people) are:
breakdown of muscle tissue, increases of an enzyme called amylase
inflammation of the pancreas (pancreatitis).
Very rare side-effects (could affect less than one in every 10,000 people) are:
serious skin reactions
severe anaemia.
Changes in fat distribution have been reported in association with antiretroviral medicines. These may include:
loss of fat from legs, arms and face
increased fat in the abdomen (belly) and other internal organs, breasts and back of the neck.
Changes in the amounts of fatty substances and glucose in the blood have also been reported. Within the first few weeks of treatment with anti-HIV medicines, some people, particularly those that have been HIV positive for some time, may develop inflammatory reactions (e.g. pain, redness, swelling, high temperature) which may resemble an infection and may be severe. It is thought that these reactions are caused by a recovery in the body's ability to fight infections, previously suppressed by HIV. If you become concerned about any new symptoms, or any changes in your health after starting HIV treatment, please discuss with your doctor immediately.
In babies and infants exposed to Nucleoside Reverse Transcriptase Inhibitors (NRTIs) during pregnancy or labour small temporary increases in blood levels of a substance called lactate have been observed. Additionally there have been very rare reports of diseases that affect the nervous system such as a delayed development and seizures. Overall, in children whose mothers took NRTIs during pregnancy, the benefit from the reduced chance of being infected with HIV is likely to be greater than the risk of suffering from side effects.
Call your doctor IMMEDIATELY if you notice any of the following. The doctor will tell you whether you should stop taking ABACAVIR/LAMIVUDINE MYLAN tablets and what you should do:
Lactic Acidosis
Some people taking ABACAVIR/LAMIVUDINE MYLAN, or other medicines like it (NRTIs), develop a condition called lactic acidosis, together with an enlarged liver.
Lactic acidosis is caused by a build-up of lactic acid in the body. It is rare; if it happens, it usually develops after a few months of treatment. It can be life-threatening, causing failure of internal organs.
Lactic acidosis is more likely to develop in people who have liver disease, especially in women.
Signs of lactic acidosis include:
deep, rapid, difficult breathing
drowsiness
numbness or weakness in the limbs
feeling sick (nausea), being sick (vomiting)
stomach pain.
Allergic (anaphylactic) reaction
The symptoms of an allergic (anaphylactic) reaction which may occur soon after starting ABACAVIR/LAMIVUDINE MYLAN include wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash (hives) or fainting.
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). When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are probably caused by the body's immune system becoming stronger, so that the body starts to fight these infections.
Your body shape may change
People taking combination therapy for HIV may find that their body shape changes, because of changes in fat distribution:
Fat may be lost from the legs, arms or face.
Extra fat may build up around the stomach, or on the breasts or internal organs.
Fatty lumps (sometimes called buffalo hump) may appear on the back of the neck.
It is not yet known what causes these changes, or whether they have any long-term effects on your health.
This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known.
Do not be alarmed by this list of possible side-effects. You may not experience any of them.
How do I store ABACAVIR/LAMIVUDINE MYLAN tablets?
Keep this medicine where children cannot reach it, such as a locked cupboard.
Keep ABACAVIR/LAMIVUDINE MYLAN tablets in a cool, dry place where it stays below 25°C.
Do not store the tablets, or any other medicine, in a bathroom or near a sink.
Do not leave them in the car or on window sills.
Keep your ABACAVIR/LAMIVUDINE MYLAN tablets in their pack until you take them.
If your doctor tells you to stop taking ABACAVIR/LAMIVUDINE MYLAN tablets, or the tablets have passed their expiry date, return any unused or expired medicine to your pharmacist.
Product description
What ABACAVIR/LAMIVUDINE MYLAN tablets look like
The tablets are white, film-coated, modified capsule shaped, biconvex tablet debossed with AL12 on one side of the tablet and M on the other side.
ABACAVIR/LAMIVUDINE MYLAN tablets are supplied in blister packs containing 30 tablets.
Ingredients
ABACAVIR/LAMIVUDINE MYLAN tablets contain 600 mg of abacavir as the sulfate salt and 300 mg of lamivudine.
Your tablets also contain the following inactive ingredients:
microcrystalline cellulose
crospovidone
magnesium stearate
silicified microcrystalline cellulose
colloidal
anhydrous silica
talc
Tablet coating OPADRY II complete film coating system 13B58894 White (ARTG No. 13119) containing: hypromellose, titanium dioxide, macrogol 400 and polysorbate 80.
