INFORMATION FOR CONSUMERS
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Please read this leaflet carefully before you start taking 3TC tablets or oral solution.
This leaflet answers some common questions about 3TC. It does not contain all of the available information.
It does not take the place of talking to your doctor or pharmacist.
3TC contains the active ingredient lamivudine, which belongs to a group of medicines called antiretrovirals.
Please note that the active ingredient in 3TC, lamivudine, is also available as a combination medicine, Combivir™ , containing another antiretroviral medicine called zidovudine.
3TC is used, in combination with other antiretrovirals, for the treatment of HIV infected adults and children.
3TC does not cure AIDS or HIV infection, but slows down production of human immunodeficiency virus. In this way it stops ongoing damage to the body's immune system, which fights infection.
3TC does not reduce your risk of passing HIV infection to others. You will still be able to pass on the HIV virus by sexual activity or by passing on blood or body secretions which carry the HIV virus. You should continue to take all the appropriate precautions.
While taking 3TC and/or any other therapy for HIV disease, you may continue to develop further infections and other complications of HIV disease. You should keep in regular contact with your doctor.
The long term risks and benefits of taking 3TC are not known.
Your doctor may have prescribed 3TC for another reason. Ask your doctor if you have any questions about why 3TC has been prescribed for you.
3TC is not addictive.
Your doctor may discuss with you the risks and benefits of taking 3TC if you are pregnant or breastfeeding.
If you have certain health conditions, your doctor may advise that you take a lower dose of 3TC. Ask your doctor if you are not sure whether you should take 3TC.
If you're not sure whether you should be taking 3TC tablets or oral solution, talk to your doctor.
If you have a long-standing viral infection of your liver called hepatitis B, it may flare up when you stop taking 3TC. This can cause serious illness, particularly if your liver is already not working very well. If you have both HIV and hepatitis B virus, when you stop taking your 3TC tablets or oral solution, your doctor is likely to arrange tests from time to time to check how well your liver is working and to measure your virus levels.
Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.
Tell your doctor if you are taking an antibacterial (antibiotic) medicine called trimethoprim (Triprim™) used for urinary tract infection. Trimethoprim is also used in combination with another antibacterial medicine called sulphamethoxazole (co-trimoxazole, also known as Bactrim™, Septrin™, Trimel™, Trisul™) used to treat Pneumocystis carinii lung infection.
Your doctor or pharmacist will be able to tell you what to do when taking 3TC tablets or oral solution with other medicines.
3TC can be used in children. The 3TC oral solution is particularly suitable for younger children.
Your doctor will tell you how many 3TC tablets or how much 3TC oral solution to take and how often.
You will also find this information on the labelling of your medicine.
Do not take or give extra 3TC tablets or oral solution. Do not take 3TC or any medicine more often than you have been told.
For adults and children over 12 years of age:
3TC tablets: The usual dose is 300mg of lamivudine daily. This can be taken as one, 150mg tablet twice daily or two 150mg tablets, once daily.
3TC oral solution: The usual dose is 15ml (containing lamivudine 150mg, the same amount as one 3TC tablet) twice daily or 30mL (containing lamivudine 300mg) once daily.
For children aged three months to 12 years, the recommended dose is 4mg per kilogram of body weight twice daily, up to a maximum of 300mg daily. The daily dose of 3TC will be calculated by your child's doctor.
The recommended dose for 3TC is reduced in people with kidney disease and depends on how well their kidneys are working.
3TC tablets should be swallowed with a drink of water.
3TC oral solution should be swallowed from a spoon able to measure 15ml of fluid.
3TC tablets and oral solution can be taken with or without food.
Because your medicine helps to control your condition but does not cure it, you will need to take 3TC every day. Do not stop taking your medicine without first talking to your doctor.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, then go back to taking it as you would normally.
Do not take a double dose to make up for the one that you missed.
Immediately telephone your doctor or Poisons Information Centre (0800 POISON, 0800 764 766) or go to the accident and emergency department at your nearest hospital, if you think that you or anyone else may have taken too much 3TC. Do this even if there are no signs of poisoning or discomfort. You may need urgent medical attention.
Keep telephone numbers for these places handy.
If you are not sure what to do, contact your doctor or pharmacist.
Tell your doctor or pharmacist that you are taking 3TC tablets or oral solution if you are about to be started on any new medicines,
including medicines you buy from a pharmacy, health food shop or supermarket.
Tell your doctor if you become pregnant or are trying to become pregnant or you are breastfeeding.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise your doctor may think that it is not working for you and change your medicine unnecessarily.
Do not stop taking 3TC tablets or oral solution, or change the dose, without first checking with your doctor.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not use 3TC tablets or oral solution to treat any other complaints unless your doctor says to.
Be careful driving or operating machinery until you know how treatment with 3TC affects you. As with many other medicines, 3TC tablets and oral solution may cause headache and tiredness in some people.
Check with your doctor as soon as possible if you have any problems while taking 3TC tablets or oral solution, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
Like many other medicines, 3TC tablets and oral solution can cause some side effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.
It is not known whether many of these side effects are due to taking 3TC alone or taking 3TC while taking other medicines. Some of these symptoms may also occur as part of HIV infection, AIDS or AIDS-related Complex (ARC).
While you are taking 3TC, it is very important that your doctor keeps a close check on your health and takes blood samples to monitor levels of red and white blood cells. If you develop anaemia (a low red cell count), neutropenia (a low white cell count) or lactic acidosis (a build up of lactic acid in the blood) your doctor may reduce your 3TC dose or stop treatment with 3TC, and recommend standard treatment for these side effects.
Your doctor may also perform tests to ensure that your liver is working properly.
Other side effects include:
If you think that 3TC is causing you to have an allergic (hypersensitivity) reaction, TELL YOUR DOCTOR IMMEDIATELY.
Symptoms of an allergic reaction may be mild or severe. They usually include some or all of the following:
Ask your doctor or pharmacist if you have any questions about the side effects of 3TC tablets or oral solution.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
Ask your doctor or pharmacist if you don't understand something on this list.
Do not be alarmed by this list of side effects. You may not experience any of them.
Keep this medicine where young children cannot reach it. A locked cupboard at least one and a half metres off the ground is a good place to store medicines.
Keep 3TC tablets in a cool, dry place where the temperature stays below 30°C.
Keep your 3TC tablets in their pack until it is time to take them.
If you take 3TC tablets out of their pack they may not work as well.
Keep 3TC oral solution in a cool, dry place where the temperature stays below 25°C.
If you are taking 3TC oral solution, always screw the lid on the bottle after taking your medicine, otherwise it may not work as well.
Discard 3TC oral solution one month after first opening the bottle.
If your doctor tells you to stop taking 3TC tablets or oral solution, or your medicine has passed its expiry date, ask your pharmacist what to do with any leftover medicine.
3TC tablets are white, diamond-shaped, and engraved with GX CJ7 on one side and 3TC on the other side. They come in white bottles, each containing 60 tablets.
3TC oral solution is a colourless to pale yellow, strawberry and vanilla flavoured liquid. It comes in a 240ml white bottle.
Lamivudine 150mg
Microcrystalline cellulose, Sodium starch glycollate, Magnesium stearate,
Hydroxypropylmethyl cellulose, Titanium dioxide, Macrogol, Polysorbate 80
Lamivudine 150mg/10ml
Sucrose (20% w/v), Methylhydroxybenzoate, Propylhydroxybenzoate, Citric acid
anhydrous, Propylene glycol, Sodium citrate, Artificial strawberry flavour,
Artificial banana flavour, Purified water
Your 3TC medicine is distributed by:
GlaxoSmithKline NZ Ltd
Quay Tower
Cnr Albert & Customs Streets
Private Bag 106600
Downtown, Auckland
NEW ZEALAND
Ph: (09) 367 2900
Fax (09) 367 2910
This is not all the information that is available on 3TC tablets and oral solution. If you have any more questions or are not sure about anything, ask your doctor or pharmacist.
Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition. You may also be able to find general information about your disease and its treatment from books in public libraries, or on the Internet.
This leaflet was prepared July 2004, Issue 3. It is copyrighted to GlaxoSmithKline (New Zealand) Ltd and may be reproduced but not altered in any way.
3TC, Retrovir and Combivir are trademarks of the GlaxoSmithKline Group of Companies.