NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
3TC ORAL SOLUTION
lamivudine
Consumer Medicine Information
What is in this leaflet?
Please read this leaflet carefully before you start 3TC oral solution.
This leaflet answers some common questions about 3TC oral solution. 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. Sometimes new risks are found even when a medicine has been used for many years. Your doctor has weighed the risks of you taking 3TC against the expected benefits it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the oral solution.
You may need to read it again.
What 3TC oral solution is used for
3TC oral solution contains lamivudine which belongs to a group of medicines called antivirals.
3TC is used together with other antivirals to slow down the progression of human immunodeficiency virus (HIV) infection, which can lead to Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses (eg AIDS-related Complex or ARC).
3TC does not cure AIDS or kill the HIV virus, but prevents further damage to the immune system by stopping production of new viruses.
3TC does 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.
While taking 3TC 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.
3TC oral solution is not addictive.
Your doctor may have prescribed 3TC oral solution for another reason.
Ask your doctor if you have any questions about why 3TC oral solution have been prescribed for you.
Before you take 3TC oral solution
When you must not take it
Do not take 3TC oral solution if you have ever had an allergic reaction to lamivudine or any of the ingredients listed at the end of this leaflet.
Read the Side Effects section to find out symptoms of allergy.
Do not take 3TC oral solution if you are pregnant, trying to become pregnant or breastfeeding, unless your doctor says you should.
Your doctor will discuss the risks and benefits of using 3TC oral solution if you are pregnant or breastfeeding.
Do not use 3TC oral solution to treat any other conditions unless your doctor says that you should do so.
Do not give 3TC oral solution to anyone else, even though their symptoms may sound similar to yours.
Do not take 3TC oral solution after the expiry or “use by” date (EXP) printed on the pack.
If you take it after the expiry date has passed, it may not work as well.
Do not take 3TC oral solution if the packaging is torn or shows signs of tampering.
If you’re not sure whether you should be taking 3TC oral solution, talk to your doctor.
Before you start to take it
You must tell your doctor if:
you are allergic to foods, dyes, preservatives or any other medicines.
you have, or have ever had, liver problems, for example jaundice, hepatitis, virus affecting the liver, enlarged liver or liver scarring (cirrhosis) or if you have any risk factors for liver problems, e.g. excessive alcohol intake, illegal intravenous drug use with shared equipment, iron or copper storage disorders
you have, or have ever had, kidney problems.
you have, or have ever had, problems with your pancreas.
you have diabetes.
you have any other illness, including those that you think are not related to HIV infection.
When you stop taking 3TC Oral solution
If you have a long-standing viral infection of your liver (hepatitis B) it may flare up.This can cause serious illness particularly if your liver is already not working very well.If you have both HIV and hepatitis B, when you stop taking your 3TC oral solution, your doctor is likely to arrange tests from time to time to check how well your liver is working and to measure virus levels.
Taking other medicines
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.
Some medicines may affect the way others work.Your doctor or pharmacist will be able to tell you what to do when taking 3TC oral solution with other medicines.
How to take 3TC oral solution
Your doctor will tell you how much 3TC oral solution to take or give and how often to take or give it.You will also find this information on the label of your medicine.
Do not take or give extra solution.Do not take or give the solution more often than you have been told.
How much to take
Adults and adolescents 12 years and older the normal dose is 15 mL of solution twice a day.Your doctor may prescribe a different dosage.
For younger children between 3 months to 12 years of age the dose of 3TC will depend on their weight in kilograms (kg). If you are giving 3TC oral solution to a child, follow your doctor’s instructions.
How to take it
3TC oral solution can be swallowed with a glass of water, if desired.
How long to take it
Because your medicine helps to control your condition, but does not cure it, you will need to take the solution every day.Do not stop taking your medicine without first talking to your doctor.
If you forget to take it
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 dose that you missed.
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 131126), or go to accident and emergency at your nearest hospital, if you think you or anyone else may have taken too many 3TC oral solution.Do this even if there are no signs of discomfort or poisoning.This 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.
While you are taking 3TC oral solution
Things you must do
Tell your doctor or pharmacist that you are taking 3TC oral solution if you are about to be started on any other medicines.
Tell your doctor if you become pregnant or are trying to become pregnant.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
Things you must not do
Do not stop taking 3TC 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 oral solution to treat any other complaints unless your doctor says to.
Things to be careful of
Be careful driving or operating machinery until you know how 3TC oral solution affects you.
If you are diabetic, blood sugar levels should be monitored, as each adult dose (15 mL) contains 3g of sugar.
Side-Effects
Check with your doctor as soon as possible if you have any problems while taking 3TC oral solution, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
Like all medicines, 3TC 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.
Tell your doctor or pharmacist if you notice any of the following and they worry you.
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
hair loss
joint and muscle pain
skin rash (without any other illness).
increased bruising or bleeding
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)
lactic acidosis
Very rare side-effects (could affect less than one in every 10,000 people) are:
unusual feelings in any part of the body, such as numbness, burning, tingling or pins and needles
numbness or weakness of the arms and legs
severe anaemia
Fat loss or fat gain has been observed with combined antiretroviral therapy. A causal relationship for this has not been established. Should any change in body shape be noticed, seek medical advice.
Other effects may show up in blood tests including increased blood levels of sugar, fatty acids (triglycerides) and cholesterol.
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 (eg 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.
Ask your doctor or pharmacist to answer any questions you may have.
Some people are allergic to medicines.
If you have any of the following symptoms soon after starting to take your medicine, DO NOT TAKE ANY MORE 3TC ORAL SOLUTION and tell your doctor IMMEDIATELY or go to the accident and emergency department at your nearest hospital:
Skin troubles such as lumpy skin rash or “hives”.
Swelling of the eyelids, face, lips, mouth or throat which may cause difficulty in swallowing or breathing.
Wheezing, chest pain or tightness.
Fainting.
These are very serious side effects. If you have them, you may have a serious allergic reaction. You may need urgent medical attention or hospitalisation. All these side effects are very rare.
If you have any of the following symptoms soon after starting to take your medicine, DO NOT TAKE ANY MORE 3TC ORAL SOLUTION and tell your doctor IMMEDIATELY or go to the accident and emergency department at your nearest hospital:
Severe stomach pain or cramps.
Nausea.
Vomiting.
These side effects may be due to a condition called pancreatitis.
If you are on medication for HIV and become very sick, with fast breathing, stop taking 3TC oral solution and consult your doctor immediately. You may have a condition known as “lactic acidosis”. The fast breathing is due to high acid levels in the blood. Your liver may not be working properly and gets big and fatty. This can be life threatening. This illness occurs more often in women than men.
See your doctor if you feel generally unwell with loss of appetite, nausea, vomiting, itching, yellowness of the skin or eyes or dark coloured urine, or if the blood tests of your liver function are abnormal. It is likely you will have to stop taking 3TC oral solution.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
Some people may get other side effects while taking 3TC oral solution. If you are concerned, talk to your doctor or pharmacist.
Ask your doctor or pharmacist if you don’t understand anything in this list.
Do not be alarmed by this list of possible side-effects. You may not experience any of them.
After taking 3TC oral solution
Storage
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a half metres above the ground is a good place to store it.
Keep 3TC oral solution in a cool, dry place at or below 25°C.
Do not store the oral solution, or any other medicine, in a bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep your 3TC oral solution in the bottle with the cap tightly closed until you take or give it.
If you take 3TC oral solution out of its pack it may not keep well.
Disposal
If your doctor tells you to stop taking 3TC oral solution, or the oral solution has passed its expiry date, ask your pharmacist what to do with any oral solution left over.
Product description
What 3TC oral solution looks like.
3TC oral solution is a clear, colourless to pale yellow solution with strawberry and banana flavours.
3TC oral solution is supplied in a white high-density polyethylene bottle, with a plastic cap.The bottle contains 240 mL of solution for oral use only and is in a carton.
Ingredients
3TC oral solution contains 10 mg/mL lamivudine.Your solution also contains the following inactive ingredients:
Sugar (20% sucrose), methyl hydroxybenzoate (218), propyl hydroxybenzoate (216), citric acid, sodium citrate dihydrate, propylene glycol, purified water, and artificial strawberry and banana flavouring.
Manufacturer
ViiV Healthcare Pty Ltd
Level 4,
436 Johnston Street,
Abbotsford, Victoria, 3067
Australia.
Further Information
This is not all the information that is available on 3TC 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 the individual advice you need.You may also be able to find out more information about your disease from books, for example in public libraries.
Counselling is also available from your local AIDS council.
Do not throw this leaflet away.
You may need to read it again.
This leaflet was prepared on
26 June 2017
The information provided applies only to: 3TC oral solution.
Trade marks are owned by or licensed to the ViiV Healthcare group of companies.
3TC oral solution: AUST R 64346
© 2017 ViiV Healthcare group of companies or its licensor.
Version 6.0
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