lamivudine
Consumer Medicine Information
What is in this leaflet
Please read this leaflet carefully before you take ZETLAM tablets.
This leaflet answers some common questions about ZETLAM.
It does not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking
ZETLAM against the expected benefits for you taking ZETLAM against the risks this
medicine could have for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
What ZETLAM is used for
ZETLAM belongs to a group of medicines called antivirals.
ZETLAM is used to treat patients 2 years of age or over with long term (chronic) viral
infection of the liver caused by hepatitis B.
Hepatitis B is a virus which damages the liver. Treatment with ZETLAM can reduce the
amount of hepatitis B virus in your body. This should lead to less liver damage.
ZETLAM has not been shown to reduce the risk of passing hepatitis B to others. You
will still be able to pass on the hepatitis virus by sexual contact or through your
blood. You should use appropriate precautions.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
It is available only with a doctor's prescription.
If you are already taking this medicine lamivudine for HIV infection (3TC™, Combivir™),
your doctor will continue to treat you with the higher dose for that treatment.
Before you take ZETLAM
Do not take if
Do not take ZETLAM if you have ever had an allergy to:
any medicine containing lamivudine
any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
You must not take ZETLAM if you are taking zalcitabine.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes.
Tell your doctor if you have or have ever had any of the following medical conditions:
kidney problems
pancreas problems
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
Tell your doctor if you are taking any other medicines, including medicines you buy
without a prescription.
Some medicines and ZETLAM may interfere with each other. These include:
zalcitabine, used to treat HIV infection (sometimes called the AIDS virus).
Medicines (usually liquids) containing sorbitol and other sugar alcohols (such as
xylitol, mannitol, lactitol or maltitol.
Other medicines containing lamivudine, used to treat HIV infection (sometimes called
the AIDS virus.
emtricitabine used to treat HIV infection or hepatitis B infection.
cladribine, used to treat hairy cell leukaemia.
If you have not told your doctor about any of the above, tell him/her before you start
taking ZETLAM.
How to take ZETLAM
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box/bottle, ask your doctor or pharmacist
for help.
How much to take
Take ZETLAM as directed by your doctor or pharmacist.
The normal dose for adults and children age 12 years or above, is one 100 mg tablet
once a day.
Your doctor may prescribe a different dosage, for example if you have kidney problems.
Each patient responds to the treatment differently. Your doctor will check you by
taking regular blood samples. The results will help decide when you should stop taking
ZETLAM.
How to take it
Swallow the tablets whole with a glass of water.
For patients who are unable to swallow tablets, the ZETLAM tablets may be crushed
and 100% of the crushed tablets could be added to a small amount of semi-solid food
or liquid, all of which should be consumed immediately.
When to take it
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
It does not matter if you take this medicine before or after food.
How long to take it
In order for ZETLAM to be effective, you must take ZETLAM every day for as long as
your doctor says you should take them.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13
11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you
think that you or anyone else may have taken too much ZETLAM. Do this even if there
are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you are not sure what to do, contact your doctor or pharmacist.
While you are taking ZETLAM
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 working as it should and change your
treatment unnecessarily.
If you forget to take a dose, do not take a double dose to make up for the dose that
you missed.
Things you must not do
Do not take ZETLAM to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine or change the dosage without first checking with
your doctor.
If you stop taking it suddenly, your hepatitis may worsen.
This can cause serious illness particularly if your liver is already not working very
well. If you do have to stop taking ZETLAM your doctor is likely to arrange tests
over the following four months to check how well your liver is working.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well or are
experiencing any side effects or allergic reactions while you are taking ZETLAM.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following list of side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
Headache
Vomiting and Diarrhoea.
Nausea
Fatigue/tiredness.
Abdominal discomfort and pain.
Coughing, with phlegm, not associated with a cold or flu.
Dizziness
Abnormal Liver function tests
Muscle disorders (including muscle pain and cramps).
The above list includes the more common side effects of your medicine.
Tell your doctor immediately if you notice any of the following:
Wheezing, swelling of the lips/ mouth, difficulty in breathing, hay fever, lumpy rash
(hives) or fainting. These could be symptoms of an allergic reaction.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
This is not a complete list of all possible side effects. Others may occur in some
people and there maybe some side effects not yet known.
After taking ZETLAM
Storage
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Keep your tablets in the bottle until it is time to take them.
If you take the tablets out of the bottle they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 30°C.
Do not store ZETLAM or any other medicine in the bathroom or near a sink. Do not leave
it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Disposal
If your doctor tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
ZETLAM lamivudine 100mg tablets are peach coloured, film-coated, capsule shaped, biconvex
bevelled edge tablets, debossed with "LN1" on one side and "M" on the other side.
The tablets are available in bottles of 28 tablets.
Ingredients
ZETLAM contains 100 mg of lamivudine as the active ingredient.
It also contains the following inactive ingredients:
Microcrystalline cellulose
Sodium starch glycollate Type A
Magnesium stearate
Propylene glycol (film coating)
Opadry Complete Film Coating System 03H520008 yellow (ARTG PI No: 107420).
Supplier
ZETLAM is supplied in Australia by:
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
Australian registration numbers:
ZETLAM lamivudine 100 mg
Bottle - AUST R 180504
This leaflet was prepared in March 2023.
ZETLAM® is a Viatris company trade mark
ZETLAM_cmi\Mar23/00