contains the active ingredient lamivudine
CONSUMER MEDICINE INFORMATION
What is in this leaflet
Please read this leaflet carefully before you start LAMIVUDINE VIATRIS tablets.
This leaflet answers some common questions about LAMIVUDINE VIATRIS tablets. It does
not contain all 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. Some new risks are found even when a medicine
has been used for many years. Your doctor has weighed the risks of you taking LAMIVUDINE
VIATRIS tablets against the expected benefits expected 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 LAMIVUDINE VIATRIS tablets are used for
LAMIVUDINE VIATRIS tablets contain lamivudine which belongs to a group of medicines
called antivirals.
Lamivudine 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 (e.g. AIDS-related Complex or ARC).
Lamivudine does not cure AIDS or kill the HIV virus, but prevents further damage to
the immune system by stopping production of new viruses.
You can still pass on HIV when taking this medicine, although the risk is lowered
by effective antiretroviral therapy. Discuss with your doctor the precautions needed
to avoid infecting other people.
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 LAMIVUDINE VIATRIS 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.
LAMIVUDINE VIATRIS tablets are not addictive.
Ask your doctor if you have any questions about why LAMIVUDINE VIATRIS tablets have
been prescribed for you.
Before you take LAMIVUDINE VIATRIS tablets
When you must not take them
Do not take LAMIVUDINE VIATRIS tablets 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 LAMIVUDINE VIATRIS tablets 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 LAMIVUDINE VIATRIS tablets
if you are pregnant or breast feeding.
Do not use LAMIVUDINE VIATRIS tablets to treat any other conditions unless your doctor
says that you should do so.
Do not give LAMIVUDINE VIATRIS tablets to anyone else, even though their symptoms
may sound similar to yours.
Do not take LAMIVUDINE VIATRIS tablets after the expiry or "use by" date (EXP) printed
on the pack.
If you take if after the expiry date has passed, it may not work as well.
Do not take LAMIVUDINE VIATRIS tablets if the packaging is torn or shows signs of
tampering.
If you're not sure whether you should be taking LAMIVUDINE VIATRIS tablets talk to
your doctor.
Before you start to take them
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
risks 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 LAMIVUDINE VIATRIS tablets
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 LAMIVUDINE
VIATRIS tablets, 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 that 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 LAMIVUDINE VIATRIS tablets with other medicines.
How to take LAMIVUDINE VIATRIS tablets
Your doctor will tell you how many LAMIVUDINE VIATRIS tablets to take and how often
to take them. You will also find this information on the label of your medicine.
Do not take extra tablets. Do not take the tablets more often than you have been told.
How much to take
Adults and adolescents 12 years and older the usual dose is one 150 mg tablet twice
a day or 300 mg once a day. Your doctor may prescribe a different dosage.
For younger children between 3 months to 12 years of age the dose of LAMIVUDINE VIATRIS
will depend on their weight in kilograms (kg). If you are giving LAMIVUDINE VIATRIS
tablets to a child, follow your doctor's instructions.
How to take them
LAMIVUDINE VIATRIS tablets should be swallowed whole with a glass of water. If you
cannot swallow the tablet(s), you may crush and combine them with a small amount of
food or drink, and take all the dose immediately.
How long to take them
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 your medicine without first
talking to your doctor.
If you forget to take them
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 the Poisons Information Centre (telephone 13
11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you
think you or anyone else may have taken too many LAMIVUDINE VIATRIS tablets. 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 LAMIVUDINE VIATRIS tablets
Things you must do
Tell your doctor or pharmacist that you are taking LAMIVUDINE VIATRIS tablets 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 LAMIVUDINE VIATRIS tablets 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 LAMIVUDINE VIATRIS tablets to treat any other complaints unless your doctor
tells you to.
Things to be careful of
Be careful driving or operating machinery until you know how LAMIVUDINE VIATRIS tablets
affects you.
Side effects
Check with your doctor as soon as possible if you have any problems while taking LAMIVUDINE
VIATRIS tablets, even if you do not think the problems are connected with the medicine
or are not listed in this leaflet.
Like all medicines, LAMIVUDINE VIATRIS tablets 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
Changes in fat distribution have been reported in association with combination antiretroviral
therapy. These may include:
loss of body fat from areas such as legs, arms and face.
increased fat appearing in areas such as abdomen (belly) and other internal organs,
breasts and the back of the neck.
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
(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 of the 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 LAMIVUDINE VIATRIS TABLETS and tell your doctor IMMEDIATELY or
go to the nearest accident and emergency department at your nearest hospital:
skin troubles such as lumpy skin rash or "hives".
swelling of the 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 LAMIVUDINE VIATRIS TABLETS and tell your doctor IMMEDIATELY or
go to the nearest 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
LAMIVUDINE VIATRIS tablets 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 a 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 LAMIVUDINE
VIATRIS tablets.
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 LAMIVUDINE VIATRIS tablets. 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 LAMIVUDINE VIATRIS tablets
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 medicines.
Keep LAMIVUDINE VIATRIS tablets in a cool dry place where the temperature stays below
30°C.
Do not store the tablets 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.
Keep your LAMIVUDINE VIATRIS tablets in the bottle with the cap tightly closed until
you take them.
If you take LAMIVUDINE VIATRIS tablets out of their pack they may not keep well.
Disposal
If your doctor tells you to stop taking LAMIVUDINE VIATRIS tablets or the tablet have
passed their expiry date, ask your pharmacist what to do with any tablets left over.
Product description
What LAMIVUDINE VIATRIS tablets looks like
LAMIVUDINE VIATRIS lamivudine 150 mg tablets are white to off-white film-coated, capsule
shaped, biconvex tablets debossed with "M105" on one side of the tablet and a score
line on the other side.
LAMIVUDINE VIATRIS lamivudine 300 mg tablets are white to off-white, film-coated,
oval shaped, biconvex tablets debossed with "M300" on one side of the tablet and blank
on the other side.
LAMIVUDINE VIATRIS 150 mg is available in bottles of 60 tablets.
LAMIVUDINE VIATRIS 300 mg is available in bottles of 30 tablets.
Ingredients
LAMIVUDINE VIATRIS tablets contain either 150 mg or 300 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 03H58736 White (ARTG PI No.: 106640).
Supplier
LAMIVUDINE VIATRIS tablets are 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
Further Information
This is not all the information that is available on LAMIVUDINE VIATRIS tablets. 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.
Australian registration numbers:
LAMIVUDINE VIATRIS lamivudine 150 mg film-coated tablet bottle: AUST R 167591
LAMIVUDINE VIATRIS lamivudine 300 mg film-coated tablet bottle: AUST R 167594
This leaflet was prepared in
August 2023.
LAMIVUDINE VIATRIS_cmi\Aug23/00