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					3TC(TM) Oral Solution
lamivudine

Consumer Medicine Information




What is in this leaflet?                3TC does not cure AIDS or kill the         become pregnant or
                                        HIV virus, but prevents further            breastfeeding, unless your
                                        damage to the immune system by             doctor says you should.
Please read this leaflet carefully
before you start 3TC oral solution.     stopping production of new viruses.        Your doctor will discuss the risks
                                        3TC does not reduce the risk of            and benefits of using 3TC oral
This leaflet answers some common
                                        passing the infection to others. You       solution if you are pregnant or
questions about 3TC oral solution. It
                                        will still be able to pass on the HIV      breastfeeding.
does not contain all of the available
                                        virus by sexual activity or by          * Do not use 3TC oral solution to
information.
                                        contamination with infected blood.        treat any other conditions
It does not take the place of talking   You should still use proper               unless your doctor says that
to your doctor or pharmacist (also      precautions.                              you should do so.
known as a chemist).
                                        While taking 3TC and/or any other       * Do not give 3TC oral solution
All medicines have benefits and         therapy for HIV disease, you may          to anyone else, even though
risks. Sometimes new risks are          continue to develop other infections      their symptoms may sound
found even when a medicine has          and other complications of HIV            similar to yours.
been used for many years. Your          infection. You should keep in           * Do not take 3TC oral solution
doctor has weighed the risks of you     regular contact with the doctor who       after the expiry or "use by"
taking 3TC against the expected         is looking after you.                     date (EXP) printed on the pack.
benefits it will have for you.
                                        3TC oral solution is not addictive.        If you take it after the expiry date
If you have any concerns about                                                     has passed, it may not work as
                                        Your doctor may have prescribed
taking this medicine, ask your                                                     well.
doctor or pharmacist.                   3TC oral solution for another reason.
                                        Ask your doctor if you have any         * Do not take 3TC oral solution if
Keep this leaflet with the oral                                                   the packaging is torn or shows
solution.                               questions about why 3TC oral
                                        solution have been prescribed for         signs of tampering.
You may need to read it again.          you.                                      If you're not sure whether you
                                                                                  should be taking 3TC oral
                                                                                  solution, talk to your doctor.


                                        Before you take 3TC                     Before you start to take it
What 3TC oral solution                  oral solution                           You must tell your doctor if:
is used for                                                                     * you are allergic to foods, dyes,
                                                                                  preservatives or any other
3TC oral solution contains              When you must not take it
                                                                                  medicines.
lamivudine which belongs to a group     * Do not take 3TC oral solution if      * you have, or have ever had,
of medicines called antivirals.           you have ever had an allergic           liver problems, for example
3TC is used together with other           reaction to lamivudine or any           jaundice, hepatitis, virus
antivirals to slow down the               of the ingredients listed at the        affecting the liver, enlarged
progression of human                      end of this leaflet.                    liver or liver scarring
immunodeficiency virus (HIV)               Read the Side Effects section to       (cirrhosis) or if you have any
infection, which can lead to Acquired      find out symptoms of allergy.          risk factors for liver problems,
Immune Deficiency Syndrome                                                        e.g. excessive alcohol intake,
                                        * Do not take 3TC oral solution if
(AIDS) and other related illnesses                                                illegal intravenous drug use
(eg AIDS-related Complex or ARC).         you are pregnant, trying to



3TC(TM) ORAL SOLUTION                                                                                                 1
    with shared equipment, iron or         How much to take                        While you are taking
    copper storage disorders
                                           Adults and adolescents 12 years and     3TC oral solution
*   you have, or have ever had,
                                           older the normal dose is 15 mL of
    kidney problems.
                                           solution twice a day. Your doctor
*   you have, or have ever had,            may prescribe a different dosage.       Things you must do
    problems with your pancreas.
                                           For younger children between 3          Tell your doctor or pharmacist
*   you have diabetes.
                                           months to 12 years of age the dose of   that you are taking 3TC oral
*   you have any other illness,            3TC will depend on their weight in      solution if you are about to be
    including those that you think         kilograms (kg). If you are giving       started on any other medicines.
    are not related to HIV
                                           3TC oral solution to a child, follow    Tell your doctor if you become
    infection.                             your doctor's instructions.             pregnant or are trying to become
                                                                                   pregnant.
When you stop taking 3TC
                                           How to take it                          Tell your doctor if, for any reason,
Oral solution
                                           3TC oral solution can be swallowed      you have not taken your medicine
If you have a long-standing viral                                                  exactly as prescribed.
                                           with a glass of water, if desired.
infection of your liver (hepatitis B) it
                                                                                   Otherwise, your doctor may think
may flare up. This can cause serious                                               that it was not effective and change
illness particularly if your liver is      How long to take it
                                                                                   your treatment unnecessarily.
already not working very well. If          Because your medicine helps to
you have both HIV and hepatitis B,         control your condition, but does not
when you stop taking your 3TC oral                                                 Things you must not do
                                           cure it, you will need to take the
solution, your doctor is likely to         solution every day. Do not stop         Do not stop taking 3TC oral
arrange tests from time to time to         taking your medicine without first      solution, or change the dose
check how well your liver is working       talking to your doctor.                 without first checking with your
and to measure virus levels.                                                       doctor.
                                           If you forget to take it                Do not give this medicine to
Taking other medicines                                                             anyone else, even if their symptoms
                                           If it is almost time for your next      seem similar to yours.
Tell your doctor if you are taking         dose, skip the dose you missed and
any other medicines, including             take your next dose when you are        Do not use 3TC oral solution to
medicines you buy without a                meant to. Otherwise, take it as         treat any other complaints unless
prescription from a pharmacy,              soon as you remember, then go           your doctor says to.
supermarket or health food shop.           back to taking it as you would
Some medicines may affect the way          normally.                               Things to be careful of
others work. Your doctor or                Do not take a double dose to make
pharmacist will be able to tell you                                                Be careful driving or operating
                                           up for the dose that you missed.
                                                                                   machinery until you know how
what to do when taking 3TC oral
                                                                                   3TC oral solution affects you.
solution with other medicines.
                                           If you take too much                    If you are diabetic, blood sugar levels
                                           (overdose)                              should be monitored, as each adult
                                           Immediately telephone your doctor       dose (15 mL) contains 3g of sugar.

How to take 3TC oral                       or Poisons Information Centre
                                           (telephone 131126), or go to
solution                                   accident and emergency at your
                                           nearest hospital, if you think you      Side-Effects
Your doctor will tell you how much         or anyone else may have taken too
3TC oral solution to take or give and      many 3TC oral solution. Do this         Check with your doctor as soon as
how often to take or give it. You          even if there are no signs of           possible if you have any problems
will also find this information on the     discomfort or poisoning. This may       while taking 3TC oral solution,
label of your medicine.                    need urgent medical attention.          even if you do not think the
Do not take or give extra solution.        Keep telephone numbers for these        problems are connected with the
Do not take or give the solution more      places handy.                           medicine or are not listed in this
                                                                                   leaflet.
often than you have been told.
                                           If you are not sure what to do,
                                                                                   Like all medicines, 3TC oral solution
                                           contact your doctor or pharmacist.
                                                                                   can cause some side-effects. If they


3TC(TM) ORAL SOLUTION                                                                                                     2
occur, they are most likely to be         take your medicine, DO NOT                to stop taking 3TC oral solution.
minor and temporary. However,             TAKE ANY MORE 3TC ORAL
                                          SOLUTION and tell your doctor             Tell your doctor if you notice
some may be serious and need                                                        anything else that is making you
medical attention.                        IMMEDIATELY or go to the
                                          accident and emergency                    feel unwell, even if it is not on this
Tell your doctor or pharmacist if                                                   list.
                                          department at your nearest
you notice any of the following and       hospital:                                 Some people may get other side
they worry you:                                                                     effects while taking 3TC oral
                                          * Skin troubles such as lumpy skin
*   Headache.                                 rash or "hives".                      solution. If you are concerned, talk
*   Diarrhoea.                            * Swelling of the eyelids, face, lips,    to your doctor or pharmacist.
*   Fatigue/tiredness.                        mouth or throat which may cause       Ask your doctor or pharmacist if
*   Abdominal discomfort and                  difficulty in swallowing or           you don't understand anything in
    pain.                                     breathing.                            this list.
* Rash.                                   * Wheezing, chest pain or
                                                                                    Do not be alarmed by this list of
                                              tightness.
* Fever.                                                                            possible side-effects. You may not
                                          * Fainting.
* Unusual feelings in any part of                                                   experience any of them.
                                          These are very serious side effects. If
    the body, such as numbness,           you have them, you may have a
    burning, tingling or pins and         serious allergic reaction. You may
    needles.                              need urgent medical attention or
* Increased bruising or bleeding.         hospitalisation. All these side effects   After taking 3TC oral
Changes in fat distribution have been     are very rare.                            solution
reported in association with
                                          If you have any of the following
combination antiretroviral therapy.       symptoms soon after starting to
These may include:                        take your medicine, DO NOT                Storage
* Loss of body fat from areas such        TAKE ANY MORE 3TC ORAL
                                                                                    Keep this medicine where children
    as legs, arms and face                SOLUTION and tell your doctor             cannot reach it.
* Increased fat appearing in areas        IMMEDIATELY or go to the
                                          accident and emergency                    A locked cupboard at least one-and-a
    such as abdomen (belly) and
                                          department at your nearest                half metres above the ground is a
    other internal organs, breasts and
                                          hospital:                                 good place to store it.
    the back of the neck
Within the first few weeks of             * Severe stomach pain or cramps.          Keep 3TC oral solution in a cool,
treatment with anti-HIV medicines,        * Nausea.                                 dry place at or below 25 degrees C.
some people, particularly those that      * Vomiting.                               Do not store the oral solution, or
have been HIV positive for some           These side effects may be due to a        any other medicine, in a bathroom
time, may develop inflammatory            condition called pancreatitis.            or near a sink.
reactions (eg pain, redness, swelling,
                                          If you are on medication for HIV          Do not leave it in the car or on
high temperature) which may
                                          and become very sick, with fast           window sills.
resemble an infection and may be
                                          breathing, stop taking 3TC oral           Heat and dampness can destroy some
severe. It is thought that these
                                          solution and consult your doctor
reactions are caused by a recovery in                                               medicines.
                                          immediately. You may have a
the body's ability to fight infections,   condition known as "lactic                Keep your 3TC oral solution in the
previously suppressed by HIV. If          acidosis". The fast breathing is          bottle with the cap tightly closed
you become concerned about any            due to high acid levels in the blood.     until you take or give it.
new symptoms, or any changes in           Your liver may not be working
                                                                                    If you take 3TC oral solution out of
your health after starting HIV            properly and gets big and fatty.
                                          This can be life threatening. This        its pack it may not keep well.
treatment, please discuss with your
doctor immediately.                       illness occurs more often in women
                                          than men.                                 Disposal
Ask your doctor or pharmacist to
answer any questions you may              See your doctor if you feel               If your doctor tells you to stop
have.                                     generally unwell with loss of             taking 3TC oral solution, or the
                                          appetite, nausea, vomiting, itching,      oral solution has passed its expiry
Some people are allergic to
                                          yellowness of the skin or eyes or         date, ask your pharmacist what to
medicines.                                dark coloured urine, or if the blood      do with any oral solution left over.
If you have any of the following          tests of your liver function are
symptoms soon after starting to           abnormal. It is likely you will have


3TC(TM) ORAL SOLUTION                                                                                                        3
Product description                       Counselling is also available from
                                          your local AIDS council.
                                          Do not throw this leaflet away.
What 3TC oral solution looks
                                          You may need to read it again.
like.
3TC oral solution is a clear,
                                          This leaflet was prepared on
colourless to pale yellow solution
with strawberry and banana flavours.      24 December 2004

3TC oral solution is supplied in a
white high-density polyethylene           The information provided applies
bottle, with a plastic cap. The bottle    only to: 3TC(TM) oral solution.
contains 240 mL of solution for oral      (TM)3TC is a trade mark of the
use only and is in a carton.              GlaxoSmithKline Group of
                                          Companies.
Ingredients
                                          3TC oral solution: AUST R 64346
3TC oral solution contains 10
mg/mL lamivudine. Your solution
also contains the following inactive      (C) 2003 GlaxoSmithKline
ingredients:                              (3TC Oral Solution Issue Number 8)
Sugar (20% sucrose), methyl
hydroxybenzoate (218), propyl
hydroxybenzoate (216), citric acid
anhydrous, sodium citrate, propylene
glycol, purified water, and artificial
strawberry and banana flavouring.

Manufacturer
Your 3TC oral solution is supplied
by:
GlaxoSmithKline Australia Pty Ltd
1061 Mountain Highway
Boronia
Victoria, 3155
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.


3TC(TM) ORAL SOLUTION                                                          4

				
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Description: 3TC oral solution