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Epilim IV by Levone


									Epilim IV®
Sodium Valproate
Consumer Medicine Information
                                        liquid when the medicine cannot be      cause difficulty in swallowing or
What is in this leaflet                 given by mouth.                         breathing.
This leaflet answers some common        Your doctor, however, may have
questions about Epilim IV.              prescribed Epilim IV for another        Before you are given it
                                        reason.                                 Tell your doctor if you have
It does not contain all of the
available information.                  Ask your doctor if you have any         allergies to:
                                        questions about why it has been         • any of the ingredients listed at
It does not take the place of talking
                                        prescribed for you.                         the end of this leaflet
to your doctor or pharmacist.
                                        There is no evidence that Epilim IV     • any other medicines
All medicines have risks and
benefits. Your doctor has weighed
                                        is addictive.                           • any other substances, such as
the risks of using Epilim IV against    This medicine is available only with        foods, preservatives or dyes
the benefits it is expected to have     a doctor’s prescription.                If you are a female patient of
for you.                                                                        child-bearing age, make sure that
                                                                                you talk to your doctor about the
If you have any concerns about
                                                                                risks associated with taking
taking this medicine, ask your
                                                                                Epilim during pregnancy.
doctor or pharmacist.                   Before you are given
                                                                                Tell your doctor if you are
Keep this leaflet with the              it                                      pregnant or intend to become
You may need to read it again.          When you must not receive               Like most medicines of this kind,
                                        it                                      Epilim may affect your developing
                                                                                baby if taken in the first trimester of
                                        You should not receive Epilim IV        pregnancy, as it is suspected of
                                        if you have or have had any of the      causing an increased risk of
What Epilim IV is                       following medical conditions:           malformations in the exposed
used for                                • liver disease (hepatic                foetus.
                                            dysfunction) or severe hepatitis.
                                                                                Your doctor will discuss the risks
Epilim IV is a medicine used to for     • a family history of hepatitis,        and benefits of taking it if you are
the treatment of epilepsy in adults         especially when caused by           pregnant.
and children.                               medicines. Medicines used in
                                            the treatment of epilepsy,          Tell your doctor if you are
Epilepsy is a condition where you
                                            including Epilim IV may have        breastfeeding or planning to
have repeated seizures (fits). There
                                            adverse effects on the liver and    breastfeed.
are many different types of seizures,
                                            the kidneys.                        Medicines used in the treatment of
ranging from mild to severe.
                                                                                epilepsy, including Epilim, pass into
Epilim IV belongs to a group of         • a urea cycle disorder or a family
                                                                                breast milk. Your doctor will
medicines called anticonvulsants.            history of urea cycle disorders.
                                                                                discuss the risks and benefits of
These medicines are thought to          • a family history of unexplained       taking it if you are breastfeeding or
work by controlling brain chemicals          infant deaths.                     planning to breastfeed.
which send signals to nerves so that    • porphyria which is a rare blood       Tell your doctor if you drink
seizures do not happen.                      disease of blood pigments          alcohol. If you have more than 2
Epilim IV may also be used to           • known ornithine                       drinks per day, you may be
control mania, a mental condition           transcarbamylase deficiency or a    putting yourself at risk of a
with episodes of overactivity,              family history of ornithine         seizure, or fit.
elation or irritability or to control       transcarbamylase deficiency.        Tell your doctor if you have or
bipolar mood disorder where             You should not be given Epilim          have had any medical conditions,
periods of mania alternate with         IV if you are allergic to it or any     especially the following:
periods of depression.                  of the ingredients listed at the end    • liver problems (hepatic
Epilim IV may be used alone or in       of this leaflet.                             insufficiency, hepatic damage)
                                        Some symptoms of an allergic
combination with other medicines                                                • kidney problems
to treat your condition.                reaction include skin rash, itching,
                                        shortness of breath or swelling of      • urea cycle disorders
Epilim IV may be used short-term        the face, lips or tongue, which may     • ornithine transcarbamylase
in place of oral Epilim tablets or                                                   (OTC) deficiency

Epilim IV CMI                                     #77119v3.0                                                   Page 1
Tell your doctor if you plan to         medicines before they are given         will decide on the treatment
have surgery.                           Epilim, for example, aspirin or         necessary.
If you have not told your doctor        any other drugs used to treat
about any of the above, tell them       epilepsy.
before you are given Epilim.            Children, especially young children,
                                        can be more sensitive to some of the    While you are
Taking other medicines                  side effects of Epilim.
                                                                                receiving it
Tell your doctor or pharmacist if       Your doctor and pharmacist have
you are taking any other                more information on medicines to
                                        be careful with or avoid while being    Things to be careful of
medicines, including any that you
buy without a prescription from         given Epilim.                           Be careful when driving or
your pharmacy, supermarket or                                                   operating machinery until you
health food store.                                                              know how Epilim IV affects you.
Some medicines and Epilim IV may                                                It may cause drowsiness in some
interfere with each other. These        How it is given                         people. Make sure you know how
include:                                                                        you react to Epilim IV before you
                                                                                drive a car, operate machinery or do
• aspirin (and other salicylates)       Epilim IV will be given to you as an
                                        infusion or injection into the veins.   anything else that could be
• medicines used to prevent clots                                               dangerous if you are drowsy or light
    (anticoagulants) e.g. warfarin.     Adults:                                 headed.
• other medicines used to treat         If you are currently taking an oral     The effects of alcohol could be
    epilepsy e.g. phenobarbitone,       formulation of Epilim (tablets,         made worse while you are
    methylphenobarbitone,               liquid or syrup) and are now            receiving Epilim IV.
    primidone, phenytoin,               changing over to Epilim IV, the         Combining it and alcohol can make
    carbamazepine, clonazepam,          total daily dose of Epilim IV should    you more sleepy, dizzy or
    felbamate, lamotrigine,             remain the same. In these               lightheaded. Your doctor may
    diazepam, lorazepam,                circumstances, Epilim IV may be         suggest you avoid alcohol while you
    oxcarbamazepine and                 given as several separate injections,   are treated with Epilim.
    ethosuximide                        drips or infusions throughout the
• medicines used to treat               day, or as one long continuous drip
    depression e.g. monoamine           or infusion lasting 24 hours a day.
    oxidase inhibitors (MAOIs),         If you are not currently taking
    selective serotonin reuptake        Epilim or any other form of sodium
                                                                                Side effects
    inhibitors (SSRIs), tricyclic       valproate by mouth, your doctor
    antidepressants                                                             All medicines have some unwanted
                                        will decide what dose you will
• oral contraceptives. Epilim IV                                                side effects. Sometimes they are
                                        receive, depending on your
    should have little effect on the                                            serious, but most of the time they
                                        condition and other factors such as
    oral contraceptive pill, however,                                           are not. Your doctor or pharmacist
                                        your weight.
    you should let your doctor know                                             has weighed the risks of using this
                                        Children:                               medicine against the benefits they
    that you are taking it
                                        The dose for children is usually 20     expect it will have for you.
• zidovudine (a medicine used to
                                        to 30mg for each kg of body weight      Do not be alarmed by this list of
    treat viral infections)
                                        every day. If epilepsy is not           possible side effects.
• antipsychotic medicines               controlled the dose may be              You may not experience any of
    including clozapine (a medicine     increased up to 40mg for each kg of     them.
    used to treat schizophrenia)        body weight every day, as long as
                                                                                Tell your doctor or nurse as soon
• mefloquine (a medicine used to        blood tests are done to check the
                                                                                as possible if you do not feel well
    treat malaria)                      amount of Epilim IV in the blood. If
                                                                                while Epilim IV is being given to
• cimetidine (used to treat             higher doses are needed, further
    stomach ulcers)                     blood tests must be done to check
                                        that Epilim IV is not causing side      Tell your doctor if you notice any
• erythromycin and carbapenem                                                   of the following and they worry
    antibiotics such as Invanz and                                              you:
                                        If you take too much                    • nausea or vomiting
These medicines and others may be
                                        (overdose)                              • abdominal cramps
affected by Epilim IV, or may affect
how well it works. You may need         Your doctor will decide what dose       • changes in appetite
different amounts of your medicine,     of Epilim IV you need, and this will    • changes in your weight
or you may need to take different       be given under close supervision,       • diarrhoea
medicines. Your doctor or               usually in a hospital setting.          • headache
pharmacist will advise you.
                                        The risk of an overdosage in these      • tremor
Tell your doctor or pharmacist if       circumstances is low. In the event of
your child is taking any other          an overdose occurring, your doctor

Epilim IV CMI                                       #77119v3.0                                                 Page 2
• unsteadiness when walking,
    dizziness or light-headedness
                                       After receiving it
                                                                              Epilim IV is supplied in New
• depression                           If you have any queries about any      Zealand by:
• hair loss                            aspect of your medicine, or any        sanofi-aventis new zealand limited
• feeling tired or drowsy              questions regarding the                Level 8, James & Wells Tower
These are the more common side         information in this leaflet, discuss
                                                                              56 Cawley Street
effects of Epilim IV. Mostly these     them with your doctor or
                                       pharmacist.                            Ellerslie
are mild and short-lived.
Tell your Doctor immediately or        Storage
go to the Accident and Emergency                                              Telephone:         (09) 580 1810
department of your nearest             If you need to store Epilim IV         This document was prepared in May
hospital if you have any thoughts      before taking it to hospital, make     2009.
of harming yourself or                 sure it is stored in a dry place
                                       where the temperature does not         Australian Register Numbers:
committing suicide.
                                       exceed 25oC.                           AUST R 104416
Tell your doctor immediately if                                               ®
you notice any of the following:       Do not store it or any other               Registered trademark
• more frequent or more severe         medicine in the bathroom, near a
   seizures (fits)                     sink, or on a windowsill.
• blood clotting problems              Do not leave it in the car.
• spontaneous bruising or              Heat and damp can destroy some
   bleeding                            medicines.
• skin rashes                          Keep it where children cannot
• signs of liver problems such as      reach it.
                                       A locked cupboard at least one and
   vomiting, loss of appetite,
                                       a half metres above ground is a
   generally feeling unwell,
   tiredness, yellowing of the skin    good place to store medicines.
   and/or eyes, dark urine or blood
   in urine, pain in the abdomen       Disposal
• swelling of the feet and legs,       If your doctor tells you to stop
   weight increase due to fluid        taking Epilim, or the medicine
   build up                            has passed its expiry date, ask
• fainting                             your pharmacist what to do with
                                       any that are left over.
• bizarre behaviour
• suicidal thoughts                    Return any unused medicine to
                                       your pharmacist.
• suicide attempts
• severe upper stomach pain, often
   with nausea, vomiting and/or
   loss of appetite especially when
   prolonged                           Product description
These are serious side effects. You
may need urgent medical attention.     What it looks like
These serious side effects are rare.   Epilim IV comes as a white powder
Tell your doctor if you notice         in a glass vial.
anything else that is making you       Each box of Epilim IV contains one
feel unwell.                           glass vial and one ampoule of
Other side effects not listed above    solvent (water for injections).
may also happen in some patients.
Some of these side effects can only    Ingredients
be found when your doctor does
tests from time to time to check       Each vial contains the active
your progress.                         ingredient sodium valproate 400mg.
Ask your doctor to answer any
questions you may have.
                                       Epilim IV is supplied in Australia
                                       sanofi-aventis australia pty ltd
                                       12-24 Talavera Road
                                       Macquarie Park NSW 2113

Epilim IV CMI                                     #77119v3.0                                                 Page 3

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