Reductil 15 Mg by junglesister


									REDUCTIL(R)10mg and
15mg capsules
sibutramine hydrochloride

Consumer Medicine Information

What is in this leaflet                  routine. The intent of Reductil is to     However, there will still be
                                         assist with moderate weight loss over     fluctuations in your weight loss as
Please read this leaflet carefully       6 months (5-10%) - 9 months for           the body uses many mechanisms to
before starting REDUCTIL.                diabetics - when used with a diet and     maintain your weight. This could be
                                         exercise programme. This is in            a reason some people do not achieve
This leaflet answers some common         accordance with modern weight-loss        any benefit from REDUCTIL.
questions about REDUCTIL. It does        practice, which emphasises that
not contain all of the available                                                   REDUCTIL is NOT meant to result
                                         moderate weight loss achieves
information.                                                                       in "overnight" weight-loss. A
                                         significant health improvement.           healthy rate of weight-loss is 0.5kg
It does not take the place of talking    Losing even modest amounts of
                                                                                   to 1kg per week. Even though some
to your doctor or pharmacist.            weight (5-10% of your initial
                                                                                   people notice an effect on the size of
                                         weight) and keeping it off has been       their meals within a few days, it can
All medicines have risks and
                                         found to reduce risks for diseases
benefits. Your doctor has considered                                               take longer for others. Weight loss
                                         such as heart disease and diabetes.
the risks and benefits of you taking                                               normally starts within 2 weeks and
                                         Set yourself realistic goals for weight   continues for up to 6 months
                                         loss and maintenance.
                                                                                   (although in some people eg
If you have any concerns about
                                         For best results, REDUCTIL should         diabetics, it could take longer). Once
taking this medicine, ask your
doctor or pharmacist.                    be used together with a low fat diet      your weight plateaus, continue to
                                         and moderate exercise supervised by       take Reductil, which will help sustain
For information about joining the        your doctor. If this is followed, you     weight loss.
Patient Support Programme, please        should notice some weight loss by
see the section 'How to Join the Free                                              Continuing to take Reductil will help
                                         the end of the first month of             you maintain this new lower weight
Patient Support Programme' at the        treatment. If you have not lost at
end of this leaflet.                                                               and assist to prevent weight being
                                         least 2kg in the first four weeks of
Keep this leaflet with the medicine.     treatment, speak to your doctor.
                                                                                   Reductil is not addictive or habit
You may need to read it again.           REDUCTIL does not work in the             forming and has been approved for
                                         same way as traditional appetite
                                                                                   long-term use in weight
                                         suppressants. It works by altering
                                         the level of two chemicals in the
                                         brain, serotonin and noradrenaline,       REDUCTIL is only available with a
What REDUCTIL is                         which help regulate energy intake         doctor's prescription.
used for                                 and output.                               Ask your doctor if you have any
                                         The result is (1) you will not need to    questions about why REDUCTIL has
REDUCTIL is used to treat very
                                         eat as much during your meals before      been prescribed for you.
overweight (obese) patients who
have not been able to lose weight        you feel full, and (2) Reductil stops
using a low calorie diet and exercise.   your metabolic rate from falling as
                                         much as it normally would.
Your ideal weight may not be
                                         Metabolic rate normally falls during
achieved even with Reductil. For the
                                         weight loss as you reduce your intake
best results Reductil should be used
                                         of food, making it harder to keep
in combination with a calorie
                                         losing weight.
controlled diet and a regular exercise

REDUCTIL(R)                                                                                                             1
What you need to know                   *   the packaging is torn or shows      *   You are taking any medicine
about weight                                signs of tampering or if the            for depression.
management                                  capsules look damaged.                  Check with your doctor or
                                        Do not take REDUCTIL if you have            pharmacist if you are unsure as to
1. Weight reduction is the initial      one of the following medical                whether or not you are taking an
   aim in a weight loss program;        conditions:                                 antidepressant.
   weight maintenance should be         *   You have an eating disorder         *   You are taking another
   the long-term aim                        such as anorexia nervosa or             medicine to lose weight.
2. Please be aware, that if you do          bulimia nervosa.                        This includes over-the-counter
   increase your level of exercise,     *   Your overweight or obesity is           medicines or herbal products.
   your weight reduction may be             due to a disease.
   delayed as the build up of muscle                                            *   You are taking a medicine that
                                        *   You have a psychiatric or
   can override fat reduction.                                                      affects your alertness
                                            mental illness, eg bipolar
3. The body needs to adjust to              disease (manic-depression).             (i.e. keeps you awake or makes
   reduced energy consumption.                                                      you sleepy) e.g. tranquillisers,
                                        *   You have hyperthyroidism
   Therefore if dietary intake is                                                   antidepressants or tryptophan.
                                            (i.e. an overactive thyroid
   reduced too much, hunger pangs
                                            gland).                             If you are not sure whether you
   can result.
                                                                                should start taking REDUCTIL,
4. In women, weight can fluctuate       *   You have high blood pressure
                                                                                talk to your doctor.
   due to water retention during the        not controlled by drugs.
   menstrual cycle.                     *   You have severe liver or kidney
                                                                                Before you start to take
                                        *   You have heart disease caused
                                            by poor blood flow in the blood     Tell your doctor if
Before you take                             vessels of the heart                1. You are allergic to foods, dyes,
REDUCTIL                                    (e.g. angina).                         preservatives or any other
                                        *   You have disease of the heart          medicines.
                                            with shortness of breath, and       2. You are or intend to become
When you must not take
                                            swelling of the feet or legs due       pregnant or breast-feed.
                                            to fluid build up.                      The use of REDUCTIL is not
Do not take REDUCTIL if:                *   You have changes in heart rate          recommended during pregnancy
*   you are elderly (over the age                                                   or breast-feeding.
                                            (fast, slow or irregular).
    65) or a child (under the age of                                            3. You have any medical
    18).                                *   You have had a stroke.
                                                                                   conditions, especially the
                                        *   You have a swelling of the
    There is not enough experience                                                 following:
                                            prostate gland that makes it
    with the use of Reductil in these                                           - high blood pressure
                                            difficult to pass urine.
    groups.                                                                     -   kidney or liver disease
                                        *   You have a tumour of the
*   you have an allergy to                  adrenal gland, which sits near      -   seizures, fits or convulsions
    REDUCTIL or any of the                  the kidney.                         -   motor or verbal tics
    ingredients listed at the end of                                            -   gallstones
                                        *   You have narrow angle
    this leaflet.
                                            glaucoma.                           -   open angle glaucoma
    Symptoms of an allergic reaction
                                            A condition in which the pressure   -   have a family history of raised
    may include an itchy rash and
                                            of fluid in the eye may be high.        pressure in the eye.
    skin blisters.
                                        *   You have a history of drug,         If you have not told your doctor
*   you are or intend to become                                                 about any of the above, tell them
                                            medication or alcohol abuse.
    pregnant or breast-feed.                                                    before you start taking
                                        *   You suffer from Gilles de la
    Like most medicines,                                                        REDUCTIL.
                                            Tourette's syndrome.
    REDUCTIL is not recommended
                                        *   You have had seizures (epilepsy
    for use during pregnancy or                                                 Taking other medicines
                                            or convulsions).
                                        Do not take REDUCTIL if you are         Because weight loss has many
*   the expiry date printed on the      taking one of the following             beneficial effects, it may also affect
    pack has passed.                    medications:                            the dose of medication you take for
                                                                                other conditions such as cholesterol,

REDUCTIL(R)                                                                                                              2
diabetes and thyroid. Make sure you     How to take REDUCTIL                     How long to take REDUCTIL
discuss all the medications that you
                                                                                 Continue taking REDUCTIL for as
are taking with your doctor. Losing
weight may mean your doctor may                                                  long as your doctor tells you.
                                        How much to take
make adjustments to these
medications.                            The usual dosage is one capsule          In case of an overdose
                                        taken once each day.
Tell your doctor or pharmacist if                                                Immediately telephone your doctor
you are taking any other                Follow all directions given to you       or the Poisons Information Centre
medicines, including any that you       by your doctor carefully.                (telephone in Australia 13 11 26, in
buy without a prescription from                                                  New Zealand 0800 POISON or
                                        These directions may differ from the
your pharmacy, supermarket or                                                    0800 764 766) for advice or go to
                                        information contained in this leaflet.
health food store.                                                               Accident and Emergency at your
Some medicines and REDUCTIL             If you do not understand the             nearest hospital if you think that
may interfere with each other.          instructions on the box, ask your        you or anyone else may have taken
                                        doctor or pharmacist for help.           too much REDUCTIL. Do this
These include:
                                                                                 even if there is no sign of
-   ketoconazole, a medicine used to                                             discomfort or poisoning.
    treat fungal infections.
                                        How to take REDUCTIL
                                                                                 You may need urgent medical
-   erythromycin or rifampicin, used    Swallow one capsule whole every
    to treat infections.                day with a glass of water. Start
-   cyclosporin, a medicine used to     with the capsule marked "Begin
    prevent organ transplant            with this capsule" on each tray,
                                        followed, on the next day, with the
    rejections or to treat certain
    problems with the immune
                                        capsule marked with that day of          While you are using
                                        the week. Continue to take one           REDUCTIL
                                        capsule daily until all the capsules
-   carbamazepine, phenobarbitone,      in the tray have been taken. All
    and phenytoin, medicines to treat   capsules are the same. They are
                                                                                 Things you must do
    epilepsy.                           marked with the day of the week to
-   dexamethasone, a medicine used      help you keep track of whether you       Tell your doctor if you experience
    to treat inflammation.              have taken your dose each day.           a rapid onset of shortness of
-   lithium, a medicine used to treat                                            breath.
    mood swings.                        When to take REDUCTIL                    Have your weight checked when
-   tryptophan, an amino acid.          Take REDUCTIL at about the               your doctor requests, to make sure
-   sumatriptan succinate,              same time each day.                      that REDUCTIL is working.
    dihydroergotamine, medicines                                                 Have your blood pressure and
                                        It does not matter if you take
    used to treat migraines.                                                     weight checked when your doctor
                                        REDUCTIL before or after food.
-   medicines used to treat severe                                               requests.
    pain.                                                                        Women should use an effective
                                        If you forget to take
-   certain medicines used to relieve                                            birth control method whilst taking
    symptoms of coughs, colds and                                                REDUCTIL eg the oral
    allergies (e.g.                     If it is almost time for your next       contraceptive pill (the pill). If you
    dextromethorphan).                  dose, skip the dose you missed and       become pregnant while taking
                                        take your next dose when you are         REDUCTIL, stop taking it and tell
-   other medicines used for weight
                                        meant to.                                your doctor immediately.
    loss. This includes
    over-the-counter medicines or       Otherwise, take it as soon as you        Tell all doctors, dentists and
    herbal products.                    remember, and then go back to            pharmacists who are treating you
These medicines may be affected by      taking your medicine as you would        that you are taking REDUCTIL.
REDUCTIL, or may affect how well        normally.                                If you plan to have surgery that
it works. Your doctor will be able to   Do not take a double dose to make        needs a general anaesthetic, tell
tell you what to do when taking         up for the dose that you missed.         your doctor or dentist that you are
REDUCTIL with other medicines.                                                   taking REDUCTIL, as with all
                                        This may increase the chance of you      your other medicines.
Your doctor and pharmacist may
                                        getting an unwanted side effect.
have more information on medicines                                               For best results, REDUCTIL
to be careful with or avoid while       If you are not sure what to do, ask      should be used together with a low
taking REDUCTIL.                        your pharmacist.                         fat diet and moderate exercise.

REDUCTIL(R)                                                                                                           3
Tell your doctor if you feel that       REDUCTIL helps most overweight           Other side effects not listed above
Reductil is not working for you.        people lose weight, but it may have      may occur in some patients. Tell
Tell your doctor if you have not        unwanted side effects in a few           your doctor if you notice anything
taken your medicine exactly as          people. All medicines can have           that is making you feel unwell.
prescribed.                             serious side effects. Some times they    Ask your doctor or pharmacist if you
                                        are serious, most of the time they are   do not understand anything in this
                                        not. You may need medical                list
Things you must not do
                                        treatment if you get some of the side
Do not stop taking REDUCTIL or          effects.
change the dosage without               Ask your doctor to answer any
checking with your doctor.              questions that you may have.             After taking REDUCTIL
Do not give REDUCTIL to anyone
                                        Tell your doctor if you notice any
else, even if they have the same
                                        of the following and they worry
condition as you.
Do not take REDUCTIL to treat           -   dry mouth                            Keep your capsules in the pack
any other complaints unless your                                                 until it is time to take them.
                                        -   headache
doctor tells you.
                                        -   hot flushes                          If you take the capsules out of the
                                        -   constipation                         pack they will not keep well.
Things to be careful of
                                        -   feeling sick, also called nausea     Keep your capsules in a cool dry
Be careful driving or operating                                                  place where the temperature stays
                                        -   haemorrhoids get worse
machinery until you know how                                                     below 25 degrees C.
                                        -   inability to sleep
REDUCTIL affects you.                                                            Do not store REDUCTIL or any
                                        -   dizziness
Like other medicines, REDUCTIL                                                   other medicine in the bathroom or
                                        -   tingling or numbness of the          near a sink.
may cause light-headedness or
                                            hands or feet
dizziness in some people. Make sure                                              Do not leave REDUCTIL in a car
you know how you react to               -   sweating
                                                                                 on hot days or on window sills.
REDUCTIL before you drive a car or      -   loss or change in taste sensation
                                                                                 Heat and dampness can destroy some
operate machinery, or do anything       -   feeling anxious
else that may be dangerous if you are   These side effects are generally not
dizzy or light-headed. If this occurs   serious.                                 Keep it where children cannot
do not drive.                                                                    reach it.
                                        Tell your doctor immediately if
If you drink alcohol,                   you notice any of the following:
light-headedness or dizziness may be                                             Disposal
                                        -   increase in high blood pressure
worse. It is important to remember                                               If your doctor tells you to stop
                                        -   fast or irregular heart beats
that the consumption of alcohol is                                               taking REDUCTIL or the capsules
not consistent with a calorie           -   changes in frequency of urination    have passed their expiry date, ask
controlled weight loss program.             or volume of urine                   your pharmacist what to do with
Your doctor is the best person to       -   unusual bleeding or bruising         any that are left over.
discuss whether you should drink            under the skin
alcoholic beverages while on            -   blurred vision
Reductil.                               -   short-term memory loss
                                        These may be serious side effects.       Product description
                                        You may need urgent medical
                                        attention. Serious side effects are
Side effects                            rare.                                    What REDUCTIL looks like
                                        If any of the following happen, stop     Reductil comes in two types of
Do not be alarmed by this list of                                                capsules:
                                        taking REDUCTIL and tell your
possible side effects. You may not
                                        doctor immediately or go to              Reductil 10mg - blue/yellow capsule
experience any of them.
                                        casualty at your nearest hospital:       with "Reductil" and "10" printed on
Tell your doctor as soon as possible    -   convulsions, fits or seizures        it.
if you do not feel well while taking
REDUCTIL.                               This is a very serious side effect and   Reductil 15mg - blue/white capsule
                                        is very rare. You may need urgent        with "Reductil" and "15" printed on
                                        medical attention or hospitalisation.    it

REDUCTIL(R)                                                                                                            4
Each box contains 30 capsules        How to Join the Free Patient
presented as two "trays" each        Support Programme
containing 15 capsules.
                                     New Balanced Life Patient Support
                                     This is a free Patient Support
Active ingredient:                   Programme available in Australia
Each capsule contains 10mg or 15mg   called the Reductil Balanced Life
of sibutramine hydrochloride.        Programme. This new personalised
                                     programme can assist in giving
Inactive Ingredients:
                                     advice on nutrition, exercise and
*   lactose                          motivation.
*   cellulose - microcrystalline
                                     To register on the web or mail
*   silica colloidal anhydrous       programme please call 1800 021
*   magnesium stearate               194 or visit
*   gelatin                
*   titanium dioxide
*   shellac                          Reductil Weigh of Life
*   lecithin                         Programme (NZ)
*   dimethicone                      There is a free Patient Support
*   sodium lauryl sulfate            Programme in New Zealand called
*   indigo carmine CI73015           the Reductil Weigh of Life. This free
                                     programme is to assist you with your
*   iron oxide black CI77499
                                     weight loss programme and provides
*   quinoline yellow CI47005 (10mg
                                     detailed advice and useful tips on
    capsule only)
                                     diet and exercise.

Distributor                          To register for the Reductil Weigh of
                                     Life Programme in New Zealand
REDUCTIL is distributed by:          please call 0800 200 626, or visit
                            and complete
Abbott Australasia Pty Ltd           the online form.
32-34 Lord Street
Botany NSW 2019                      Australian registration
Australia                            numbers
Free phone 1800 225 311              Reductil 10mg - AUST R 68115
                                     Reductil 15mg - AUST R 68116
Abbott Laboratories (NZ) Ltd
227 Cambridge Terrace                Date of preparation
Naenae                               January 2006
New Zealand                          Version 05
Free phone 0800 73 72 71

REDUCTIL(R)                                                                  5

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