Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I using Contrave?
Contrave contains the active ingredients naltrexone hydrochloride and bupropion hydrochloride.
Contrave is used in obese or overweight adults to manage weight together with a reduced
calorie diet and physical exercise.
2. What should I know before I use Contrave?
Do not use if you have ever had an allergic reaction to Contrave or any of the ingredients
listed at the end of the CMI.
Do not take Contrave if you are pregnant or plan to become pregnant. Talk to your
doctor if you have any other medical conditions, take any other medicines or are breastfeeding
or intend to breastfeed.
3. What if I am taking other medicines?
Some medicines may interfere with Contrave and affect how it works.
4. How do I take Contrave?
Carefully follow all directions given by your doctor or other healthcare professionals
and never change the dose yourself.
The starting dose is one tablet once a day in the morning. The dose is gradually increased
over a four-week period.
Swallow the tablet whole with a glass of water. Do not cut, chew or crush the tablets.
5. What should I know while using Contrave?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Contrave.
Reduce the energy content of your diet and exercise regularly.
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Things you should not do
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Do not take any other medicines while taking Contrave without first telling your doctor.
Do not change your dose without first checking with your doctor.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how Contrave
affects you.
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Drinking alcohol
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Avoid or minimise drinking alcohol when taking Contrave.
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Looking after your medicine
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Store in a cool dry place where the temperature stays below 25°C and keep out of reach
of children.
Do not freeze.
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6. Are there any side effects?
There are a number of side effects associated with this medicine. It is important
to be aware of them so that you can identify any symptoms if they occur (see the full
CMI for more details).
Common side effects include nausea or vomiting, dizziness, dry mouth, constipation
and headache.
Serious side effects include seizures, allergic reactions and mental disturbances
like suicidal thoughts, irritability, anxiety or agitation and some skin reactions.
Active ingredients:
Naltrexone hydrochloride & Bupropion hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Contrave. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Contrave.
Where to find information in this leaflet:
1. Why am I taking Contrave?
Contrave contains two active ingredients - naltrexone hydrochloride and bupropion
hydrochloride. Contrave works on areas on the brain involved in the control of food intake and energy
use.
Contrave is used in obese or overweight adults to manage weight together with a reduced
calorie diet and physical exercise.
Your doctor will review your treatment after 16 weeks, and you should only continue
using Contrave if you have lost at least 5% of your initial body weight.
Contrave will only assist in reducing body weight if it is used in conjunction with
a reduction in calorie intake and/or an increase in physical activity.
2. What should I know before I take Contrave?
Warnings
Do not use Contrave if you:
are allergic to naltrexone hydrochloride, bupropion hydrochloride, or any of the ingredients
listed at the end of this leaflet. Always check the ingredients to make sure you can
use this medicine.
have high blood pressure that is not controlled with medicines.
have ever had a seizure.
have a brain tumour.
are usually a heavy drinker and have just suddenly stopped drinking a lot of alcohol
or are going to stop while you are taking this medicine.
have recently stopped taking sedatives (sleeping tablets) or medicines to treat anxiety
or epilepsy or you plan to stop them while you are taking this medicine.
are taking any other medicines containing naltrexone hydrochloride or bupropion hydrochloride.
have an eating disorder or had one in the past, such as bulimia or anorexia nervosa.
are regularly using opioids or opiate agonists (for example methadone), or you are
going through acute withdrawal (cold turkey).
have or have had a bipolar disorder (extreme mood swings).
are taking medicines called monoamine oxidase inhibitors (MAOIs) or have taken them
in the last 14 days.
have severe liver disease.
have end-stage kidney disease.
the packaging is torn or shows signs of tampering.
Check with your doctor if you:
feel depressed, contemplate suicide, have a history of attempting suicide, experience
panic attacks or any other mental health problems.
are aged 65 years or older. Contrave has not been adequately studied in older people
to know if they will respond to Contrave in the same way as younger adults.
have high blood pressure.
have heart disease.
have liver or kidney problems.
have mood disorders including depression or mania.
are galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
have a condition called Brugada syndrome (a rare hereditary syndrome that affects
the heart rhythm) or if cardiac arrest or sudden death occurred in your family.
take any medicines for any other condition.
are at risk of having a seizure. Contrave may cause seizures (fits) in some people.
Seizures are more likely while taking Contrave if you:
have had a serious head injury, head trauma or stroke.
regularly drink a lot of alcohol.
regularly use medicines to help you to sleep (sedatives).
are dependent on or addicted to cocaine or other stimulating products.
have diabetes for which you use insulin or tablets.
have a brain or spinal tumour or infection.
have severe liver disease.
have low blood sugar or salt levels.
have hypoxia, a condition where oxygen levels in your tissues are low.
are taking medicines that may increase the chance of having a fit.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not use Contrave if you are pregnant or intend to become pregnant. Weight loss
offers no potential benefit to a pregnant woman and may result in harming your baby.
Talk to your doctor if you are breastfeeding or intend to breastfeed. Contrave passes
into human milk and is not recommended during breastfeeding.
Use in Children
Contrave is not recommended for use in children less than 18 years because it has
not been adequately studied in these patients.
3. What if I am using other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may increase your chance of having a seizure when taking Contrave.
These medicines need to be used very carefully. Examples include:
antidepressants
antipsychotics
asthma medicines such as theophylline and systemic corticosteroids
antimalarials
tramadol
sedating antihistamines
quinolone antibiotics
insulin or oral diabetic medicines
sedatives, such as benzodiazepines.
Some medicines may interfere with Contrave and affect how it works.
These include:
Medicines for depression known as monoamine oxidase inhibitors, even if you have stopped
taking them now, but have taken them within the last 14 days. Your doctor or pharmacist
can tell you what to do if you are taking any of these medicines.
opioid painkillers e.g., codeine, morphine, methadone.
medicines used to treat high blood pressure such as metoprolol.
medicines used to treat irregular heart rhythm such as propafenone or flecainide.
medicines for Parkinson's disease such as levodopa or amantadine.
ticlopidine or clopidogrel, mainly used in the treatment of heart disease or stroke.
medicines used in the treatment of HIV infection and AIDS, such as efavirenz and ritonavir.
medicines for depression or other mental health conditions that affect serotonin levels,
such as amitriptyline, desipramine, venlafaxine, imipramine, paroxetine, fluoxetine,
citalopram, escitalopram, risperidone, haloperidol and thioridazine.
digoxin, used to treat certain heart problems.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Contrave.
4. How do I take Contrave?
How much to take
The starting dose is one tablet once a day in the morning. The dose will be gradually
increased as follows:
Week 1: One tablet once a day in the morning
Week 2: One tablet twice a day, one in the morning and one in the evening
Week 3: Three tablets every day, two in the morning and one in the evening
Week 4 and onward: Two tablets twice a day, two in the morning and two in the evening.
The maximum recommended daily dose of Contrave is two tablets taken twice a day.
If you have liver or kidney problems, you may need a lower dose of Contrave.
Swallow the tablet whole with a glass of water. Do not cut, chew or crush the tablets.
Follow the instructions provided and use Contrave until your doctor tells you to stop.
When to take Contrave
Contrave should be taken with food.
Continue using Contrave as long as your doctor recommends it.
Some people do not respond to Contrave. Treatment should not be continued for more
than 16 weeks if you have not lost more than 5% of your initial body weight.
If you forget to take Contrave
Contrave should be used regularly at the same time each day.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you take too much Contrave
If you think that you have taken too much Contrave, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26 in Australia or 0800 764 766 [0800 POISON] in New Zealand), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you take too much Contrave you may experience some of the following symptoms: seizure,
hallucinations, loss of consciousness, increased heart rate or irregular heartbeat,
fever, muscle stiffness and/or pain, low blood pressure and breathing difficulties.
5. What should I know while using Contrave?
Things you should do
remind any doctor, dentist or pharmacist you visit that you are using Contrave.
reduce the energy content of your diet by at least 500 kcal (2092 kJ). A review of
your diet by a dietician is recommended.
review your treatment with your doctor after 16 weeks to monitor your weight-loss.
tell your doctor before you undergo a blood or any other laboratory tests. Contrave
may interfere with laboratory tests.
keep enough medicine to last weekends and holidays.
Call your doctor straight away if you:
have depression and it gets worse or you any have thoughts about suicide or doing
harm to yourself.
All thoughts or talk about suicide are serious, including:
thoughts or talk about death or suicide
thoughts or talk about self-harm
an increase in aggressive behaviour, irritability or agitation.
become pregnant while taking this medicine.
experience hypersensitivity reactions. Serious skin reactions, including Stevens-Johnson
syndrome and acute generalised exanthematous pustulosis (AGEP), have been reported
in association with Contrave treatment. Stop using Contrave and seek medical attention
immediately if you notice any of the symptoms related to these serious skin reactions
described in section 6 - side effects.
Things you should not do
Do not take any other medicines while taking Contrave without first telling your doctor.
Do not take this medicine for a longer time than your doctor has prescribed.
Do not change your dose without first checking with your doctor.
Do not give this medicine to anyone else, even if their condition seems similar to
yours.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Contrave
affects you.
Contrave may cause dizziness in some people and therefore may affect alertness.
Drinking alcohol
Avoid or minimise
drinking alcohol when taking Contrave.
Tell your doctor if you drink alcohol.
Excessive use of alcohol may increase your chance of having a seizure.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Store Contrave below 25°C in a cool dry place away from moisture, heat or sunlight;
for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Do not freeze.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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The most commonly reported side effects are:
nausea or vomiting
dizziness
dry mouth
constipation
headache
Changes in behaviour:
mood swings
difficulty sleeping or abnormal dreams
feeling spacey or jittery
forgetfulness or difficulty concentrating
weakness or lack of energy
tremor
sexual function problems such as delayed ejaculation or difficulty getting an erection.
Stomach or bowel problems:
diarrhoea
loss of appetite
stomach pain or cramps
burping
sudden need to urinate.
Changes in your senses:
taste disorders
ringing in the ears
feeling thirsty
excessive sweating
hot flushes
chills
watery eyes.
tingling or numbness of the hands or feet
Other effects:
toothache or jaw pain
joint or muscle pain
chest pain
hair loss
irregular menstrual periods
vaginal dryness
fast or irregular heartbeat
feeling faint when standing up from sitting or lying down
muscle stiffness
feeling agitated
lack of coordination
unstable blood pressure.
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Seizures:
If you have a seizure, tell your doctor when you have recovered.
Do not take any more Contrave tablets until you have spoken to your doctor.
Symptoms of a seizure include:
convulsions
usually loss of consciousness.
Someone who has had a seizure may be confused afterwards and may not remember what
has happened.
You can reduce the chance of having a seizure by giving your doctor all the information
they need before taking Contrave and carefully following your doctor's directions
while taking Contrave.
Allergic Reactions:
wheezing
swelling of the lips, mouth or eyelids
difficulty breathing
hayfever
hives (itchy skin rash).
Mental disturbances:
suicidal thoughts
suicide attempts
feeling hostile
irritability, anxiety, panic attacks or agitation.
Serious skin reactions:
acute generalised exanthematous pustulosis - a red, scaly widespread rash with bumps
under the skin and blisters accompanied by fever. The symptoms usually appear at the
initiation of treatment.
Erythema multiforme and Stevens Johnson Syndrome - Erythema multiforme is a severe
condition of the skin that may affect the mouth and other parts of the body, with
red, often itchy spots starting on the limbs. Stevens Johnson Syndrome is a rare
skin condition with severe skin blisters, bleeding in the lips, eyes, mouth, nose
and genitals.
Other effects:
bleeding from the rectum
skin or the whites of your eyes turning yellow
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Contrave contains
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Active ingredients
(main ingredients)
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Naltrexone hydrochloride and bupropion hydrochloride
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Other ingredients
(inactive ingredients)
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Cysteine hydrochloride monohydrate
Microcrystalline cellulose
Hyprolose
Magnesium stearate
Lactose
Lactose monohydrate
Crospovidone
Indigo carmine aluminium lake
Hypromellose
Disodium edetate
Silicon dioxide
OPADRY II complete film coating system 85F90663 BLUE.
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Potential allergens
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Contain sugars as lactose.
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Do not take this medicine if you are allergic to any of these ingredients.
What Contrave looks like
Contrave is a blue, biconvex, round tablet with "NB-890" on one side.
It is available in blisters in pack sizes of 28 (starter pack) and 112 tablets. (AUST
R 288372).
Who distributes Contrave
Australia:
iNova Pharmaceuticals (Australia) Pty Limited
ABN: 13 617 871 539
Level 10, 12 Help Street
Chatswood, NSW 2067
Telephone (toll free): 1800 630 056
New Zealand:
iNova Pharmaceuticals (New Zealand) Limited
C/- Simpson Grierson,
Private Bag 92518,
88 Shortland Street
AUCKLAND 1141
Telephone (toll free): 0508 375 394
This leaflet was prepared in Aug 2023.