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.
1. Why am I using Duromine?
Duromine contains the active ingredient phentermine. Duromine is used to reduce body
weight in obese or overweight patients. For more information, see Section
1. Why am I using Duromine? in the full CMI.
2. What should I know before I use Duromine?
Do not use if you have ever had an allergic reaction to phentermine or any of the
ingredients listed at the end of the CMI.
There are a number of circumstances in which a person should not use this medicine
or may need to use caution. It is important to understand if these apply to you before
taking Duromine (see the full CMI for more details).
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
4. How do I use Duromine?
Carefully follow all directions given by your doctor or other healthcare professionals
and never change the dose yourself.
The usual dose of Duromine is one capsule a day.
Swallow the capsule whole with plenty of water. Do not chew or open the capsules.
5. What should I know while using Duromine?
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Things you should do
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Remind any doctor, dentist, or pharmacist you visit that you are using Duromine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
Duromine.
Stop taking and contact your doctor immediately if you become pregnant while taking
Duromine.
Tell your doctor immediately if you experience sudden or rapid weight loss, difficulty
breathing, chest pain, fainting, and swelling of the lower limbs or if you cannot
exercise as much as you usually can.
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Things you should not do
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Do not take Duromine to treat any other conditions unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
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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 Duromine
affects you.
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Drinking alcohol
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Do not drink alcohol whilst taking Duromine.
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Looking after your medicine
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Keep your capsules in the blister-foil pack until it is time to take them.
Store in a cool dry place where the temperature stays below 30°C and keep out of reach
of children.
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6. Are there any side effects?
Common side effects include changes in your heartbeat, high blood pressure, restlessness,
trouble sleeping, nervousness, tremor, headache, dizziness, fainting, nausea, vomiting,
diarrhoea or constipation, stomach cramps, dry or unpleasant taste in mouth, trouble
urinating, skin rashes, sexual function problems, feelings of extreme happiness followed
by depression and tiredness.
Serious side effects include heart attack, stroke, chest pain, myocardial infarction
and difficulty breathing.
Active ingredient(s): Phentermine (fen-ter-mean)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Duromine. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking Duromine.
Where to find information in this leaflet:
5. What should I know while taking Duromine?
1. Why am I taking Duromine?
Duromine contains the active ingredient phentermine. Phentermine is combined with a resin which slowly releases the phentermine so the
effect of Duromine lasts all day.
Duromine is used to reduce body weight in obese or overweight patients.
Duromine is an appetite suppressant that works by directly affecting the area of the
brain that controls your appetite making you feel less hungry.
Duromine should be used as a part of an overall weight management plan, which includes
a medically controlled diet and exercise program.
Your doctor will assess whether Duromine is suitable for you.
2. What should I know before I take Duromine?
Warnings
Do not use Duromine if:
You are allergic to phentermine, or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can use this medicine. Some
of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue, or other parts of the body
rash, itching or hives on the skin.
You are taking any similar medicines to reduce weight.
You have any of the following medical conditions:
very high blood pressure
high blood pressure in the lungs
problems with your heart valves
disease related to blood vessels in the brain
severe heart disease including changes in the rhythm or rate of the heartbeat
narrowing of the blood vessels due to thickening or hardening of the blood vessel
wall
overactive thyroid gland
psychiatric illness including anorexia nervosa (loss of appetite) and depression
glaucoma (high pressure in the eye).
It is past the expiry date printed on the pack or if the packaging is torn or shows
signs of tampering.
You are a child under the age of 12 years. Safety and effectiveness in children younger
than 12 years have not been established.
You are elderly.
You are currently taking, or have taken within the last 14 days, antidepressant medicines
called mono-amine oxidase inhibitors (MAOIs).
You have previously misused drugs or alcohol.
Check with your doctor if you:
Have any other medical conditions including:
high blood pressure
heart disease such as angina (chest pain)
diabetes
epilepsy
Take any medicines for any other condition.
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
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
3. What if I am taking 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 interfere with Duromine and affect how it works.
These include:
other medicines for weight reduction
medicines for depression or obsessive-compulsive disorder or other mental illness
ergot-like medicines for migraine
some cough and cold remedies
thyroid hormones
medicines for lowering high blood pressure.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Duromine.
4. How do I take Duromine?
How much to take
The usual dose is one capsule a day, however your doctor will prescribe the right
dose for you.
Swallow the capsules whole with plenty of water. Do not chew or open the capsules.
Carefully follow the instructions provided and use Duromine until your doctor tells
you to stop.
Increasing the dose may not necessarily make you lose more weight or make you lose
weight faster. However, you will more likely experience side effects. Your doctor
will tell you how long you are to take Duromine for.
When to take Duromine
Take Duromine first thing in the morning, at breakfast time so that it does not keep
you awake at night.
Taking Duromine at the same time each day will have the best effect. It will also
help you remember when to take it. It does not matter if you take this medicine before
or after food.
Do not change the dose unless your doctor tells you to do so.
If you forget to use Duromine
Duromine should be used regularly at the same time each day. If you miss your dose
at breakfast, take it no later than lunchtime.
If you take Duromine any later than lunchtime you may have trouble sleeping at night.
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 use too much Duromine
If you think that you have taken too much Duromine, 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.
5. What should I know while taking Duromine?
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are taking Duromine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
Duromine.
Check with your doctor or pharmacist before you start to take any cough or cold medication.
Call your doctor straight away if you:
Become pregnant while taking this medicine.
Experience sudden or rapid weight loss, difficulty breathing, chest pain, fainting,
and swelling of the lower limbs and if you cannot exercise as much as you usually
can.
Things you should not do
Do not take Duromine to treat any other conditions unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Duromine
affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
Do not drink alcohol whilst taking Duromine.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Keep your capsules in the blister-foil in the carton until it is time to take them.
Store Duromine below 30°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 windowsills.
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
Serious side effects
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 Duromine contains
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Active ingredient
(main ingredient)
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Phentermine
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Other ingredients
(inactive ingredients)
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lactose monohydrate
liquid paraffin
magnesium stearate
gelatin capsules hard PI (1947)
titanium dioxide
iron oxide black (CI 77499)
sodium polystyrene sulfonate
In addition:
Duromine 15 mg contains:
brilliant blue FCF (CI 42090)
iron oxide yellow (CI 77492)
Duromine 30 mg contains:
iron oxide red (CI 77491)
Duromine 40 mg contains:
erythrosine (CI 45430)
sunset yellow FCF (CI 5985)
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Potential allergens
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Contain sugars as lactose monohydrate
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Do not take this medicine if you are allergic to any of these ingredients.
Duromine capsules are gluten-free.
What Duromine looks like
Duromine capsules are available in three strengths in packs of 30, 60* and 90* capsules:
15 mg - AUST R 10941
Grey and green and marked DUROMINE 15
30 mg - AUST R 76680
Grey and reddish brown and marked DUROMINE 30
40 mg - AUST R 10942**
Grey and orange and marked DUROMINE 40
Duromine capsules are available in two strengths in packs of 7 capsules:
15 mg - AUST R 10941
Grey and green and marked DUROMINE 15
30 mg - AUST R 76680
Grey and reddish brown and marked DUROMINE 30
* Not marketed in Australia
** Not marketed in New Zealand
Who distributes Duromine
Australia
iNova Pharmaceuticals (Australia) Pty Limited
Level 10, 12 Help Street
Chatswood NSW 2067
Tel: 1800 630 056
New Zealand
iNova Pharmaceuticals (New Zealand) Pty Limited
Auckland
Tel: 0508 375 394
This leaflet was prepared in April 2023.