Consumer Medicine Information

Duromine™

Phentermine capsules 15mg and 30mg

What is in this leaflet

This leaflet answers some common questions about Duromine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. If you need any more information about Duromine please ask your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risk of your taking Duromine against the benefits it can have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may want to read it again.

Your medicine

The name of your medicine is Duromine. Duromine capsules contain the active ingredient, phentermine. Phentermine is combined with a resin which slowly releases the phentermine so the effect of Duromine lasts all day.

What Duromine is used for

Duromine is used to reduce body weight in obese or overweight patients. Your doctor will determine if you are overweight enough to use Duromine. Duromine 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 should include a medically controlled diet and exercise program.
Duromine is only available with a doctor's prescription. It has been prescribed for you only.  Do not give it to anyone else even if their condition is the same as yours. Your doctor may prescribe Duromine for another purpose. If you are not sure why you are taking this medicine ask your doctor.
Note: Duromine is a controlled drug C5. It should be kept in a secure place and under no circumtances should it be given to anyone else.

Before using Duromine

When you must not use Duromine

• if you have any of the following medical conditions:
• very high blood pressure;
• high blood pressure in the lung;
• problems with the valves in your heart
• disease related to blood vessels in the brain;
• severe heart disease including changes in the rhythm or rate of the heart beat;
• 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)
• if you are currently taking, or have taken within the last 14 days, antidepressant medicines from the mono-amine oxidase inhibitor (MAOI) class such as phenelzine (eg Nardil) or tranylcypromine (eg Parnate).
• if you are allergic to phentermine or to any of the ingredients listed under "Product Description".
• if you have previously misused drugs or alcohol
• after the "use by" date on the box.

Before you start to use Duromine

• Tell your doctor if you are taking any of these medicines:
• any medicines for weight reduction
• any medicines for depression or obsessive compulsive disorder such as fluoxetine (eg Prozac, Erocap, Lovan, Zactin); sertraline (eg, Zoloft); paroxetine (eg Aropax); clomipramine (eg Anafranil, Placil).
• ergot-like medicines for migraine such as ergotamine (eg Cafergot, Ergodryl, Migral)
• any cough and cold remedies containing pseudoephedrine, phenylpropanolamine or phenylephrine.
• thyroid hormones.
• any medication for mental illness
• medicines for lowering high blood pressure including clonidine, methyldopa or guanethidine.
• any medicines that you buy without a prescription.
• Tell your doctor if you:
• are pregnant or intending to become pregnant
• are breastfeeding
• have high blood pressure
• have heart disease such as angina (chest pain)
• have diabetes
• have epilepsy.

Using Duromine

How to take Duromine

• In adults and children over 12 years, the usual dose of Duromine is one capsule every day. However, your doctor will prescribe the right dose for you.
• Take Duromine first thing in the morning, at breakfast time so that it does not keep you awake at night.
• Swallow Duromine capsules with plenty of water. Do not chew or open the capsules.
• Follow your doctor's instructions exactly and never change the dose yourself. Increasing the dose may not necessarily make you lose more weight or make you lose weight faster. However you will most likely experience more side effects. Your doctor will tell you how long you are to take Duromine for.

Duromine is not recommended for elderly patients or for children younger than twelve years.

While you are using Duromine

• You should regularly visit your doctor for a medical check up.
• Tell your doctor immediately if you experience sudden or rapid weight loss, difficulty breathing, chest pain, fainting, swelling of the lower limbs and if you can not exercise as much as you usually can.
• Be careful driving or operating machinery until you know how Duromine affects you.
• DO NOT drink alcohol whilst taking Duromine.
• Check with your doctor or pharmacist before you start to take any cough or cold medication.

If you forget to take Duromine

If you forget to take your Duromine dose at breakfast take it no later than lunchtime. Alternatively, skip the dose you missed and take your next dose at the normal time on the next day. If you take Duromine any later than lunch-time you may have trouble sleeping at night.
Never take a double dose to make up for a dose you have missed. If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

Side Effects

All medicines can have side effects and this may occur with the normal use of Duromine. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Duromine.
Tell your doctor immediately if you experience sudden or rapid weight loss, difficulty breathing, chest pain, fainting, swelling of the lower limbs and if you can not exercise as much as you usually can.
Duromine may make you feel more awake than usual. You may have trouble sleeping.
Duromine can have some effects on the heart. You may notice your heart seems to beat faster and harder, and your blood pressure may be raised slightly.
Other side effects you may notice include irregular heart beats, chest pain, feeling restless, feelings of extreme happiness followed by depression and tiredness, nervousness, tremor (shaking), headache, dizziness, nausea, vomiting, diarrhoea or constipation, stomach cramps, dry mouth or an unpleasant taste in your mouth, difficulty passing urine, skin rashes, impotence and changes in sexual drive, swelling of the face.
If you have any side effect whether it is listed above or not, please tell your doctor.

If you take too much Duromine

If you think that you (or anyone else) may have taken too much Duromine, contact your doctor or Poisons Information Centre (in Australia call 131126; in New Zealand call toll free 0800 POISON or 0800 764 766) or go to the Accident and Emergency department at the nearest hospital.

Storage Conditions

Please keep Duromine in a cool dry place where the temperature stays below 30°C. Keep Duromine capsules in the blister-foil in the carton until it is time to take them. Keep Duromine capsules where children cannot reach them.

Product Description

What Duromine looks like

Duromine capsules are available in Australia in three strengths, 15mg, 30mg or 40mg, in packs of 30 capsules.

Duromine capsules are available in New Zealand in two strengths, 15mg or 30mg, in packs of 30 capsules.

• Duromine 15mg capsules:
• grey and green and marked DUROMINE 15
• AUST R 10941
• Duromine 30mg capsules:
• grey and reddish brown and marked DUROMINE 30
• AUST R 76680
• Duromine 40mg capsules:
• Grey and orange and marked DUROMINE 40
• AUST R 10942

Ingredients

Duromine capsules contain phentermine, lactose, liquid paraffin, magnesium stearate, gelatin, titanium dioxide, carbon black (CI 77266). In addition, Duromine 15mg contains brilliant blue FCF (CI 42090), iron oxide yellow (CI 77492); Duromine 30mg contains iron oxide red (CI 77491); Duromine 40mg contains erythrosine (CI 45430), sunset yellow FCF (CI 15985). Duromine capsules are gluten-free.

Sponsor

DUROMINE is manufactured and supplied in Australia by:

iNova Pharmaceuticals (Australia) Pty Limited ABN 88 000 222 408
9-15 Chilvers Road
Thornleigh NSW 2120
Australia

DUROMINE is distributed in New Zealand by:

iNova Pharmaceuticals (New Zealand) Limited
c/o Simpson Grierson
Level 27
88 Shortland Street
AUCKLAND

This leaflet was prepared in March 2003.