METOPIRONE CAPSULES 250MG

Active substance: METYRAPONE

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PATIENT INFORMATION LEAFLET
Metopirone® Capsules 250 mg
metyrapone
Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet please tell your doctor or pharmacist.
The information in this leaflet has been divided into the following sections:
1. What Metopirone is and what it is taken for
2. Check before you take Metopirone
3. How to take Metopirone
4. Possible side effects
5. How to store Metopirone
6. Further information

1. What Metopirone is and what it is taken for
Metopirone belongs to a group of medicines called endocrine medicines. It
works by decreasing the production of certain types of steroids.
Metopirone is used to diagnose and treat Cushing’s syndrome (a condition when
the body produces too much cortisol which is a type of steroid).
It is also used to treat some types of water retention in patients suffering from
certain kidney problems, cirrhosis of the liver, or heart failure.

2. Check before you take Metopirone
Do not take Metopirone:
• if you are allergic (hypersensitive) to metyrapone or any of the ingredients of
Metopirone (see Section 6 Further information)
• if you are pregnant, trying to become pregnant or breast-feeding
• if you suffer from an under-active adrenal gland (sometimes known as
Addison’s disease).
If any of the above applies to you, or if you are not sure, speak to your doctor or
pharmacist before you take Metopirone.

Take special care with Metopirone
Before you take Metopirone tell your doctor if:
• you have cirrhosis of the liver
• you suffer from an under-active thyroid gland (causing weight gain, dry brittle
hair or sensitivity to the cold)
• you suffer from an under-active pituitary gland (causing an imbalance of some
hormones)
• you have high blood pressure.
Metopirone may temporarily lower the amount of hormones produced by your
adrenal gland but your doctor will correct this using appropriate steroid
medication.
If any of the above applies to you, or if you are not sure, speak to your doctor or
pharmacist before you take Metopirone.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken/used any
of the following medicines as they may interfere with Metopirone:




anticonvulsants to treat epilepsy
antidepressants or other medicines for
mental illness
any hormone treatments



anti-thyroid medicines

(e.g. phenytoin or barbiturates)
(e.g. amitriptyline or
chlorpromazine)
(e.g. clomifene, tetracosactide,
growth hormone, treatments for
infertility or thyroid hormone)
(e.g. carbimazole,
propylthiouracil or iodine).

Please tell your doctor or pharmacist if you are taking or have recently
taken/used any other medicines, including medicines obtained without a
prescription.
Taking with food and drink
Metopirone should be swallowed whole with a drink of milk or after a meal. This
will reduce the chance of the tablets making you feel sick.
Pregnancy and breast-feeding
No information is available on the safety of Metopirone in pregnancy. It is not
known if Metopirone passes into breast-milk. Do not take Metopirone if you are
pregnant, planning to become pregnant or breast-feeding. If you become
pregnant whilst taking Metopirone tell your doctor immediately.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Taking Metopirone may make you feel dizzy or tired. If you are affected you
should not drive or work with machinery until this effect has worn off.
Important information about some of the ingredients of Metopirone
Metopirone contains:
- this preservative can cause skin rashes
• sodium ethyl (E215)
and (rarely) breathing difficulties.
- this preservative can cause skin rashes
• sodium propyl hydroxybenzoate
and (rarely) breathing difficulties.
(E217)
- which can be harmful in high doses. It
• glycerin
can cause headaches, stomach upsets
and diarrhoea.

3. How to take Metopirone
Always take Metopirone exactly as your doctor has told you to. You should check
with your doctor or pharmacist if you are not sure.
Metopirone should be swallowed whole with a drink of milk or after a meal. Do
not chew the capsules.
The usual dose for each condition is given below.
Diagnosis of Cushing’s syndrome
To determine if you have Cushing’s syndrome you will be kept in hospital for 4
days. Your urine will be tested each day. The first 2 days are used to check your
normal test results. On the third day 3 Metopirone capsules (750 mg) will be
given to you every 4 hours. In total 6 doses (4.5 g) will be given to you. The
fourth day of your hospital stay will give the results of your test. You will then be
told by your doctor whether or not you have Cushing’s syndrome.
Treatment of Cushing’s syndrome
The usual dose is between one (250 mg) and 24 capsules (6 g) each day. Your
doctor will decide the correct dose for you.
Treatment of water retention
The usual dose is 12 capsules (3 g) a day, divided throughout the day. You will
also be given a steroid medicine at the same time.
If you are elderly, you will receive the same doses as above.
If the patient is a child, the doctor will choose a suitable dose based on your
child’s weight.

If you are not sure how many capsules to take, ask your doctor or pharmacist.
What to do if you take more Metopirone than you should
If you accidentally take too many Metopirone capsules, or someone else takes
any of this medicine, you should tell your doctor at once or contact your nearest
accident and emergency department. Show any left over medicines or the empty
packet to the doctor.
If you forget to take Metopirone
Don’t worry. If you forget to take a dose, take it as soon as possible, unless it is
almost time to take the next dose. DO NOT take a double dose. Then go on as
before.
If you stop taking Metopirone
DO NOT stop taking Metopirone suddenly as this can make your condition worse.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.

4. Possible side effects
Do not worry. Like all medicines, Metopirone can cause side effects, although not
everyone gets them.
Common side effects (that affect less than 1 person in 10) of Metopirone include:
• feeling or being sick
• dizziness, feeling drowsy or tired
• headache
• low blood pressure (causing dizziness and light-headedness).
Rare side effects (that affect less than 1 person in 1,000) of Metopirone include:
• stomach pain
• skin rash
• an under-active adrenal gland (resulting in an imbalance of hormones)
• an increase in body hair.
If any of the side effects gets worse, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.

5. How to store Metopirone
Keep out of the reach and sight of children.

Do not take Metopirone after the expiry date which is stated on the carton and
bottle. The expiry date refers to the last day of that month.
Do not store above 30°C and protect from moisture and heat. Keep the
container tightly closed.
Do not take Metopirone if you notice any change in the colour of the capsules.
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist on how to dispose of medicines no longer required. These
measures will help protect the environment.

6. Further information
What is in Metopirone?
The active ingredient in this medicine is metyrapone 250 mg.
The other ingredients are
• tablet core: glycerin, polyethylene glycol 400, polyethylene glycol 4000 and
water
• capsule shell: sodium ethyl hydroxybenzoate (E215), ethyl vanillin, gelatin, pmethoxy acetophenone, sodium propyl hydroxybenzoate (E217) and titanium
dioxide (E171).
What Metopirone looks like and contents of the pack
Metopirone capsules come in plastic bottles of 100 capsules.
Each oblong capsule is yellowish-white. Each capsule has ‘HRA’ printed on one
side. The printing is in red ink.
Marketing Authorisation Holder and Manufacturer
The product licence holder is: Laboratoire HRA Pharma, 15 rue Béranger, 75003,
Paris, FRANCE
Metopirone is manufactured by:
DELPHARM LILLE S.A.S.
ZI DE ROUBAIX-EST
RUE DE TOUFFLERS
59390 LYS-LEZ-LANNOY CEDEX FRANCE
The information in this leaflet applies only to Metopirone. If you have any
questions or you are not sure about anything, ask your doctor or a pharmacist.
This leaflet was last approved: December 2012
Metopirone is a registered trademark of Laboratoire HRA Pharma

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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