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METOPIRONE CAPSULES 250MG

Active substance(s): METYRAPONE / METYRAPONE

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• anti-thyroid medicines

PATIENT INFORMATION LEAFLET

Metyrapone

Folder n° : 162413
METOPIRONE

NEW ITEM CODE

MOCK-UP

OLD ITEM CODE

-

TYPE

Leaflet

STRENGTH(S)

250 mg

PHARMA. FORM

capsules

ZONE

-

COUNTRY

UK

LANGUAGE

English

MANUFACTURER

DELPHARM

FORMAT

343 x 603 mm

TECH. LAYOUT REF.

C135-A

PRINTED COLOURS: 1

BLACK

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

171.5

PRODUCT NAME

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.

1. What Metopirone is and what it is taken for

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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.

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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).

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DATE (day/month/year)

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.
During treatment with Metopirone
Metopirone may temporarily lower the amount of hormones produced by
your adrenal gland but your doctor will correct this using appropriate steroid
medication.
If you develop shortness of breath and fever over hours or days contact your
doctor as soon as possible as you may be developing a serious lung infection.
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
(e.g. phenytoin or barbiturates)
• antidepressants or other medicines
(e.g. amitriptyline, chlorpromazine or
for mental illness
alprazolam)
• any hormone treatments
(e.g. clomifene, tetracosactide, growth
hormone, treatments for infertility or
thyroid hormone)

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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
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:
• sodium ethyl (E215)
- this preservative can cause skin rashes
and (rarely) breathing difficulties.
• sodium propyl hydroxybenzoate - this preservative can cause skin rashes
(E217)
and (rarely) breathing difficulties.
• glycerin
- which can be harmful in high doses.
It can cause headaches, stomach upsets
and diarrhoea.

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.
Other side effects (frequency unknown) of Metopirone include:
• Decreased or insufficient production of blood cells due to abnormal function
of the bone marrow.
• High blood pressure
• Hair loss
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.

3. How to take Metopirone

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.

Always take Metopirone exactly as your doctor has told you to. You should
check with your doctor or pharmacist if you are not sure.

Do not store above 30°C and protect from moisture and heat. Keep the
container tightly closed.

Metopirone should be swallowed whole with a drink of milk or after a meal.
Do not chew the capsules.

Do not take Metopirone if you notice any change in the colour of 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.

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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
• capsule core: glycerin, polyethylene glycol 400, polyethylene glycol 4000
and water
• capsule shell: sodium ethyl hydroxybenzoate (E215), ethyl vanillin, gelatin,
p-methoxy 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.
PARC D’ACTIVITES ROUBAIX-EST
22 RUE DE TOUFFLERS CS 50070
59452 LYS-LEZ-LANNOY 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 2016
Metopirone is a registered trademark of Laboratoire HRA Pharma

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17 maxi

Metopirone® Capsules 250 mg

If you stop taking Metopirone
DO NOT stop taking Metopirone suddenly as this can make your condition worse.

25

(e.g. carbimazole, propylthiouracil or
iodine).
• Allergic disorder
(cyproheptadine)
• Fever, pain
(paracetamol, acetaminophen)
Please tell your doctor or pharmacist if you are taking or have recently
taken/used any other medicines, including medicines obtained without a
prescription.

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PRODUCT NAME

METOPIRONE

NEW ITEM CODE

MOCK-UP

OLD ITEM CODE

-

TYPE

Leaflet

STRENGTH(S)

250 mg

PHARMA. FORM

capsules

ZONE

-

COUNTRY

UK

LANGUAGE

English

MANUFACTURER

DELPHARM

FORMAT

343 x 603 mm

TECH. LAYOUT REF.

C135-A

PRINTED COLOURS: 1

BLACK

171.5

Folder n° : 162413

TECHNICAL COLOURS Technical data

FONT

Helvetica Neue

MIN. FONT SIZE

11 pts

SOFTWARE

Indesign CC

BAR CODES

Laetus

DATE (day/month/year)

14/12/2016

VERSION

1

343

-

40.2

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9
603

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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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