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CORTIMENT 9 MG PROLONGED RELEASE TABLETS

Active substance(s): BUDESONIDE / BUDESONIDE MICRONISED

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Package leaflet: Information for the user

Cortiment® 9 mg

Prolonged release tablets
Budesonide
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.









• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor. This
includes any possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet:
1. What Cortiment is and what it is used for
2. What you need to know before you take Cortiment
3. How to take Cortiment
4. Possible side effects
5. How to store Cortiment
6. Contents of the pack and other information


1. What Cortiment is and what it is
used for
Cortiment tablets contain a medicinal product called
budesonide. This belongs to a category of medicinal
products called ‘corticosteroids’. These are used to reduce
inflammation.
Cortiment tablets are used for adults for the treatment of
inflammation of the large intestine (colon) and the rectum.
This is called ulcerative colitis.


2. What you need to know before you take
Cortiment

Do not take Cortiment
If you are allergic to budesonide or one of the other
ingredients of this medicine (listed in section 6).

Cortiment 9 mg tablets contain lecithin which is a derivate
from soya oil. If you are allergic to peanut or soya, do not
use this medicinal product.
Warnings and precautions
Talk to your doctor before taking Cortiment:
• if you have an infection, such as a virus infection, a
bacterial infection or a fungal infection;
• if you have ever had tuberculosis (TBC);
• if you have ever had high blood pressure;
• if you have diabetes;
• if you ever had brittle bones;
• if you ever had a stomach ulcer;
• if you ever had elevated eyeball pressure (glaucoma)
or grey cataract;
• if a family member has ever had diabetes or elevated
eyeball pressure (glaucoma);
• if you ever had liver problems;
• if you or a family member ever had problems with
mental health;
• if you are scheduled to undergo surgery soon or are
going through a stressful period.
While taking Cortiment tablets, try to avoid people with
measles or chicken pox. Inform your doctor if you think
you have been infected with chicken pox or measles while
taking this medicine.
If you have any doubts about whether one of the above
applies to you, contact your doctor before you take
Cortiment tablets.
Other medicines and Cortiment
Tell your doctor if you are taking, have recently taken
or might take any other medicines, including over-thecounter medicines or herbal medicines. This is necessary
because Cortiment tablets affect how some medicines
work and some medicines may affect how Cortiment
works.

Tell your doctor if you are taking, have recently taken or
might take one of the following medicines:
• steroids, such as prednisolone or dexamethasone;
• cholestyramine, which is used to lower cholesterol
levels or treat itching caused by liver problems,
antacids;
• ketoconazole or itraconazole, which are substances
used to treat fungal infections;
• medicines that contain oestrogens, such as
hormone replacement therapy (HRT) and some oral
contraceptives;
• cardiac glycosides and diuretics.
• HIV protease inhibitors (such as ritonavir and
nelfinavir)
• Carbamazepine, which is used for treatment of
epilepsy.
Cortiment with food, drink and alcohol
Do not drink grapefruit juice when taking Cortiment
tablets. This may affect the working of the medicine.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine.
Driving and using machines
It is unlikely that Cortiment will affect your ability to drive
and use machines. Care is required because this type of
medicine may sometimes cause dizziness or fatigue.
Cortiment contains lactose
Cortiment tablets contain lactose, a type of sugar. If you
have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this
medicinal product.

3. How to take Cortiment
Always take this medicine exactly as your doctor has told
you. Check with your doctor if you are not sure.
• The recommended dose is one tablet in the morning
before or with breakfast.
• Swallow the tablet whole with a glass of water, the
tablet must not be broken, crushed or chewed.
• Usually you will take this medicine daily for a
maximum of eight weeks. Your doctor may then
gradually lower the number of times you take the
medicine.
• Keep taking Cortiment tablets as your doctor has
told you, even if you start feeling better.
Additional information when taking Cortiment tablets
If you will undergo surgery soon or are going through a
stressful period, the doctor may ask you to take steroid
tablets. This is particularly true if you have been taking
high doses of Cortiment tablets or a similar medicine for
a long time.
Use in children
Cortiment tablets are not recommended for use in
children.
If you take more Cortiment than you should
If you take more Cortiment tablets than you should, inform
your doctor immediately.
If you forget to take Cortiment
• If you forget to take a Cortiment tablet, take it as
soon as you remember. If it is almost time for your
next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten
tablet.
If you stop taking Cortiment
Do not stop taking Cortiment tablets without discussing
it with your doctor first. If you suddenly stop taking the
medicine, you may become ill.
If you have any further questions about the use of this
medicine, ask your doctor.


4. Possible side effects


Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you have an allergic reaction, contact your doctor
immediately. Signs may include hives or swelling of
the face, lips, mouth, tongue and throat. This can make
it difficult to breathe.
The following side effects may occur when taking
Cortiment. If one of the side effects becomes serious or
you develop a side effect not listed in the leaflet, consult
your doctor.
Common (may affect up to 1 in 10 people)
• Reflux
• Muscle cramps and stomach pain
• Heart palpitations
• Blurred vision
• Skin rash or itchiness
• Heavy or irregular menstruation in women
• Low potassium levels in the blood, which can cause
muscle weakness or fatigue, thirst or a tingling
sensation
• Cushing-like symptoms, such as a round face, acne,
weight gain and a tendency to bruise easily
• Nausea or headache
• Reduced response to an infection
• Change in behaviour, such as nervousness, insomnia or
mood swings
Uncommon (may affect up to 1 in 100 people)
• Somnolence
• Diarrhoea
• Bloated abdomen, abdominal pain
• Stomach complaints or indigestion
• Pain in your limbs
• Swelling in your legs
• Tremor
Very rare (may affect up to 1 in 10,000 people)
• A serious allergic reaction (called anaphylaxis) which
can lead to breathing difficulties and shock
• Slowed growth in children under the age of 18 years.
Medicines like Cortiment tablets (corticosteroids) may
affect the normal production of steroid hormones in your
body. The effects include:
• changes to bone mineral density (brittle bones);
• glaucoma (high eyeball pressure);
• effect on the adrenal gland (small gland near the
kidney).
Psychological problems may develop when taking steroids
like Cortiment. Discuss it with your doctor if you (or
someone who uses this medicine) have (has) symptoms
of psychological problems. This is particularly important if
you are depressed and may be thinking about committing
suicide. In very rare cases, psychological problems have
developed when high doses were taken for a long time.
Do not worry about this list of possible side effects. You
may not get any of these side effects.
If you have a lot of trouble with one of these side effects,
or get a side effect not listed in this leaflet, contact your
doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse.
This includes any side effects not listed in this leaflet. You
can also report side effects directly (see details below).
By reporting side effects you can help provide more
information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace, IRL
Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517.
Website: www.hpra.ie
E-mail: medsafety@hpra.ie


5. How to store Cortiment


Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and on the blister pack after EXP. This
lists a month and year. The expiry date refers to the last
day of that month.
Store below 30°C.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.


6. Contents of the pack and other
information


What Cortiment contains
• The active substance in this medicine is budesonide.
Each tablet contains 9 mg of budesonide.
• The other ingredients (excipients) in this medicine are:
tablet core: stearic acid (E570), lecithin (E322),
microcrystalline cellulose (E460),

hydroxypropylcellulose (E463), lactose monohydrate,
silica colloidal hydrated (E551), magnesium stearate
(E470b)
film coating: methacrylic acid-methyl methacrylate
copolymer (1:1), methacrylic acid-methyl methacrylate
copolymer (1:2), talcum powder (E553b), titanium
dioxide (E171), triethyl citrate
What Cortiment looks like and contents of the pack
Cortiment is supplied in white to off-white, round, double
convex tablets with a film coating, and ‘MX9’ engraved on
one side of the tablet. The tablets are supplied in blister
packs with aluminium press-through foil in a cardboard
carton.
This medicine is available in packs of 10, 20, 30, 50, 60 or
80 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder
UK
Ferring Pharmaceuticals Ltd.
Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
PL 03194/0113
Ireland
Ferring Ireland Ltd., United Drug House, Magna Drive,
Magna Business Park, Citywest Road, Dublin 24,
Ireland.
PA 1009/XX/XXX
Manufacturer
Cosmo S.p.A.
Via C. Colombo 1,
20020 Lainate,
Milan,
Italy
This medicinal product is authorised in the Member
States of the EEA under the following names:
Cortiment:




Netherlands, Cyprus, Czech Republic,
Estonia, Greece, Ireland, Italy,
Lithuania, Romania, Slovakia, Spain,
UK

CortimentMMX:



Austria, Bulgaria, Croatia, Finland,
Germany, Hungary, Iceland, Malta,
Norway, Poland, Portugal.

Budesonide Ferring: Belgium, Latvia, Luxembourg.
Budezonid Ferring: Slovenia

This leaflet was last revised in: October 2014.

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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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