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CORTIMENT 9 MG PROLONGED RELEASE TABLETS

Active substance(s): BUDESONIDE / BUDESONIDE MICRONISED / BUDESONIDE / BUDESONIDE MICRONISED / 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 substance called
budesonide. Budesonide belongs to a category of
medicinal products called ‘corticosteroids’, which 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).
If you are allergic to peanut or soya since Cortiment
contains lecithin, which is a derivative from soya oil.
Warnings and precautions
Contact your doctor if you experience blurred vision or
other visual disturbances.
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 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 transfer from other cortisone therapy to
Cortiment as this may result in e.g. pain in the
muscles and joints, tiredness, headache, nausea,
and vomiting;
• if you know that you need to be vaccinated;
• if you have been treated with a stronger cortisone
preparation before starting treatment with
Cortiment, your symptoms may reappear;
• if you get an infection during the treatment,
Cortiment can hide the signs of infection and the
infection may get worse. You may get infections
easier during the treatment with Cortiment, since
your body’s resistance towards infections may be
reduced;
• if you are scheduled to undergo surgery soon or are
going through a stressful period;
• if you have not yet had measles or chicken pox.
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 or a close family member have had problems
with mental health.

Taking cortisone preparations at high doses and for a
prolonged period may affect all parts of the body and in
very rare cases psychological problems (see section 4.
Possible side effects).
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 medicines
obtained without a prescription. This is necessary
because Cortiment tablets affect how some medicines
work and some medicines may affect how Cortiment
works. Some medicines may increase the effects of
Cortiment and your doctor may wish to monitor you
carefully if you are taking these medicines (including some
medicines for HIV, ritonavir, cobicistat).
It is particularly important that you tell your doctor if you
are taking, have recently taken or might take one of the
following medicines:
• ketoconazole or itraconazole, which are
substances used to treat fungal infections;
• medicines used for HIV treatment (e.g. ritonavir,
nelfinavir, cobicistat-containing products);
• carbamazepine, which is used for treatment of
epilepsy;
• cardiac glycosides and diuretics;
• medicines that contain oestrogens, such as
hormone replacement therapy (HRT) and some
oral contraceptives;
• cholestyramine, which is used to lower cholesterol
levels or treat itching caused by liver problems, or
antacids which is used to neutralise the acid made
by your stomach.
Cortiment with food, drink and alcohol
Do not drink grapefruit juice when taking Cortiment
tablets. This may affect the way the medicine works.
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 and lecithin (soya oil)
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.
Cortiment contains lecithin (soya oil). If you are allergic to
peanuts or soya, do not use 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 other
steroid tablets as well.
Use in patients with reduced kidney or liver function
Cortiment was not studied specifically in patients with
kidney or liver problems.Talk to your doctor.
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. You may need to stop the treatment
gradually. 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, immediately contact
your doctor or go to a hospital. 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; most of the side effects mentioned below can
also be expected with other steroid treatment.
Common (may affect up to 1 in 10 people)
• Nausea
• Stomach ache
• Bloated abdomen
• Dry mouth
• Indigestion (dyspepsia)
• Pounding heart beats (palpitations)
• 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
• Headache
• Change in behaviour, such as nervousness, insomnia
and mood swings
• Depression
• Acne
• Extreme tiredness (fatigue)
• Muscle pain, muscle cramps
• Decrease of the hormone cortisol in the blood
Uncommon (may affect up to 1 in 100 people)
• Flatulence
• Dizziness
• Change in behaviour, such as mood swings
• Feeling of restlessness with hyperactivity
• Anxiety
• Swelling of the legs
• Back pain
• Muscle spasms
• Influenza
• Shaking
Rare (may affect up to 1 in 1,000 people)
• Aggression
• Purple or black-and-blue spots on the skin
• Glaucoma (increased pressure in the eye)
• Opacity of the lens or capsule of the eye (cataract)
• Blurred vision
Some of the side effects mentioned above are typical for
steroid medication and may occur depending on your
dose, period of treatment, whether you have or have had
treatment with other cortisone preparations, and your
individual susceptibility.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible 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; Email: 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.
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 (soya)
(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), talc (E553b), titanium dioxide (E171),
triethyl citrate
What Cortiment looks like and contents of the pack
Cortiment is supplied as 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
PA 1009/026/001
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: Austria, Bulgaria, Cyprus, Czech republic,
Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Malta, the Netherlands,
Norway, Romania, Slovakia, Spain, Sweden, UK
CortimentMMX: Croatia, Poland
Coramen: Portugal
Budesonide Ferring: Belgium, Latvia, Lithuania,
Luxembourg
Budezonid Ferring: Slovenia
This leaflet was last revised in April 2017.
Cortiment, FERRING and the FERRING Logo are
trademarks of Ferring B.V.

2000080/0

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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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