CORTIMENT 9 mg Extended-Release Tablets

Зміст інструкції

1. CORTIMENT 9 mg, prolonged-release tablets
   1. What is Cortiment 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. Package contents and other information

CORTIMENT 9 mg, prolonged-release tablets

Budesonide

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of 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 is Cortiment and what it is used for

Cortiment tablets contain a substance called budesonide. Budesonide belongs to a group of
medicines called "corticosteroids", used to reduce inflammation.
Cortiment tablets are used in adults for the treatment of inflammation of the large intestine (colon) and
the rectum. This condition 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 any of the other ingredients of this medicine (listed in
section 6).
If you are allergic to peanuts or soy, as Cortiment contains lecithin, a derivative of soybean 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, including viral, bacterial or fungal infections;
• if you have ever had high blood pressure;
• if you have diabetes;
• if you have ever suffered from fragile bones;
• if you have ever had stomach ulcers;
• if you have ever had high pressure inside the eye (glaucoma) or cataracts;
• if a family member has ever had diabetes or high pressure inside the eye (glaucoma);
• if you have ever had liver problems;
• if you are switching from another cortisone-based therapy to Cortiment, as this may result in, for example, muscle and joint pain, fatigue, headache, nausea and vomiting;
• if you know you are going to be vaccinated;
• if you have been treated with a more potent cortisone preparation before starting treatment with Cortiment, symptoms may recur;
• if you develop an infection during treatment, Cortiment may mask the signs of the infection, which may worsen. You may contract infections more easily during treatment with Cortiment, as resistance to infections may be reduced;
• if you are planning to have surgery soon, or are going through a period of stress;
• if you have never had chickenpox or measles. While taking Cortiment tablets, try to avoid contact with people affected by chickenpox or measles. Talk to your doctor if you think you have caught chickenpox or measles while taking this medicine;
• if you or a close family member has had mental health problems.

Taking cortisone preparations at high doses and for a prolonged period can have effects on every part
of the body and, in very rare cases, psychological problems may occur (see section 4 “Possible
side effects”).
If you have any doubts about whether the above applies to you, talk to your doctor before taking
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 important because Cortiment tablets
influence the action of some medicines, and some medicines can affect the action of Cortiment
tablets. Some medicines can increase the effects of Cortiment and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment
of HIV; ritonavir, cobicistat).
It is particularly important that you inform your doctor if you are taking, have recently taken or
might take any of the following medicines:

• ketoconazole or itraconazole, substances used to treat fungal infections;
• medicines used to treat HIV (e.g. ritonavir, nelfinavir, products containing cobicistat);
• carbamazepine, used to treat epilepsy;
• cardiac glycosides and diuretics;
• medicines containing estrogens, such as hormone replacement therapy (HRT) and some oral contraceptives;
• cholestyramine, used to reduce cholesterol levels or relieve itching caused by liver problems or antacids used to neutralize stomach acid.

Cortiment with food, drinks and alcohol
Do not drink grapefruit juice while taking Cortiment tablets. This can affect the way
the medicine works.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy, 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. You should use
caution, as this type of medicine can sometimes cause dizziness or fatigue.

Cortiment contains lactose and lecithin (soybean oil)
Cortiment tablets contain lactose, a type of sugar. If your doctor has told you that you suffer from
an intolerance to certain sugars, contact him before taking this medicine.
Cortiment contains lecithin (soybean oil). If you are allergic to peanuts or soy, do not use this medicine.

For athletes
The use of the drug without therapeutic necessity constitutes doping and can still result in positive
anti-doping tests.

3. How to take Cortiment

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor.

• The recommended dose is one tablet in the morning, before or during breakfast.
• Swallow the tablet whole, with a glass of water. The tablet must not be crushed, powdered or chewed.
• Normally you will take this medicine every day, for a maximum of 8 weeks. Afterwards, your doctor may gradually reduce the frequency of taking the medicine.
• Continue to take Cortiment tablets following your doctor’s instructions, even if you start to feel better.

Further information while taking Cortiment tablets
If you are about to undergo surgery or are going through a period of stress, your doctor may
tell you to take other steroid tablets as well.

Use in patients with reduced kidney or liver function
Cortiment has not been specifically studied in patients with kidney or liver problems. Talk to your
doctor.

Use in children
The use of Cortiment tablets is not recommended 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 a dose of Cortiment tablets, take it as soon as you remember. However, if the time for the next dose is not far off, skip the missed dose.
• Do not take a double dose to make up for a missed dose.

If you stop taking Cortiment
Do not stop taking Cortiment tablets without first talking to your doctor. You may need to
stop treatment gradually. If you suddenly stop taking this medicine, you may
become ill again.
If you have any doubts 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.
manifest.

If you have an allergic reaction, contact your doctor immediately or call emergency
medical services. Symptoms may include hives or swelling of the face, lips, mouth, tongue
and throat. This can make it difficult to breathe.
With Cortiment, the following side effects may occur; many of the side effects listed below are also
expected during treatment with other steroids.

Common (may affect up to 1 in 10 people)

• Symptoms similar to those of Cushing's syndrome, such as a rounded face, acne, weight gain and a tendency to develop sores
• Low levels of potassium in the blood, with possible muscle weakness or fatigue, thirst or a tingling sensation
• Changes in behaviour, such as nervousness, insomnia and mood swings
• Depression
• Headache
• Heart palpitations
• Nausea
• Stomach pain
• Bloated abdomen
• Dry mouth
• Indigestion (dyspepsia)
• Skin rash or itching
• Acne
• Muscle pain, muscle cramps
• Heavy or irregular periods in women
• Extreme fatigue
• Decreased cortisol hormone in the blood

Uncommon (may affect up to 1 in 100 people)

• Flu
• Increased white blood cells
• Changes in behaviour, such as mood swings
• Feeling restless with hyperactivity
• Anxiety
• Dizziness
• Tremor
• Flatulence
• Back pain
• Muscle spasms
• Swelling of the legs

Rare (may affect up to 1 in 1000 people)

• Aggression
• Glaucoma (increased pressure in the eye)
• Clouding of the lens or capsule of the eye (cataract)
• Blurred vision
• Purple or black/blue spots on the skin

Very rare (may affect up to 1 in 10000 people)

• Severe allergic reaction (called anaphylaxis) that can lead to difficulty breathing and potential shock Some of the side effects listed above are typical of steroid drugs and may occur depending on the dosage, duration of treatment, whether you have or have had treatment with other cortisone preparations and depending on your individual susceptibility.

Psychological problems may occur during the period of taking steroids such as Cortiment. Talk to
your doctor if you (or someone taking this medicine) develops (has developed) symptoms of
psychological problems. This is particularly important if you suffer from depression or have suicidal thoughts.
In very rare cases, psychological problems have occurred with long-term use of high doses.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at the address “ www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa ”.
By reporting side effects you can help provide more information on the safety of
this medicine.

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 package and on the blister pack
after “Exp.”. The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cortiment contains

• The active ingredient is budesonide. Each tablet contains 9 mg of budesonide.
• The other ingredients (excipients) of this medicine are: tablet core: stearic acid (E570), lecithin (soy) (E322), microcrystalline cellulose (E460), hydroxypropylcellulose (E463), lactose monohydrate, hydrated colloidal silica (E551), magnesium stearate (E470b) tablet coating: methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and methyl methacrylate copolymer (1:2), talc (E553b), titanium dioxide (E171), triethyl citrate.

Description of the appearance of Cortiment and package contents
Cortiment presents as film-coated tablets, round, biconvex, from white to off-white in color, with the inscription "MX9" imprinted on one side. The tablets are supplied in blister packs with an aluminum layer, inside a cardboard box.
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 and Manufacturer
Marketing Authorisation Holder
Ferring S.p.A.
Via Senigallia, 18/2
20161 Milano
Italy
Manufacturer
Cosmo Spa
Via C. Colombo 1
20020 Lainate
Milano
Italy

This medicine is authorised in the Member States of the European Economic Area under the following
names:
Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Malta, Netherlands, Norway, Romania, Slovakia, Spain, Sweden, United
Kingdom: Cortiment
Croatia, Poland: Cortiment
Portugal: Coramen
Belgium, Latvia, Lithuania, Luxembourg: Budesonide Ferring
Slovenia: Budezonid Ferring