Cortiment mmx

Patient Information Leaflet

Cortiment, 9 mg, prolonged-release tablets
Budesonide
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm others, even if their symptoms are similar.
• If any adverse effects occur in the patient, including any adverse effects not listed in this leaflet, inform your doctor. See section 4.

Leaflet Contents

1. What Cortiment is and what it is used for
2. Important information before taking 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 the active substance budesonide. Budesonide belongs to a group of substances called "glucocorticosteroids", which are used to reduce inflammation.
Cortiment tablets are used in adults to treat:

• Ulcerative colitis, which is inflammation of the large intestine (colon) and rectum.
• Flares of microscopic colitis, a chronic inflammatory condition of the large intestine (colon) usually presenting with chronic watery diarrhoea.

2. Important information before using Cortiment

When not to use Cortiment
If the patient is allergic to budesonide or any of the other ingredients of this medicine
(listed in section 6).
If the patient is allergic to peanuts or soya, because Cortiment contains lecithin
derived from soya oil.

Warnings and precautions
If the patient experiences blurred vision or any other visual disturbances, they should contact their doctor.
Before starting treatment with Cortiment tablets, discuss the following with your doctor:

• if the patient has an infection, e.g. viral, bacterial or fungal,
• if the patient has had high blood pressure,
• if the patient has diabetes,
• if the patient has had osteoporosis (brittle bones),
• if the patient has had peptic ulcer disease,
• if the patient has had increased intraocular pressure (glaucoma) or cataracts,
• if the patient’s family has a history of diabetes or increased intraocular pressure (glau游戏副本),
• if the patient has had liver function disorders,
• if the patient is switching from treatment with other corticosteroid medicines to treatment with Cortiment, as this may lead to, for example, muscle and joint pain, fatigue, headache, nausea and vomiting,
• if the patient knows they need to be vaccinated,
• if the patient has previously been treated with stronger corticosteroid medicines before starting treatment with Cortiment, as symptoms may recur,
• if the patient develops an infection during treatment, because Cortiment may mask the signs of infection and the infection may worsen; infections may also occur more easily during treatment with Cortiment, as the body's immune response to infections may be reduced,
• if the patient has a surgical procedure planned soon or is going through a period of stress,
• if the patient has not previously had measles or chickenpox; during treatment with Cortiment tablets, contact with people who have measles or chickenpox should be avoided; inform the doctor if the patient thinks they may have been exposed to chickenpox or measles while taking this medicine,
• if the patient or a close relative has had mental health problems.

Taking corticosteroid medicines in high doses and for a prolonged period may affect
all parts of the body and, very rarely, mental health (see section 4. Possible side effects).
If in doubt whether any of the above situations apply to the patient, consult a doctor before using Cortiment tablets.

Cortiment and other medicines
Tell the doctor about all medicines the patient is currently taking or has recently taken,
including those obtained without a prescription. This is important because Cortiment tablets may
affect the action of other medicines, and other medicines may affect the action of Cortiment tablets. Some
medicines may increase the effect of Cortiment, and the doctor may need to monitor the patient closely
(especially certain HIV medicines: ritonavir, cobicistat).
It is especially important to inform the doctor about currently taking, recently taken, or planned use of the following medicines:

• ketoconazole or itraconazole, used to treat fungal infections,
• medicines used to treat HIV infection (e.g. ritonavir, nelfinavir, medicines containing cobicistat),
• carbamazepine, used to treat epilepsy,
• cardiac glycosides and diuretics,
• medicines containing estrogens, such as those used in hormone replacement therapy and some oral contraceptives,
• cholestyramine, used to lower cholesterol levels or to treat itching caused by liver disorders, or antacids.

Cortiment with food, drink and alcohol
Do not drink grapefruit juice while taking Cortiment tablets. It may interfere with the way the medicine works.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
baby, she should consult her doctor before using this medicine.

Driving and operating machinery
It is unlikely that Cortiment will affect the ability to drive or operate machinery. However, caution is advised, as this medicine may occasionally cause dizziness or fatigue.

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Cortiment contains lactose and lecithin (soya oil)
Cortiment tablets contain lactose (a type of sugar). If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.
Cortiment contains lecithin (soya oil). This medicine should not be used if the patient is allergic to
peanuts or soya.

3. How to use Cortiment

This medicine should always be used exactly as your doctor has instructed. If in doubt, consult your doctor.

• The recommended dose for ulcerative colitis and microscopic colitis is one tablet taken in the morning before or during a meal.
• The tablet should be swallowed whole with a glass of water; the tablets must not be broken, crushed, or chewed.
• The medicine is usually taken once daily for a maximum period of eight weeks. After this time, your doctor may recommend gradually reducing the frequency of dosing.
• Cortiment tablets should be taken according to your doctor's instructions, even if symptoms improve.

Additional information on the use of Cortiment tablets
If the patient has a surgical procedure scheduled in the near future or is going through a stressful period, the doctor may recommend taking additional steroid medications.
Use in patients with impaired kidney or liver function
Cortiment has not been studied in patients with impaired kidney or liver function. This should be discussed with your doctor.
Use in children and adolescents
Cortiment tablets are not indicated for use in children and adolescents.
Taking more Cortiment than recommended
If more Cortiment than recommended is taken, contact your doctor immediately.
Missed dose of Cortiment

• If a dose of Cortiment is missed, it should be taken as soon as possible. If it is almost time for the next dose, the missed dose should be skipped.
• Do not take a double dose to make up for a missed dose.

Stopping Cortiment
Do not stop taking Cortiment tablets without first consulting your doctor. Gradual withdrawal of the medicine may be required. Abruptly stopping the medicine may worsen the patient's condition.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone will experience them.
If the patient experiences an allergic reaction, seek medical advice immediately or call the emergency number - 112.
Symptoms may include urticaria or swelling of the face, lips, mouth, tongue, and throat.
This may cause difficulty in breathing.
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The following adverse reactions may occur during treatment with Cortiment; most of the adverse reactions listed below may also occur during treatment with other steroid therapies.

Common adverse reactions (may occur in up to 1 in 10 people)

• Symptoms resembling Cushing's syndrome, such as rounded face, acne, increased body weight, and easy bruising
• Low blood potassium levels, which may cause muscle weakness, fatigue, thirst, or tingling sensations
• Behavioral changes such as nervousness, insomnia, mood changes
• Depression
• Headache
• Palpitations
• Nausea
• Abdominal pain
• Abdominal distension
• Dry mouth
• Indigestion
• Rash or itching of the skin
• Acne
• Muscle pain, muscle cramps
• Heavy or irregular menstrual periods in women
• Severe fatigue
• Reduced blood levels of the hormone cortisol

Uncommon adverse reactions (may occur in up to 1 in 100 people)

• Influenza-like illness
• Increased white blood cell count
• Behavioral changes such as mood changes
• Feeling of restlessness with hyperactivity
• Anxiety
• Dizziness
• Tremor
• Bloating
• Back pain
• Muscle cramps
• Swelling of the legs

Rare adverse reactions (may occur in up to 1 in 1,000 people)

• Aggression
• Glaucoma (increased pressure in the eyeball)
• Clouding of the eye lens (cataract)
• Blurred vision
• Purple or dark red-purple skin spots

Very rare adverse reactions (may occur in up to 1 in 10,000 people)

• Severe allergic reaction (called anaphylaxis), which may lead to breathing difficulties and potentially shock

Some of the adverse reactions listed above are typical of treatment with corticosteroid medicines and may occur depending on the dose, duration of treatment, concomitant treatment with other corticosteroid preparations, and individual sensitivity.
Psychological problems may occur during treatment with corticosteroid medicines such as Cortiment. A doctor should be consulted if the patient (or another person taking this medicine) experiences symptoms indicating psychological problems. This is particularly important if the patient has depression or is thinking about suicide. In very rare cases, psychological problems have occurred during long-term treatment with high doses.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Medical Devices and Biocidal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C,
02-222 Warsaw,
Tel: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the 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 stated on the carton and blister pack following the label EXP.
The expiry date refers to the last day of the stated month.
Store below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such practices help protect the environment.

6. Contents of the packaging and other information

What Cortiment contains

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

What Cortiment looks like and contents of the pack

Cortiment is white or almost white, round, biconvex coated tablets with the imprint "MX9" on one side. The tablets are supplied in blisters with aluminium foil lid, placed in a cardboard box.

This medicine is available in Poland in a pack containing 30 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Ferring GmbH
Wittland 11
D-24109 Kiel
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Germany

Manufacturer
Cosmo S.p.A.
Via C. Colombo 1
20045 Lainate
Milan
Italy

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