Cortiment Mmx

Package Leaflet: Information for the Patient

Cortiment 9mg, prolonged-release tablets
Budesonide

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Table of Contents of the Leaflet

• 1. What is Cortiment and what is it 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 is Cortiment and what is it 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 for the treatment of:

• ulcerative colitis, which is inflammation of the colon (large intestine) and rectum.
• flare-ups of microscopic colitis, which is a chronic inflammation of the colon (large intestine) usually with chronic watery diarrhea.

2. Important information before taking Cortiment

When not to 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 soya, as Cortiment contains soya lecithin.

Warnings and precautions

If you experience blurred vision or other vision disturbances, contact your doctor.
Before starting treatment with Cortiment tablets, discuss with your doctor:

• if you have an infection, e.g. viral, bacterial or fungal,
• if you have had high blood pressure,
• if you have diabetes,
• if you have had osteoporosis (brittle bones),
• if you have had stomach ulcers,
• if you have had increased pressure in the eye (glaucoma) or cataracts,
• if there is a history of diabetes or increased pressure in the eye (glaucoma) in your family,
• if you have had liver problems,

Taking corticosteroid medicines like Cortiment for a long time can affect all parts of your body and, in very rare cases, your mental health (see section 4. Possible side effects).
If you are unsure whether any of the above applies to you, tell your doctor before taking Cortiment tablets.

Cortiment and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, including those obtained without a prescription. This is important because Cortiment tablets can affect the way other medicines work, and other medicines can affect the way Cortiment tablets work. Some medicines may increase the effects of Cortiment and your doctor may want to monitor your condition closely if you are taking these medicines (including certain HIV medicines: ritonavir, cobicistat).
It is especially important to tell your doctor if you are taking or have taken:

• ketokonazole or itraconazole, used to treat fungal infections,
• medicines used to treat HIV infection (e.g. ritonavir, nelfinavir, products containing cobicistat),
• carbamazepine, used to treat epilepsy.
• cardiac glycosides and diuretics,
• estrogen-containing medicines, such as hormone replacement therapy and some oral contraceptives,
• cholestyramine, used to lower cholesterol levels or treat itching caused by liver problems, 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor for advice before taking this medicine.

Driving and using machines

It is unlikely that Cortiment will affect your ability to drive or use machines. However, be careful as this medicine can sometimes cause dizziness or tiredness.
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Cortiment contains lactose and soya lecithin

Cortiment tablets contain lactose (a type of sugar). If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.
Cortiment contains soya lecithin. Do not take this medicine if you are allergic to peanuts or soya.

3. How to take Cortiment

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor.

• The recommended dose for ulcerative colitis and microscopic colitis is one tablet taken in the morning before a meal or during a meal.
• Swallow the tablet whole with a glass of water; do not break, crush, or chew the tablets.
• The medicine is usually taken once a day for a maximum of 8 weeks. After this time, your doctor may recommend gradually reducing the frequency of taking the medicine.
• Take Cortiment tablets as directed by your doctor, even if you feel better.

Additional information on taking Cortiment tablets

If you are scheduled to have surgery in the near future or are going through a stressful period in your life, your doctor may recommend taking other steroid medicines as well.

Use in patients with kidney or liver problems

Cortiment has not been studied in patients with kidney or liver problems. Discuss this with your doctor.

Use in children and adolescents

Cortiment tablets are not recommended for use in children and adolescents.

Taking more than the recommended dose of Cortiment

If you have taken more than the recommended dose of Cortiment, tell your doctor immediately.

Missing a dose of Cortiment

• If you miss a dose of Cortiment, take it as soon as possible. If it is almost time for your next dose, do not take the missed dose.
• Do not take a double dose to make up for a missed dose.

Stopping treatment with Cortiment

Do not stop taking Cortiment tablets without first talking to your doctor. You may need to gradually stop taking the medicine. Stopping treatment suddenly may worsen your condition.
If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, Cortiment can cause side effects, although not everybody gets them.

If you experience an allergic reaction, seek medical attention immediately - call 112. Symptoms may include hives or swelling of the face, lips, mouth, tongue, and throat. This can cause difficulty breathing.

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During treatment with Cortiment, the following side effects may occur; most of the side effects listed below can also occur during other steroid therapies.

Common side effects (may affect up to 1 in 10 people)

• Cushing's syndrome-like symptoms, such as rounded face, acne, weight gain, and easy bruising
• Low potassium levels in the blood, which can cause muscle weakness, tiredness, thirst, or tingling
• Changes in behavior, such as nervousness, insomnia, mood changes
• Depression
• Headache
• Palpitations
• Nausea
• Abdominal pain
• Abdominal distension
• Dry mouth
• Indigestion
• Rash or skin itching
• Acne
• Muscle pain, muscle cramps
• Excessive or irregular menstrual periods in women
• Extreme tiredness
• Low cortisol levels in the blood

Uncommon side effects (may affect up to 1 in 100 people)

• Influenza
• Increased white blood cell count
• Changes in behavior, such as mood changes
• Restlessness with hyperactivity
• Anxiety
• Dizziness
• Tremors
• Bloating
• Back pain
• Muscle cramps
• Swelling of the feet

Rare side effects (may affect up to 1 in 1,000 people)

• Aggression
• Glaucoma (increased pressure in the eye)
• Cataracts (clouding of the lens in the eye)
• Blurred vision
• Purple or dark red spots on the skin

Very rare side effects (may affect up to 1 in 10,000 people)

• Severe allergic reaction (anaphylaxis), which can cause difficulty breathing and potentially lead to shock

Some of the side effects listed above are typical of steroid treatment and may occur depending on the dose, duration of treatment, concurrent treatment with other corticosteroid preparations, and individual sensitivity.
If you experience any side effects, including those not listed in this leaflet, tell your doctor. You can also report side effects directly to the Department of Medicines Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C,
02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
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 stated on the carton and blister after EXP.
The expiry date refers to the last day of the 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 required. This will help protect the environment.

6. Contents of the pack 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), soya lecithin (E322), microcrystalline cellulose (E460), hydroxypropylcellulose (E463), lactose monohydrate, colloidal silicon dioxide (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.

What Cortiment looks like and contents of the pack

Cortiment is a white or almost white, round, biconvex, film-coated tablet with "MX9" engraved on one side of the tablet. The tablets are packaged in blisters with an aluminum foil lid, placed in a cardboard box.
This medicine is available in Poland in a pack containing 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized in the Member States of the European Economic Area and in 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
Date of last revision of the leaflet:November 2021
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