9 mg prolonged-release tablet 
budesonide

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

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

1. What Cortiment is and what it is used for

Cortiment contains a substance called budesonide. Budesonide belongs to a group of medicines called cortisone that is used to reduce inflammation.

Cortiment is used in adults to treat

  • ulcerative colitis, which is an inflammation of the colon ( colon ) and rectum ( rectum )
  • acute relapse of microscopic colitis, which is a disease with chronic inflammation of the colon, usually with chronic watery diarrhea

Budesonide contained in Cortiment may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using 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 because Cortiment contains lecithin which comes from soybean oil

Warnings and cautions

Talk to your doctor before taking Cortiment:

  • if you have an infection such as a viral, bacterial, or fungal infection
  • if you have had high blood pressure
  • if you have diabetes
  • if you have had osteoporosis
  • if you have had stomach ulcers
  • if you have had increased pressure in the eye ( glaucoma ) or cataracts
  • if someone in your immediate family has had diabetes or increased pressure in the eye ( glaucoma )
  • if you have had liver problems
  • if you switch from another cortisone treatment to Cortiment as this can result in eg muscle and joint pain, fatigue, headaches, nausea, and vomiting
  • if you know you need to be vaccinated
  • if you have been treated with a stronger cortisone preparation before treatment with Cortiment, your symptoms may return
  • If you get an infection during treatment, Cortiment can hide signs of infection and infection can get worse. You can more easily get an infection during treatment with Cortiment because the body’s resistance to infection can decrease.
  • if you are going to undergo surgery in the near future or undergo a stressful period
  • if you have not yet had measles or chickenpox. Try to avoid people who have measles or chickenpox while taking Cortiment tablets. Talk to your doctor if you think you have been infected with chickenpox or measles while taking this medicine.
  • if you or a close relative has had a mental illness

Taking cortisone in high doses and for a long period of time can affect all parts of the body and in very rare cases cause mental problems (see section 4. Possible side effects ).

If you are not sure if any of the above applies to you, talk to your doctor before taking Cortiment.

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 may affect the way some medicines work and some medicines may affect how Cortiment works. Some medicines may increase the effects of Cortiment and your doctor may want to monitor you closely if you are taking these medicines (eg some medicines for HIV: ritonavir, cobicistat).

It is especially important that you tell your doctor if you are taking, have recently taken, or might take any of the following medicines:

  • ketoconazole or itraconazole, which is used to treat fungal infections
  • medicines for HIV (eg ritonavir and nelfinavir, medicines containing cobicistat)
  • carbamazepine, which is used to treat epilepsy
  • cardiac glycosides and diuretics
  • Estrogen- containing medicines, such as hormone replacement therapy and certain oral contraceptives ( birth control pills )
  • cholesterol, which is used to lower cholesterol levels or reduce itching caused by liver problems, or antacids (antacids)

An assortment of food, drink, and alcohol

Do not drink grapefruit juice while taking Cortiment. It may affect the way the medicine works.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Cortiment probably does not affect your ability to drive or use tools or machines. Caution should be exercised as this type of medicine can sometimes cause dizziness or fatigue.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Cortiment contains lactose and lecithin (soybean oil)

Cortiment contains lactose which is 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 medicine.

Cortiment contains lecithin (soybean oil). If you are allergic to peanuts or soy, do not use this medicine.

3. How to use Cortiment

Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.

  • The recommended dose for ulcerative colitis and microscopic colitis is 1 tablet in the morning before or with breakfast.
  • Swallow the tablet whole with a glass of water, the tablet must not be split, crushed, or chewed.
  • You will usually take this medicine daily for up to 8 weeks. Your doctor will then gradually reduce the frequency with which you take this medicine. Continue to take Cortiment as your doctor has told you, even if you start to feel better.

Additional information while taking Cortiment

If you are going to have surgery in the near future or are in a period of a lot of stress, your doctor may ask you to take other steroid tablets as well.

Use in patients with renal or hepatic impairment

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

Use for children

Cortiment is not recommended for children. 

If you forget to use Cortiment

  • If you forget to take a dose of Cortiment, take it as soon as you remember. If it is soon time for your next dose, skip the missed dose.
  • Do not take a double dose (two doses at the same time) to compensate for a missed dose.

If you stop taking Cortiment

Do not stop taking Cortiment without talking to a doctor first. You may need to stop treatment gradually. If you suddenly stop taking this medicine, you may start to feel unwell.

If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

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

The following side effects may occur with Cortiment. Most of the side effects mentioned below can also be expected with other cortisone treatment.

Common (may affect up to 1 in 10 people)

  • Cushing-like symptoms such as the round face, acne, weight gain, and increased tendency to bruise
  • Low potassium levels in the blood can cause muscle weakness or fatigue, thirst, or “tingling”
  • Behavioral changes such as nervousness, difficulty sleeping, and mood swings
  • Depression
  • Headache
  • Palpitation
  • Nausea
  • Abdominal pain
  • Stretched abdomen
  • Dry mouth
  • Indigestion ( dyspepsia )
  • Skin rash or itching
  • Acne
  • Muscle pain, muscle cramps
  • Abundant or irregular menstruation in women
  • Extreme fatigue
  • Reduction of the hormone cortisol in the blood

Uncommon (may affect up to 1 in 100 people)

  • Influenza
  • Increase in white blood cells
  • Behavioral changes such as mood swings
  • Restlessness and hyperactivity
  • Concern
  • Dizziness
  • Shaking
  • Weather tensions
  • Back pain
  • Muscle spasms
  • Swelling in the legs

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

  • Aggression
  • Glaucoma (increased pressure in the eye)
  • Clouding of the eye lens or lens capsule (cataract)
  • DimsynPurple or blue-black spots on the skin

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

  • Severe allergic reaction ( anaphylaxis ) which may cause breathing difficulties and possible shock

Some of the side effects mentioned above are typical of cortisone treatment and may occur depending on the dose, treatment period if you are taking or have taken other cortisone preparations, and your individual sensitivity.

Mental disorders can occur when taking cortisone such as Cortiment. Talk to your doctor if you (or anyone taking this medicine) show signs of mental illness. This is especially important if you are depressed or may have suicidal thoughts. Very rare mental disorders have occurred when high doses have been 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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

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 blister after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is budesonide. Each tablet contains 9 mg budesonide.
  • The other ingredients (excipients) are: Tablet core – stearic acid (E570), lecithin (soy) (E322), microcrystalline cellulose (E460), hydroxypropyl cellulose (E463), lactose monohydrate, colloidal hydrated silica (E551) E4macrylate acid methyl methacrylate copolymer (1: 1), methacrylic acid-methyl methacrylate copolymer (1: 2), talc (E553b), titanium dioxide (E171), triethyl citrate 

What the medicine looks like and the contents of the pack

Cortiment is available as white to off-white, round, biconvex, film-coated tablets marked with “MX9” on one side. The tablets are delivered in a blister pack with aluminum foil printing foil in a 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

Ferring Läkemedel AB

Box 4041

203 11 Malmö

040-691 69 00

Manufacturer

Cosmo S.pA.

Via C. Colombo 1

Laminate

Milan

Italy

Muhammad Nadeem

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