3 mg hard depot capsules 
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 or pharmacist.
  • 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

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

1. What Entocort is and what it is used for

Entocort capsules reduce inflammation in the small intestine and the first part of the large intestine.

Entocort is used to treat Crohn’s disease of the small intestine and the first part of the large intestine. Crohn’s disease is an inflammatory bowel disease that causes symptoms in the form of diarrhea, fever, and stomach pain.

Entocort is used to treat microscopic colitis, which is a disease with chronic inflammation of the colon, often with watery diarrhea. Entocort can be used both for active illness and in severe cases to prevent recurring problems (maintenance treatment).

2. What you need to know before taking Entocort

Do not take Entocort

  • if you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before using Entocort, especially if you have or have had any of the following conditions:

  • bacterial, fungal, or viral infection
  • any liver disease
  • bone loss ( osteoporosis )
  • gastric ulcer
  • high blood pressure
  • diabetes (also applies to diabetes in the family)
  • any eye disease (also applies to eye disease in the family)

Measles and chickenpox can have a more difficult course when you take Entocort. Therefore, contact a doctor if you are exposed to an infection.

Contact a doctor if you experience blurred vision or other visual disturbances.

When you switch from regular cortisone tablets to Entocort or end treatment with Entocort, you may temporarily experience some symptoms such as rash, runny nose, and muscle aches. If you get such problems or get a headache, get tired or nauseous, consult a doctor.

If you are going to have surgery, you should tell your doctor that you are taking Entocort as you may need to add regular cortisone tablets for a period of time.

Children and young people

In children and adolescents treated with Entocort, regular monitoring of height growth is recommended.

Other medicines and Entocort

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may affect or be affected by treatment with Entocort, for example:

  • certain medicines for fungal infections (eg ketoconazole and itraconazole)
  • medicines for menopausal symptoms ( estrogen ) and pregnancy ( birth control pills )
  • carbamazepine (for epilepsy )
  • certain drugs can increase the effects of Entocort and your doctor may need to monitor your treatment carefully if you are taking these drugs (such as some anti-HIV drugs: ritonavir (or other HIV – protease inhibitors ), cobicistat).

Entocort can affect a test that is done to check the function of the pituitary gland, called the ACTH stimulation test, so that the test gives incorrectly low values.

Entocort with food and drink

Intake of grapefruit juice should be avoided during treatment with Entocort, as grapefruit may increase the uptake of budesonide from the intestine (juices of other fruits such as apple or orange do not affect the uptake of budesonide).

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.

There is a risk that the fetus is affected. Therefore, always talk to your doctor before using Entocort if you are pregnant.

Budesonide passes into breast milk. Therefore, talk to your doctor before regular use of Entocort during breast-feeding.

Driving and using machines

Entocort does not affect your ability to drive or use machines.

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.

Entocort contains sucrose (sugar)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Entocort

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The prolonged-release capsules must not be divided or chewed but must be swallowed whole with a glass of water.

If you have difficulty swallowing, you can open the capsule and swallow the contents together with a tablespoon of apple puree. The contents must not be broken or chewed.

Crohn’s disease

The recommended dose for adults and children over 8 years with bodyweight over 25 kg:

In case of active disease: 3 prolonged-release capsules in the morning for 8 weeks.

It may take between 2 and 4 weeks for Entocort to take full effect.

Do not forget to take the prolonged-release capsules even if you feel better.

Treatment should be stopped by gradually reducing dose one.

Microscopic colitis

The recommended dose for adults:

In case of active disease: 3 prolonged-release capsules in the morning for 8 weeks. When treatment is to be stopped, dose one should first be reduced during the last two weeks.

Maintenance treatment: 2 prolonged-release capsules in the morning (or lowest effective dose ).

If you take more Entocort then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Entocort

Do not take a double dose to make up for a forgotten dose. Only continue with the next dose according to the schedule originally prescribed by your doctor.

If you stop taking Entocort

Do not stop taking Entocort without first consulting your doctor, as your doctor may want your dose to be reduced slowly.

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

4. Possible side effects

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

Common (affects 1 to 10 users in 100):

  • low potassium in the blood
  • behavioral changes such as nervousness, insomnia, mood swings, and depression
  • abnormally fast or irregular heartbeat
  • indigestion ( dyspepsia )
  • hives and rash
  • muscle cramps
  • menstrual disorders
  • fat deposits on the torso and face, skin changes, fluid accumulation in the body (so-called Cushing-like symptom picture).

Uncommon (affects 1-10 users in 1000):

  • tremors
  • restlessness, a strong drive to be physically active with concomitant mental anxiety ( psychomotor hyperactivity) 
  • anxiety

Rare (affects 1-10 users in 10,000):

  • aggressiveness
  • cloudiness of the lens (even the back of the lens), glaucoma ( glaucoma ), blurred vision
  • bluish-purple discoloration of the skin caused by bleeding under the skin.

Very rare (affects less than 1 user in 10,000):

  • severe allergic reactions
  • growth inhibition

5. How to store Entocort

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

Store in the original package. Moisture sensitive. Screw the lid on the jar firmly.

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

1 prolonged-release capsule contains:

  • The active substance is budesonide 3 mg.
  • The other ingredients are ethylcellulose, acetyl, the copolymer of methacrylic acid, triethyl citrate, antifoam M, polysorbate 80, talc, sucrose (sugar), corn starch, coloring agents (titanium dioxide E 171, iron oxide E 172), gelatin, liquid paraffin, colloidal silicon dioxide, sodium, ammonium hydroxide, potassium hydroxide, shellac.

Other ingredients are included to give the capsule the right properties and for it to be manufactured.

What the medicine looks like and the contents of the pack

Hard, gray/pink, opaque gelatin capsules, labeled “CIR 3 mg”.

Supplied in a plastic jar (HDPE) containing 50 or 100 prolonged-release capsules.

The lid contains a desiccant.

Marketing Authorisation Holder

Tillotts Pharma GmbH, Warmbacher Str. 80, 79618 Rheinfelden, Germany.

The local representative of the marketing authorization holder:

Tillotts Pharma AB, Gustavslundsvägen 135, 167 51 Bromma.

Manufacturer

AstraZeneca AB, 151 85 Södertälje.

Recipharm Fontaine SAS,

Rue des Prés Potets

21121 Fontaine-les-Dijon

France

Muhammad Nadeem

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