9 mg enterogranulate 
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. See section 4.

In this leaflet you will find information about: 
1. What Budenofalk granules are and what they are used for 
2. What you need to know before you take Budenofalk granules 
3. How to take Budenofalk granules 
4. Possible side effects 
5. How to store Budenofalk granules 
6. Package contents and other information 

1. What Budenofalk granules are and what they are used for

Budenofalk granules contain the active substance budesonide, a type of topical steroid used to treat chronic inflammatory bowel disease.

Budenofalk granules are used in the treatment of

  • Crohn’s disease :  mild to moderate acute attacks of chronic inflammation in the lower part of the small intestine (ileum) and / or the upper part of the colon (ascending colon )
  • acute episodes of collagen colitis (a disease with chronic inflammation of the colon characterized by chronic , watery diarrhea).

2. What you need to know before taking Budenofalk granules

Do not take Budenofalk granules

  • if you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6)
  • if you have a serious liver disease ( liver cirrhosis )

Warnings and cautions

Talk to your doctor or pharmacist before taking Budenofalk granules if you have:

  • tuberculosis
  • high blood pressure
  • diabetes , or if someone in the family has been diagnosed with diabetes
  • bone loss ( osteoporosis )
  • ulcers in the stomach or first part of the small intestine (peptic ulcer )
  • increased pressure in the eyes ( glaucoma ) or eye problems such as cloudiness of the lens ( cataract ) or if someone in the family has been diagnosed with glaucoma
  • severe liver problems

Budenofalk granules are not suitable for patients with Crohn’s disease of the upper gastrointestinal tract.

Sometimes this disease can cause symptoms outside the gut (eg affecting skin, eyes and joints). These symptoms are unlikely to be ameliorated by treatment with this medicine.

Typical effects of cortisone drugs can occur and can affect all parts of the body, especially if you take Budenofalk granules in high doses and for long periods (see section 4, Possible side effects ).

Additional precautions for treatment with Budenofalk granules:

  • Tell your doctor if you have an infection . The symptoms of some infections may deviate from normal or be unclear.
  • If you have not had these diseases, stay away from people who have chickenpox or herpes zoster ( shingles ). These can seriously affect you. If you come in contact with someone who has chickenpox or shingles , contact your doctor immediately.
  • Tell your doctor if you have not had measles.
  • If you know you need to get vaccinated, talk to your doctor first.
  • If you have any surgery, tell your doctor that you are taking Budenofalk granules .
  • If you have been treated with a stronger cortisone preparation before you start taking Budenofalk granules , your symptoms may return when you change medicines. Contact your doctor if this happens.
  • Contact a doctor if you experience blurred vision or other visual disturbances.

Other medicines and Budenofalk granules

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

  • cardiac glycosides such as digoxin (medicines used to treat heart disease)
  • diuretics (to remove excess fluid from the body)
  • ketoconazole or itraconazole (to treat fungal infections)
  • antibiotics to treat infections (eg clarithromycin)
  • carbamazepine (to treat epilepsy )
  • rifampicin (to treat tuberculosis )
  • estrogen or birth control pills
  • cimetidine (to inhibit acid production in the stomach).

Some medicines may increase the effects of Budenofalk granules and your doctor may want to monitor you closely if you are taking these medicines (eg some medicines for HIV: ritonavir, cobicistat).

If you are taking cholestyramine (for hypercholesterolemia and also to treat diarrhea) or antacids (for digestion) in addition to Budenofalk granules , take these medicines at least 2 hours apart .

Budenofalk granules may affect the results of any tests performed by your doctor or hospital. Tell your doctor that you are taking Budenofalk granules before any test.

Budenofalk granules with food and drink

You should not drink grapefruit juice while taking this medicine as it may alter the effects of the medicine.

Pregnancy and breastfeeding

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.

Only take Budenofalk granules during pregnancy if your doctor tells you to.

Budesonide in small amounts is converted into breast milk. If you are breast-feeding, only take Budenofalk granules if your doctor tells you to.

Driving and using machines

Budenofalk granules are not expected to 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 vigilance. 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.

Budenofalk granules contain sucrose, lactose and sorbitol

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

This medicine contains 900 mg sorbitol per sachet . Sorbitol is a source of fructose. If you have been told by your doctor that you have an intolerance to some sugars, or if you have been diagnosed with hereditary fructose intolerance , a rare, inherited disease that prevents you from breaking down fructose, talk to your doctor before taking this medicine.

3. How to take Budenofalk granules

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

The recommended dose is

Crohn’s disease and collagen colitis

Adults (over 18 years)

Take a sachet in the morning if you have not received any other information from your doctor.

Use for children and adolescents

Budenofalk granules should NOT be used by children under 18 years of age.

Method of administration

Budenofalk granules should only be taken by mouth.

You should take Budenofalk granules about ½ hour before breakfast. Put granulesdirectly on the tongue and swallow it with a glass of water. Do not chew on granulesas it may not work properly.

Duration of treatment

Your treatment should last for about 8 weeks.

Your doctor will decide how long you should continue to take the medicine, depending on your condition.

If you forget to take Budenofalk granules

If you miss a dose , just continue the treatment with the prescribed dose . Do not take a double dose to make up for a forgotten dose.

If you stop taking Budenofalk granules

Talk to your doctor if you want to stop or stop treatment earlier. It is important that you do not stop taking the medicine abruptly as it may make you ill. Keep taking this medicine until your doctor tells you to stop, even if you start to feel better.

Your doctor will probably want to reduce the dose one at a time , from one sachetevery day to one sachet every other day for at least 2 weeks.

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.

If you get any of the following symptoms after taking this medicine, contact your doctor immediately:

  • infection
  • headache
  • behavioral changes such as depression, irritation, euphoria , restlessness, anxiety and aggression.

The following side effects have also been reported:

Common (may affect up to 1 in 10 people)

  • Cushing’s syndrome – e.g. with rounded face, weight gain, decreased glucose tolerance, high blood sugar, high blood pressure , fluid retention in the body (eg swollen legs), increased excretion of potassium ( hypokalaemia ), irregular menstruation in women, unwanted body hair in women, impotence , abnormal laboratory results ( impaired adrenal function), red streaks on the skin (stretch marks), acne
  • stomach upset, irritated stomach ( dyspepsia ), abdominal pain
  • increased risk of infection
  • muscle and joint pain, muscle weakness, muscle twitching
  • bone loss ( osteoporosis )
  • headache
  • mood swings, e.g. depression, irritation and euphoria
  • rash due to hypersensitivity reactions , red spots caused by bleeding in the skin, delayed wound healing, local skin reactions, e.g. contact dermatitis

Uncommon (may affect up to 1 in 100 people)

  • ulcers in the stomach or small intestine
  • restlessness with increased physical activity, anxiety

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

  • dimsyn
  • inflammation of the pancreas
  • bone loss caused by poor blood circulation
  • aggression
  • bruises

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

  • stunted growth in children
  • constipation
  • increased pressure in the brain, possibly with increased pressure in the eyes (swelling of the optic nerve papilla) in adolescents
  • increased risk of blood clots, inflammation of the blood vessels (may occur after long-term cortisone treatment)
  • fatigue, general malaise

These side effects are typical when treated with steroids and most can also be expected when treated with other steroids . They may occur depending on your dose, the duration of treatment, whether you have received or are being treated with other cortisone preparations, and your individual sensitivity. If you have been treated with a stronger cortisone preparation before starting treatment with Budenofalk granules, your symptoms may return when the medicine is changed.

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. 

5. How to store Budenofalk granules

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 sachet. The expiration date is the last day of the specified month.

No special storage instructions.

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 sachet of enterogranulate contains 9 mg budesonide

The other ingredients are ammonio methacrylate copolymer (type A) (Eudragit RL), ammonio methacrylate copolymer (type B) (Eudragit RS), anhydrous citric acid, lactose monohydrate , lemon flavor, magnesium stearate, methacrylic acid-methyl methacrylate copolymer (1: 1) 100 methyl methacrylate copolymer polymer (1: 2) (Eudragit S 100), povidone K25, sucralose, sugar spheres (consisting of sucrose and maize starch), sorbitol (E420), talc, triethyl citrate, xanthan gum. (See section 2 for more information on lactose , sucrose and sorbitol).

What the medicine looks like and contents of the pack

Budenofalk granules are white to off-white enterogranules and white to light yellow powder with lemon flavor in a sachet .

Budenofalk granules are available in pack sizes of 15, 20, 30, 50 and 60 sachets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Dr. Falk Pharma GmbH

Leinenweberstr. 5

79108 Freiburg

Germany

Information provided by :

Vifor Pharma Nordiska AB 
Gustav III: s Boulevard 46

169 73 Solna


This medicinal product is authorized by the Member States of the European Economic Area under the names:

Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Ireland, Luxembourg, Netherlands, Norway, Portugal, Romania, Slovakia, Slovenia, , United Kingdom: Budenofalk

Austria: Budo-San

France: MIKICORT

Italy: Intesticort mono

Spain: Intestifalk

Muhammad Nadeem

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