Budenofalk 9mg gastro-resistant granules

• Keep this leaflet. 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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. Contents of the pack and other information

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

• tuberculosis
• high blood pressure
• diabetes, or if diabetes has been diagnosed in your family
• brittle bones (osteoporosis)
• ulcers in the stomach or first part of the small intestine (peptic ulcer)
• increased pressure in your eye (glaucoma) or eye problems such as clouding of the lens (cataracts) or if glaucoma has been diagnosed in your family
• severe liver problems

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

Sometimes this disease may cause symptoms outside the intestine (e.g. affecting the skin, eyes and joints) which are unlikely to respond to this medicine.

Typical effects of cortisone preparations may occur which may affect all parts of the body, particularly when you take Budenofalk granules at high doses and for prolonged periods (see section 4. Possible side effects).

• Tell your doctor if you have an infection. The symptoms of some infections can be atypical or less pronounced.
• Keep away from people who have chickenpox or herpes zoster (shingles), if you have never had them. They could affect you severely. If you do come into contact with chickenpox or shingles, see your doctor straight away.
• Tell your doctor if you have not yet had measles.
• If you know that you need to be vaccinated, please speak to your doctor first.
• If you know that you are due to have an operation, please tell your doctor that you are using Budenofalk granules.
• If you have been treated with a stronger cortisone preparation before starting treatment with Budenofalk granules, your symptoms may reappear when the medicine is changed. If this happens, contact your doctor.
• Contact your doctor if you experience blurred vision or other visual disturbances.

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

• cardiac glycosides such as digoxin (medicines used to treat heart conditions)
• diuretics (to remove excess fluid from the body)
• ketoconazole or itraconazole (to treat fungal infections)
• antibiotic drugs used to treat infections (such as clarithromycin)
• carbamazepine (used in the treatment of epilepsy)
• rifampicin (for treating tuberculosis)
• oestrogens or oral contraceptives
• cimetidine (used to inhibit the production of acid in the stomach)

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

If you take cholestyramine (for hypercholesterolaemia and also used to treat diarrhoea) or antacids (for indigestion) in addition to Budenofalk granules, take these medicines at least 2 hours apart.

Budenofalk granules could affect the results of tests performed by your doctor or in hospital. Tell your doctor that you are taking Budenofalk granules before any tests are carried out.

You should not drink grapefruit juice whilst you are taking this medicine as this can alter its effects.

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

You should only take Budenofalk granules during pregnancy if your doctor tells you to.

Budesonide passes in small amounts into the breast milk. If you are breastfeeding you should only take Budenofalk granules if your doctor tells you to.

Budenofalk granules are not expected to affect your ability to drive or operate machinery.

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

This medicine contains 900 mg sorbitol in each sachet. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take or receive this medicine.

Crohn’s disease and microscopic colitis

Adults (over 18 years)

Take one sachet in the morning unless your doctor instructs you otherwise.

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

Budenofalk granules are for oral use only.

You should take the Budenofalk granules about ½ hour before breakfast. Place the granules directly on the tongue and then swallow them with a glass of water. Do not chew the granules as they may not work properly.

Your treatment should last about 8 weeks.

Your doctor will decide how long you are to continue the medication, depending on your condition.

If you have taken too much medicine on one occasion, take your next dose as prescribed. Do not take a smaller amount. Contact a doctor if you are in doubt, so he or she can decide what to do; take the carton and this leaflet with you if possible.

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

Speak to your doctor if you want to interrupt or end your treatment early. It is important that you do not stop taking your medicine abruptly as it could make you ill. Keep taking your medicine until your doctor tells you to stop, even if you start to feel better.

Your doctor will probably want to reduce your dose gradually, from one sachet every day to one sachet every other day for at least 2 weeks.

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

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below.

or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is budesonide. Each sachet with gastro-resistant granules contains 9 mg of budesonide.

The other ingredients are ammonio methacrylate copolymer (type A) (Eudragit RL), ammonio methacrylate copolymer (type B) (Eudragit RS), citric acid, lactose monohydrate, lemon flavour, magnesium stearate, methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L 100), methacrylic acid-methyl methacrylate copolymer (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 further information on lactose, sucrose and sorbitol).

Budenofalk granules are white to off-white coloured gastro-resistant granules and white to pale yellow powder with lemon flavour, filled into one sachet.

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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

This medicinal product is authorised in the Member States of the EEA under the following names:

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

France: MIKICORT

Italy: Intesticortmono

Austria: Budo-San^®

Spain: Intestifalk^®