Budesonide Dr. Falk Pharma 4 mg suppositories

• 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 Budesonide Dr. Falk Pharma 4 mg suppositories are and what they are used for
2. What you need to know before you use Budesonide Dr. Falk Pharma 4 mg suppositories
3. How to use Budesonide Dr. Falk Pharma 4 mg suppositories
4. Possible side effects
5. How to store Budesonide Dr. Falk Pharma 4 mg suppositories
6. Contents of the pack and other information

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

Talk to your doctor or pharmacist before using this medicine if you have

• tuberculosis
• high blood pressure
• diabetes, or if you have a family history of diabetes
• 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 you have a family history of glaucoma
• liver problems
• kidney problems

Further precautions during treatment with Budesonide Dr. Falk Pharma suppositories

• 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 this medicine.
• Contact your doctor if you experience blurred vision or other visual disturbances.

This medicine could affect the results of tests performed by your doctor or in hospital. Tell your doctor that you are using Budesonide Dr. Falk Pharma suppositories before any tests are carried out.

Elderly patients should be closely monitored for side effects.

This medicine should not be used in children and adolescents under 18 years of age. The use of this medicine in patients younger than 18 years of age has not yet been studied.

Tell your doctor or pharmacist if you are using, have recently used or might use 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)
• clarithromycin, an antibiotic used to treat infections
• carbamazepine (used in the treatment of epilepsy)
• rifampicin (for treating tuberculosis)
• oestrogens or oral contraceptives

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

You should not drink grapefruit juice whilst you are using 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 using this medicine.

You should only use this medicine during pregnancy if your doctor tells you to.

Budesonide passes in small amounts into the breast milk. If you are breast-feeding you should only use this medicine if your doctor tells you to.

Budesonide Dr. Falk Pharma suppositories are not expected to affect your ability to drive or operate machinery.

The recommended dose is one Budesonide Dr. Falk Pharma suppository daily.

This medicine may only be used rectally, so it has to be inserted through the anus. Do NOT take it by mouth.

Budesonide Dr. Falk Pharma suppositories should be administered at bedtime, so the suppository remains in place for as long as possible.

• If possible, the suppository should be inserted after a bowel movement.
• Wash your hands thoroughly.
• Carefully remove the suppository from the strip just before use.
• Warming the suppository shortly beforehand with the palms of your hands may make insertion easier.
• Hold the suppository between the thumb and index finger.
• Lie down on your side in a comfortable position
• Insert the suppository gently and deeply into the back passage (rectum) with the pointed side first.
• Wash your hands thoroughly again.

Your doctor will decide how long you need to continue the treatment with this medicine. This will depend on your condition. Acute episodes of ulcerative proctitis, which is an inflammation of the rectum causing ulceration and bleeding, generally subside after 6 - 8 weeks.

If you have used too many suppositories on one occasion, use your next dose as prescribed. Do not use 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 use a double dose to make up for a forgotten dose.

Speak to your doctor if you want to interrupt or end your treatment early. Keep using your medicine until your doctor tells you to stop, even if you start to feel better.

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:

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
• The other ingredients are ascorbyl palmitate E 304(i) and hard fat.

Budesonide Dr. Falk Pharma suppositories are white, torpedo-shaped suppositories (approximately 2 cm length) with a smooth surface.

Budesonide Dr. Falk Pharma suppositories are available in packs containing 12, 30 or 60 suppositories.

Not all pack sizes may be marketed.

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