Intestifalk 4 mg suppositories

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Intestifalk 4mg suppositories

budesonideRead this entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Intestifalk is and what it is used for
2. What you need to know before using Intestifalk
3. How to use Intestifalk
4. Possible side effects
5. How to store Intestifalk
6. Contents of the pack and other information

1. What Intestifalk is and what it is used for

Intestifalk contains the active substance budesonide, a locally-acting corticosteroid used to treat inflammatory diseases of the intestine.

Intestifalk is indicated in adult patients for the treatment of acute episodes of inflammatory disease of the rectum (ulcerative proctitis).

2. What you need to know before using Intestifalk

Do not use Intestifalk

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

Warnings and precautions

Talk to your doctor or pharmacist before using Intestifalk if you have:

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

Additional precautions during treatment with Intestifalk

• Inform your doctor if you have an infection. Symptoms of some infections may be atypical or less pronounced.
• Avoid contact with people who have chickenpox or shingles (herpes zoster) if you have never had these diseases before. They could seriously affect you. If you come into contact with chickenpox or shingles, see your doctor immediately.
• Inform your doctor if you have never had measles.
• If you need to receive any vaccine during treatment with this medicine, inform your doctor beforehand.
• Inform your doctor that you are using Intestifalk if you are scheduled for surgery.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Intestifalk may affect the results of tests performed by your doctor or in hospital. Inform your doctor that you are using Intestifalk before any test is carried out.

Use of the medicine Intestifalk 4 mg suppositories may lead to positive results in doping tests.

Elderly patients

Close monitoring for adverse effects is recommended in elderly patients.

Children and adolescents

Intestifalk must not be used in children and adolescents under 18 years of age. The use of this medicine has not been studied in patients under 18 years of age.

Other medicines and Intestifalk

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

• cardiac glycosides such as digoxin (medicines used to treat heart conditions)
• diuretics (to remove excess fluid from your body)
• ketoconazole or itraconazole (to treat fungal infections)
• clarithromycin, an antibiotic used to treat infections
• carbamazepine (used in the treatment of epilepsy)
• rifampicin (to treat tuberculosis)
• estrogens or oral contraceptives

Some medicines may increase the effects of Intestifalk, so your doctor may monitor you closely if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

Use of Intestifalk with food and drinks

You should not drink grapefruit juice during treatment with this medicine, as it may alter its effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Intestifalk should only be used during pregnancy if prescribed by your doctor.

Budesonide passes into breast milk in small amounts. If you are breastfeeding, Intestifalk should only be used if prescribed by your doctor.

Driving and using machines

Intestifalk is not expected to have any effect on the ability to drive or operate machinery.

3. How to use Intestifalk

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose is one 4 mg Intestifalk suppository per day.

Method of administration

This medicine is for rectal use only and must be inserted into the anus. DO NOT take orally.

Intestifalk should be administered at bedtime so that the suppository remains in place for as long as possible.

How to insert the suppository

Duration of treatment

Your doctor will decide for how long you need to continue using this medicine. The duration of treatment depends on the nature of your illness. Acute episodes of inflammatory bowel disease (ulcerative proctitis) usually resolve after 6–8 weeks.

If you use more Intestifalk than you should

If you have used too many suppositories at one time, take the next dose as prescribed. Do not use a smaller amount. If you have any doubts, contact your doctor so that they can decide what you should do; if possible, bring the package and the leaflet with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Intestifalk If you miss a dose, continue treatment with the prescribed dose. Do not use a double dose to make up for the missed dose.

If you stop treatment with Intestifalk

Talk to your doctor if you wish to stop or end your treatment early. Continue using your medicine until your doctor tells you otherwise, even if you start to feel better.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported during the use of Intestifalk:

Very common: may affect up to 1 in 10 people

• decrease in the amount of cortisol hormone in the blood

Uncommon: may affect up to 1 in 100 people

• reduced function of the adrenal glands (small glands located next to the kidneys)
• headache
• flushing
• abdominal pain, flatulence, severe abdominal pain due to acute inflammation of the pancreas
• skin rash
• changes in menstrual periods such as irregular periods

The following adverse effects have been reported with similar medicines to Intestifalk (corticosteroids) and may therefore also occur with this medicine. The frequency of these adverse effects is currently unknown:

• increased risk of infections
• Cushing's syndrome, associated with excess corticosteroids, causing "moon face", weight gain, high blood sugar (hyperglycaemia), fluid accumulation in tissues (e.g. swollen legs), low potassium levels in the blood (hypokalaemia), unwanted body hair growth in women, impotence, stretch marks on the skin, acne
• mood disturbances such as depression, irritability, or euphoria
• restlessness with increased physical activity, anxiety, aggression
• blurred vision
• increased risk of blood clots, inflammation of blood vessels, high blood pressure
• dyspepsia, stomach and small intestine ulcers, constipation
• allergic skin rash, red spots on the skin due to bleeding, delayed wound healing, skin reactions such as contact dermatitis, bruising
• muscle and joint pain, muscle weakness, muscle twitching (fasciculations)
• bone weakness (osteoporosis), bone damage due to poor blood circulation (osteonecrosis)
• fatigue and general feeling of being unwell

These adverse effects are typical of steroid medicines. They may occur depending on the dose, duration of treatment, whether you have taken or are currently taking other cortisone preparations, and your individual sensitivity.

If you have previously been treated with a more potent cortisone preparation before starting treatment with Intestifalk 4 mg suppositories, your symptoms may reappear when switching medications. If this occurs, contact your doctor.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Intestifalk 4 mg suppositories

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

Do not store above 25 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Intestifalk

• The active substance is budesonide.
• The other components are ascorbyl palmitate (ascorbyl-palmitate E 304(i)) and solid semisynthetic glycerides.

Appearance of the product and contents of the pack

Intestifalk are white, torpedo-shaped suppositories (approximately 2 cm in length) with a smooth surface.

Intestifalk is available in packs containing 12, 30, 55 or 60 suppositories.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Dr. Falk Pharma GmbH

Leinenweberstr. 5

79108 Freiburg

Germany

Tel.: +49 (0)761 1514-0

Fax: +49 (0)761 1514-321

E-mail: [email protected]

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Dr. Falk Pharma España

Camino de la Zarzuela, 19

28023 Madrid

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany, Austria, Belgium, Denmark, Slovakia, Slovenia, Finland, Hungary, Ireland, Latvia, Lithuania, Luxembourg, Norway, Netherlands, Portugal, Czech Republic, Romania, Sweden: Budenofalk.

Cyprus, Croatia: Budosan.

Greece: Budenofalk procto.

Italy: Intesticortproct.

France: Mikicort.

Spain: Intestifalk.

Date of the most recent review of this leaflet: December 2023

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.es/