PRODUCT INFORMATION FOR THE USER

Intestifalk 3 mg gastro-resistant capsules

budesonide

Read this entire leaflet carefully before you start taking 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Intestifalk contains the active ingredient budesonide, a type of local-acting steroid used to treat chronic inflammatory diseases of the intestine and liver.

Intestifalk is used in the treatment of:

• Crohn's disease: acute attacks of mild to moderate chronic intestinal inflammationinvolving the lower part of the small intestine (ileum) and/or the upper part of the large intestine (ascending colon).
• Microscopic colitis:a disease with subtypes of collagenous and lymphocytic colitis, characterized by chronic inflammation of the large intestine, usually accompanied by chronic watery diarrhea.

Autoimmune hepatitis: a disease with chronic liver inflammation.

Do not take Intestifalk:

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

Warnings and precautions

Consult your doctor before starting to take Intestifalkif you have:

• tuberculosis
• high blood pressure.
• diabetes, or if a member of your family has been diagnosed with diabetes
• bone fragility (osteoporosis)
• ulcer in the stomach or first part of the small intestine (peptic ulcer)
• increased pressure in the eye (glaucoma) or problems like cataracts, or ifa member of your familyhas been diagnosed with glaucoma
• severe liver problems

Intestifalk is not suitable for patients with Crohn's disease that affects the upper gastrointestinal tract.

This disease may sometimes cause extraintestinal symptoms (e.g. affecting the skin, eyes, and joints) that are unlikely to respond to this medication.

You may experience typical effects of cortisone preparations that can affect all parts of the body,particularly if you take this medicationat high doses and for prolonged periods (see section 4. Possible side effects).

Additional precautions during treatment with Intestifalk

• Inform your doctor if you have an infection. The symptoms of some infections may be atypical or less pronounced.
• Avoid people who have chickenpox or shingles (herpes zoster), if you have not had them before. They can severely affect you. If you come into contact with chickenpox or herpes, see your doctor immediately.
• Inform your doctor if you have not had measles.
• Inform your doctor if you are to receive any vaccine while taking this medication.
• Inform your doctor that you are using this medication in case of a scheduled surgical intervention.
• If you have been treated with a more potent cortisone preparation before starting treatment with Intestifalk, your symptoms may reappear when changing the medication. If this occurs, inform your doctor.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• If you have autoimmune hepatitis, your doctor will perform regular liver function tests and adjust the dose of this medication periodically.

Intake of Intestifalk with other medications

Inform your doctor or pharmacist if you are taking or have recently taken any other medication. In particular:

• cardiotonic glucosidessuch as digoxin (medication used to treat heart rhythm disorders)
• diuretics(medications used to treat excess fluid in your body)
• ketoconazole or itraconazole(to treat fungal infections)
• antibiotics, medications to treat infections (such as clarithromycin)
• carbamazepineused in the treatment of epilepsy)
• rifampicin(to treat tuberculosis)
• estrogens or oral contraceptives
• cimetidine(used to inhibit acid production in the stomach)

Some medications may increase the effects of Intestifalk, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

If you takecholestyramine(to treat hypercholesterolemia and also used to treat diarrhea) orantacids(for indigestion) with Intestifalk, take these medications at leasttwo hours apart.

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

Intake of Intestifalk with food and drinks

You should not takegrapefruit juiceduring your treatment with this medication as it may modify its effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

You should only take Intestifalkduring pregnancy if your doctor advises you to.

Budesonide passes in small amounts into breast milk. If you are breastfeeding, you should only take Intestifalk if your doctor advises you to.

Driving and operating machinery

It is not expected that Intestifalk will affect your ability to drive or operate machinery.

Intestifalk contains saccharose and lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Crohn's Disease

Take three capsules once a day in the morning or 1 capsule three times a day (morning, noon, and night) unless your doctor indicates otherwise.

Duration of treatment

Your treatment should last approximately 8 weeks.

Microscopic colitis (collagenous and lymphocytic colitis)

Acute inflammation treatment

Take three capsules once a day in the morning unless your doctor indicates otherwise.

Maintenance treatment

Maintenance treatment should only be initiated if symptoms reappear after interrupting initial treatment. Depending on the evolution of the disease, your doctor will decide how many capsules you should take per day. The usual dose is two capsules once a day in the morning (a total of 6 mg of budesonide per day). Alternatively, take two capsules in the morning on the first day and one capsule in the morning on the second day (corresponding to an average of 4.5 mg of budesonide per day). Continue taking the medication, alternating the daily dose of two capsules and one capsule.

Duration of treatment

Acute inflammation treatment should last approximately 8 weeks. Your doctor will determine the duration of maintenance treatment. Maintenance treatment is normally administered for a maximum of 12 months. If indicated, your doctor may extend the duration of treatment.

Autoimmune hepatitis

Acute inflammation treatment:

Take one capsule three times a day (morning, noon, and night) unless your doctor indicates otherwise. Depending on laboratory results, your doctor will decide how long you should take three capsules per day.

Maintenance treatment:

Take one capsule two times a day (morning and night) unless your doctor indicates otherwise. Depending on laboratory results, your doctor will decide how long you should take two capsules per day.

Note: In most cases, your doctor will prescribe Intestifalk along with azathioprine, a medication that works by reducing the body's immune response.

Duration of treatment

Depending on blood and liver tissue analysis results, your doctor will decide how long you should continue using the medication and how many capsules per day you should take.

Use in children (all indications)

Intestifalk should not be used in children under 12 years old.

There is only limited experience with the use of this medication in children over 12 years old.

Administration form

Intestifalk should be taken orally only.

Capsules should be swallowed whole with a glass of water approximately half an hour before meals. Do not chew the capsules.

If you take more Intestifalk than you should

If you take too much medication at once, limit yourself to taking the prescribed dose when it is your next dose.

Do not take a lower dose. If you have any doubts, contact your doctor so that they can decide what you should do. If possible, bring the box and the leaflet with you.

If you forgot to take Intestifalk

If you forgot to take a dose, continue treatment with the prescribed dose. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Intestifalk

Talk to your doctor if you want to interrupt or conclude your treatment before. It is essential not to stop taking your medication suddenly, as this could harm you. Continue taking your medication until your doctor tells you to, even if you start feeling better.

Your doctor will probably want to reduce your dose gradually over two weeks.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

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

• Infection
• Headache
• Changes in behavior such as depression, irritability, euphoria, anxiety, or aggression.

The following side effects have also been reported:

Frequent: can affect up to 1 in 10 people

• Cushing's syndrome - for example, a "moon face," increased body weight, reduced glucose tolerance, increased blood sugar, high blood pressure, fluid retention in tissues (e.g., swollen legs), increased potassium excretion (hypokalemia), irregular periods in women, unwanted hirsutism in women, impotence, abnormal laboratory findings (reduced adrenal function), red stretch marks on the skin (striae), acne
• Indigestion, irritable stomach (dyspepsia), abdominal pain
• Increased risk of infection
• Muscle and joint pain, muscle weakness, muscle cramps
• Bone fragility (osteoporosis)
• Headache
• Mood changes, such as depression, irritability, or euphoria
• Urticaria due to hypersensitivity reactions, red patches due to skin bleeding, delayed wound healing, local skin reactions such as contact dermatitis

Rare: can affect up to 1 in 100 people

• Ulcers in the stomach or small intestine
• Anxiety with increased physical activity

Uncommon: can affect up to 1 in 1,000 people

• Blurred vision
• Pancreatitis
• Bone loss due to poor blood circulation (osteonecrosis)
• Aggression
• Ecchymoses

Very rare: can affect up to 1 in 10,000 people

• Delayed growth in children
• Constipation
• Increased intracranial pressure, possibly with increased ocular pressure (inflammation of the optic disc) in adolescents
• Increased risk of thrombosis, inflammation of blood vessels (associated with the conclusion of corticosteroid treatment after long-term treatment)
• Fatigue, general feeling of malaise

These side effects are typical of steroid medications and most of them are also predictable for treatments with other steroids. They can appear depending on the dose, duration of treatment, whether a treatment with other corticosteroid preparations has been followed or is being followed, and personal sensitivity.

If you have received treatment with a more potent corticosteroid preparation before starting treatment with Intestifalk, your symptoms may reappear when switching medications.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special conditions for preservation.

Do not use this medication after the expiration date that appears on the packaging and on the blister.The expiration date refers to the last day of the month.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Please ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Intestifalk

The active principle of Intestifalk is budesonide. Each gastro-resistant capsule contains 3 mg of budesonide.

The other components are copolymer of dimethylaminoethyl methacrylate (type A) (Eudragit RL), copolymer of dimethylaminoethyl methacrylate (type B) (Eudragit RS) lactose monohydrate, cornstarch, copolymer of methacrylic acid and methyl methacrylate (1:1) (Eudragit L 100), copolymer of methacrylic acid and methyl methacrylate (1:2) (Eudragit S 100), povidone K25, purified water, sucrose, talc, triethyl citrate, gelatin, erythrosine (E 127), titanium dioxide (E 171), iron oxide red and black (E 172), sodium lauryl sulfate (see also the end of section 2 for more important information on lactose and sucrose) .

Appearance of the product and contents of the packaging

Intestifalk are hard, gastro-resistant capsules of pink color contained in blister strips.

Intestifalk is available in packaging sizes of 10, 50, 90, 100 or 120 capsules.

Not all packaging sizes may be marketed.

Marketing authorization holder and manufacturer responsible

DR. FALK PHARMA GmbH

Leinenweberstr.5

79108 Freiburg

Germany

Phone: +49 (0) 761 / 1514-0

Fax: +49 (0) 761 / 1514-321

Email: [email protected]

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Spain

Dr. Falk Pharma España

Camino de la Zarzuela, 19

28023 Madrid

Phone: 91 372 95 08

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

Denmark, Finland, United Kingdom, Ireland, Sweden: Budenofalk

Spain: Intestifalk 3 mg gastro-resistant capsules

France: Mikicort

Italy: Intesticort

Last review date of this leaflet: 12/2019

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