Leaflet: information for the user

Intestifalk Uno 9 mg gastro-resistant granule

Budesonide

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given 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 Uno granulated contains the active ingredient budesonide, a type of local-acting steroid for the treatment of chronic inflammatory diseases of the intestine.

This medication is used for the treatment of

• Crohn's disease: acute episodes 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).

Acute episodes of microscopic colitis: a disease with the subtypes of collagen colitis and lymphocytic colitis, characterized by chronic inflammation of the large intestine that is often accompanied by chronic watery diarrhea.

Do not takeIntestifalk Uno granulated:

• if you areallergicto budesonide or any of the other components of this medication(listed in section 6).
• if you have asevere liver disease(cirrhosis).

Warnings and precautions

Consult your doctor before starting to take Intestifalk Uno granulated if you have:

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

Intestifalk Uno granulated is not suitable for patients with Crohn's disease affecting the upper gastrointestinal tract.

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

Typical side effects of corticosteroid preparations may occur, affecting all parts of the body, particularly if you take this medication at high doses and for prolonged periods of time (see section 4. Possible side effects).

Additional precautions during treatment with Intestifalk Uno granulated:

• Inform your doctor if you have an infection. Some infection symptoms may be atypical or less pronounced.
• Avoid people with chickenpox or shingles (herpes zoster) if you have not had them before. They may 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 vaccinations.
• Inform your doctor that you are using this medication in case of surgery.
• If you have been treated with a more potent corticosteroid preparation before starting treatment with Intestifalk Uno granulated, your symptoms may reappear when switching medications. If this occurs, contact your doctor.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Intake of Intestifalk Uno with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. In particular:

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

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

If you takecolestiramine(to treat hypercholesterolemia and also used to treat diarrhea) orantacids(for indigestion) withIntestifalk Uno granulated, take these medicationsat least two hours apart.

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

Intake ofIntestifalk Uno granulatedwith food and drinks

Do not takefreshly squeezed orange juiceduring your treatment withthis medication,as it may alter its effects.

Pregnancy and breastfeeding

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

You should only take Intestifalk Uno granulatedduring pregnancy if your doctor advises you to.

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

Driving and operating machinery

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

Intestifalk Uno granulated contains saccharose, lactose, and sorbitol

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

This medication contains 900 mg of sorbitol in each sachet. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the person cannot break down fructose, consult with your doctor before taking or receiving this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist again if you are unsure.

The recommended dose is:

Microscopic colitis and Crohn's disease

Adults

(18 years of age or older)

Take one packet in the morning, unless your doctor tells you otherwise.

Use in children and adolescents

Intestifalk Uno granules should not be used in children under 18 years of age.

Administration method

Intestifalk Uno should only be taken orally.

Take Intestifalk Uno granules approximately ½ hour before breakfast. Place the granules directly on the tongue and swallow with a glass of water. Do not chew the granules as they will not work properly.

Treatment duration

Your treatment should last approximately 8 weeks.

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

If you take more Intestifalk Uno granules than you should

If you take too much medication at one time, just take the next dose when it is due. Do not take a lower dose. If you are unsure, contact your doctor to decide what to do. If possible, bring the box and the package insert with you.

If you forget to take Intestifalk Uno granules

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

If you interrupt treatment with Intestifalk Uno granules

Speak with your doctor if you want to interrupt or conclude your treatment early.

It is essential not to stop taking your medication abruptly as this could harm you. Continue taking your medication until your doctor tells you to, even if you start feeling better.

Your doctor will likely want to reduce your dose gradually, from one packet per day to one packet every other day, for at least two weeks.

If you have any other questions about using this medication, ask your doctor or pharmacist.

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

If you experience 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, restlessness, anxiety, or aggression.

The following side effects have also been reported:

Frequent: may affect up to 1 in 10 people

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

Rare: may affect up to 1 in 100 peoplepeople

• Ulcers in the stomach or small intestine
• Restlessness with increased physical activity, anxiety

Uncommon: may affect up to 1 in 1,000 peoplepeople

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

Very rare: may affect up to 1 in 10,000 peoplepeople

• 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 administration 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 may appear depending on the dose, duration of treatment, whether a treatment with a more potent corticosteroid preparation has been followed or is being followed, and the individual's personal predisposition.

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

Reporting of side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this prospectus.You can also report them directly through the Spanish System for the 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.

Do not usethis medicationafter the expiration date that appears on the box and on the packets. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection pointof the pharmacy. If in doubt, please ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition ofIntestifalk Uno granulated

• The active ingredient is budesonide. Each sachet with gastro-resistant granules contains 9 mg of budesonide.
• The other components arecopolymer of dimethylaminoethyl methacrylate (type A) (Eudragit RL), copolymer of dimethylaminoethyl methacrylate (type B) (Eudragit RS), citric acid, lactose monohydrate, lemon essence, magnesium stearate, copolymer of methacrylic acid and methyl methacrylate (1:1) (Eudragit L100), copolymer of methacrylic acid and methyl methacrylate (1:2) (Eudragit S100), povidone K25, sucralose, saccharose, cornstarch, sorbitol (E420), talc, triethyl citrate, xanthan gum (for more information on lactose, saccharose, and sorbitol see section 2).

Appearance of the product and contents of the package

Intestifalk Uno granulated are gastro-resistant white to off-white granulesand white to pale yellow powderwith lemon essence, introduced in a sachet.

Intestifalk Uno granulatedis available in package sizes of 15, 20, 30, 50, and 60 sachets.

Not all package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

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

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

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

Austria: Budo-San.

France: MIKICORT

Italy: Intesticortmono

Spain: Intestifalk

Last review date of this leaflet: February 2021

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/