INTESTIFALK UNO 9 mg GASTRO-RESISTANT GRANULES

Introduction

Package Leaflet: Information for the User

Intestifalk Uno 9 mg Gastro-Resistant Granules

Budesonide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.

Contents of the package leaflet:

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

1. What is Intestifalk Uno granules and what is it used for

Intestifalk Uno granules contain the active substance budesonide, a type of steroid with local action to treat chronic inflammatory diseases of the intestine.

This medicine is used for the treatment of

• Crohn's disease: mild to moderate acute episodes of chronic inflammation of the intestine with involvement of 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 subtypes of collagenous colitis and lymphocytic colitis, characterized by chronic inflammation of the large intestine that is usually accompanied by chronic watery diarrhea.

2. What you need to know before you take Intestifalk Uno granules

Do not takeIntestifalk Uno granules:

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

Warnings and precautions

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

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

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

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

The typical effects of cortisone preparations may occur, which can affect all parts of the body, particularly if you take this medicine at high doses and for prolonged periods (see section 4. Possible side effects).

Additional precautions during treatment with Intestifalk Uno granules:

• Tell your doctor if you have an infection. The symptoms of some infections may be atypical or less marked.
• Stay away from people who have chickenpox or shingles (herpes zoster) if you have not had them before. They can affect you severely. If you come into contact with chickenpox or shingles, see your doctor immediately.
• Tell your doctor if you have not had measles yet.
• If you are going to receive any vaccine, tell your doctor beforehand.
• Tell your doctor that you are using this medicine in case of surgery.
• If you have been treated with a more potent cortisone preparation before starting treatment with Intestifalk Uno granules, your symptoms may recur when switching medicines. If this happens, contact your doctor.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Taking Intestifalk Uno with other medicines

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

• cardiac glycosidessuch as digoxin (medicines used to treat heart conditions)
• diuretics(to eliminate excess fluid in your body)
• ketoconazole or itraconazole(to treat fungal infections)
• antibioticsto 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 medicines may increase the effects of Intestifalk Uno granules, so your doctor will monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

If you take cholestyramine(to treat high cholesterol and also used to treat diarrhea) or antacids(for indigestion) with Intestifalk Uno granules, take these medicines at least 2 hours apart.

Intestifalk Uno granules may affect the results of tests performed by your doctor or in a hospital. Tell your doctor that you are taking Intestifalk Uno granules before undergoing any test.

TakingIntestifalk Uno granuleswith food and drinks

Do notdrink grapefruit juiceduring 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 have a baby, ask your doctor for advice before taking this medicine.

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

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

Driving and using machines

It is unlikely that Intestifalk Uno granules will affect your ability to drive or use machines.

Intestifalk Uno granules contain sucrose, lactose, and sorbitol

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

This medicine 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 some 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 medicine.

3. How to take Intestifalk Uno granules

Follow the instructions for administration of this medicine exactly as prescribed by your doctor.

If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

Crohn's disease and microscopic colitis

Adults

(over 18 years old)

Take one sachet in the morning, unless your doctor advises otherwise.

Use in children and adolescents

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

Method of administration

Intestifalk Uno should only be taken orally.

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

Duration of treatment

Your treatment should last approximately 8 weeks.

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

If you take moreIntestifalk Uno granulesthan you should

If you take too much medicine 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, take the pack and this leaflet with you.

If you forget to takeIntestifalk 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 forgotten dose.

If you stop takingIntestifalk Uno granules

Talk to your doctor if you want to stop or conclude your treatment beforehand.

It is important that you do not stop taking your medicine abruptly, as this could make you ill. Continue taking your medicine until your doctor tells you to, even if you start to feel better.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following symptoms after taking this medicine, you should 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:

Common: may affect up to 1 in 10 people

• Cushing's syndrome, for example, with rounded face, weight gain, 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
• Dyspepsia (indigestion, irritable stomach), abdominal pain
• Increased risk of infection
• Muscle and joint pain, muscle weakness, muscle spasms
• Bone fragility (osteoporosis)
• Headache
• Mood changes, such as depression, irritability, or euphoria
• Rash due to hypersensitivity reactions, red spots due to bleeding in the skin, delayed wound healing, local skin reactions such as contact dermatitis

Uncommon: may affect up to 1 in 100 people

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

Rare: may affect up to 1 in 1,000 people

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

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

• Growth retardation 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 end of cortisone administration after long-term treatment)
• Fatigue, feeling of general malaise

These side effects are typical of steroid medicines and most of them are also predictable for treatments with other steroids. They may occur depending on the dose, duration of treatment, whether you have followed or are following treatment with other cortisone preparations, and your personal propensity.

If you have received treatment with a more potent cortisone preparation before starting treatment with Intestifalk Uno granules, your symptoms may recur when switching medicines.

Reporting of side effects

If you experience 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 through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Intestifalk Uno granules

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

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition ofIntestifalk Uno granules

• 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 flavor, magnesium stearate, methacrylic acid-methyl methacrylate copolymer (1:1) (Eudragit L100), methacrylic acid-methyl methacrylate copolymer (1:2) (Eudragit S100), povidone K25, sucralose, sucrose, corn starch, sorbitol (E420), talc, triethyl citrate, xanthan gum (for more information on lactose, sucrose, and sorbitol, see section 2).

Appearance and pack contents

Intestifalk Uno granules are white to off-white gastro-resistant granules and white to pale yellow powderwith a lemon flavor, in a sachet.

Intestifalk Uno granules are available in pack sizes of 15, 20, 30, 50, and 60 sachets.

Not all pack sizes may be marketed.

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]

You can obtain more information about this medicine by contacting the local representative of the marketing authorization holder:

Spain

Dr. Falk Pharma España

Camino de la Zarzuela, 19

28023 Madrid

This medicine is authorized in the Member States of the European Economic Area under 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

Date of last revision of this leaflet: February 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/