Intestifalk Uno 9 mg gastro-resistant granulate

Patient Information Leaflet

Introduction

Patient Information Leaflet

Intestifalk Uno 9 mg gastro-resistant granules

Budesonide

Please read all of this leaflet carefully before you start taking this medicine, as 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Intestifalk Uno granules contains the active substance budesonide, a type of locally-acting steroid used to treat chronic inflammatory intestinal diseases.

This medicine is used to treat:

• Crohn's disease: mild to moderate acute episodes of chronic intestinal inflammation affecting 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 collagenous colitis and lymphocytic colitis, characterized by chronic inflammation of the large intestine, usually accompanied by chronic watery diarrhoea.

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

DO NOT take Intestifalk Uno granules:

• 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 (hepatic cirrhosis).

Warnings and precautions

Talk to 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.
• fragile bones (osteoporosis).
• stomach or duodenal ulcers (peptic ulcer).
• increased pressure in the eye (glaucoma) or eye problems such as clouding of the lens (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 affecting the upper gastrointestinal tract.

Sometimes this disease may cause extraintestinal symptoms (e.g. affecting the skin, eyes, and joints) which are unlikely to respond to this medicine.

Typical cortisone-like effects may occur and may affect any part 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:

• 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 not had these diseases before. They may seriously affect you. If you come into contact with chickenpox or shingles, contact your doctor immediately.
• Inform your doctor if you have not yet had measles.
• If you know you need to receive any vaccine, inform your doctor beforehand.
• Inform your doctor that you are taking this medicine if you are undergoing surgery.
• If you have previously been treated with a more potent cortisone preparation before starting treatment with Intestifalk Uno granules, 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.

Taking Intestifalk Uno granules with other medicines

Inform 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 eliminate excess fluid from 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 acid production in the stomach)

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 used for HIV: ritonavir, cobicistat).

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

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

Taking Intestifalk Uno granules with food and drink

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

Pregnancy and breast-feeding

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

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

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

Driving and using machines

Intestifalk Uno granules are not expected to affect your ability to drive or use machinery.

Intestifalk Uno granules contain sucrose, lactose, and sorbitol

If your doctor has told you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.

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

3. How to take Intestifalk Uno granules

Follow exactly the instructions for use of this medicine as given by your doctor.

If in doubt, please consult your doctor or pharmacist again.

Recommended dose:

Crohn's disease and microscopic colitis

Adults

(over 18 years of age)

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

Use in children and adolescents

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

Method of administration

Intestifalk Uno must only be taken orally.

You should 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.

Duration of treatment

Your treatment should last approximately 8 weeks.

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

If you take more Intestifalk Uno granulesthan you should

If you take too much medicine at one time, take the next dose at the usual time. Do not take a lower dose. If you have any doubts, contact your doctor so that he or she can decide what you should do. If possible, bring the pack and the leaflet with you.

If you forget to take Intestifalk Uno granules

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

If you stop taking Intestifalk Uno granules

Talk to your doctor if you wish to stop or end your treatment early.

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

Your doctor will likely 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences 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 adverse effects have also been reported:

Frequent: may affect up to 1 in 10 people

• Cushing's syndrome, for example with rounded face, increased body weight, reduced glucose tolerance, elevated blood sugar, high blood pressure, fluid retention in tissues (e.g., swollen legs), increased potassium excretion (hypokalemia), irregular menstrual periods in women, unwanted body hair in women, impotence, abnormal laboratory results (reduced adrenal function), red stretch marks on the skin (striae), acne
• Dyspepsia (indigestion, upset stomach), 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
• Skin rash due to hypersensitivity reactions, red spots due to bleeding under 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
• Inflammation of the pancreas
• 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 (optic disc swelling) in adolescents
• Increased risk of thrombosis, inflammation of blood vessels (associated with discontinuation of cortisone treatment after long-term therapy)
• Fatigue, general feeling of malaise

These adverse effects are typical of steroid medicines, and most of them are also expected with treatment using other steroids. They may occur depending on the dose, duration of treatment, whether you have previously or are currently receiving treatment with other cortisone preparations, and your individual susceptibility.

If you have previously been treated with a more potent cortisone preparation before starting treatment with Intestifalk Uno granules, your symptoms may reappear when switching medications.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the carton and sachets. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Intestifalk Uno granules

• The active substance is budesonide. Each sachet containing gastro-resistant granules contains 9 mg of budesonide.
• The other components are ammonium methacrylate copolymer (type A) (Eudragit RL), ammonium methacrylate copolymer (type B) (Eudragit RS), citric acid, lactose monohydrate, lemon flavour, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (1:1) (Eudragit L100), methacrylic acid and 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 of the product and contents of the pack

Intestifalk Uno granules are gastro-resistant granules of white to off-white colour and white to pale yellow powder with lemon flavour, contained 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]

Further information on this medicinal product is available upon request to 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 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 the most recent revision of this leaflet: February 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http*://www.aemps.gob.es/*