Label:Information for the User

Intestifalk 2 mg/Rectal Foam Dose

budesónida

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Contents of the package and additional information

Intestifalk rectal foam contains the active ingredient budesonide, a local corticosteroid anti-inflammatory for the treatment of inflammatory intestinal diseases.

Intestifalk rectal foam is indicated for the treatment of:

a type of inflammatory disease of the rectum and large intestine (sigmoid colon) called ulcerative colitis by doctors.

No use Intestifalk espuma rectal

• If you are allergic to 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 use Intestifalk espuma rectal 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 pressure in the eye (glaucoma) or eye problems such as cataracts or if a family member has been diagnosed with glaucoma.
• serious liver problems.

You may experience typical effects of cortisone preparations that can affect all parts of the body, particularly if you use Intestifalk espuma rectal at high doses and for prolonged periods of time (see section 4. Possible side effects).

Additional precautions during treatment with Intestifalk espuma rectal:

• 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 affect you severely. 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 before receiving any vaccine while taking this medication.
• Inform your doctor that you are using Intestifalk espuma rectal in case of scheduled surgery.
• If you have been treated with a more potent cortisone preparation before starting treatment with Intestifalk espuma rectal, your symptoms may reappear when switching medications. If this occurs, inform your doctor.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Use of Intestifalk espuma rectal with other medications

Inform your doctor or pharmacist if you are using or have used recently, or may need to use other medications. In particular:

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

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

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

Use of Intestifalk espuma rectal with food and drinks

Do not takegrapefruit juiceduring your treatment withIntestifalk espuma rectal, as it may modify its effects

Pregnancy and breastfeeding

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

You should only use Intestifalk espuma rectal during pregnancy if your doctor advises you to.

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

Driving and operating machinery

It is not expected that Intestifalk espuma rectal will have effects onyour ability to drive or operate machinery.

Intestifalk espuma rectal contains propylene glycol, cetomacrogol and cetearyl alcohol

This medication contains 600.3mg of propylene glycol in each pulse of Intestifalk espuma rectal. Propylene glycol may cause skin irritation.

Cetomacrogol and cetearyl alcohol (components of the emulsifying wax) may produce local skin reactions (such as contact dermatitis).

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

The recommended dose is:

Posology for adults over 18 years old

The normal dose is 1 spray application, once a day in the morning or before going to bed. The best results are achieved by using Intestifalk rectal foam after emptying your intestines.

Use in children and adolescents

Intestifalk rectal foam should not be used in children under 18 years old, as there is very limited experience in this group.

Administration method

This medication can only be used rectally, so it must be inserted through the anus.It is not indicated for oral use. Do not ingest.

Illustration of the aerosol container

The applicator and its protective cap are in a special mold. Please take the mold firmly and pull the applicator with force.

Preparation for the use of the foam:

Connect the applicator firmly to the discharge tube of the container. Shake the container for approximately 15 seconds to mix the contents.

Before using for the first time, remove the safety closure (plastic flap) from the dosing head.

Turn the container head until the semicircular notch located below the head is in line with the applicator. Now the aerosol is ready to use.

Use of the foam:

Place your index finger on the top of the dosing head and turn the aerosol downwards. Note that the aerosol only works properly when held with the dosing head turned downwards as vertically as possible.

After administering the foam, separate the applicator and dispose of it with your household waste using one of the plastic bags provided. For the next application, use a new applicator.

To avoid accidental loss of foam between applications, turn the dosing head so that the semicircular notch is in the opposite direction to the discharge tube.

• Wash your hands and try not to evacuate your intestines until the next morning.
• If you are going to a hospital or seeing another doctor or dentist, tell them that you are using this medication.

Treatment duration

The duration of treatment depends on the nature of your disease.

Your doctor will decide how long you need to continue using the medication.

Mild acute episodes of inflammatory bowel disease (ulcerative colitis) usually subside after 6-8 weeks.

If you feel that the effect of Intestifalk rectal foam is too strong or too weak, consult your doctor.

If you use more Intestifalk rectal foam than you should

If you have used too much medication on one occasion, use the next dose as prescribed. Do not use a lower dose. If you are unsure, contact your doctor to decide what to do, if possible, bring the box and the leaflet with you.

If you forgot to use Intestifalk rectal foam

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

If you interrupt treatment with Intestifalk rectal foam

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

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

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

If you have any of the following symptoms after using 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:

Frequent: may affect up to 1 in 10 people

• Burning or pain in the rectum
• Cushing's syndrome, for example, a "moon 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 hirsutism in women, impotence, abnormal laboratory findings (reduced adrenal function), red stretch marks on the skin (striae), acne
• Indigestion, irritable stomach (dyspepsia)
• Increased risk of infection
• Muscle and joint pain, muscle weakness, muscle cramps
• Osteoporosis (bone fragility)
• Headache
• Changes in mood, such as depression, irritability, or euphoria
• Rash 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 people

• Increased appetite
• Blood abnormalities (increased erythrocyte sedimentation rate, increased white blood cell count)
• Nausea, abdominal pain, gas, abdominal discomfort or numbness, anal fissure, mouth ulcers, urgent need to empty the intestines, rectal bleeding.
• Ulcers in the stomach or small intestine
• Liver function changes
• Pancreatic function changes, variations in adrenal hormones
• Urinary tract infections
• Dizziness, altered sense of smell
• Insomnia, restlessness with increased physical activity, anxiety

• A sweating increase, weakness

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

• Delayed growth in children
• Constipation
• Increased intracranial pressure, possibly with increased intraocular pressure (inflammation of the optic disc) in adolescents

(inflamación del disco óptico) en adolescentes

• Increased risk of thrombosis, inflammation of blood vessels (associated with the

retirada de cortisona tras un tratamiento a largo plazo)

• General feeling of malaise, fatigue

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 you have followed or are following a treatment with other corticosteroid preparations, and your personal sensitivity.

Some of the adverse reactions were reported only after long-term oral administration of budesonide.

Due to its local action, the risk ofreactions adverse toIntestifalk 2 mg rectal foam is generally lower than the treatment with systemic glucocorticoids (its action extends mainly throughout the body).

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

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: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 use this medication after the expiration date that appears on the box and on the pressurized container.The expiration date is the last day of the month indicated.

The contents of the container should be used within 4 weeks once opened.

Do not store above 25º C.

Do not refrigerate or freeze.

The container is pressurized and contains a flammable propellant.

Do not expose to temperatures above 50ºC, protect from direct sunlight.

Do not pierce or burn even when empty.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition of Intestifalk rectal foam

The active ingredient is budesonide. Each dose contains 2 mg of budesonide.

The other components are cetyl alcohol, emulsifying wax, purified water, disodium edetate, stearyl macrogol ether, propylene glycol, citric acid monohydrate, and n-butane, isobutane, and propane as propellants.

Appearance of the product and contents of the packaging

Intestifalk rectal foam is a firm, creamy foam of white to grayish white color, presented in a pressurized container.

Intestifalk rectal foam is available in boxes with 1 pressurized container, 14 applicators, and 14 plastic bags or in boxes with 2 pressurized containers, 28 applicators, and 28 plastic bags for hygienic disposal of the applicators.

Not all packaging may be marketed.

Holder of the marketing authorization and manufacturer responsible

Dr. Falk Pharma GmbH

Leinenweberstr.5

79108 Freiburg

Germany

TEL +49 (0) 761 / 1514-0

E-mail:[email protected]

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

Spain

Dr. Falk Pharma España

Camino de la Zarzuela, 19

28023 Madrid

This medication is authorized in the member statesof the European Economic Areawith the following names:

Denmark, Finland, Greece, Ireland, Romania, Sweden, and the United Kingdom:

Budenofalk.

Austria: Budo-San.

Italy: Intesticort.

Spain: Intestifalk.

Date of the last review of this leaflet:September 2020

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS) http://www.aemps.es/