Intestifalk 2 mg/dose rectal foam

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Intestifalk 2 mg/dose rectal foam

budesonide

Read the entire leaflet carefully before you start using 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 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Intestifalk rectal foam is and what it is used for
2. What you need to know before using Intestifalk rectal foam
3. How to use Intestifalk rectal foam
4. Possible side effects
5. How to store Intestifalk rectal foam

Contents of the pack and other information

1. What Intestifalk rectal foam is and what it is used for

Intestifalk rectal foam contains the active substance budesonide, a locally-acting corticosteroid anti-inflammatory agent used to treat inflammatory bowel diseases.

Intestifalk rectal foam is indicated for the treatment of:

an inflammatory disease affecting the rectum and the large intestine (sigmoid colon), known by physicians as ulcerative colitis.

2. What you need to know before using Intestifalk rectal foam

Do not use Intestifalk rectal foam

• 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

Consult your doctor before starting to use Intestifalk rectal foam if you have:

• Tuberculosis.
• High blood pressure.
• Diabetes or if a member of your family has been diagnosed with diabetes.
• Weak bones (osteoporosis).
• Stomach or duodenal ulcers (peptic ulcer).
• Increased eye pressure (glaucoma) or eye problems such as clouding of the lens (cataracts), or if a family member has been diagnosed with glaucoma.
• Severe liver problems.

Typical effects of cortisone-containing preparations may occur and may affect all parts of the body, especially if you use Intestifalk rectal foam at high doses and for prolonged periods (see section 4. Possible side effects).

Additional precautions during treatment with Intestifalk rectal foam:

• 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 never had these diseases. They may seriously affect you. If you come into contact with chickenpox or shingles, see your doctor immediately.
• Inform your doctor if you have never had measles.
• If you need to receive any vaccine during treatment with this medicine, inform your doctor beforehand.
• Inform your doctor that you are using Intestifalk rectal foam if you are scheduled for surgery.
• If you have previously been treated with a more potent cortisone preparation before starting Intestifalk rectal foam, 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.

Using Intestifalk rectal foam with other medicines

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

• Cardiac glycosides such as digoxin (medicines used to treat heart conditions)
• Diuretics (medicines used to treat fluid retention)
• Ketoconazole or itraconazole (to treat fungal infections)
• Antibiotics, medicines to treat infections (such as clarithromycin)
• Carbamazepine (used in the treatment of epilepsy)
• Rifampicin (to treat tuberculosis)
• Estrogens or oral contraceptives

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

Some medicines may increase the effects of Intestifalk rectal foam, so your doctor will closely monitor you if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

Use of Intestifalk rectal foam with food and drinks

You must not drink grapefruit juice during treatment with Intestifalk rectal foam, as it may alter its effects.

Pregnancy and breastfeeding

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

You should only use Intestifalk rectal foam during pregnancy if your doctor specifically advises you to do so.

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

Driving and using machines

Intestifalk rectal foam is not expected to affect your ability to drive or operate machinery.

Intestifalk rectal foam contains propylene glycol, cetyl alcohol, and cetostearyl alcohol

This medicine contains 600.3 mg of propylene glycol per spray of Intestifalk rectal foam. Propylene glycol may cause skin irritation.

Cetyl alcohol and cetostearyl alcohol (a component of the emulsifying wax) may cause local skin reactions (such as contact dermatitis).

3. How to use Intestifalk rectal foam

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Dosage for adults over 18 years of age

The usual dose is 1 spray application once daily, in the morning or at bedtime. Optimal results are achieved by using Intestifalk rectal foam after evacuating the bowel.

Use in children and adolescents

Intestifalk rectal foam must not be used in children under 18 years of age, as experience with this product in this population is very limited.

Method of administration

This medicine can only be used rectally and must therefore be inserted into the anus. It is not intended for oral use. Do not swallow.

Aerosol container illustration

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

Preparation for use of the foam:

Firmly connect the applicator to the discharge tube of the container. Shake the container for approximately 15 seconds to mix the contents.

Before first use, remove the safety seal (plastic tab) from the dosing head.

Rotate the container's head until the semicircular notch located beneath the head aligns with the applicator. The aerosol is now ready for use.

Use of the foam:

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

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

To prevent inadvertent loss of foam between applications, turn the dosing head so that the semicircular notch is facing opposite to the discharge tube.

• Wash your hands and try not to empty your bowel until the following morning.
• If you go to a hospital or visit another doctor or dentist, tell them that you are using this medicine.

Duration of treatment

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

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

Mild acute episodes of inflammatory bowel disease (ulcerative colitis) generally resolve within 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 of the medicine on one occasion, use the next dose as prescribed. Do not use a smaller amount. If you have any doubts, contact your doctor so they can decide what you should do. If possible, bring the pack and the leaflet with you.

If you forget to use Intestifalk rectal foam

If you miss a dose, continue treatment with the next prescribed dose. Do not use a double dose to make up for the missed dose.

If you interrupt treatment with Intestifalk rectal foam

Talk to your doctor if you wish to interrupt or discontinue your treatment early. It is important not to stop using your medicine suddenly, as this could make you unwell. Continue using your medicine until your doctor tells you otherwise, even if you start to feel better.

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 cause adverse effects, although not everyone experiences them.

If you experience any of the following symptoms after using this medicine, you should contact your doctor immediately:

• Infection
• Headache
• Changes in behaviour such as depression, irritability, euphoria, restlessness, anxiety, or aggressiveness.

The following adverse 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, moon face, increased body weight, reduced glucose tolerance, elevated blood sugar, high blood pressure, fluid retention in tissues (for example: swollen legs), increased potassium excretion (hypokalemia), irregular menstrual periods in women, unwanted hirsutism in women, impotence, abnormal laboratory findings (reduced adrenal function), development of red stretch marks on the skin (striae), acne
• Indigestion, upset stomach (dyspepsia)
• 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

• Increased appetite
• Blood disorders (increased erythrocyte sedimentation rate, increased white blood cell count)
• Nausea, abdominal pain, gas, bloating or tingling in the abdomen, anal fissure, mouth ulcers, urgent need to empty the bowels, rectal bleeding
• Stomach or small intestine ulcers
• Changes in liver function parameters
• Pancreatic function disorders, variations in adrenal hormones
• Urinary tract infections
• Dizziness, disturbances in sense of smell
• Insomnia, restlessness with increased physical activity, anxiety
• Increased sweating, weakness

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

• Blurred vision
• Inflammation of the pancreas
• Bone loss due to poor blood circulation (osteonecrosis)
• Aggressiveness
• 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

withdrawal of cortisone after long-term treatment)

• Fatigue, general feeling of malaise

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

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

Due to its local action, the risk of adverse reactions with Intestifalk 2 mg rectal foam is generally lower than with systemic-acting glucocorticosteroids (whose action spreads throughout the entire body).

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 rectal foam

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 the pressurized container. The expiry date refers to the last day of the month indicated.

The contents of the container should be used within 4 weeks after first opening.

Do not store above 25°C.

Do not refrigerate or freeze.

The container is pressurized and contains a flammable propellant.

Do not expose to temperatures above 50°C; protect from direct sunlight.

Do not pierce or burn, even when empty.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Intestifalk rectal foam

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

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

Appearance of the product and contents of the container

Intestifalk rectal foam is a firm, creamy white to greyish-white foam contained in a pressurized container.

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

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
E-mail: [email protected]

Further information on this medicinal product is available by contacting 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 European Economic Area member states under the following names:
Denmark, Finland, Greece, Ireland, Romania, Sweden and United Kingdom:
Budenofalk.
Austria: Budo-San.
Italy: Intesticort.
Spain: Intestifalk.

Date of the most recent review of this leaflet: September 2020

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