INTESTICORTMONO 9 mg Gastro-Resistant Granules

Зміст інструкції

1. Intesticortmono 9 mg gastro-resistant granules
   1. What is Intesticortmono and what it is used for
   2. What you need to know before taking Intesticortmono
2. Intesticortmono is not indicated in patients with Crohn's disease affecting the
   1. How to take Intesticortmono 9 mg granules
   2. Possible side effects
   3. How to store Intesticortmono
   4. Package Contents and Other Information

Intesticortmono 9 mg gastro-resistant granules

Budesonide

Read this leaflet carefully before you start to take this medicinebecause
it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Intesticortmono and what it is used for

Intesticortmono contains the active ingredient budesonide, a type of local-acting steroid,
used in the treatment of chronic inflammatory diseases of the intestine.
Intesticortmono is used in the treatment of

• Crohn's disease: acute mild or moderate attacks of chronic inflammation of the intestine affecting the last section of the small intestine (ileum) and/or the upper part of the large intestine (ascending colon).
• Acute forms of microscopic colitis: a disease with two subtypes, collagenous and lymphocytic colitis, characterized by chronic inflammation of the large intestine, typically accompanied by chronic watery diarrhea.

2. What you need to know before taking Intesticortmono

DO NOT take Intesticortmono if

• you are allergicto budesonide or any of the other ingredients of this medicine (listed in section6),
• you have a severe liver disease(hepatic cirrhosis).

Warnings and precautions
Talk to your doctor before taking this medicine if you suffer from:

• tuberculosis
• high blood pressure
• diabetes, or if diabetes has been diagnosed in your family
• fragile bones (osteoporosis)
• stomach or duodenal ulcers (peptic ulcer)
• increased pressure inside the eye (glaucoma) or eye problems, such as clouding of the lens (cataract) or if glaucoma has been diagnosed in your family
• severe liver problems

Intesticortmono is not indicated in patients with Crohn's disease affecting the

gastrointestinal tract.
Sometimes, the disease can cause symptoms outside the intestine (e.g. affecting the skin,
eyes and joints) that do not respond easily to this medicine.
Typical effects of corticosteroid preparations may appear, which can affect all parts
of the body, especially if you take Intesticortmono at high doses and for a long time (see
section 4. Possible side effects).

Other precautions during treatment with Intesticortmono

• Tell your doctor if you have an infection. The symptoms of some infections may be atypical or less pronounced.
• Stay away from people with chickenpox or herpes zoster (shingles), if you have never had these diseases, because they can seriously harm you. Contact your doctor immediately if you come into contact with people with chickenpox or herpes zoster.
• Tell your doctor if you have not yet had measles.
• Consult your doctor before undergoing vaccination.
• Tell your doctor that you are using Intesticortmono before undergoing surgery.
• If you have received a more potent corticosteroid preparation before starting treatment with Intesticortmono, the symptoms may reappear when the medicine is changed. In this case, consult your doctor.
• Contact your doctor if you experience blurred vision or other visual disturbances.

For those who practice sports: the use of the drug without therapeutic need constitutes
doping and may still result in positive doping tests.

Other medicines andIntesticortmono granules
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 in the treatment of heart conditions)
• diuretics(to eliminate excess fluid from the body)
• ketoconazole or itraconazole(for the treatment of fungal infections)
• antibioticsmedicines used in the treatment of infections (such as clarithromycin)
• carbamazepine(used in the treatment of epilepsy)
• rifampicin(for the treatment of tuberculosis)
• estrogens or oral contraceptives
• cimetidine(used to inhibit acid production in the stomach)

Some medicines can increase the effects of Intesticortmono granules and your doctor
may want to keep you under close observation if you are taking these medicines
(including some medicines for the treatment of HIV: ritonavir, cobicistat).
If you are taking cholestyramine(for hypercholesterolemia as well as in the treatment of diarrhea)
or antacids(for indigestion) in addition to Intesticortmono, these medicines must
be taken at least 2 hours apart.
Intesticortmono 9 mg granules may compromise the results of tests performed by your doctor
or in hospital. Before undergoing any tests, tell your doctor that you are taking
Intesticortmono 9 mg granules.

Intesticortmono with food and drink
Do not drink grapefruit juice when taking this medicine, as this may alter
its effect.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor for advice before taking this
medicine.
Take Intesticortmono during pregnancy only if it is prescribed by your doctor.
Budesonide passes in small amounts into breast milk. If you are breastfeeding, take
Intesticortmono only if it is prescribed by your doctor.

Driving and operating machinery
Intesticortmono should not impair the ability to drive or operate
machinery.

Intesticortmono contains sucrose, lactose and sorbitol
If your doctor has diagnosed you with intolerance to certain sugars, contact him 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 are intolerant to certain sugars, or if you have a
diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients
cannot metabolize fructose, talk to your doctor before taking this
medicine.

3. How to take Intesticortmono 9 mg granules

Take this medicine following exactly the instructions of your doctor. If you have
any doubts, consult your doctor or pharmacist.

The recommended dose is
Crohn's disease and microscopic colitis

Adults (over 18 years)
Take one sachet in the morning, unless otherwise prescribed by your doctor.
Use in children and adolescents
Intesticortmono must NOT be used in children and adolescents under 18 years of age.

Method of administration
Intesticortmono is for oral use only.
Take Intesticortmono 9 mg granules approximately half an hour before breakfast. Place the
granules directly on your tongue and swallow them with a large glass of water. Do not
chewthe granules, as their effect may be reduced.

Duration of treatment
The treatment usually lasts about 8 weeks.
The doctor will decide how long you need to continue therapy, depending on your
health conditions.

If you take more Intesticortmono than you should
If you have taken too much medicine at once, take the next dose as
prescribed. Do not take a lower amount. If in doubt, consult your doctor, who

If you forget to take Intesticortmono
If you forget to take a dose, simply continue your treatment at the prescribed
dosage. Do not take a double dose to make up for a missed dose.

If you stop taking Intesticortmono
If you want to stop or prematurely end the treatment, consult your doctor. It is
important that you do not stop the medicine abruptly, as this may harm you.
Continue to take the medicine until your doctor tells you to stop it,
even if you start to feel better.
The doctor will probably want to reduce the dose gradually, from one sachet a day to one
sachet every two days, for at least 2 weeks.
If you have any doubts 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, contact your doctor immediately:

• infection
• headache
• changes in behaviour, such as depression, irritability, euphoria, agitation, 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, roundness of the face, weight gain, reduced
glucose tolerance, increased blood glucose, high blood pressure,
fluid retention in the tissues (e.g. swollen legs), increased potassium excretion
(hypokalaemia), menstrual irregularities in women, increased unwanted hair
in women, impotence, abnormal laboratory test results (reduced adrenal function), red stretch marks on the skin (striae), acne.
indigestion, irritated stomach (dyspepsia), abdominal pain
increased risk of infections
muscle and joint pain, muscle weakness, muscle cramps
fragile bones (osteoporosis)
headache
mood changes, such as depression, irritability or euphoria
skin rashes due to hypersensitivity reactions, red spots from bleeding on the
skin, delayed wound healing, local skin reactions, such as contact dermatitis

Uncommon: may affect up to 1 in 100 people
ulcers of the stomach or small intestine
agitation 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
slowed growth in children
constipation
increased pressure in the brain, possibly with increased pressure
in the eye (swelling of the optic disc) in adolescents
increased risk of blood clotting, inflammation of blood vessels
(associated with stopping the use of corticosteroids after long-term therapy)
fatigue, general feeling of unwellness
These side effects are typical of steroid therapy and most of them can
also occur after treatment with other steroids. They may occur
depending on the dose, duration of treatment, any current or past treatments
with other corticosteroid preparations and individual susceptibility.
If you have received a more potent corticosteroid preparation before starting treatment with
Intesticortmono 9 mg granules, your symptoms may reappear when the medicine
is changed.

Reporting of side effects
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Intesticortmono

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 package and on the
sachet. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Package Contents and Other Information

What Intesticortmono contains
The active ingredientis budesonide. Each sachet of gastro-resistant granules contains
9 mg of budesonide.
The other ingredientsare ammonium methacrylate copolymer (type A) (Eudragit RL),
ammonium methacrylate copolymer (type B) (Eudragit RS), anhydrous citric acid, lactose
monohydrate, lemon flavour, magnesium stearate, methacrylic acid-methyl methacrylate
copolymer (1:1) (Eudragit L 100), methacrylic acid-methyl methacrylate copolymer (1:2)
(Eudragit S 100), povidone K25, sucralose, sugar spheres (consisting of sucrose and
corn starch), sorbitol (E420), talc, triethyl citrate, xanthan gum (for further

important information on lactose, sucrose and sorbitol, see paragraph2).

Description of the appearance of Intesticortmono and package contents
Intesticortmono are white or off-white gastro-resistant granules and white or pale yellow
powder with a lemon flavour, contained in a sachet.

Intesticortmonois available in packs of 15, 20, 30, 50 and 60 sachets. Not all pack sizes
may be marketed.

Marketing Authorisation 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]

This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations:
Belgium, Bulgaria, Czech Republic, Cyprus, Denmark, Finland, Germany, Greece,
Hungary, Ireland, Luxembourg, Netherlands, Norway, Portugal, United Kingdom,
Romania, Slovakia, Slovenia, Sweden,: Budenofalk
Austria: Budo-San
France: Mikicort
Italy: Intesticortmono
Spain: Intestifalk