Intesticortmono

Package leaflet: Information for the user

Intesticortmono 9 mg gastro-resistant granules

Budesonide
Please read all of this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 Intesticortmono is and what it is used for

Intesticortmono contains the active substance budesonide, a type of locally-acting steroid,
used in the treatment of chronic inflammatory bowel diseases.
Intesticortmono is used to treat

• Crohn's disease: mild to moderate acute flare-ups of chronic inflammation of the intestine affecting the terminal part of the small intestine (terminal ileum) and/or the upper part of the large intestine (ascending colon).
• Acute forms of microscopic colitis: a disease with two subtypes, collagenous colitis and lymphocytic colitis, characterized by chronic inflammation of the large intestine, typically associated with chronic watery diarrhoea.

2. What you need to know before taking Intesticortmono

Do not take Intesticortmono if

• you are allergic to budesonide or to any of the other ingredients of this medicine (listed in section 6),
• you have 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
• brittle 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 for patients with Crohn's disease affecting the upper gastrointestinal tract.
Sometimes, the disease may cause symptoms outside the intestine (e.g. affecting the skin, eyes, and joints) that may not respond readily to this medicine.
Typical corticosteroid effects may occur, which can affect all parts of the body, especially if Intesticortmono is taken at high doses and for a prolonged period (see section 4. Possible side effects).

Additional precautions during treatment with Intesticortmono

• 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, as they could seriously affect you. Contact your doctor immediately if you are exposed to chickenpox or shingles.
• Inform your doctor if you have not had measles.
• Consult your doctor before receiving any vaccination.
• Inform your doctor that you are taking Intesticortmono before undergoing surgery.
• If you previously received a more potent corticosteroid before starting treatment with Intesticortmono, symptoms may reappear when switching medications. In this case, consult your doctor.
• Contact your doctor if you experience blurred vision or other visual disturbances.

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Other medicines and Intesticortmono granules
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular:

• cardiac glycosides such as digoxin (medicines used to treat heart conditions)
• diuretics (to eliminate excess fluid from the body)
• ketoconazole or itraconazole (used to treat fungal infections)
• antibiotics used to treat infections (such as clarithromycin)
• carbamazepine (used to treat epilepsy)
• rifampicin (used to treat tuberculosis)
• estrogens or oral contraceptives
• cimetidine (used to inhibit stomach acid production)

Some medicines may increase the effects of Intesticortmono granules, and your doctor may wish to monitor you closely if you are taking these medicines (including some HIV treatments: ritonavir, cobicistat).
If you are taking cholestyramine (for hypercholesterolemia and also for diarrhea treatment) or antacids (for indigestion) in addition to Intesticortmono, these medicines should be taken at least 2 hours apart.
Intesticortmono 9 mg granules may interfere with test results performed by your doctor or in hospital. Before undergoing any test, inform your doctor that you are taking Intesticortmono 9 mg granules.

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Take Intesticortmono during pregnancy only if prescribed by your doctor.
Budesonide passes into breast milk in small amounts. If you are breastfeeding, take Intesticortmono only if prescribed by your doctor.

Driving and using machines
Intesticortmono should not impair your ability to drive or operate machinery.

Intesticortmono contains sucrose, lactose, and sorbitol
If your doctor has diagnosed you with an intolerance to certain sugars, contact 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 a sugar intolerance, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition 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 exactly as directed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Recommended dose
Crohn's disease and microscopic colitis
Adults (over 18 years of age)
Take one sachet in the morning, unless otherwise prescribed by your doctor.
Use in children and adolescents
Intesticortmono MUST NOT be used in individuals 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 the tongue and swallow them with a full glass of water. Do NOT
chew the granules, as this may reduce their effectiveness.
Duration of treatment
Treatment usually lasts about 8 weeks.
Your doctor will decide how long you should continue therapy, depending on your
individual health condition.
If you take more Intesticortmono than you should
If you have taken too much medicine at one time, take the next dose as prescribed. Do not
take a lower amount. If in doubt, consult your doctor, who will decide on the appropriate
action; if possible, bring the pack and this leaflet with you.
If you forget to take Intesticortmono
If you forget to take a dose, simply continue your treatment as prescribed. Do not take a
double dose to make up for the missed dose.
If you stop taking Intesticortmono
If you wish to stop or end treatment early, consult your doctor. It is important that you do
not stop taking the medicine abruptly, as this could harm you.
Continue taking the medicine until your doctor tells you to stop, even if you start to feel
better.
Your doctor will likely want to gradually reduce your dose, from one sachet per day to one
sachet every two days, for at least 2 weeks.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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, rounded face, increased body weight, reduced glucose tolerance, increased blood glucose, high blood pressure, fluid retention in tissues (e.g. swollen legs), increased potassium loss (hypokalaemia), menstrual irregularities in women, increased unwanted hair growth 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 spasms
Bone fragility (osteoporosis)
Headache
Mood changes, such as depression, irritability, or euphoria
Skin rashes due to hypersensitivity reactions, red spots on the skin due to bleeding (petechiae), delayed wound healing, local skin reactions such as contact dermatitis
Uncommon: may affect up to 1 in 100 people
Stomach or small intestine ulcers
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 supply (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 eye pressure (papilloedema) in adolescents
Increased risk of blood clots, inflammation of blood vessels (associated with discontinuation of corticosteroids after long-term therapy)
Fatigue, general feeling of malaise

These side effects are typical of steroid therapy, and most of them may also occur during treatment with other steroids. They may depend on the dose, duration of treatment, concomitant or previous treatments with other corticosteroid preparations, and individual susceptibility.
If you previously received a more potent corticosteroid before starting treatment with Intesticortmono 9 mg granules, your symptoms may reappear when switching to this medicine.

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 stated on the carton and sachet. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via 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 substance is budesonide. Each sachet of 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), 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 section 2).
Description of the appearance of Intesticortmono and contents of the pack
Intesticortmono are gastro-resistant granules of white or off-white colour and white or
light yellow powder with a lemon odour, contained in a sachet.
Intesticortmono is 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 European Economic Area Member States
under the following names:
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