Intesticortproct

Package leaflet: information for the patient

Intesticortproct 4 mg suppositories

budesonide
Please read all of this leaflet carefully before you start using this medicine, as 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 effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Intesticortproct 4 mg suppositories is and what it is used for
2. What you need to know before using Intesticortproct 4 mg suppositories
3. How to use Intesticortproct 4 mg suppositories
4. Possible side effects
5. How to store Intesticortproct 4 mg suppositories
6. Contents of the pack and other information

1. What Intesticortproct 4 mg suppositories is and what it is used for

Intesticortproct 4 mg suppositories contains the active substance budesonide, a type of corticosteroid with local action used for the treatment of inflammatory bowel disease.
Intesticortproct 4 mg suppositories is used in adults for the treatment of acute episodes of inflammatory disease of the rectum (ulcerative proctitis).

2. What you need to know before using Intesticortproct 4 mg suppositories

Do not use Intesticortproct 4 mg suppositories

• 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 or pharmacist before using Intesticortproct 4 mg suppositories if you have:

• tuberculosis
• high blood pressure
• diabetes, or if there is a family history of diagnosed diabetes
• 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 there is a family history of diagnosed glaucoma
• liver problems
• kidney problems

Other precautions during treatment with Intesticortproct 4 mg suppositories

• 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. You could become seriously ill. If you come into contact with someone with chickenpox or shingles, contact your doctor immediately.
• Inform your doctor if you have never had measles.
• If you know you need to be vaccinated, consult your doctor first.
• If you know you are going to have surgery, inform your doctor that you are using Intesticortproct 4 mg suppositories.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Intesticortproct 4 mg suppositories may affect the results of tests performed by your doctor or in hospital. Inform your doctor that you are using Intesticortproct 4 mg suppositories before undergoing any test.
Elderly
Elderly patients should be closely monitored for the possible occurrence of adverse effects.
Children and adolescents
Intesticortproct 4 mg suppositories must not be used in children and adolescents under 18 years of age. The use of this medicine in patients under 18 years of age has not yet been studied.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Other medicines and Intesticortproct 4 mg suppositories
Inform your doctor 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 remove excess fluid from the body)
• ketoconazole or itraconazole (for treating fungal infections)
• clarithromycin, an antibiotic used to treat infections
• carbamazepine (used for the treatment of epilepsy)
• rifampicin (for the treatment of tuberculosis)
• estrogens or oral contraceptives

Some medicines may increase the effects of Intesticortproct 4 mg suppositories, and your doctor may wish to monitor you closely if you are taking such medicines (including some medicines for HIV: ritonavir, cobicistat).
Intesticortproct 4 mg suppositories with food and drink
Do not drink grapefruit juice during treatment with this medicine, as it may alter its effects.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before using this medicine.
You should use Intesticortproct 4 mg suppositories during pregnancy only if specifically instructed by your doctor.
Budesonide passes into breast milk in small amounts. If you are breastfeeding, you should use Intesticortproct 4 mg suppositories only if instructed by your doctor.
Driving and using machines
Intesticortproct 4 mg suppositories are not expected to affect the ability to drive or operate machinery.

3. How to use Intesticortproct 4 mg suppositories

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Dosage
The recommended dose is one 4 mg Intesticortproct suppository daily.

Method of administration
This medicine is for rectal use only, meaning it must be inserted into the anus. DO NOT take it by mouth.
Intesticortproct 4 mg suppositories should be used at bedtime so that the suppository remains in place as long as possible.

How to insert the suppository
If possible, insert the suppository after bowel evacuation.
Wash your hands thoroughly.
Carefully remove the suppository from the strip immediately before use.

If you briefly warm the suppository in the palm of your hand, insertion will be easier.
Hold the suppository between your thumb and index finger.

Lie on your side in a comfortable position and gently insert the suppository well into the rectum, with the pointed end first.

Wash your hands again thoroughly.

Duration of treatment
Your doctor will determine how long you should continue treatment with this medicine, depending on your condition. Acute episodes of inflammatory bowel disease (ulcerative colitis) usually resolve within 6–8 weeks.

If you use more Intesticortproct 4 mg suppositories than you should
If you accidentally use too many suppositories, take the next dose as prescribed. Do not reduce the dose. If in doubt, consult a doctor for advice; if possible, bring the package and this leaflet with you.

If you forget to use Intesticortproct 4 mg suppositories
If you miss a dose, continue treatment at the prescribed dosage. Do not use a double dose to make up for the missed dose.

If you stop using Intesticortproct 4 mg suppositories
If you wish to stop or discontinue treatment early, speak to your doctor. Continue using the medicine until your doctor tells you to stop, even if you feel better.

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 everybody gets them.
The following side effects have been reported during the use of Intesticortproct 4 mg suppositories:

Very common: may affect more than 1 in 10 people

• reduction in cortisol hormone levels in the blood.

Uncommon: may affect up to 1 in 100 people

• reduced function of the adrenal glands (small glands near the kidneys)
• headache
• hot flushes
• abdominal pain, flatulence, severe abdominal pain due to acute inflammation of the pancreas
• skin rash
• changes in menstrual cycles, such as irregular periods.

The following side effects have been reported with similar medicines to Intesticortproct 4 mg suppositories (corticosteroids) and may therefore also occur with this medicine. The frequency of these events is currently unknown:

• increased risk of infection
• Cushing's syndrome, associated with taking too many corticosteroids, causing rounding of the face, weight gain, high blood sugar (hyperglycaemia), fluid retention in tissues (e.g. swollen legs), reduced potassium levels in the blood (hypokalaemia), increased unwanted hair growth in women, impotence, red stretch marks on the skin (striae), acne
• mood changes such as depression, irritability or euphoria
• restlessness with increased physical activity, anxiety, aggression
• blurred vision
• increased risk of blood clots, inflammation of blood vessels, high blood pressure
• indigestion, ulcers in the stomach and small intestine, constipation
• allergic skin rash, red spots due to bleeding under the skin, delayed wound healing, skin reactions such as contact dermatitis, bruising
• muscle and joint pain, muscle weakness, muscle cramps
• weakening of bones (osteoporosis), bone damage due to poor blood supply (osteonecrosis)
• fatigue and general feeling of being unwell.

These side effects are typical of steroid medicines. Their occurrence depends on the dose, duration of treatment, previous or concomitant treatment with other corticosteroid preparations, and individual sensitivity.
If you have been treated with a stronger corticosteroid preparation before starting treatment with Intesticortproct 4 mg suppositories, symptoms may reappear when switching medicines. In this case, consult your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Intesticortproct 4 mg suppositories

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 carton and blister after
Exp. The expiry date refers to the last day of that month.
Do not store above 25 °C.
Do not dispose of any medicine 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 Intesticortproct 4 mg suppositories contains

• The active substance is budesonide.
• The other components are ascorbyl palmitate E 304(i) and solid glycerides.

Description of the appearance of Intesticortproct 4 mg suppositories and contents of the pack
Intesticortproct 4 mg suppositories are white, torpedo-shaped suppositories (approximately 2 cm long) with a smooth surface.
Intesticortproct 4 mg suppositories are available in packs containing 12, 30 or 60 suppositories.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Dr. Falk Pharma GmbH
Leinenweberstr. 5
79108 Freiburg
Germany
E-mail: [email protected]

Marketing Authorisation Holder in Italy:
DR. FALK PHARMA S.r.l.,
via Vittor Pisani n.20 – 20124, Milan, Italy

This medicinal product is authorised in the European Economic Area countries under the following trade names:
Austria, Belgium, Denmark, Finland, Germany, Ireland, Luxembourg, Norway, Netherlands, Portugal, Sweden: Budenofalk
Italy: Intesticortproct
France: “Tradename”
Spain: Intestifalk