INTESTICORTPROCT 4 mg Suppository

Зміст інструкції

1. Intesticortproct 4 mg suppositories
   1. What is Intesticortproct 4 mg suppositories and what is it 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
2. Intesticortproct 4 mg suppositories, symptoms may reappear when changing
   1. How to store Intesticortproct 4 mg suppositories
   2. Contents of the pack and other information

Intesticortproct 4 mg suppositories

budesonide

Read this leaflet carefully before using 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 pass it on to others, even if they have the same symptoms as you, 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 Intesticortproct 4 mg suppositories is and what it is used for
• 2. What you need to know before you use 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 is Intesticortproct 4 mg suppositories and what is it used for?

Intesticortproct 4 mg suppositories contain the active ingredient budesonide, a type of steroid with local action used for the treatment of inflammatory bowel disease.
Intesticortproct 4 mg suppositories are used in adult patients 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 any of the other ingredients of this medicine (listed in section 6)
• if you have a severe liver disease (hepatic cirrhosis).

Warnings and precautions
Talk to your doctor or pharmacist before using Intesticortproct 4 mg suppositories if you suffer from:

• tuberculosis
• high blood pressure
• diabetes, or if there are diagnosed cases of diabetes in your family
• fragile bones (osteoporosis)
• ulcers in the stomach or in the first part of the small intestine (peptic ulcer)
• increased pressure inside the eye (glaucoma) or eye problems such as clouding of the lens (cataract), or if there are diagnosed cases of glaucoma in your family
• liver problems
• kidney problems

Other precautions during treatment with Intesticortproct 4 mg suppositories

• Tell your doctor if you have an infection. The symptoms of some infections may be atypical or less pronounced.
• Stay away from people who have chickenpox or shingles (herpes zoster), if you have never had them. You may become seriously ill. If you come into contact with people affected by chickenpox or herpes zoster, consult your doctor immediately.
• Tell your doctor if you have never had measles.
• If you know you are going to be vaccinated, consult your doctor first.
• If you know you are going to have surgery, tell your doctor that you are using Intesticortproct 4 mg suppositories.
• See 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. Tell your doctor that you are using Intesticortproct 4 mg suppositories before undergoing
any tests.

Elderly
Elderly patients should be carefully monitored for the possible occurrence of undesirable effects.

Children and adolescents
Intesticortproct 4 mg suppositories should not be used in children and adolescents under the age of
18 years. The use of this medicine in patients under 18 years has not yet been studied.

For athletes:the use of the drug without therapeutic need constitutes doping and
may still result in positive doping tests.

Other medicines and Intesticortproct 4 mg suppositories
Tell your doctor if you are taking, have recently taken or might take any other medicines.
In particular:

• cardiac glycosidessuch as digoxin (medicines used to treat heart disease)
• diuretics(to remove excess fluid from the body)
• ketoconazole or itraconazole(to treat fungal infections)
• clarithromycin, an antibioticused 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 want to monitor you carefully if you take such medicines (including some medicines for
HIV: ritonavir, cobicistat).

Intesticortproct 4 mg suppositories with food and drink
During the use of this medicine do not drink grapefruit juice, as it may alter its effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before using this medicine.
You should only use Intesticortproct 4 mg suppositories during pregnancy if your doctor has told you to.
Budesonide passes in small amounts into breast milk. If you are breastfeeding, you should use
Intesticortproct 4 mg suppositories only if your doctor has told you to.

Driving and using machines
It is not expected that Intesticortproct 4 mg suppositories will impair the ability to drive vehicles and use
machinery.

3. How to use Intesticortproct 4 mg suppositories

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

Dosage
The recommended dose is one Intesticortproct 4 mg suppository per day.

Method of administration
This medicine can only be used rectally, i.e. by inserting it into the anus. DO NOT
take it by mouth.
Intesticortproct 4 mg suppositories should be taken at bedtime so that the suppository
remains in position for as long as possible.

How to insert the suppository
If possible, the suppository should be inserted after bowel evacuation.
Wash your hands thoroughly.
Carefully remove the suppository from the blister pack just
before use.
If you briefly warm the suppository with the palm of
your hand, insertion will be easier.

Hold the suppository between your thumb and forefinger.
Lie on your side in a comfortable position and
insert the suppository gently and deeply into the
rectum, with the pointed end facing forward.

Wash your hands thoroughly again.

Duration of treatment
The doctor will determine how long you should continue treatment with this medicine. This
will depend on your health condition. Acute episodes of inflammatory bowel disease
(ulcerative colitis) generally subside after 6-8 weeks.

If you use more Intesticortproct 4 mg suppositoriesthan you should
If you have used an excessive amount of suppositories on one occasion, take the next dose as
prescribed. Do not use a lower amount. If you have any doubts, consult a doctor so that they can

If you forget to use Intesticortproct 4 mg suppositories
If you miss a dose, continue treatment at the prescribed dosage. Do not take 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 prematurely, consult your doctor.
Continue using the medicine until the doctor tells you to stop, even if you feel better.
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.
During the use of Intesticortproct 4 mg suppositories, the following side effects have been reported:

Very common: may affect more than 1 in 10 people

• reduction of cortisol hormone in the blood.

Uncommon: may affect up to 1 in 100 people

• reduction of the 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, for example irregular cycles.

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

• increased risk of infection
• Cushing's syndrome, which is associated with taking too many corticosteroids and causes rounding of the face, weight gain, high blood sugar (hyperglycemia), fluid accumulation in the tissues (e.g. swollen legs), reduced potassium levels in the blood (hypokalemia), increased unwanted hair in women, impotence, red streaks on the skin (stretch marks), acne
• mood changes such as depression, irritation or euphoria
• restlessness with increased physical activity, anxiety, aggression
• blurred vision
• increased risk of blood clot formation, inflammation of blood vessels, high blood pressure
• dyspepsia, ulcers in the stomach and small intestine, constipation
• allergic skin rash, red spots due to bleeding inside the skin, delayed wound healing, skin reactions such as contact dermatitis, bruising
• muscle and joint pain, muscle weakness, muscle contraction
• weakening of the bones (osteoporosis), damage to the bones due to poor blood circulation (osteonecrosis)
• fatigue and a general feeling of being unwell.

These side effects are typical of steroid drugs. Their occurrence depends on the dose,
duration of treatment, previous or ongoing treatment with other cortisone preparations and
individual sensitivity.
If you have been treated with a stronger cortisone preparation before starting treatment with

Intesticortproct 4 mg suppositories, symptoms may reappear when changing

medicinal product. In this case, consult your doctor.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please
consult your doctor or pharmacist. You can also report adverse reactions directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions
you can contribute to providing 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 box and blister after
Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Intesticortproct 4 mg suppositories contains

• The active substanceis budesonide.
• The other ingredientsare 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 consists of white, torpedo-shaped (approximately 2 cm long) suppositories with a smooth surface.
Intesticortproct 4 mg suppositories is 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]
Distributor for sales in Italy:
DR. FALK PHARMA S.r.l.,
via Vittor Pisani n.20 – 20124, Milan, Italy

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