Inteb

Package leaflet: Information for the patient

Inteb 3 mg modified-release hard capsules

Equivalent medicine
Please read all of this leaflet carefully before you start 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 others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Inteb is and what it is used for

Inteb reduces inflammation in the small intestine and the initial part of the large intestine.
Inteb is used for the treatment of Crohn's disease affecting the small intestine and the initial part of the large intestine.
Crohn's disease is an inflammatory bowel disease that causes symptoms such as diarrhoea, fever, and stomach pain.
Inteb is used to treat microscopic colitis, a disease that causes chronic inflammation of the colon and often leads to watery diarrhoea.
Inteb can be used to treat active disease as well as severe cases to prevent relapses (maintenance treatment).

2. What you need to know before taking Inteb

Do not take Inteb

• if you are allergic to budesonide or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Inteb if you have:

• an infection caused by bacteria, fungi, or viruses
• liver problems
• osteoporosis
• gastric ulcer
• hypertension
• diabetes (even if there is a family history of diabetes)
• any eye disease (even if there is a family history of eye diseases)

Chickenpox and measles may be more severe while taking Inteb. Therefore, if you have been exposed to or infected with either, contact your doctor.
Contact your doctor if you experience blurred vision or other vision disturbances.
When switching from oral corticosteroid tablets to Inteb, or when stopping Inteb, you may temporarily experience symptoms such as rash, runny nose, and muscle pain.
Contact your doctor if you experience any of these effects or if you are concerned about headache, fatigue, or nausea.
If you are due to undergo surgery, you must inform your doctor that you are taking Inteb, as you may need additional treatment with oral corticosteroids for a period of time.

Children and adolescents
Regular monitoring of height growth is recommended in children and adolescents receiving treatment with Inteb.

Other medicines and Inteb
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect or be affected by treatment with Inteb, for example:

• certain antifungal medicines (e.g. itraconazole)
• medicines used to treat Cushing's syndrome – when the body produces excess cortisol (ketoconazole tablets)
• medicines for menopausal symptoms (estrogens) and pregnancy (contraceptive pills)
• carbamazepine (for epilepsy)
• some medicines may increase the effects of Inteb, and your doctor may need to monitor your treatment closely if you are taking these medicines (e.g. certain HIV treatments: ritonavir (or other protease inhibitors), cobicistat).

Inteb may interfere with a test used to assess pituitary function, the so-called ACTH stimulation test, leading to falsely low results.

Inteb with food and drinks
Grapefruit juice should be avoided during treatment with Inteb because grapefruit may increase the absorption of budesonide from the intestine (juices from other fruits such as orange or apple do not affect budesonide absorption).

Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
There is a risk that the medicine may affect the fetus. Therefore, always consult your doctor before taking Inteb if you are pregnant.
Budesonide is excreted in breast milk. Talk to your doctor before taking Inteb regularly while breastfeeding.

Driving and using machines
It is unlikely that Inteb affects the ability to drive or operate machinery.

Inteb contains sugar spheres (corn starch, sucrose)
Inteb contains sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Inteb

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The capsules must be swallowed whole with water.
If you have difficulty swallowing, you may open the capsule and take the contents mixed with a spoonful of apple puree. The capsules must not be broken or chewed.

Crohn’s disease
Recommended daily dose for adults and children over 8 years of age weighing more than 25 kg:
For treatment of active disease: 3 modified-release capsules (i.e. 9 mg of budesonide) in the morning for 8 weeks. It may take 2 to 4 weeks before Inteb has full effect.
Do not forget to take the capsules even if you feel better.
Treatment should be discontinued by gradually reducing the dose.

Microscopic colitis
Recommended dose in adults:
For treatment of active disease: 3 modified-release capsules (i.e. 9 mg of budesonide) in the morning for 8 weeks. Towards the end of treatment, the dose should be regularly reduced over the last two weeks.
Maintenance therapy: 2 capsules (i.e. 6 mg of budesonide) (or the lowest effective dose).

Use in children
The use of Inteb in children is not recommended.

If you take more Inteb than you should
If you take more Inteb than you should, inform your doctor or pharmacist immediately.

If you forget to take Inteb
Do not take a double dose to make up for the missed dose. Continue with the next dose as scheduled by your doctor.

If you stop taking Inteb
Do not stop taking Inteb without first consulting your doctor. If you suddenly stop taking the capsules, you may feel unwell.

If you have any further 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 may occur with this medicine:
Common (may affect up to 1 in 10 people)

• low levels of potassium in the blood
• changes in behaviour such as nervousness, insomnia, mood swings and depression
• unusually fast or irregular heartbeat
• difficulty digesting (dyspepsia)
• hives and skin rashes
• muscle cramps
• menstrual disorders
• fat deposits on the torso and face, skin changes, fluid accumulation in the body (the so-called cushingoid syndrome)

Uncommon (may affect up to 1 in 100 people)

• tremors
• restlessness, excessive motor activity with concomitant mental anxiety (psychomotor hyperactivity)
• anxiety

Rare (may affect up to 1 in 1,000 people)

• aggression
• clouding of the natural lens of the eye including the back of the lens, glaucoma, blurred vision
• blue-violet skin discolouration due to bleeding under the skin

Very rare (may affect up to 1 in 10,000 people)

• severe allergic reactions
• growth retardation

Reporting of side effects
If you experience any side effects, 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 Inteb

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle. The expiry date refers to the last day of that month.
If the capsules change colour or show any other signs of deterioration, consult your doctor or pharmacist before taking the medicine.
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.
Keep the medicine in the original bottle to protect it from light and moisture.
This medicine does not require any special storage temperature.

6. Package contents and other information

What Inteb contains

• The active substance is budesonide.
• The other components are:

Capsule contents
Ethylcellulose
Methacrylic acid-ethyl acrylate copolymer
Oleic acid
Polysorbate 80
Sugar spheres (corn starch, sucrose)
Talc
Triethyl citrate
Medium-chain triglycerides

Capsule shell
Iron oxide black E172
Iron oxide red E172
Titanium dioxide E171
Gelatin

Description of the appearance of Inteb and contents of the pack
Inteb capsules are approximately 19 mm long, opaque gelatin capsules with a light grey body and an orange cap. The capsules are filled with white to off-white pellets.

Inteb is available in HDPE bottles with a polypropylene screw cap, containing a silica desiccant. Packs contain 20, 45, 50, 90 or 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
S.F. Group Srl
Via Tiburtina, 1143
00156 – Rome
Italy

Manufacturers
Laboratorios Liconsa S.A.
Avenida Miralcampo 7,
Poligono Industrial Miralcampo,
19200 Azuqueca De Henares, Guadalajara
Spain

This medicinal product has been authorized in the European Economic Area Member States under the following names: