Xirobud

Patient Information Leaflet

Xirobud, 3 mg, prolonged-release hard capsules
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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Xirobud is and what it is used for

Xirobud reduces inflammation in the small intestine and the initial part of the large intestine.
Xirobud is used in the treatment of Crohn's disease affecting the small intestine and the initial
segment of the large intestine. Crohn's disease is an inflammatory bowel disease which causes
symptoms such as diarrhoea, fever and abdominal pain.
Xirobud is used in the treatment of microscopic colitis, a chronic inflammatory disease of the
colon which often causes watery diarrhoea. Xirobud may be used both for the treatment of active
disease and, in severe cases, to prevent relapse (maintenance therapy).

2. Important information before taking Xirobud

When not to take Xirobud:

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

Warnings and precautions
Before starting treatment with Xirobud, consult a doctor or pharmacist if the patient has:

• bacterial, fungal, or viral infections
• any liver disease
• osteoporosis
• peptic ulcer
• hypertension
• diabetes (also applies to patients with a family history of diabetes)
• any eye diseases (also applies to patients with a family history of eye diseases)

Measles and chickenpox may worsen in patients taking this medicine. Contact a doctor if the patient has measles or chickenpox, or suspects exposure to these diseases.
Contact a doctor if the patient experiences blurred vision or other visual disturbances.
After switching from regular cortisone tablets to Xirobud or after discontinuing Xirobud, transient symptoms such as rash, cold symptoms, and muscle pain may occur. If any of these symptoms occur, or if the patient experiences headache, fatigue, or nausea, medical advice should be sought.
If the patient is scheduled for surgery, inform the doctor about taking Xirobud, as additional regular cortisone tablets may be required for a certain period.

Children and adolescents
Regular monitoring of growth is recommended in children and adolescents treated with Xirobud.

Xirobud with other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Some medicines may affect treatment with Xirobud, or Xirobud may affect the action of other medicines, for example:

• certain antifungal medicines (e.g. itraconazole)
• medicines used in the treatment of Cushing's syndrome—when the body produces excessive cortisol (e.g. ketoconazole tablets)
• medicines used to treat menopausal symptoms (estrogens) and contraceptives (oral contraceptives)
• carbamazepine (a medicine used to treat epilepsy)
• certain medicines may enhance the effect of Xirobud, and careful monitoring by a doctor may be necessary for patients taking such medicines (e.g. certain medicines used to treat HIV infection: ritonavir (or other HIV protease inhibitors), cobicistat).

Xirobud may affect pituitary function test results—so-called ACTH stimulation test—results of these tests may show falsely low values.

Xirobud with food and drink
During treatment with Xirobud, grapefruit juice should be avoided, as grapefruit may increase intestinal absorption of budesonide (other juices, such as apple or orange juice, do not affect budesonide absorption).

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
There is a risk of harm to the fetus. Therefore, always consult a doctor before using Xirobud if the patient is pregnant.
Budesonide passes into breast milk. Therefore, discuss this with a doctor before starting regular use of Xirobud during breastfeeding.

Driving and operating machinery
It is unlikely that Xirobud will affect the ability to drive or operate machinery.

Xirobud contains sugar pellets (corn starch, sucrose)
Xirobud contains sucrose, a type of sugar. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

3. How to take Xirobud

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
The capsules should be swallowed whole with water.
Do not chew or crush the capsules.
Patients who may have difficulty swallowing the capsule whole may open it and, after gently
mixing its contents with a tablespoon of apple puree, swallow the mixture. The capsule contents
should not be crushed or chewed.
Crohn's disease:
Recommended dose for adults and children over 8 years of age weighing more than 25 kg:
For treatment of active disease: 3 prolonged-release capsules (i.e. 9 mg budesonide),
in the morning, for 8 weeks. The full effect of Xirobud is usually achieved within 2 to 4 weeks
of treatment.
Do not forget to take the prolonged-release capsules, even if the patient feels better.
Treatment should be discontinued by gradually reducing the dose.
Microscopic colitis:
Recommended dose for adults:
For treatment of active disease: 3 prolonged-release capsules (i.e. 9 mg budesonide),
in the morning, for 8 weeks. If treatment is nearing completion, the dose should be gradually reduced
during the final two weeks.
Maintenance treatment: 2 capsules (i.e. 6 mg budesonide) (or the lowest effective dose).
Use in children
Xirobud is not recommended for use in children.
Taking more Xirobud than recommended
If more Xirobud has been taken than recommended, consult a doctor or pharmacist immediately.
Missing a dose of Xirobud
Do not take a double dose to make up for a missed dose. Take the next dose according to the
prescribed schedule.
Stopping Xirobud treatment
Do not stop taking Xirobud without first consulting your doctor. Abruptly stopping the capsules
may cause a relapse of the disease.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
This medicine may cause the following adverse reactions:
Common (may affect up to 1 in 10 people)

• low blood potassium levels
• behavioral changes such as nervousness, insomnia, mood changes, and depression
• abnormally fast or irregular heartbeat
• indigestion (dyspepsia)
• hives or rash
• muscle cramps
• menstrual disorders
• central obesity and facial fat accumulation, skin changes, fluid retention (so-called clinical picture of Cushing's syndrome).

Uncommon (may affect up to 1 in 100 people)

• tremors
• anxiety, intense urge for physical activity accompanied by mental anxiety (psychomotor agitation)
• anxiety.

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

• aggression
• clouding of the natural lens of the eye, including the posterior lens, glaucoma, blurred vision
• blue-violet skin discoloration due to subcutaneous bleeding.

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

• severe allergic reactions
• growth suppression.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
Adverse reactions can also be reported to the responsible entity.

5. How to store Xirobud

Keep this medicine out of 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 the stated month.
If the tablets change colour or show any other signs of deterioration, consult a doctor or pharmacist before taking this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
Store in the original packaging to protect from light and moisture.
No special storage temperature requirements apply.

6. Contents of the pack and other information

What Xirobud contains

• The active substance is budesonide.
• The other components of the medicine are:

Contents of the capsule
Ethylcellulose
Ammonium hydroxide 28%
Copolymer of methacrylic acid and ethyl acrylate (1:1)
Oleic acid
Polysorbate 80
Sucrose spheres (corn starch, sucrose)
Talc
Triethyl citrate
Medium-chain triglycerides

Capsule shell
Black iron oxide (E 172)
Red iron oxide (E 172)
Titanium dioxide (E 171)
Gelatin

What Xirobud looks like and contents of the pack
Xirobud is a gelatin capsule approximately 19 mm long, with a light grey, opaque body and an orange, opaque cap. The capsules are filled with white or almost white pellets.

Xirobud is available in HDPE bottles with a PP screw cap containing a desiccant, packed in a cardboard box containing 100 capsules.

Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: [email protected]

Manufacturer
Laboratorios LICONSA, S.A.
Avenida Miralcampo 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara
Spain

This medicinal product is authorised in the following European Economic Area countries under the following names:
Sweden: Budesonid Medical Valley 3 mg kapsel med modifierad frisättning, hård
Denmark: Budesonid Medical Valley
Finland: Budesonid Medical Valley 3 mg säädellysti vapauttava kapseli, kova
Netherlands: Budesonide Xiromed 3 mg, capsules met gereguleerde afgifte
Norway: Budesonid Medical Valley
Poland: Xirobud