Xirobud

Package Leaflet: Information for the User

Xirobud, 3 mg, prolonged-release hard capsules

Budesonide

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

• 1. What is Xirobud and what is it used for
• 2. 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 is Xirobud and what is it used for

Xirobud reduces inflammation in the small intestine and the beginning of the large intestine.
Xirobud is used to treat Crohn's disease affecting the small intestine and the beginning of the large intestine. Crohn's disease is an inflammatory disease of the intestines that causes symptoms such as diarrhea, fever, and abdominal pain.
Xirobud is used to treat microscopic colitis, a chronic inflammatory disease of the large intestine, which often causes watery diarrhea. Xirobud can be used for both the treatment of the active phase of the disease and in severe cases to prevent its recurrence (maintenance treatment).

2. Before you take Xirobud

When not to take Xirobud:

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

Warnings and precautions

Before taking Xirobud, discuss with your doctor or pharmacist if you have:

• bacterial, fungal or viral infections
• any liver disease
• osteoporosis
• peptic ulcer
• high blood pressure
• diabetes (including a family history of diabetes)
• any eye problems (including a family history of eye problems)

Measles and chickenpox can be more serious in patients taking this medicine. Contact your doctor if you have measles or chickenpox or suspect you have come into contact with someone who has these diseases.
Contact your doctor if you experience blurred vision or other vision disturbances.
After switching from ordinary cortisone tablets to Xirobud or after stopping Xirobud, temporary symptoms such as rash, runny nose, and muscle pain may occur. If you experience any of these symptoms or feel headache, fatigue, or nausea, consult your doctor.
If you are going to have surgery, tell your doctor that you are taking Xirobud, as you may need to take ordinary cortisone tablets for a while.

Children and adolescents

Regular growth monitoring is recommended for children and adolescents treated with Xirobud.

Xirobud with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
Some medicines may affect the treatment with Xirobud or Xirobud may affect the action of other medicines, for example:

• some antifungal medicines (e.g. itraconazole)
• medicines used to treat Cushing's syndrome - when the body produces too much cortisol (e.g. ketoconazole in tablets)
• medicines used to treat menopausal symptoms (estrogens) and contraceptives (birth control pills)
• carbamazepine (a medicine used to treat epilepsy)
• some medicines may enhance the effect of Xirobud and may require careful monitoring by your doctor (e.g. some medicines used to treat HIV infection: ritonavir (or other HIV protease inhibitors), cobicistat).

Xirobud may affect the results of tests for adrenal function - so-called ACTH stimulation test - the results of these tests may show falsely low values.

Xirobud with food and drink

During treatment with Xirobud, avoid drinking grapefruit juice, as grapefruit may increase the absorption of budesonide from the intestine (other juices, such as apple or orange juice, do not affect the absorption of budesonide).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is a risk of harm to the unborn child. Therefore, before taking Xirobud, you should always consult your doctor if you are pregnant.
Budesonide passes into breast milk. Therefore, you should discuss this with your doctor before regularly taking Xirobud during breastfeeding.

Driving and using machines

It is unlikely that Xirobud will affect your ability to drive or use machines.

Xirobud contains sugar spheres (maize starch, sucrose)

Xirobud contains sucrose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Xirobud

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Swallow the capsules whole with water.
Do not chew or crush the capsules.
Patient who may have difficulty swallowing the capsule whole may open it and, after gently mixing its contents with a tablespoon of apple sauce, swallow. The contents of the capsule should not be chewed or crushed.

Crohn's disease:

Recommended dose for adults and children over 8 years of age, weighing more than 25 kg:
For the treatment of the active phase of the 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 stop taking the prolonged-release capsules, even if you feel better.
Treatment should be discontinued by gradually reducing the dose.

Microscopic colitis:

Recommended dose for adults:
For the treatment of the active phase of the disease: 3 prolonged-release capsules (i.e. 9 mg budesonide), in the morning, for 8 weeks. If treatment is approaching the end, the dose should be gradually reduced over the last two weeks.
Maintenance treatment: 2 capsules (i.e. 6 mg budesonide) (or the smallest effective dose).

Use in children

Xirobud is not recommended for use in children.

Overdose

If you take more Xirobud than you should, contact your doctor or pharmacist immediately.

Missed dose

Do not take a double dose to make up for a forgotten dose. Take the next dose as prescribed by your doctor.

Stopping treatment

Do not stop taking Xirobud without first talking to your doctor. Stopping treatment suddenly may cause the disease to recur.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xirobud can cause side effects, although not everybody gets them.
Xirobud may cause the following side effects:

Common (may affect up to 1 in 10 people)

• low potassium levels in the blood
• behavioral changes such as nervousness, insomnia, mood changes, and depression
• abnormal heart rhythm
• indigestion (dyspepsia)
• hives or rash
• muscle cramps
• menstrual disorders
• central obesity and facial swelling, skin changes, fluid retention (Cushing's syndrome).

Uncommon (may affect up to 1 in 100 people)

• tremors
• restlessness, increased physical activity with accompanying mental anxiety (psychomotor hyperactivity)
• anxiety.

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

• aggression
• clouding of the natural lens of the eye, also the back of the lens, glaucoma, blurred vision
• blue-purple discoloration of the skin, resulting from 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Side effects can be reported to the national reporting system via the Medicines Agency website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xirobud

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 bottle. The expiry date refers to the last day of the month.
If the capsules become discolored or show any other signs of deterioration, consult your doctor or pharmacist before taking this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
Store in the original package to protect from light and moisture.
No special storage precautions are required.

6. Contents of the pack and other information

What Xirobud contains

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

Contents of the capsule
Ethylcellulose
Ammonium hydroxide 28%
Methacrylic acid and ethyl acrylate copolymer (1:1)
Oleic acid
Polysorbate 80
Sucrose spheres (maize 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 available as hard gelatin capsules, approximately 19 mm in length, 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 cap containing a desiccant, in a cardboard box, containing 100 capsules.

Marketing Authorisation Holder

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: safety@medicalvalley.se

Manufacturer

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

This medicine is authorised in the Member States of the European Economic Area under the following names:

Xirobud is approved for marketing in the following countries:

Sweden
Budesonid Medical Valley 3 mg capsule with modified release, hard
Denmark
Budesonid Medical Valley
Finland
Budesonid Medical Valley 3 mg controlled release capsule, hard
Netherlands
Budesonide Xiromed 3 mg, capsules with regulated release
Norway
Budesonid Medical Valley
Poland
Xirobud

Date of last revision of the package leaflet: