Patient Information Leaflet

BUDESONIDE DOC

3 mg modified-release hard capsules
Generic medicine
Please read 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 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, as it could 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:

What BUDESONIDE DOC is and what it is used for
What you need to know before taking BUDESONIDE DOC
How to take BUDESONIDE DOC
Possible side effects
How to store BUDESONIDE DOC
Contents of the pack and other information

1. What BUDESONIDE DOC is and what it is used for

BUDESONIDE DOC reduces inflammation in the small intestine and the first part of the large intestine.
BUDESONIDE DOC is used to treat Crohn's disease of the small intestine and the first part of the large intestine.
Crohn's disease is an inflammatory bowel disease that causes symptoms such as diarrhoea, fever, and stomach pain.
BUDESONIDE DOC is used to treat microscopic colitis, a disease that causes chronic inflammation of the colon and often leads to watery diarrhoea. BUDESONIDE DOC 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 BUDESONIDE DOC

Do not take BUDESONIDE DOC

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 BUDESONIDE DOC if you have:

a bacterial, fungal, or viral infection
liver problems
osteoporosis
gastric ulcer
high blood pressure
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 BUDESONIDE DOC. If you are or have been infected, contact your doctor.
Contact your doctor if you experience blurred vision or other visual disturbances.
When switching from corticosteroid tablets to BUDESONIDE DOC or when stopping BUDESONIDE DOC treatment, you may temporarily experience symptoms such as skin rash, runny nose, and muscle pain.
Contact your doctor if you experience any of these symptoms or if you are concerned about headache, fatigue, or nausea.
If you are undergoing surgery, inform your doctor that you are taking BUDESONIDE DOC, as additional treatment with corticosteroid tablets may be required for a period of time.
For those engaged in sports activities
Using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
Regular monitoring of height growth is recommended in children and adolescents receiving BUDESONIDE DOC treatment.
Other medicines and BUDESONIDE DOC
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 BUDESONIDE DOC, 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 BUDESONIDE DOC, and your doctor may need to closely monitor your treatment if you are taking these medicines (e.g. certain HIV treatments: ritonavir (or other protease inhibitors), cobicistat).

BUDESONIDE DOC may interfere with a test used to assess pituitary function, the so-called ACTH stimulation test, leading to falsely low results.
BUDESONIDE DOC with food and drinks
Grapefruit juice should be avoided during treatment with BUDESONIDE DOC, as grapefruit may increase the intestinal absorption of budesonide (juices from other fruits such as orange or apple do not affect budesonide absorption).
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think 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 BUDESONIDE DOC if you are pregnant.
Budesonide is excreted in breast milk. Talk to your doctor before regularly taking BUDESONIDE DOC during breastfeeding.
Driving and using machines
It is unlikely that BUDESONIDE DOC will affect your ability to drive or operate machinery.
BUDESONIDE DOC contains sugar spheres (corn starch, sucrose)
BUDESONIDE DOC 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 BUDESONIDE DOC

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The capsules must be swallowed whole with water.
If you have difficulty swallowing, you may open the capsule and ingest 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 BUDESONIDE DOC reaches its 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. When approaching the end of treatment, the dose should be gradually 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 BUDESONIDE DOC in children is not recommended.

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

If you forget to take BUDESONIDE DOC
Do not take a double dose to make up for the forgotten dose. Continue with the next dose as prescribed by your doctor.

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

If you have any further questions 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.
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
abnormally fast or irregular heartbeat
difficulty in 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 symptoms)

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 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 . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store BUDESONIDE DOC

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 that month.
If the capsules change colour or show any signs of deterioration, consult your doctor or pharmacist before taking the medicine.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Store 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 BUDESONIDE DOC contains

The active substance is budesonide.
The other components are: Capsule contents Ethylcellulose Methacrylic acid-ethyl acrylate copolymer Oleic acid Polysorbate 80 Sugar spheres (maize starch, sucrose) Talc Triethyl citrate Medium-chain triglycerides

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

Description of the appearance of BUDESONIDE DOC and package contents
BUDESONIDE DOC capsules are approximately 19 mm long, opaque gelatin capsules with a light grey body and an orange opaque cap. The capsules contain white to off-white pellets.
BUDESONIDE DOC is available in HDPE bottles with polypropylene screw caps containing a silica desiccant, in pack sizes of 20, 45, 50 or 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici Srl
Via Turati 40
20121 Milan
Italy

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

This medicinal product has been authorised in the Member States of the European Economic Area under the following names:
SE: Budesonid DOC
IT: BUDESONIDE DOC