Ondemet

Package leaflet: Information for the patient

Ondemet, 0.25 mg/mL, suspension for nebulization
Ondemet, 0.5 mg/mL, suspension for nebulization
Budesonidum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Ondemet is and what it is used for
2. Important information before using Ondemet
3. How to use Ondemet
4. Possible side effects
5. How to store Ondemet
6. Contents of the pack and other information

1. What Ondemet is and what it is used for

Ondemet belongs to a group of medicines called glucocorticosteroids (cortisone). Medicines in this group have anti-inflammatory effects.
Ondemet is indicated for:

• Treatment, reduction, and prevention of inflammatory conditions of the airways in asthma
• Treatment of symptoms of chronic obstructive pulmonary disease by reducing airway inflammation
• Treatment of severe croup syndrome (laryngitis, which may cause breathing difficulties)

Ondemet should not be used as a substitute for a bronchodilator medicine.

2. Important information before using Ondemet

When not to use Ondemet

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

Warnings and precautions

Before starting treatment with Ondemet, consult a doctor or pharmacist if:

• the patient has or has had liver disease or liver problems
• the patient suffers from tuberculosis (active or inactive)
• the patient has fungal or viral respiratory tract infections

When switching from a corticosteroid-containing medicine to Ondemet, allergic symptoms such as rhinitis and eczema may recur. The patient may also experience fatigue, headache, muscle and joint pain, and sometimes nausea and vomiting. This is because the amount of corticosteroid naturally produced by the body may decrease following prolonged use of corticosteroid medicines. These problems usually resolve over time with continued treatment with Ondemet, but if symptoms are severe, immediately contact a doctor.
After taking the medicine, rinse the mouth with water to minimize the risk of developing oral or throat fungal infection. Contact a doctor if symptoms of fungal infection occur.
In rare cases, long-term treatment with Ondemet may slow down growth in children and adolescents. If a child is using this medicine for a prolonged period, the doctor will usually monitor the child's growth regularly.
If asthma symptoms worsen, consult a doctor. This may indicate the need to adjust the dosage or change treatment.
In case of an acute asthma attack, use a fast-acting bronchodilator.
If blurred vision or other visual disturbances occur, contact a doctor.

Children and adolescents
The doctor should regularly monitor the growth of children undergoing long-term treatment with Ondemet.
If growth is slowed, therapy should be re-evaluated.

Ondemet and other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned for use, including over-the-counter and herbal medicines.
Some medicines may affect treatment with Ondemet, for example those containing:

• ketoconazole or itraconazole (found in medicines used to treat fungal infections)
• saquinavir, indinavir, ritonavir, nelfinavir, amprenavir, lopinavir, fosamprenavir, atazanavir, or tipranavir (so-called HIV protease inhibitors used in HIV treatment)

Ondemet may affect pituitary gland function test results, specifically the ACTH stimulation test, leading to falsely low values.

Pregnancy and breastfeeding
Experience with use during pregnancy does not indicate an increased risk of developmental abnormalities. However, before using the medicine during pregnancy, consult a doctor, as asthma symptoms may change and treatment adjustments may be necessary.
Budesonide passes into breast milk. The effect of therapeutic doses of Ondemet on breastfed infants is considered unlikely. Ondemet may be used during breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Ondemet does not affect the ability to drive or operate machinery.

3. How to use Ondemet

This medicine should always be used exactly as your doctor has instructed. If you have any doubts,
contact your doctor or pharmacist.
Your doctor will tell you how much medicine to take. This will depend on the severity of your condition.
Ondemet should be used daily or as directed by your doctor, even if there are no symptoms of asthma.
Ondemet is administered using a nebulizer (an inhalation device). When inhaled through a mouthpiece or face mask, the medicine is carried by the inhaled air into the airways. Therefore, it is important to breathe calmly and evenly during dosing – see the instructions for use.

Instructions for using the nebulizer.
Ondemet should only be used with a special inhalation device called a nebulizer.

Instructions for using Ondemet ampoules

1. Separate the required number of ampoules from the strip. Keep the remaining ampoules in the sachet to protect them from light.
2. Gently shake the ampoule(s) for 30 seconds.

3. Hold the ampoule(s) in an upright position. Unscrew the top part of the ampoule(s).

4. Pour the prescribed amount of medicine into the nebulizer chamber. The single-dose container is marked with a line. If only 1 ml is to be used, hold the single-dose container upside down and empty it until the liquid level reaches the line.

5. Use the nebulizer according to the manufacturer's instructions and your doctor's recommendations.
6. Discard used ampoules. If any medicine remains unused in the ampoule, it may be used within 12 hours of opening the ampoule.
7. Using a face mask or mouthpiece, calmly and deeply inhale the mist from the nebulizer while sitting or standing in an upright position. When using a face mask, ensure that the mask fits properly. A face mask may be used for children to make inhalation easier.
8. Rinse your mouth with water. Spit out the water. Do not swallow. If using a face mask, also wash your face.
9. After each use, wash the medicine container, mouthpiece (or face mask) of the nebulizer with a mild detergent, then rinse thoroughly and dry. Refer to the instructions for cleaning and disinfecting the nebulizer.

An opened single-dose ampoule should be used within 12 hours and stored away from light before use.
Since at the beginning of nebulization there should always be at least 2 ml in the nebulization chamber, if the patient is to inhale only 1 ml of Ondemet, it should be diluted with saline (sodium chloride solution 9 mg/ml [0.9%] for injection).

Use of a higher than recommended dose of Ondemet
If too high a dose of Ondemet is used once, it should not cause harmful effects.
However, if doses higher than those recommended by the doctor have been used for a prolonged period (several months), adverse effects may occur.
If an overdose of the medicine has been taken, or if the medicine has been accidentally ingested by a child, contact your doctor or hospital for risk assessment and advice.
It is important to take the dose as indicated on the packaging or as directed by your doctor. Do not increase or decrease the dose without consulting your doctor.

Missed dose of Ondemet
If one prescribed dose of Ondemet has been missed, take the next dose as scheduled. Do not use a double dose to make up for the missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.

Serious adverse effects:

Common (may occur in less than 1 in 10 people)

• Lung inflammation (in patients with COPD).

Tell the doctor if any of the following symptoms occur during treatment with Ondemet, as they may be symptoms of lung inflammation:

• fever or chills
• increased mucus production, change in mucus colour
• worsening cough or increased difficulty breathing.

Rare (may occur in less than 1 in 1,000 people)

• Angioedema (swelling around the eyes, lips, genitals, hands, feet or other parts of the body), anaphylaxis (swelling of lips and tongue, tightness in throat, difficulty breathing, feeling faint), bronchospasm (constriction of airway muscles).

Stop using Ondemet immediately and contact a doctor immediately if any of the following symptoms occur, as they may be related to angioedema, anaphylaxis or bronchospasm:

• swelling of the face, tongue or throat
• difficulty swallowing
• difficulty breathing
• urticaria (hives)

Other possible adverse effects:

Common (occur in less than 1 in 10 people)

• Throat irritation, cough, oral candidiasis (fungal infection of the mouth and/or throat). Oral candidiasis is less likely if the mouth is rinsed with water after using Ondemet.

Uncommon (occur in less than 1 in 100 people)

• Blurred vision, cataract (clouding of the eye lens), depression, anxiety, muscle cramps, tremor

Rare (occur in less than 1 in 1,000 people)

• Immediate and delayed allergic reactions, such as urticaria and other skin rashes
• Adverse effects of corticosteroids. Inhaled corticosteroids may affect the body's physiological production of steroid hormones, especially with long-term use of high doses. Adverse effects include:
• Changes in bone mineral density (thinning of the bones).
• Glaucoma (increased pressure in the eye).
• Reduced growth rate in children and adolescents.
• Suppression of adrenal function (a small gland located near the kidney).

The likelihood of these effects is significantly lower with inhaled corticosteroids than with oral corticosteroid tablets.

• Bruising, dysphonia (voice disorders), hoarseness, anxiety, behavioural disturbances (mainly in children).

Adverse effects with unknown frequency; frequency cannot be estimated from available data

• sleep disorders,
• aggression, feeling of intense excitement and/or irritability.
• glaucoma (increased pressure in the eye)

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ondemet

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging, sachet, and ampoule following EXP. The expiry date refers to the last day of the stated month.
Do not freeze.
Store in the original packaging to protect from light.
Shelf life after opening the aluminium sachet: 3 months.
Shelf life after opening the vial: 12 hours. Please note that if only 1 ml has been used, the remaining volume is no longer sterile.
Shelf life after dilution of the medicinal product: the prepared suspension should be used within 30 minutes.
This product does not require any special storage conditions.
Medicines must 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.

6. Contents of the pack and other information

What Ondemet contains

• The active substance is budesonide.
  Ondemet 0.25 mg/mL: Each 2 mL ampoule contains 0.5 mg of budesonide.
  Ondemet 0.5 mg/mL: Each 2 mL ampoule contains 1 mg of budesonide.
• Other ingredients are: edetate disodium (E385), sodium chloride, polysorbate 80 (E433), anhydrous citric acid (E330), sodium citrate (E331), hydrochloric acid and sodium hydroxide (for pH adjustment), and water for injections.

What Ondemet looks like and contents of the pack

• Each ampoule contains 2 mL of a liquid, white to almost white in colour.
• Ampoules are packed in strips of 5 in sealed aluminium foil sachets (PET/Alu/PE).
• Pack sizes: Each pack contains 10, 20, 40, 60, 80 or 120 ampoules. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva k.s.
Dolní Měcholupy
U kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer
Genetic S.p.A.
Contrada Canfora
84084 Fisciano, Italy

This medicinal product is authorised in the European Economic Area under the following names:
Sweden, Norway: Budesonide Zentiva
Poland: Ondemet

For further information, contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel.: +48 22 375 92 00