BENODIL 0.25 mg/ml Suspension

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Benodil, 0.125 mg/ml, nebulizer suspension
3. Benodil, 0.25 mg/ml, nebulizer suspension
4. Benodil, 0.5 mg/ml, nebulizer suspension
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Benodil and what is it used for
   1. What is Benodil
   2. What is Benodil used for
   3. Benodil is NOT indicated for relieving acute bronchospasm (constriction of airway muscles that causes wheezing) and shortness of breath (apnea).
   4. How Benodil works
6. Important information before using Benodil
   1. When not to use Benodil
   2. Warnings and precautions
   3. Benodil and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. The medicine contains sodium
7. How to use Benodil
   1. Method of administration
   2. WARNING!
   3. You should carefully read the instructions for using the nebulizer set.
   4. Instructions for using Benodil ampoules
   5. You should read the instructions for cleaning and disinfecting the nebulizer.
   6. Using a higher dose of Benodil than recommended
   7. Missing a dose of Benodil
8. Possible side effects
   1. If you experience any of the following side effects, you should stop using Benodil and contact your doctor immediately:
   2. Rare (occurring in less than 1 in 1,000 patients):
   3. Very rare (occurring in less than 1 in 10,000 patients):
   4. Other side effects:
   5. Common (occurring in less than 1 in 10 patients):
   6. Uncommon (occurring in less than 1 in 100 patients):
   7. Rare (occurring in less than 1 in 1,000 patients):
   8. Frequency not known (cannot be estimated from the available data):
   9. Reporting side effects
9. How to store Benodil
10. Contents of the packaging and other information
    1. What Benodil contains
    2. What Benodil looks like and what the packaging contains
    3. Marketing authorization holder and manufacturer
    4. Marketing authorization holder
    5. Manufacturer
    6. Date of the last update of the leaflet:

Leaflet accompanying the packaging: information for the user

Benodil, 0.125 mg/ml, nebulizer suspension

Benodil, 0.25 mg/ml, nebulizer suspension

Benodil, 0.5 mg/ml, nebulizer suspension

Budesonide

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Benodil and what is it used for

What is Benodil

Benodil is a nebulizer suspension that contains budesonide as the active substance. This substance belongs to a group of medicines called "corticosteroids".

What is Benodil used for

Benodil is used to treat:

• asthma, when the use of a pressure inhaler or powder inhaler is not suitable.
• croup syndrome - acute laryngitis, tracheitis, and bronchitis, regardless of etiology, associated with significant narrowing of the upper airways, shortness of breath, or "barking" cough, leading to respiratory disorders.
• exacerbation of chronic obstructive pulmonary disease (COPD), when the use of budesonide in the form of a nebulizer suspension is justified. COPD is a chronic lung disease that causes shortness of breath and coughing.

Benodil is NOT indicated for relieving acute bronchospasm (constriction of airway muscles that causes wheezing) and shortness of breath (apnea).

How Benodil works

During inhalation, Benodil directly enters the lungs, reducing and preventing swelling and inflammation of the lungs.

2. Important information before using Benodil

When not to use Benodil

• 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 to use Benodil, you should discuss it with your doctor or pharmacist. You should contact your doctor immediately:

• If the patient's breathing worsens or wakes up frequently at night with an asthma attack.
• If the patient feels that their chest is tightly constricted in the morning or if the chest constriction lasts longer than usual.
• If the patient experiences blurred vision or other vision disturbances. These symptoms may indicate that the patient's condition is not properly controlled and that additional or different treatment may be needed.

You should contact your doctor as soon as possible, but still continue to use Benodil:

• If shortness of breath or apnea persists, as additional treatment may be necessary.

Before using Benodil, you should inform your doctor or pharmacist:

• If the patient has a lung infection, a cold, or a chest infection.
• If the patient has liver function disorders.

Benodil and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those that are available without a prescription. In particular, you should inform your doctor if you are taking any of the following medicines:

• steroid medicines
• medicines used to treat fungal infections, such as ketoconazole or itraconazole
• HIV protease inhibitors, such as ritonavir and nelfinavir (used in patients with AIDS).

Some medicines may enhance the effect of Benodil, and your doctor may want to closely monitor your condition while taking such medicines (including some HIV medicines: ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine. If you become pregnant while using Benodil, you should not stop using it, but consult your doctor immediately.

Driving and using machines

Benodil does not affect the ability to drive or use machines.

The medicine contains sodium

The medicine contains 6.99 mg of sodium (the main component of common salt) in each ampoule (2 ml). This corresponds to 0.35% of the maximum recommended daily sodium intake in the diet for adults. The medicine may be diluted; see "How to use Benodil" below. The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared dilution of the medicine. To obtain accurate information about the sodium content in the solution used to dilute the medicine, you should read the patient leaflet for the diluent used.

3. How to use Benodil

Benodil is used by inhalation. This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult your doctor or pharmacist. Asthma treatment

In case it is not possible to adjust the appropriate doses of Benodil, medicines with other strengths are available.

• The doctor will inform the patient about the dose of Benodil to be used and the duration of treatment with Benodil. This will depend on the severity of the asthma symptoms. Improvement in health may occur within 2 days. However, the full therapeutic effect may occur only after 4 weeks. The doctor may reduce the dose of the medicine to the smallest dose that controls the asthma symptoms, if the patient's health improves.
• It is essential to use Benodil every day, even if the patient does not have any asthma symptoms at that time.
• The maximum daily dose (2 mg of budesonide) for infants and children under 12 years of age should be administered only to children with severe asthma and for a limited time.

Treatment of croup syndrome The usual dose for infants and children with croup syndrome is 2 mg of budesonide per day. This dose can be administered in whole or divided into two doses of 1 mg each, given at 30-minute intervals. This dosing regimen can be repeated every 12 hours, up to 36 hours, or until the patient's condition improves. Treatment of COPD Patients with chronic obstructive pulmonary disease should be treated with doses of 1-2 mg of Benodil per day. Treatment should be divided into 2 single doses every 12 hours. Patients with kidney or liver function disorders There is no data on the difference in the efficacy of budesonide in patients with kidney or liver function disorders.

Method of administration

Inhalation. Preparation for inhalation If the patient is using the treatment alone at home, the doctor or pharmacist will show how to inhale Benodil using a nebulizer at the first use of the inhalation. Children should use Benodil only under adult supervision. An example of an inhalation set in the form of a PARI LC PLUS nebulizer is equipped with a mouthpiece or a suitable face mask (PARI Baby bend) with a compressor (PARI Boy SX) necessary to inhale Benodil.

WARNING!

DO NOT use Benodil with an ultrasonic nebulizer.

You should carefully read the instructions for using the nebulizer set.

Instructions for using Benodil ampoules

• 1. Tear off the appropriate number of ampoules from the strip. Leave the rest in the sachet.
• 2. Shake the ampoule gently for 30 seconds.
• 3. Holding the ampoule vertically, open it by twisting off the top part.
• 4. Squeeze the prescribed dose of the medicine into the nebulizer chamber.
• 5. Discard the empty ampoule(s). Close the nebulizer lid.
• 6. Connect the face mask or mouthpiece to the nebulizer, according to the instructions.
• 7. Connect the nebulizer to the air compressor.
• 8. Turn on the compressor. Using the mask or mouthpiece, breathe in the "mist" calmly and deeply, sitting or standing upright. If using a mask, make sure it fits properly.
• 9. When the "mist" no longer appears in the mouthpiece or face mask, the inhalation is complete.
• 10. The duration of nebulization of the entire medicine depends on the type of equipment used. It also depends on the amount of medicine used.
• 11. A few drops of the medicine will remain in the nebulizer after inhalation.
• 12. After inhalation, rinse your mouth with water. Spit out the water. Do not swallow. If you used a face mask, also wash your face with water.
• 13. After each use of the inhaler, clean the nebulizer tank intended for the medicine and the mouthpiece (or face mask).

Unused suspension should be discarded immediately.

You should read the instructions for cleaning and disinfecting the nebulizer.

Benodil can be mixed with a 9 mg/ml (0.9%) sodium chloride solution for injection. The mixture should be used within 30 minutes.

Using a higher dose of Benodil than recommended

It is essential to take the dose of the medicine as indicated in the leaflet or as recommended by the doctor. Do not increase or decrease the dose of the medicine without consulting your doctor. If you have taken a higher dose of Benodil than recommended, you can continue the treatment as usual. If you have taken a higher dose of Benodil more than once, you should consult your doctor or pharmacist for advice.

Missing a dose of Benodil

If you miss a dose of the medicine, you should skip the missed dose and take the next dose as usual. Do not take a double dose to make up for the missed dose. If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, you should stop using Benodil and contact your doctor immediately:

Rare (occurring in less than 1 in 1,000 patients):

• facial swelling, especially around the mouth (with possible swelling of the lips, tongue, eyes, ears)
• itching, skin rash, or irritation (contact dermatitis), hives, and bronchospasm (constriction of airway muscles that causes wheezing). This may indicate an allergic reaction.

Very rare (occurring in less than 1 in 10,000 patients):

• sudden wheezing after inhaling the medicine.

Other side effects:

Common (occurring in less than 1 in 10 patients):

• thrush (fungal infection) in the mouth. The occurrence of this side effect will be less likely if the patient rinses their mouth with water after using Benodil.
• mild sore throat, cough, and hoarse voice
• pneumonia (lung infection) in patients with COPD. You should tell your doctor if any of the following symptoms occur while using budesonide; these may be symptoms of a lung infection:
• fever or chills
• increased production of mucus, change in the color of mucus
• increased coughing or increased difficulty breathing.

Uncommon (occurring in less than 1 in 100 patients):

• cataract (clouding of the lens in the eye)
• muscle cramps
• tremors
• depression
• anxiety
• blurred vision.

Rare (occurring in less than 1 in 1,000 patients):

• facial rash after using a face mask. Washing the face after using a mask helps prevent this.
• sleep disturbances, anxiety, nervousness, overexcitement, or irritability. There is a greater likelihood of these symptoms occurring in children.
• bruises
• loss of voice
• slowed growth rate in children and adolescents
• effect on the adrenal glands (small gland near the kidney).

Frequency not known (cannot be estimated from the available data):

• glaucoma (increased pressure in the eye).

Inhaled corticosteroids may affect the normal production of steroid hormones in the body, especially when using large doses for a long time. These symptoms are much less likely to occur with inhaled corticosteroids than with corticosteroid tablets. Budesonide in the form of a nebulizer suspension should be used before meals to minimize side effects on the throat.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Benodil

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the ampoule, sachet, and carton. The expiry date refers to the last day of the month. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number. Do not freeze. Store in the original packaging to protect from light. Shelf life after opening the sachet: 3 months. The contents of the ampoule should be used within 12 hours of opening. After dilution: use within 30 minutes. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Benodil contains

• The active substance of the medicine is budesonide.

Benodil, 0.125 mg/ml, nebulizer suspension: Each 2 ml ampoule contains 0.25 mg of budesonide. Benodil, 0.25 mg/ml, nebulizer suspension: Each 2 ml ampoule contains 0.5 mg of budesonide. Benodil, 0.5 mg/ml, nebulizer suspension: Each 2 ml ampoule contains 1 mg of budesonide.

• The other ingredients are: disodium edetate, sodium chloride, polysorbate 80, anhydrous citric acid, sodium citrate, and water for injection.

What Benodil looks like and what the packaging contains

Each ampoule contains a white or almost white nebulizer suspension. Ampoules are packed 5 in a sachet. Pack size: 10, 20, 40, or 60 ampoules. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Manufacturer

Genetic S.p.A, Nucleo Industriale, Contrada Canfora, 84084 Fisciano (SA), Italy, Polpharma S.A., ul. Pelplińska 19, 83-200 Starogard Gdański

Date of the last update of the leaflet: