Benodil

Package leaflet: Information for the user

Benodil, 0,125 mg/ml, suspension for nebulization
Benodil, 0,25 mg/ml, suspension for nebulization
Benodil, 0,5 mg/ml, suspension for nebulization
Budesonidum
Please read carefully the entire leaflet before use, 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 pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Benodil is and what it is 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 pack and other information

1. What Benodil is and what it is used for

What Benodil is
Benodil is a suspension for nebulization containing budesonide as the active substance.
This substance belongs to a group of medicines called "corticosteroids".

What Benodil is used for
Benodil is used in the treatment of:

• Asthma, when use of a pressurized metered-dose inhaler or dry powder inhaler is inappropriate.
• Croup syndrome – acute laryngotracheobronchitis of any etiology, associated with significant narrowing of the upper airways, dyspnea, or "barking" cough, leading to respiratory disturbances.
• Exacerbations of chronic obstructive pulmonary disease (COPD), when administration of budesonide as a nebulized suspension is justified. COPD is a chronic lung disease causing breathlessness and cough.

Benodil is NOT indicated for relief of acute bronchospasm (constriction of the airway muscles causing wheezing) and dyspnea (shortness of breath).

How Benodil works
When inhaled, Benodil reaches directly into the lungs, reducing and preventing swelling and inflammation in the lungs.

2. Important information before using Benodil

When not to use Benodil

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

Warnings and precautions
Before starting treatment with Benodil, discuss this with your doctor or pharmacist.
Contact your doctor immediately:

• If the patient's breathing worsens or if they frequently wake up at night due to asthma attacks.
• If the patient feels tightness in the chest in the morning or if chest tightness lasts longer than usual.
• If the patient experiences blurred vision or other visual disturbances. These symptoms may indicate that the patient's condition is not adequately controlled and that additional or alternative treatment may be required.

Contact your doctor as soon as possible, but continue using
Benodil:

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

Before using Benodil, inform your doctor or pharmacist:

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

Benodil with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines the patient plans to use, even those available without a prescription.
In particular, inform your doctor if the patient is 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 wish to monitor the patient carefully when taking such medicines (including certain HIV medicines: ritonavir, cobicistat).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
If the patient becomes pregnant while using Benodil, do not stop treatment, but consult your doctor immediately.
Driving and using machines
Benodil has no influence on the ability to drive, operate machinery or handle tools.
Sodium content
Benodil contains 6.99 mg of sodium (the main component of table salt) in each ampoule (2 ml). This corresponds to 0.35% of the maximum recommended daily dietary sodium intake for adults.
The medicine may be diluted; see below "How to use Benodil". The sodium content originating from the diluent should be taken into account when calculating the total sodium content in the prepared diluted solution. For accurate information on the sodium content of the solution used to dilute the medicine, refer to the patient leaflet of the diluent used.

3. How to use Benodil

Benodil is administered by inhalation.
This medicine should always be used as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.
Asthma treatment

In cases where appropriate doses of Benodil cannot be matched, medicines with different strengths are available.

• The physician will inform the patient what dose of the medicine to use and how long the treatment with Benodil will last. This will depend on how severe the asthma symptoms are. Improvement in health may occur within 2 days. However, full therapeutic effect may take up to 4 weeks. The physician may reduce the dose to the lowest dose providing control of asthma symptoms if the patient's condition improves.

• It is important to use Benodil every day, even if the patient has no asthma symptoms at that time.

• The maximum daily dose (2 mg budesonide) for infants and children under 12 years of age should be given only to children with severe asthma and for a limited period of time.

Treatment of croup syndrome
The usual dose in infants and children with croup syndrome is 2 mg budesonide per day. This dose may be administered as a single dose or divided into two 1 mg doses given 30 minutes apart. This dosing regimen may be repeated every 12 hours, for 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 Benodil per day. Treatment should be divided into two single doses administered every 12 hours.

Patients with renal or hepatic impairment
There is no data available regarding differences in efficacy of budesonide in patients with renal or hepatic impairment.

Method of administration
Inhalation use.

Preparation for inhalation
If the patient is using the treatment independently at home, the physician or pharmacist will demonstrate how to inhale Benodil using a nebulizer at the first administration. Children should use Benodil only under adult supervision.

An example nebulization kit includes the PARI LC PLUS nebulizer with a mouthpiece or an appropriate face mask (PARI Baby bend) and an air compressor (PARI Boy SX), which is necessary for inhaling Benodil.

WARNING!
DO NOT use Benodil with an ultrasonic nebulizer.

Carefully read the instructions for using the nebulization kit.

Instructions for using Benodil ampoules

1. Detach the required number of ampoules from the strip. Leave the remainder in the sachet.
2. Gently shake the ampoule for 30 seconds.
3. Holding the ampoule in an upright position, open it by twisting off the top.
4. Squeeze the prescribed amount of medication into the nebulizer chamber.
5. Discard the empty ampoule(s). Close the nebulizer cover.
6. Connect the face mask or mouthpiece to the nebulizer as instructed.
7. Connect the nebulizer to the air compressor.
8. Turn on the compressor. Using the mask or mouthpiece, breathe calmly and deeply through the "mist" while sitting or standing in an upright position. If using a mask, ensure it fits properly.
9. When no more "mist" appears in the mouthpiece or face mask, the inhalation is complete.
10. The duration of nebulization of the entire dose depends on the type of equipment used and the volume of medication administered.
11. A few drops of medication will remain in the nebulizer after inhalation.
12. After inhalation, rinse the mouth with water and spit it out. Do not swallow. If a face mask was used, wash the face with water as well.
13. After each use, clean the nebulizer chamber and mouthpiece (or face mask).

Any unused suspension must be discarded immediately.

Refer to the instructions for cleaning and disinfecting the nebulizer.

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

Use of a higher than recommended dose of Benodil

It is important to take the medicine exactly as stated in the package leaflet or as directed by the physician. Do not increase or decrease the dose without consulting the physician.

If a single higher than recommended dose of Benodil is taken, continue treatment as usual. If more than the recommended dose is taken repeatedly, contact a physician or pharmacist for advice.

Missed dose of Benodil

If the patient forgets to take a dose, skip the missed dose and take the next dose at the usual time. Do not use a double dose to make up for a missed dose.

If there are any further doubts about the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, stop using Benodil immediately and contact your doctor straight away:
Rare (affects fewer than 1 in 1,000 patients):

• swelling of the face, particularly around the mouth (with possible swelling of lips, tongue, eyes, ears)
• itching, skin rash or irritation (contact dermatitis), urticaria and bronchospasm (constriction of muscles in the airways causing wheezing). These may indicate an allergic reaction.

Very rare (affects fewer than 1 in 10,000 patients):

• sudden wheezing after inhaling the medicine.

Other adverse reactions:
Common (affects fewer than 1 in 10 patients):

• oral thrush (fungal infection in the mouth). The likelihood of this reaction can be reduced if the patient rinses the mouth with water after using Benodil.
• mild sore throat, cough and hoarseness
• pneumonia (lung infection) in patients with COPD. Inform your doctor if any of the following symptoms occur during budesonide treatment; they may be symptoms of lung infection:
  • fever or chills
  • increased mucus production, change in mucus colour
  • worsening cough or increased difficulty breathing.

Uncommon (affects fewer than 1 in 100 patients):

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

Rare (affects fewer than 1 in 1,000 patients):

• facial rash after using a face mask. Washing the face after using the mask may help prevent this.
• sleep disorders, anxiety, restlessness, excessive excitement or irritability. These symptoms are more likely in children.
• bruising
• loss of voice
• slowed growth rate in children and adolescents
• effects on the adrenal glands (a small gland next to the kidney).

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

• glaucoma (increased pressure in the eye).

Inhaled glucocorticosteroids may affect the normal production of steroid hormones in the body, especially when high doses are used over a prolonged period. These effects are much less likely with inhaled corticosteroids than with corticosteroid tablets.
Budesonide in the form of a nebuliser suspension should be used before a meal to minimise adverse effects on the throat.
Reporting of adverse reactions
If any adverse reactions occur, including any 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Benodil

Keep this medicine 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 stated month.
The marking on the packaging following "EXP" indicates the expiry date, and following "Lot" indicates the batch number.
Do not freeze.
Store in the original packaging to protect from light.
Shelf-life after first opening of the sachet: 3 months.
The contents of an ampoule should be used within 12 hours after opening.
After dilution: use within 30 minutes.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Benodil contains

• The active substance is budesonide.

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

• Other ingredients are: disodium edetate, sodium chloride, polysorbate 80, anhydrous citric acid, sodium citrate, and water for injections.

What Benodil looks like and contents of the pack
Each ampoule contains a white or almost white suspension for nebulization. Ampoules are packed
5 in a sachet.
Pack sizes: 10, 20, 40 or 60 ampoules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne 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
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański