Berodual

Leaflet attached to the packaging: information for the user

Berodual, (0.5 mg + 0.25 mg)/ml, solution for nebulization
Fenoterol hydrobromide + Ipratropium bromide

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 you need to.
• If you have any further questions, you should 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 experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Berodual and what is it used for

Berodual contains two active substances, fenoterol, which belongs to a group of substances called "selective beta-2-adrenergic receptor agonists" and ipratropium bromide, which belongs to a group of substances called "anticholinergic agents". The different mechanisms of bronchodilation of the two substances make them suitable for the treatment of asthma and other inflammatory conditions associated with reversible bronchospasm. Berodual is effective shortly after administration and is therefore used for the treatment of acute asthma attacks. The medicine is indicated as a bronchodilator in the prevention (prevention) and treatment of symptoms of chronic obstructive pulmonary disease with reversible bronchospasm: asthma, and in particular chronic bronchitis. If the patient has asthma or chronic obstructive pulmonary disease (COPD), the doctor may prescribe an additional anti-inflammatory medication, in accordance with current treatment standards for these diseases.

2. Important information before using Berodual

When not to use Berodual:

• if the patient is allergic to fenoterol hydrobromide, ipratropium bromide, atropine-like substances or any of the other ingredients of this medicine (listed in section 6).
• if the patient has tachyarrhythmia (heart rhythm disorders with accelerated heart activity).
• if the patient has a heart condition called hypertrophic obstructive cardiomyopathy.

Warnings and precautions

Before starting treatment with Berodual, you should discuss it with your doctor or pharmacist:

• in case of sudden bronchospasm after inhalation: you should stop using Berodual immediately and consult a doctor who will look for alternative treatment.
• in case of acute, rapidly worsening shortness of breath, the patient should contact a doctor immediately.
• if the patient has narrow-angle glaucoma (increased pressure in the eye): during inhalation, you should protect your eyes.
• if the patient notices vision disturbances, such as eye pain or discomfort, blurred vision, halos (rings) or colored images with eye redness, you should consult an ophthalmologist immediately, as these symptoms may be related to complications (dilated pupils, increased intraocular pressure, narrow-angle glaucoma).
• if the patient has recently had a myocardial infarction (heart attack).
• if the patient has diabetes.
• if the patient has heart or vascular disorders.
• if the patient has severe heart disease: you should consult a doctor immediately in case of chest pain or other symptoms of worsening heart disease.
• if the patient experiences symptoms such as difficulty breathing or chest pain: you should consult a doctor immediately for evaluation, as these symptoms may indicate both respiratory and heart diseases.
• if the patient has a pheochromocytoma (a type of adrenal gland tumor).
• if the patient has hyperthyroidism (overactive thyroid).
• if the patient has had urinary retention in the past or if it is suspected.
• if the patient notices loss of appetite, constipation, water retention or swelling of the legs, irregular pulse or muscle weakness: these may be signs of low potassium levels. Special precautions may be necessary (e.g. blood tests).
• if the patient has cystic fibrosis: gastrointestinal motility disorders may occur.
• if breathing problems persist or worsen: you should consult a doctor, as it is necessary to check the treatment being administered. It may be necessary to add other medications to the treatment. Never increase the prescribed dose, as this can lead to serious side effects.
• if the patient is using other medicines belonging to the group of "selective beta-2-adrenergic receptor agonists"; you should use these medicines only under the strict supervision of a doctor (see section "Berodual and other medicines").

After using Berodual, immediate hypersensitivity reactions may occur, such as: rare cases of urticaria, angioedema (sudden swelling of the throat, skin and mucous membranes of the mouth and throat that can make breathing difficult), rash, bronchospasm, swelling of the mouth and throat, and rapidly progressing, life-threatening allergic reactions. If these symptoms occur, you should immediately consult a doctor or go to the hospital. You should be particularly careful when spraying Berodual, so that the medicine does not get into the eyes. It is recommended to use the solution through a mouthpiece. If this is not possible, a nebulizer mask should be used, which fits tightly to the face. If it is necessary to use Berodual for long-term treatment of asthma, the doctor will recommend using Berodual only in case of acute symptoms, and not regularly. If it is necessary to take Berodual for long-term treatment of mild forms of other conditions with reversible bronchospasm, the doctor may recommend using Berodual only in case of acute symptoms and irregularly. The doctor may also decide to prescribe additional medication or higher doses of anti-inflammatory medication. Using Berodual may lead to positive results for fenoterol in non-clinical tests, e.g. in the context of improving sports performance (doping).

Berodual and other medicines

You should tell your doctor about all medicines you are currently taking, or have recently taken, as well as any medicines you plan to take. Other bronchodilators may enhance the effect of Berodual. Concomitant use of other beta-2-adrenergic receptor agonists, oral anticholinergic agents, and xanthine derivatives (theophylline) may also enhance side effects. Since the long-term concomitant use of other anticholinergic agents with Berodual has not been studied, you should consult a doctor for advice. Some medicines used to treat high blood pressure (so-called "beta-adrenolytics") reduce the effect of Berodual. The use of beta-2-adrenergic agonists, such as those contained in Berodual, together with theophylline, corticosteroids, or diuretics (which increase urine production), may cause a decrease in potassium levels, especially in severe asthma. Low potassium levels make the patient prone to irregular heartbeat, especially if they are taking digoxin or if the patient's blood has too little oxygen. In this situation, the doctor may decide to take special precautions (e.g. blood tests). It is important for the doctor to know if the patient is taking antidepressant medicines (monoamine oxidase inhibitors or tricyclic antidepressants). In such cases, you should be careful when using beta-2-adrenergic receptor agonists, as their effect may be enhanced. The inhalation of halogenated anesthetic agents, such as halothane, trichloroethylene, and enflurane, may enhance the effect of beta-2-adrenergic receptor agonists on the cardiovascular system (i.e. may cause irregular heartbeat).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before using this medicine. Although non-clinical studies for fenoterol hydrobromide or ipratropium bromide and human data did not show a risk to the unborn child, Berodual should only be used if your doctor considers it necessary. This is especially true during the first trimester and immediately before delivery (Berodual has a tocolytic effect on the uterus). Non-clinical studies have shown that fenoterol hydrobromide passes into breast milk. It is not known whether ipratropium bromide passes into breast milk. Therefore, Berodual should only be used during pregnancy and breastfeeding if your doctor has explicitly recommended it.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines. During treatment with Berodual, side effects such as dizziness, muscle tremors, accommodation disorders (vision disturbances), pupil dilation, and blurred vision may occur. Therefore, you should be careful when driving a car or operating machines. If you experience any of the above side effects, you should avoid performing potentially hazardous activities, such as driving or operating machines.

Berodual contains benzalkonium chloride

The medicine contains 0.1 mg of benzalkonium chloride per ml. Benzalkonium chloride may cause wheezing (whistling breathing) or respiratory disorders (bronchospasm), especially in patients with asthma.

3. How to use Berodual

This medicine should always be used as directed by your doctor. If you are unsure, you should ask your doctor or pharmacist. When starting treatment and during treatment, patients should be under medical supervision, e.g. in a hospital setting. The doctor may, however, decide on treatment at home in certain circumstances. The dosage adjustment depends on the doctor's decision, who will adjust it to the individual needs of the patient. Treatment should always be started with the lowest recommended dose. Administration should be stopped after achieving sufficient relief of symptoms. The following dosages are recommended: Adults (including elderly patients) and adolescents over 12 years of age: Treatment of acute asthma attacks: Depending on the severity of the acute attack, the doctor will decide on the appropriate dose, which may range from 1 ml (20 drops) to 2.5 ml (50 drops). In particularly severe cases, e.g. under medical supervision in the emergency department of a hospital, doses of up to 4 ml (80 drops) may be used. Children between 6 and 12 years of age: Treatment of acute asthma attacks: Depending on the severity of the acute attack, the doctor will decide on the appropriate dose, which may range from 0.5 ml (10 drops) to 2 ml (40 drops). Children under 6 years of age (with a body weight of less than 22 kg): Berodual should only be administered under medical supervision: the doctor will adjust the dose according to the child's body weight, 0.1 ml (2 drops) per kg of body weight, up to a maximum of 0.5 ml (10 drops). Method of administration Berodual solution for nebulization should be used in accordance with the following rules: The solution for nebulization should be administered by inhalation using nebulizers. Do not take orally. The medicine can be administered using various nebulizers available on the market. Patients should follow the manufacturer's instructions for proper use, storage, and maintenance of the nebulizer. If a wall-mounted oxygen installation is available, a flow rate of 6-8 liters per minute should be used. The dose delivered to the lungs and the amount of medicine absorbed into the blood may depend on the type of nebulizer and the efficiency of the device, and may be higher than with Berodual N inhalation aerosol, solution. The inhalation time can be adjusted by the volume of the solution. The recommended dose should be diluted with 0.9% sodium chloride solution to a volume of 3 to 4 ml and inhaled until sufficient relief of symptoms is achieved. The medicine should not be diluted with distilled water. The solution for nebulization should be diluted before each use, and any remaining, unused diluted solution should be discarded. A new diluted solution for nebulization should be prepared each time before use. The diluted solution should be used immediately after preparation. If you feel that the effect of the medicine is too strong or too weak, you should consult your doctor.

Using a higher than recommended dose of Berodual

In case of using a higher than recommended dose of Berodual, you should consult a doctor or pharmacist. Symptoms of overdose are mainly related to the effect of fenoterol hydrobromide and include: tachycardia (accelerated heart activity), palpitations, tremors, increased or decreased blood pressure, increased difference between systolic and diastolic blood pressure, angina pectoris (chest pain), arrhythmias, flushing. Metabolic acidosis (disturbances of acid-base balance in the body) and hypokalemia (decreased potassium levels in the blood) have also been observed during the use of fenoterol in doses higher than recommended for the approved indications of Berodual. Potential symptoms of overdose of ipratropium bromide (such as dryness of the oral mucosa, accommodation disorders) are mild.

Missing a dose of Berodual

If you have been prescribed Berodual for regular use and you miss a dose, you should take it as soon as possible, but do not take a double dose to make up for the missed dose. Then you should take the next dose at the usual time. If you have asthma, you should only use Berodual during acute attacks.

Stopping treatment with Berodual

If you stop using Berodual, breathing problems may recur or worsen. Therefore, you should use Berodual for as long as your doctor recommends. Before stopping treatment with Berodual, you should always consult your doctor. If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Berodual can cause side effects, although not everybody gets them. After using Berodual, immediate hypersensitivity reactions may occur, such as: rare cases of urticaria, angioedema (sudden swelling of the throat, skin and mucous membranes of the mouth and throat that can make breathing difficult), rash, bronchospasm, swelling of the mouth and throat, and rapidly progressing, life-threatening allergic reactions. If these symptoms occur, you should immediately consult a doctor or go to the hospital. Like other inhaled medicines, Berodual may cause local irritation. The most common side effects reported during clinical trials are cough, dry mouth, headache, muscle tremors, pharyngitis, nausea, dizziness, dysphonia (voice disorders), tachycardia (accelerated heart activity), palpitations, vomiting, increased systolic blood pressure, and nervousness.

• cough

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

• rapid heartbeat
• accelerated pulse
• palpitations
• increased systolic blood pressure
• muscle tremors
• nervousness
• headache
• dizziness
• local irritation, such as pharyngitis
• voice disorders
• dry mouth
• nausea
• vomiting

Rare (may occur in less than 1 in 1000 people)

• life-threatening allergic reactions (anaphylactic reactions)
• hypersensitivity (allergic reactions)
• low potassium levels
• irregular heartbeat
• atrial fibrillation (very rapid irregular heart rhythm)
• supraventricular tachycardia (abnormal rapid heart rhythm)
• insufficient blood flow to the heart muscle
• decreased diastolic blood pressure
• excitement
• psychiatric disorders
• increased eye pressure (glaucoma)
• increased intraocular pressure
• accommodation disorders
• pupil dilation
• blurred vision
• eye pain
• redness of the white part of the eye
• swelling of the outer protective layer of the eye
• halo vision (ring)
• throat irritation
• bronchospasm
• swelling of the throat (swelling of the upper part of the throat)
• sudden spasm of the vocal cords (may affect breathing and speech)
• paradoxical bronchospasm (inhalation-induced bronchospasm)
• dry throat
• stomatitis (inflammation of the oral mucosa)
• glossitis (inflammation of the tongue)
• diarrhea associated with gastrointestinal motility disorders
• constipation
• swelling in the mouth
• skin rash
• urticaria
• pruritus
• angioedema (rapidly progressing swelling of the skin or mucous membranes, which can cause breathing difficulties)
• excessive sweating
• muscle pain
• muscle spasms
• muscle weakness
• urinary retention

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 Berodual

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Store in the original packaging (cardboard box) to protect from light. Do not use this medicine after the expiry date stated on the packaging after: EXP. The expiry date refers to the last day of the month. Shelf life after first opening the bottle: 1 year. 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 needed. This will help protect the environment.

6. Contents of the packaging and other information

What Berodual contains

• The active substances of the medicine are: fenoterol hydrobromide and ipratropium bromide. 1 ml (20 drops) of the solution for nebulization contains 0.5 mg of fenoterol hydrobromide and 0.25 mg of ipratropium bromide.
• The other ingredients of the medicine are: benzalkonium chloride, disodium edetate dihydrate, sodium chloride, hydrochloric acid 1N, purified water.

What Berodual looks like and what the packaging contains

Packaging: a brown glass bottle type III, placed in a cardboard box. The bottle is equipped with a dropper and closed with a plastic cap. Packaging size: 20 ml.

Marketing authorization holder

Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim/Rhein Germany

Manufacturer

ISTITUTO DE ANGELI S.R.L Localita Prulli, 103/C-50066 Reggello (FI) Italy For more detailed information about this medicine, you should contact the local representative of the marketing authorization holder: Poland Boehringer Ingelheim Sp. z o.o. Tel.: +48 22 699 0 699

Date of last revision of the leaflet:

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Information intended only for healthcare professionals:

Overdose

SymptomsSymptoms of overdose are mainly related to the effect of fenoterol. Potential symptoms of overdose due to excessive beta-adrenergic stimulation are, in particular: tachycardia, palpitations, muscle tremors, increased or decreased blood pressure, increased difference between systolic and diastolic blood pressure, angina pectoris, arrhythmias, flushing. Metabolic acidosis and hypokalemia have also been observed during the use of fenoterol in doses higher than recommended for the approved indications of Berodual. Potential symptoms of overdose of ipratropium bromide (such as dryness of the oral mucosa, accommodation disorders) are mild, as the systemic bioavailability of inhaled ipratropium is very low. TreatmentYou should stop treatment with Berodual. You should consider monitoring acid-base balance and electrolytes. Administration of sedatives may be necessary, and in severe cases, intensive therapy may be required. As specific antidotes, beta-adrenergic receptor blockers can be used, preferably beta-selective ones, but keeping in mind the possible decrease in bronchodilation and carefully adjusting the dose in patients with asthma or chronic obstructive pulmonary disease due to the risk of severe bronchospasm, which can be fatal.