Bromiduo

Package Leaflet: Information for the User

Bromiduo, (0.5 mg + 0.25 mg)/ml, Solution for Nebulisation
Fenoterol Hydrobromide + Ipratropium Bromide

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, 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, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

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

1. What is Bromiduo and what is it used for

Bromiduo 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 bronchoconstriction. Bromiduo is effective shortly after administration and is therefore used for the treatment of acute asthma attacks. The medicine is indicated as a bronchodilator for prophylaxis (prevention) and treatment of symptoms of chronic obstructive pulmonary disease with reversible bronchospasm: asthma, and especially chronic obstructive pulmonary disease (COPD). If the patient has asthma or COPD, the doctor may prescribe an additional anti-inflammatory medication, in accordance with current treatment standards for these diseases.

2. Important information before using Bromiduo

When not to use Bromiduo:

Warnings and precautions

Before starting treatment with Bromiduo, discuss with your doctor or pharmacist:

After using Bromiduo, 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, seek medical attention immediately. Be careful when spraying Bromiduo to avoid getting the medicine in the eyes. It is recommended to use the solution with a mouthpiece. If this is not possible, use a nebuliser mask that fits tightly to the face. If it is necessary to use Bromiduo for long-term treatment of asthma, the doctor will recommend using Bromiduo only for acute symptoms, and not regularly. If it is necessary to take Bromiduo for long-term treatment of mild forms of other conditions with reversible bronchoconstriction, the doctor may recommend using Bromiduo only for acute symptoms and irregularly. The doctor may also decide to prescribe additional medication or higher doses of anti-inflammatory medication. Using Bromiduo may lead to positive results for fenoterol in non-clinical tests, e.g. in the context of improving sports performance (doping).

Bromiduo and other medicines

Tell your doctor about all the medicines you are taking, or have recently taken, and about the medicines you plan to take. Other bronchodilators may enhance the effect of Bromiduo. Concomitant use of other beta-2-adrenergic receptor agonists, anticholinergic agents for oral use, and xanthine derivatives (theophylline) may also enhance side effects. Since the long-term concomitant use of other anticholinergic agents with Bromiduo has not been studied, consult a doctor for advice. Some medicines used to treat high blood pressure (called "beta-adrenolytics") reduce the effect of Bromiduo. The use of beta-2-adrenergic agonists, such as those contained in Bromiduo, with theophylline, corticosteroids, or diuretics (which increase urine production) may cause a decrease in potassium levels, especially in severe asthma. Decreased potassium levels make the patient prone to irregular heartbeat, especially if digoxin is used 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, caution should be exercised when using beta-2-adrenergic receptor agonists, as their effect may be enhanced. The inhalation of halogenated anaesthetics, 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, 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, Bromiduo should only be used if prescribed by a doctor. This is especially true for the first trimester and immediately before delivery (Bromiduo 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, Bromiduo should only be used during pregnancy and breastfeeding if prescribed by a doctor.

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 Bromiduo, side effects such as dizziness, muscle tremors, accommodation disorders (vision disturbances), pupil dilation, and blurred vision may occur. If the patient experiences any of these side effects, they should avoid performing potentially hazardous activities, such as driving or operating machinery.

Bromiduo contains benzalkonium chloride

The medicine contains 0.04 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 Bromiduo

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. When starting treatment and during treatment, patients should be under medical supervision, e.g. in a hospital. The doctor may, however, decide on treatment at home in certain cases. Dose adjustment depends on the doctor's decision, who will adjust it to the individual needs of the patient. Treatment should always start with the lowest recommended dose. Administration should be stopped after sufficient relief of symptoms has been achieved. The recommended dose is: Adults (including elderly patients) and adolescents over 12 years: 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 from 6 to 12 years: 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 (with a body weight of less than 22 kg): Bromiduo 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 The solution for nebulisation should be used with the following rules: The solution for nebulisation should be administered by inhalation using nebulisers. Do not take orally. The medicine can be administered using various nebulisers available on the market. Patients should follow the manufacturer's instructions for the proper use, storage, and maintenance of the nebuliser. If a wall oxygen installation is available, a flow rate of 6-8 litres 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 nebuliser and the efficiency of the device. 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 the solution is completely used up. The medicine should not be diluted with distilled water. The solution for nebulisation should be diluted before each use, and any remaining, undiluted solution should be discarded. A new diluted solution for nebulisation should be prepared each time. The diluted solution should be used immediately after preparation. If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Using a higher than recommended dose of Bromiduo

If you use more Bromiduo than you should, consult a doctor or pharmacist. Symptoms of overdose are mainly related to the effect of fenoterol. Potential symptoms of overdose due to excessive beta-adrenergic stimulation include: tachycardia, palpitations, tremors, increased or decreased blood pressure, increased difference between systolic and diastolic blood pressure, angina pectoris (chest pain), arrhythmias, flushing. Metabolic acidosis and hypokalaemia have also been observed during the use of fenoterol in doses higher than recommended for the approved indications of Bromiduo. Potential symptoms of ipratropium bromide overdose (such as dryness of the oral mucosa, accommodation disorders) are mild, as the systemic bioavailability of inhaled ipratropium is very low.

Forgetting to use Bromiduo

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

Stopping the use of Bromiduo

If you stop using Bromiduo, breathing problems may recur or worsen. Therefore, use Bromiduo for as long as your doctor recommends. Before stopping the use of Bromiduo, consult a doctor. 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. After using Bromiduo, 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, seek medical attention immediately. As with other inhaled medicines, Bromiduo may cause local irritation. The most common side effects reported during clinical trials are: cough, dryness of the mouth, headache, muscle tremors, pharyngitis, nausea, dizziness, dysphonia (voice disorders), tachycardia (rapid heart rate), palpitations, vomiting, increased systolic blood pressure, and nervousness. Frequent (may affect up to 1 in 10 people)

• Cough Uncommon (may affect up to 1 in 100 people)
• rapid heartbeat
• accelerated pulse
• palpitations
• increased systolic blood pressure
• muscle tremors
• nervousness
• headache
• dizziness
• local irritation, such as pharyngitis
• voice disorders
• dryness of the mouth
• nausea
• vomiting

Rare (may affect up to 1 in 1,000 people)

• life-threatening allergic reactions (anaphylactic)
• hypersensitivity (allergic reactions)
• decreased 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 pressure in the eyeball (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)
• pharyngitis
• 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)
• dryness of the throat
• stomatitis
• glossitis
• diarrhoea associated with gastrointestinal motility disorders
• constipation
• swelling in the mouth
• skin rash
• urticaria
• pruritus
• angioedema (rapidly progressing swelling of the skin or mucous membranes that can cause breathing difficulties)
• excessive sweating
• muscle pain
• muscle cramps
• muscle weakness
• urinary retention

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse. 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.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorisation holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bromiduo

Keep this medicine out of the sight and reach of children. There are no special precautions for storage. 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 stated. Shelf life after first opening the bottle: 1 year. 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 pack and other information

What Bromiduo contains

• The active substances of the medicine are: fenoterol hydrobromide and ipratropium bromide. 1 ml (20 drops) of the solution for nebulisation 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 (E 386), sodium chloride, hydrochloric acid 1M solution, purified water.

What Bromiduo looks like and contents of the pack

Bottle made of orange glass type III with a HDPE screw cap, with a protective device and a dropper made of LDPE, placed in a cardboard box. Pack size: 25 ml.

Marketing authorisation holder

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów tel.: +48 22 732 77 00

Importer:

Adamed Pharma S.A. ul. Marszałka Józefa Piłsudskiego 5 95-200 Pabianice "Nord Farm" Sp. z o.o. Al. Piłsudskiego 141 92-318 Łódź

Date of last revision of the leaflet:

Information intended for healthcare professionals only:

Overdose

SymptomsSymptoms of overdose are mainly related to the effect of fenoterol. Potential symptoms of overdose due to excessive beta-adrenergic stimulation include: tachycardia, palpitations, tremors, increased or decreased blood pressure, increased difference between systolic and diastolic blood pressure, angina pectoris (chest pain), arrhythmias, flushing. Metabolic acidosis and hypokalaemia have also been observed during the use of fenoterol in doses higher than recommended for the approved indications of Bromiduo. Potential symptoms of ipratropium bromide overdose (such as dryness of the oral mucosa, accommodation disorders) are mild, as the systemic bioavailability of inhaled ipratropium is very low. TreatmentDiscontinue treatment with Bromiduo. Consider monitoring acid-base balance and electrolytes. Administer sedatives, in severe cases intensive therapy. As specific antidotes, beta-adrenergic receptor blockers can be used, preferably beta1-selective, but beware of the possible decrease in bronchodilation and carefully adjust the dose in patients with asthma or COPD, due to the risk of severe bronchospasm, which can be fatal.