Berodual N 50 mcg/21 mcg per dose inhaler – fenoterol and ipratropium for asthma and chronic obstructive bronchitis
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- Stock: Zabrana online prodaje
- Brand: OSTALO
- Model: BR-60516654102
Berodual N is an inhaled medicine containing two active substances that widen the airways: fenoterol (a selective beta-2 adrenergic receptor agonist) and ipratropium bromide (an anticholinergic). The two substances act through different mechanisms and work quickly, so the medicine is also suitable for relieving acute asthma attacks.
This page refers to Berodual N pressurised inhalation solution (metered-dose inhaler) – 50 micrograms of fenoterol hydrobromide and 21 micrograms of ipratropium bromide per actuation, 200 doses per inhaler. In Serbia it is available on prescription. Berodual nebuliser solution has different doses – never transfer the dosage from one form to the other.
Important warning
- Supply status in Serbia: prescription-only medicine.
- If an asthma attack does not settle after four puffs, or your breathing suddenly gets worse, see a doctor or go to the nearest hospital immediately.
- Do not increase the prescribed dose yourself – a maximum of 8 puffs a day; overuse can cause serious side effects.
- Do not let the medicine get into your eyes (risk of raised eye pressure and angle-closure glaucoma).
- Read the package leaflet before use. This page is for information only and is not an offer to buy the medicine online.
What is the Berodual N inhaler used for and how should it be used correctly?
Key facts about the medicine
| Medicine name | Berodual® N, 50 micrograms/dose + 21 micrograms/dose, pressurised inhalation solution |
|---|---|
| Active substances | fenoterol hydrobromide and ipratropium bromide monohydrate |
| Strength | 50 micrograms fenoterol hydrobromide + 21 micrograms ipratropium bromide monohydrate per actuation |
| Pharmaceutical form | pressurised inhalation solution (metered-dose inhaler) |
| Therapeutic group | drugs for obstructive airway diseases – adrenergics in combination with anticholinergics (ATC R03AL01) |
| Pack | one pressurised inhaler containing 10 mL of solution (200 doses) |
| Marketing authorisation holder | BOEHRINGER INGELHEIM SERBIA D.O.O. BEOGRAD |
| Manufacturer | Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany |
| ALIMS licence number | 000457669 2023 of 03.06.2024 |
| Supply status | prescription-only medicine |
What is Berodual N used for?
According to the official leaflet, Berodual N is used for the prevention and bronchodilator treatment (widening of the airways) of conditions with reversible narrowing of the airways, such as:
- bronchial asthma, including relief of acute attacks;
- chronic obstructive bronchitis.
If regular use is needed, your doctor may also prescribe an anti-inflammatory medicine.
How is it used and dosed?
The medicine is for inhalation only. Your doctor will adjust the dose; unless prescribed otherwise, the leaflet gives the following doses for adults and children over 6 years:
- Acute asthma attack: 2 puffs. If breathing does not noticeably improve within 5 minutes, a further 2 puffs may be taken. If the attack does not settle after 4 puffs, contact a doctor or the nearest hospital immediately.
- Long-term treatment: 1–2 puffs per use, no more than 8 puffs a day (on average 1–2 puffs 3 times a day), with at least 3 hours between inhalations.
- In asthma the inhaler is used only during acute attacks (as needed), not regularly.
- Children: only on medical advice and under adult supervision.
Before first use, remove the protective cap and press the valve twice; if the inhaler has not been used for more than three days, actuate the valve once. Breathe out deeply, close your lips around the mouthpiece (arrow on the base of the canister pointing upwards), breathe in deeply while pressing the canister, hold your breath for a few seconds and then breathe out. The mouthpiece is designed only for Berodual N – do not use it with other inhalers. Rinse the mouthpiece with warm water at least once a week and let it air-dry. The canister is not transparent; shaking it shows whether liquid remains, and after 200 doses the inhaler should be replaced.
Special patient groups
- Children over 6 years: use only on medical advice and under adult supervision.
- Kidney or liver impairment: caution is needed – tell your doctor before starting.
- Diabetes: blood sugar may rise, so it should be checked more often.
- Cystic fibrosis: gut motility disorders may occur.
Contraindications – when the medicine must not be used
- allergy to fenoterol hydrobromide, ipratropium bromide, atropine-like substances or any of the excipients;
- hypertrophic obstructive cardiomyopathy (a heart muscle disease);
- tachyarrhythmia (fast, irregular heartbeat).
Warnings and precautions
- Like other inhaled medicines, Berodual N can cause paradoxical bronchospasm (sudden narrowing of the airways) – stop using it and contact a doctor immediately.
- Special care is needed with: poorly controlled diabetes, recent heart attack, myocarditis, severe heart and blood vessel disease (ischaemic heart disease, arrhythmias, severe heart failure), phaeochromocytoma, overactive thyroid, a tendency to angle-closure glaucoma, difficulty passing urine (e.g. enlarged prostate), kidney or liver failure.
- Chest pain or difficulty breathing require urgent medical assessment – they may signal heart or airway disease.
- High doses can cause a sudden fall in blood potassium (signs: loss of appetite, constipation, swollen legs, irregular pulse, muscle weakness).
- If symptoms do not improve or get worse, your doctor should review your treatment; do not increase the dose on your own.
- Use of the medicine may give a positive result for fenoterol in doping tests.
- The medicine contains 14 mg of alcohol (ethanol) per actuation – an amount that has no noticeable effects.
Interactions with other medicines
Tell your doctor or pharmacist about all the medicines you take, especially:
- other airway-widening medicines (beta-2 agonists, oral anticholinergics, theophylline) – they may increase the effect and side effects; long-term use with other anticholinergics is not recommended;
- beta-blockers (medicines for blood pressure and the heart) – they may weaken the effect of Berodual N;
- theophylline, corticosteroids and diuretics – together with the medicine they may lower blood potassium; the risk of rhythm disorders is higher with digoxin;
- MAO inhibitors and tricyclic antidepressants – the effect of beta-2 agonists may be increased;
- inhaled anaesthetics (halothane, trichloroethylene, enflurane) – greater sensitivity of the heart to rhythm disorders.
Pregnancy and breast-feeding
There is no evidence of harmful effects of fenoterol and ipratropium on pregnancy, but the usual precautions apply – consult your doctor before use. Fenoterol can slow uterine contractions, and use at the end of pregnancy or in high doses may cause trembling, a fast heartbeat, blood sugar changes and low potassium in the newborn. Fenoterol passes into breast milk, so caution is needed in breast-feeding women.
Driving and using machines
No studies have been performed, but dizziness, tremor, accommodation disorder, dilated pupils and blurred vision may occur. If you notice these effects, do not drive or operate machinery.
Possible side effects
- Common (up to 1 in 10): cough.
- Uncommon (up to 1 in 100): nervousness, headache, tremor, dizziness, fast heartbeat, palpitations, sore throat (pharyngitis), hoarseness, nausea, vomiting, dry mouth, increased systolic blood pressure.
- Rare (up to 1 in 1,000): allergic reactions including anaphylaxis, low potassium, agitation, raised eye pressure and glaucoma, blurred vision, eye pain, irregular heartbeat and atrial fibrillation, paradoxical narrowing of the airways, throat swelling, dry throat, diarrhoea, constipation, rash, hives, sweating, muscle cramps, urinary retention, low platelet count.
- Very rare: increased blood sugar; frequency not known: hyperactivity.
Report any suspected side effect to your doctor, pharmacist or ALIMS.
Overdose, missed dose and stopping treatment
- Overdose: contact a doctor immediately. Flushing, dizziness, headache, fast or irregular heartbeat, a fall or rise in blood pressure, restlessness, chest pain, marked tremor, raised blood sugar and low potassium may occur.
- Missed dose (with regular use): take it as soon as you remember and the next one at the usual time – do not take a double dose. In asthma the medicine is used only during attacks.
- Stopping: breathing problems may return or worsen – stop treatment only after talking to your doctor.
When to seek medical help immediately?
- an asthma attack that does not settle after 4 puffs, or a sudden worsening of breathing
- sudden choking or wheezing immediately after a puff (paradoxical bronchospasm)
- chest pain, strong palpitations or an irregular heartbeat
- swelling of the face, lips, tongue or throat, hives or difficulty swallowing (allergic reaction)
- eye pain, blurred vision or haloes around lights with red eyes
Pharmacist's advice
The most common mistake is poor inhaler technique: breathe out before inhaling, press the canister just as you start to breathe in and hold your breath for a few seconds. Make sure the spray does not get into your eyes.
If you need the inhaler more and more often, this is a sign that the disease is not under control – see your doctor instead of increasing the number of puffs yourself. Note how many puffs you use each day and bring this record to your check-up.
Availability and price
Berodual N is a prescription-only medicine and, under the regulations of the Republic of Serbia, cannot be ordered online. This page is for information only.
To check availability and dispensing conditions, please contact a pharmacy.
Related information
For additional care and support with asthma and airway problems, see also the Inhalers category – products in this category do not replace the medicine you have been prescribed.
Composition, pack and manufacturer
- Active substances: 50 micrograms fenoterol hydrobromide and 21 micrograms ipratropium bromide monohydrate per actuation.
- Excipients: anhydrous citric acid; purified water; anhydrous ethanol 99%; propellant norflurane.
- Appearance: clear, colourless to slightly yellowish or slightly brownish solution in a stainless-steel canister with a metering valve, mouthpiece and light-grey cap.
- Pack: carton containing one inhaler (10 mL, 200 doses).
- Marketing authorisation holder: Boehringer Ingelheim Serbia d.o.o. Beograd, Milentija Popovića 5a, Belgrade. Manufacturer: Boehringer Ingelheim Pharma GmbH & Co. KG, Germany.
Storage
- Store below 25 °C, protected from direct sunlight and freezing; do not expose to temperatures above 50 °C.
- The canister is pressurised – it must not be forced open.
- Shelf life: 3 years. Keep out of the sight and reach of children.
- Do not throw the inhaler into household waste or drains – return it to a pharmacy.
Frequently asked questions
How many puffs of Berodual N may I use per day?
The leaflet states a maximum of 8 puffs a day in long-term treatment, at least 3 hours apart. In an asthma attack 2 puffs are used, and another 2 after 5 minutes if there is no improvement; if there is no relief even after 4 puffs, emergency help is needed.
Can I use Berodual N every day for asthma?
In asthma the Berodual N inhaler is used only during acute attacks. If you need it regularly, your doctor should review your treatment and, if necessary, start or increase an anti-inflammatory medicine.
How do I know when the inhaler is empty?
The canister is not transparent. Shake it to check whether liquid remains; the inhaler contains 200 doses and should then be replaced, even if a little solution is left.
What is the difference between Berodual N and Berodual nebuliser solution?
Berodual N is a pressurised metered-dose inhaler, while Berodual nebuliser solution is diluted and given with a nebuliser and has completely different dosing. Your doctor decides on the form and dose.
Sources
- ALIMS – Summary of Product Characteristics, Berodual® N, 50 mcg/dose + 21 mcg/dose, pressurised inhalation solution (Serbian)
- ALIMS – Package leaflet, Berodual® N (August 2024, Serbian)
Date sources were checked: 24.10.2026.
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