Berotec n 100

Package leaflet: Information for the patient

Berotec N 100, 100 micrograms/dose, inhalation aerosol, solution
Fenoteroli hydrobromidum
Please read all of this leaflet carefully before using the medicine, because 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. The medicine may harm another person, 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 is Berotec N 100 and what is it used for
2. Important information before using Berotec N 100
3. How to use Berotec N 100
4. Possible side effects
5. How to store Berotec N 100
6. Contents of the pack and other information

1. What is Berotec N 100 and what is it used for

Berotec N 100 contains fenoterol, which belongs to a group of medicines called selective beta-adrenergic receptor agonists. It works by dilating the airways and is therefore used in the treatment of asthma attacks and other conditions associated with reversible bronchoconstriction.
The effect of Berotec N 100 occurs immediately after inhalation, so it can be used in the treatment of acute asthma attacks.
Berotec N 100 is used to dilate the airways in the treatment of acute asthma attacks and conditions with reversible airway narrowing, particularly in chronic obstructive bronchitis, as well as in preventing exercise-induced asthma attacks.
If you suffer from steroid-responsive asthma, your doctor may additionally prescribe anti-inflammatory medicines.

2. Information before using Berotec N 100

When not to use Berotec N 100:
if the patient is allergic to fenoterol hydrobromide or any of the other
ingredients of this medicine (listed in section 6),
if the patient has heart rhythm disorders associated with rapid heart rate,
if the patient has a heart disease called obstructive hypertrophic cardiomyopathy.

Warnings and precautions
Before starting treatment with Berotec N 100, consult your doctor or pharmacist
if:
the patient has recently had a myocardial infarction (heart attack);
the patient has diabetes;
the patient has cardiovascular disorders;
the patient with severe heart disease develops or has chest pain or other
symptoms indicating worsening of heart disease; in such case, contact your doctor immediately;
the patient has a phaeochromocytoma (a type of adrenal gland tumour);
the patient has hyperthyroidism;
the patient is taking other medicines from the group of sympathomimetics; use of these medicines is possible
only under strict medical supervision. Other bronchodilators belonging to the group of
anticholinergics (e.g. tiotropium, ipratropium) may be used at the same time.

If any of the following situations occur, contact your doctor immediately:

• inhalation causes narrowing of the airways; in this case, stop using Berotec N 100 immediately, as continued use may be life-threatening. Your doctor will recommend alternative treatment.
• symptoms such as difficulty breathing or chest pain occur; consult your doctor to determine whether they are due to heart or respiratory disease.
• symptoms such as loss of appetite, constipation, fluid retention or leg swelling, irregular heartbeat, or muscle weakness occur. These may result from decreased potassium levels in the blood, especially if Berotec N 100 is used concomitantly with theophylline, corticosteroids, or diuretics. Low blood potassium levels may increase the risk of heart rhythm disturbances in patients treated with digoxin, as well as in patients with low blood oxygen levels. As a precaution, appropriate tests (e.g. blood tests) may be necessary.
• acute, rapidly worsening shortness of breath occurs.
• breathing difficulties do not improve or worsen. Contact your doctor to reassess the current treatment plan. Your doctor may consider adding further medications. Never use a higher dose than prescribed, as this may lead to serious adverse effects.

If prolonged use of Berotec N 100 is required, your doctor will provide detailed instructions on its use, as Berotec N 100 is usually intended for treatment of acute symptoms and is not recommended for regular, long-term use. Your doctor may also decide to prescribe additional anti-inflammatory medications or increase their doses.
Use of Berotec N 100 may lead to positive test results for fenoterol in doping tests, e.g. in athletes aiming to enhance performance.

Berotec N 100 and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to use.
Other bronchodilator medicines may enhance the effect of Berotec N 100.
Concomitant use of other beta-adrenergic receptor stimulants, oral anticholinergic drugs, and xanthine derivatives (e.g. theophylline) may also increase the frequency of adverse effects.
Use of Berotec N 100 together with other medicines such as theophylline, corticosteroids, or diuretics may further reduce potassium levels in the blood – see section "Warnings and precautions".
Some medicines used to treat high blood pressure (called beta-blockers) may reduce the effect of Berotec N 100.
Inform your doctor if the patient is taking certain antidepressants (monoamine oxidase inhibitors (MAO inhibitors) or tricyclic antidepressants). Exercise caution when using such medicines, as they may enhance the effect of Berotec N 100.
Inhalation of halogenated general anaesthetics such as halothane, trichloroethylene, and enflurane may enhance the effect of Berotec N 100 (e.g. may cause irregular heartbeat).

Pregnancy, breastfeeding and fertility
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.
Non-clinical studies and human experience have not provided evidence of harmful effects of fenoterol hydrobromide during pregnancy. However, Berotec N 100 should be used during pregnancy only if considered necessary by the doctor. This is particularly important during the first trimester of pregnancy and immediately before delivery (Berotec N 100 inhibits uterine contractions).
Non-clinical studies have shown that fenoterol hydrobromide passes into breast milk. Therefore, Berotec N 100 should be used during breastfeeding only if considered necessary by the doctor.

Driving and using machines
No studies on the effect of the medicine on the ability to drive or operate machinery have been conducted. However, adverse effects such as dizziness may occur during treatment. Therefore, if any of the above-mentioned adverse effects occur, the patient should avoid potentially hazardous activities such as driving or operating machinery.

This medicine contains ethanol and sodium
This medicine contains 15.597 mg of alcohol (ethanol) per spray. The amount of alcohol in each spray of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce noticeable effects.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Berotec N 100

This medicine should always be used exactly as your doctor has instructed. If in doubt, consult your
doctor or pharmacist.
Berotec N 100 should generally be used on an as-needed basis, rather than regularly.
Seek immediate medical help if asthma symptoms (coughing, shortness of breath, wheezing or chest
tightness) worsen, or if breathlessness prevents speaking, eating or sleeping.
Using Berotec N 100 more than twice a week to treat asthma symptoms, apart from preventive use
before physical exertion, indicates poorly controlled asthma and increases the risk of severe asthma
attacks (asthma exacerbation), which may lead to serious complications and may be life-threatening
or even fatal. Contact your doctor as soon as possible to review your asthma treatment.
If you are taking daily medication for lung inflammation, such as an inhaled corticosteroid, it is
important to continue using it regularly, even if you feel better.
Recommended dose
Your doctor will adjust the dosage individually for each patient. Unless otherwise advised, the
following doses apply to adults and children over 6 years of age:
a) Symptomatic treatment of acute asthma attacks and other conditions with reversible airway
obstruction
One dose (one puff) of the aerosol is usually sufficient to relieve symptoms in most cases. In more
severe cases, if there is no significant improvement in breathing after 5 minutes, an additional dose
may be taken, but no more than 8 puffs of aerosol per day.
If the asthma attack does not subside after 2 puffs of aerosol, a greater number of doses may be
required. In such cases, the patient should immediately contact a doctor or go to the nearest hospital.
b) Prevention of exercise-induced asthma attacks
1–2 puffs before physical exertion, up to a maximum of 8 puffs of aerosol per day.
Use in children and adolescents
Berotec N 100 inhalation aerosol should only be used in children on a doctor’s advice and under the
supervision of an adult.
Instructions for use
Berotec N 100 inhalation aerosol should be used as described below.
Before first use, press the canister valve twice.
Each time the product is used, follow these steps:

1. Remove the protective cap.
2. Breathe out deeply.
3. Hold the inhaler as shown in Fig. 1, with lips sealed around the mouthpiece. The arrow on the canister and the base of the canister should be pointing upwards.

(Fig. 1)

4. Breathe in as deeply as possible, while at the same time pressing firmly on the base of the canister to release one metered dose of medicine. Hold your breath for a few seconds, then remove the mouthpiece from your mouth and breathe out. Repeat the same steps (points 2–4) if a second dose is required.
5. Replace the protective cap after use.
6. If the inhaler has not been used for three days, press the valve once before using it again.

The canister is not transparent, so it is not possible to see whether it is empty. A new canister provides
200 sprays, each containing 100 micrograms of fenoterol hydrobromide. After this number of sprays,
a small amount of solution may still remain in the canister. However, the canister should be replaced
with a new one to ensure that each spray delivers the correct dose of medicine.
Always keep the mouthpiece clean and wash it with warm water. If using soap or detergent, rinse the
mouthpiece thoroughly with clean water.
The inhaler mouthpiece should be cleaned at least once a week. It is important to keep the mouthpiece
clean to ensure that medicine does not deposit on its walls and block the inhaler.
To clean the inhaler mouthpiece, first remove the protective cap and take the canister out of the
mouthpiece. Rinse the mouthpiece with warm water until all visible dirt is removed.

(Fig. 2)
After cleaning, shake the mouthpiece dry and leave it to air-dry. Do not use any drying devices. When
the mouthpiece is dry, reinsert the canister into the mouthpiece and replace the protective cap.

(Fig. 3)
WARNING:
The plastic mouthpiece has been specially designed for use with Berotec N 100 inhalation aerosol to
ensure delivery of the correct dose of medicine each time. The mouthpiece must never be used with
any other inhalation aerosol, and conversely, Berotec N 100 inhalation aerosol must not be used with
any mouthpiece other than the one supplied with the product.
The canister is under pressure and must never be opened with force or exposed to temperatures
above 50°C.
Use of more than the recommended dose of Berotec N 100
If more medicine is used than recommended, consult your doctor or pharmacist.
Symptoms of overdose are related to excessive effects on the cardiovascular system. These include
the adverse reactions listed in section 4, particularly: increased heart rate, palpitations (awareness of
strong heartbeats), tremor, changes in blood pressure, decreased diastolic and increased systolic
blood pressure, chest pain, irregular heartbeat and facial flushing. Increased blood acidity
(metabolic acidosis) and decreased blood potassium levels have also been observed during use of
fenoterol at doses higher than recommended for Berotec N 100.
Missed dose of Berotec N 100
Do not use a double dose to make up for a missed dose.
Stopping Berotec N 100
If you stop using Berotec N 100, breathing problems may return or worsen. Therefore, continue using
Berotec N 100 for as long as your doctor has instructed. In other cases, speak to your doctor before
stopping treatment with Berotec N 100.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions have been reported during clinical trials and post-marketing safety monitoring of Berotec N 100:

Common (occur in fewer than 1 in 10 people):

• Tremor
• Cough

Uncommon (occur in fewer than 1 in 100 people):

• Bronchospasm induced by inhalation
• Decreased blood potassium levels, including severe cases
• Stimulation
• Heart rhythm disorders
• Nausea
• Vomiting
• Itching

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

• Hypersensitivity reactions
• Nervousness
• Headache
• Dizziness
• Tachycardia
• Palpitations
• Myocardial ischaemia
• Throat irritation
• Excessive sweating
• Skin reactions such as rash, urticaria
• Muscle pain
• Muscle cramps
• Muscle weakness
• Diastolic blood pressure decrease and systolic blood pressure increase

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +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 authorization holder. Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Berotec N 100

Keep the medicine out of the sight and reach of children.
No special storage instructions are required for this medicine.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Berotec N 100 contains

• The active substance is fenoterol hydrobromide. One dose of the inhalation aerosol contains 100 micrograms of fenoterol hydrobromide.
• Other components of the medicine are: 1,1,1,2-tetrafluoroethane (HFA 134a), anhydrous citric acid, purified water, anhydrous ethanol.

This medicine contains fluorinated greenhouse gases.
Each inhaler contains 9.17 g of HFA 134a (1,1,1,2-tetrafluoroethane), equivalent to 0.01311 tonnes
of CO₂ equivalent (global warming potential GWP = 1430).
What Berotec N 100 looks like and contents of the pack
Berotec N 100 is available in a 17 ml stainless steel container containing 10 ml of solution, with a metering valve and a plastic mouthpiece, packed in a cardboard box.
Pack size: 1 container of 10 ml (200 doses).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Boehringer Ingelheim International GmbH
Binger Strasse 173
D-55216 Ingelheim/Rhein
Germany
Manufacturer:
Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
D-55216 Ingelheim/Rhein
Germany
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Poland
Boehringer Ingelheim Sp. z o.o.
Tel.: +48 22 699 0 699