Atrovent n

Package leaflet: Information for the patient

ATROVENT N, 20 micrograms/dose, inhalation aerosol, solution
Ipratropii bromidum
Please read all of this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask 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.

Leaflet contents:

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

1. What Atrovent N is and what it is used for

Atrovent N is a bronchodilator with anticholinergic properties. Atrovent N is indicated as a bronchodilator in the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and in bronchial asthma.

2. Important information before using Atrovent N

When not to use Atrovent N

• if the patient is allergic to atropine or its derivatives (such as the active substance ipratropium bromide) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Atrovent N, discuss with your doctor:

• if the patient has narrow-angle glaucoma (increased pressure in the eye),
• if the patient has urinary retention,
• if the patient has cystic fibrosis: gastrointestinal motility disorders may occur.

Contact your doctor immediately:

• if bronchospasm is triggered by inhalation: stop using Atrovent N immediately, as this may be life-threatening. Seek medical advice for alternative treatment.
• if ocular complications occur, such as: eye pain or discomfort, blurred vision, seeing rainbow-colored halos around lights, or altered color vision associated with redness of the eyes; consult your doctor promptly to determine whether these symptoms may be due to complications (pupil dilation, increased intraocular pressure, narrow-angle glaucoma).
• if breathing problems do not improve or worsen: contact your doctor, who will reassess the treatment plan. The doctor may consider adding further medications.

Never use a higher dose than prescribed, as this may lead to severe adverse reactions.

• Immediately after administration, hypersensitivity reactions may occur, including rare cases of urticaria, angioedema (sudden swelling of the skin or mucous membranes, possibly causing breathing difficulties), rash, bronchospasm, swelling of the oral and pharyngeal mucosa, and rapidly progressing, life-threatening allergic reactions.

Do not allow Atrovent N to get into the eyes.
Atrovent N and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines planned for future use.
Unless clearly advised by your doctor, avoid long-term concurrent use of Atrovent N with other medicines belonging to the so-called "anticholinergic" group.
Beta-2 adrenergic receptor agonists and xanthine derivatives (theophylline) may enhance bronchodilating effects.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Although non-clinical studies have not shown any adverse effects of ipratropium bromide on the unborn child, Atrovent N should only be used during pregnancy if considered necessary by the doctor.
It is not known whether ipratropium passes into human breast milk. Therefore, Atrovent N should only be used in breastfeeding women if considered necessary by the doctor.
Driving and operating machinery
No studies have been conducted on the effect on the ability to drive or operate machinery. However, during treatment with Atrovent N, adverse effects such as dizziness, visual disturbances, pupil dilation, and blurred vision may occur.
Therefore, caution is advised when driving or operating machinery.
Atrovent N contains ethanol
This medicine contains 8.415 mg of alcohol (ethanol) per spray (per measured dose).
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 cause noticeable effects.

3. How to use Atrovent N

Atrovent N must always be used as directed by the physician. If in doubt, consult your doctor or pharmacist.
The doctor will adjust the dosage according to the individual needs of the patient. The following dosage is recommended for adults and children over 6 years of age:
Adults and children over 6 years of age:
2 doses (sprays) per administration, 4 times daily, but not more than 12 sprays per day.
Do not exceed the recommended daily dose.
If treatment does not result in significant improvement, or if the patient's condition worsens, consult your doctor to establish a new treatment plan. In case of sudden or rapidly worsening shortness of breath (difficulty breathing), contact your doctor immediately.
It is recommended that Atrovent N inhalation aerosol be used in children only on a doctor's prescription and under the supervision of an adult.
In acute exacerbations of chronic obstructive pulmonary disease, the doctor may recommend treatment with Atrovent, solution for nebulization.

Instructions for use
Carefully read the instructions for use to ensure proper administration and use of Atrovent N, as described below:
Before first use of the inhaler, press the metering valve twice.
Each time the medicine is used, follow these steps:

1. Remove the protective cap.
2. Breathe out deeply.
3. Hold the inhaler in the position shown in Fig. 1, seal lips around the mouthpiece. The arrow on the canister and the bottom of the canister should point upwards.

(Fig. 1)

4. Breathe in as deeply as possible, while simultaneously pressing firmly on the bottom of the canister to release one metered dose of the medicine. Hold your breath for a few seconds, then remove the mouthpiece from your mouth and breathe out. Repeat the same steps for the second inhalation.
5. After use, replace the protective cap.
6. If the inhaler has not been used for three days, press the metering valve once before the next use.

The canister is not transparent. Therefore, it is not possible to see whether it is already empty. The inhaler delivers 200 sprays. After this number of doses has been used (usually after 3 weeks of use according to the recommended dosage), a small amount of solution may still remain in the canister. However, the inhaler should be replaced with a new one to ensure that each spray delivers the correct dose of medicine.
The inhaler mouthpiece should be cleaned at least once a week. It is important to keep it clean to ensure that the medicine does not deposit on the mouthpiece walls and block the inhaler.
To clean the inhaler mouthpiece, first remove the protective cap and remove the medicine canister from the mouthpiece. Rinse the mouthpiece thoroughly with warm water until all visible contamination is removed.

(Fig. 2)
After cleaning, shake off excess water from the mouthpiece and leave it to dry in the air. Do not use any drying devices. When the inhaler mouthpiece is dry, reinsert the medicine canister into the mouthpiece and replace the protective cap.

(Fig. 3)
WARNING:
The plastic mouthpiece has been specially designed for use with the Atrovent N 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, the Atrovent N inhalation aerosol must not be used with any mouthpiece other than the one supplied with the medicine.
High pressure is maintained inside the canister. Never use force when opening it, and do not expose it to temperatures above 50°C.

Use of a higher than recommended dose of Atrovent N
If a higher than recommended dose of the medicine is taken, consult your doctor or pharmacist immediately.
Mild symptoms of ipratropium bromide overdose may occur, such as: dryness of the oral mucosa, blurred vision, and increased heart rate.

Missed dose of Atrovent N
If Atrovent N has been prescribed for regular use and the patient forgets to take a dose, it should be taken as soon as possible. However, do not take a double dose to make up for the missed dose. Take the next dose at the usual time.

Stopping treatment with Atrovent N
If treatment with Atrovent N is stopped, breathing difficulties may recur or worsen. Therefore, continue using Atrovent N for as long as prescribed by your doctor.
In any case, talk to your doctor before stopping treatment with Atrovent N.
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 everyone experiences them.
As with all inhaled medicines, Atrovent N may cause symptoms of local irritation. The most commonly reported adverse reactions observed in clinical trials were: headache, throat irritation, cough, dryness of the oral mucosa, gastrointestinal motility disorders (including constipation, diarrhoea and vomiting), nausea and dizziness.

The following adverse reactions have been reported during clinical trials and post-marketing safety monitoring of Atrovent N.
The frequency of adverse reactions is defined using the following classification:

• Very common: occurs in more than 1 in 10 patients
• Common: occurs in more than 1 in 100 but less than 1 in 10 patients
• Uncommon: occurs in more than 1 in 1,000 but less than 1 in 100 patients
• Rare: occurs in more than 1 in 10,000 but less than 1 in 1,000 patients
• Very rare: occurs in less than 1 in 10,000 patients
• Frequency not known (frequency cannot be estimated from available data)

Common (occurs in more than 1 in 100 but less than 1 in 10 patients):

• headache,
• dizziness,
• throat irritation,
• cough,
• dryness of the oral mucosa,
• nausea,
• gastrointestinal motility disorders.

Uncommon (occurs in more than 1 in 1,000 but less than 1 in 100 patients):

• rapidly progressing, life-threatening allergic reactions (anaphylactic reactions),
• hypersensitivity,
• angioedema (sudden swelling of the skin or mucous membranes, possibly causing breathing difficulties), affecting the tongue, lips and face,
• palpitations,
• supraventricular tachycardia (abnormally rapid heartbeat),
• bronchoconstriction,
• inhalation-induced (paradoxical) bronchoconstriction,
• laryngospasm (sudden spasms of the vocal cords affecting breathing and speech),
• pharyngeal mucosal oedema (swelling in the upper part of the throat),
• blurred vision,
• mydriasis (pupil dilation),
• increased intraocular pressure,
• glaucoma,
• eye pain,
• visual halos,
• conjunctival hyperaemia,
• corneal oedema (swelling of the eye's protective outer layer),
• sore throat,
• diarrhoea,
• constipation,
• vomiting,
• stomatitis (inflammation of the mouth),
• oral oedema,
• urinary retention,
• rash,
• pruritus (itching).

Rare (occurs in more than 1 in 10,000 but less than 1 in 1,000 patients):

• atrial fibrillation (very rapid, irregular heartbeat),
• increased heart rate,
• accommodation disorders (visual focusing disturbances),
• urticaria (hives).

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 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 may also be reported to the Marketing Authorisation Holder or its representative. Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Atrovent N

Store below 25 °C.
Do not freeze.
Protect from direct sunlight.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after EXP.
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 you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Atrovent N contains

• The active substance is ipratropium bromide. One metered dose (spray) contains 21 micrograms of ipratropium bromide ( Ipratropii bromidum ), equivalent to 20 micrograms of anhydrous ipratropium bromide.
• The other components are: HFA 134a (1,1,1,2-tetrafluoroethane), anhydrous citric acid, anhydrous ethanol, purified water.

This medicine contains fluorinated greenhouse gases.
Each inhaler contains 12.33 g of HFA 134a (1,1,1,2-tetrafluoroethane), equivalent to 0.01763 tonnes of CO\₂\ equivalent (global warming potential GWP = 1430).
What Atrovent N looks like and contents of the pack
1 container containing 10 ml of solution (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, please contact the representative of the Marketing Authorisation Holder:
Poland
Boehringer Ingelheim Sp. z o.o.
Tel.: +48 22 699 0 699