ATROVENT 20 micrograms PRESSURIZED INHALATION SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Atrovent 20 micrograms inhalation solution in pressurized container

ipratropium bromide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Atrovent and what is it used for
2. What you need to know before you use Atrovent
3. How to use Atrovent
4. Possible side effects
5. Storing Atrovent

1. Contents of the pack and further information

1. What is Atrovent and what is it used for

Atrovent belongs to a group of medicines called anticholinergic bronchodilators, which work by relaxing the muscle of the bronchi, making it easier to breathe.

Atrovent belongs to a group of medicines called inhalation bronchodilators.

Atrovent is used for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). COPD is a lung disease where there is an obstruction to the flow of air through the bronchi, causing difficulty breathing.

2. What you need to know before you use Atrovent

Do not use Atrovent

• If you are allergic (hypersensitive) to ipratropium bromide, to substances similar to ipratropium such as atropine or its derivatives, or to any of the other components of this medicine (listed in section 6).
• If you have acute attacks of coughing, wheezing, and difficulty breathing (bronchospasm) that require a rapid response.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Atrovent:

• If you have cystic fibrosis (a disease that affects the mucous and sweat glands, affecting several organs), as you may be more prone to gastrointestinal motility disorders.
• When you have acute difficulty breathing that worsens rapidly. You should consult your doctor immediately.
• Immediate allergic reactions, such as hives, angioedema (swelling of the face, lips, mouth, tongue, or throat that can cause difficulty swallowing or breathing), skin rash, cough, wheezing, and difficulty breathing (bronchospasm), swelling of the mouth and throat (oropharyngeal edema), and generalized allergic reaction (anaphylaxis) may occur.
• If you have prostatic hyperplasia (enlargement of the prostate) or obstruction of the neck of the bladder (if the bladder outlet is obstructed).
• If you are prone to increased intraocular pressure (narrow-angle glaucoma).
• If you spray the solution into your eyes, eye complications such as pupil dilation, increased intraocular pressure (narrow-angle glaucoma), eye pain, and blurred vision may occur, so it is essential to follow your doctor's instructions strictly for administration. The risk of the spray penetrating the eye is limited, since inhalation is done with a mouthpiece and is manually controlled.
• If you experience a combination of eye symptoms, such as pain or discomfort in the eyes, blurred vision, halos (diffuse lights), or colored images along with eye redness, these may be signs of narrow-angle glaucoma, so you should consult a doctor immediately.
• As with other inhalation medicines, Atrovent may cause paradoxical bronchospasm, which can be life-threatening. If this occurs, treatment should be discontinued immediately and your doctor informed to substitute an alternative treatment.

Other medicines and Atrovent

Tell your doctor or pharmacist if you are using or have recently used or may need to use another medicine.

It is not recommended to administer Atrovent simultaneously with other anticholinergic medicines for an extended period.

Beta-adrenergics (e.g., salbutamol) and xanthine derivatives (e.g., theophylline) are other bronchodilator medicines and may enhance the bronchodilator effect. Atrovent may increase the anticholinergic effects of other medicines.

Atrovent can be administered in combination with other medicines commonly used in the treatment of chronic obstructive pulmonary disease (COPD), including beta-adrenergic medicines, methylxanthines (e.g., theophylline), steroids, and sodium cromoglycate, without the appearance of harmful interactions.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The safety of the medicine during pregnancy has not been established. The benefit of using the medicine should be carefully weighed against the potential risk to the fetus, so the usual precautions in the use of medicines during this period should be observed.

It is not known whether ipratropium bromide can pass into breast milk. However, it is unlikely to be ingested by the infant in significant amounts, especially since the preparation is administered by inhalation. Nevertheless, it should be administered with caution to breastfeeding women.

Driving and using machines

There are no studies on the effects on the ability to drive and use machines. However, it is warned that side effects such as dizziness, eye difficulties in focusing, pupil dilation, and blurred vision may occur during treatment with Atrovent. Therefore, caution is recommended when driving and using machines.

Atrovent contains ethanol

This medicine contains about 8 mg of alcohol (ethanol) per spray.

The amount 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 does not produce any noticeable effect.

3. How to use Atrovent

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to use your medicine.

The correct use of the inhalation solution is crucial for the success of the treatment.

Before the first use of each container, the dosing device will be actuated 1 or 2 times after shaking.

Before each application, the following instructions will be followed:

(fig. 1)

1. Remove the protective cap.
   1. Perform a deep exhalation (expulsion of air through the mouth).

1. Hold the inhaler with your hand in the manner indicated in figure 1 and firmly press the mouthpiece with your lips. The arrow and the base of the container should be pointing upwards.
2. Perform a strong inhalation (intake of air) and, at the same time, press firmly on the base of the container, releasing a spray of inhalation solution. Hold your breath for a few seconds, then remove the mouthpiece and exhale (release the air) slowly. If you cannot inhale deeply due to difficulty breathing, you can facilitate breathing by applying a spray of inhalation solution to the mouth before administering the medicine.
3. Once used, replace the protective cap.
4. If the inhaler has not been used for a period of 3 days, the valve will need to be actuated once more.

Since the container is not transparent, it is impossible to see when it is empty.

The container will provide 200 doses. When the indicated number of doses has been used (usually after 3 weeks if used as recommended), it may seem that the container still contains a small amount of liquid. Nevertheless, the inhaler should be replaced to ensure that you are getting the correct amount of medicine in each inhalation.

Clean the mouthpiece at least once a week. It is essential to keep the mouthpiece clean to ensure that the medicine does not accumulate and block the spray. To wash it, remove the protective cap and the container from the mouthpiece. Rinse by passing hot water through the mouthpiece until any visible residue of medicine or dirt is eliminated (figure 2).

(fig. 2)

After cleaning, shake the mouthpiece and let it air dry without using any heating system. Once the mouthpiece is dry, replace the container and the protective cap (figure 3).

(fig. 3)

WARNING: The plastic mouthpiece has been specially designed for use with Atrovent to ensure that the correct amount of preparation is always obtained. The mouthpiece should never be used with another pressurized inhalation solution, nor should Atrovent be used with a different mouthpiece than the one provided with the product.

If you think the effect of Atrovent is too strong or too weak, tell your doctor or pharmacist.

Atrovent 20 micrograms inhalation solution in pressurized container is administered by inhalation.

The dosage (number of inhalations per day) should be adapted to the needs of each patient. For adults and children over 6 years, the following dosage is recommended:

2 inhalations (equivalent to 40 micrograms of anhydrous ipratropium bromide), 4 times a day.

Since the need for higher doses suggests that additional treatment with another medicine may be necessary, a daily total dose of 12 inhalations (240 micrograms of anhydrous ipratropium bromide) should not be exceeded.

You should consult your doctor if you do not achieve significant improvement or if your condition worsens, in order to determine if a new treatment is necessary. You should also consult your doctor immediately if you experience significant difficulty breathing or if difficulty breathing worsens rapidly.

In children, Atrovent should only be administered under medical supervision and always under the supervision of an adult.

Your doctor will indicate the duration of your treatment with Atrovent. Do not stop treatment before then, as your doctor is the person to give you precise instructions.

If you use more Atrovent than you should

Symptoms such as dry mouth, visual accommodation disorders (difficulty focusing), and tachycardia (increased heart rate) may occur.

If you have used more Atrovent than you should, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Atrovent

Do not use a double dose to make up for forgotten doses.

If you have any other 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.

Common side effects (occurring in at least 1 in 100 patients) with the administration of Atrovent are headache, dizziness, cough, throat irritation, nausea, dry mouth, and gastrointestinal motility disorders (e.g., change in bowel habits, gastroesophageal reflux, dyspepsia (indigestion)).

Uncommon side effects (occurring in at least 1 in 1,000 patients) are hypersensitivity, anaphylactic reaction (severe allergic reaction), blurred vision, mydriasis (pupil dilation), increased intraocular pressure, halos (diffuse lights), or colored images associated with eye redness (glaucoma), eye pain, halos (diffuse lights), eye redness, corneal edema (corneal swelling), palpitations, supraventricular tachycardia, constipation, diarrhea, vomiting, stomatitis (mouth inflammation), oral edema (mouth swelling), rash, pruritus (itching), angioedema (swelling of the face, lips, mouth, tongue, or throat that can cause difficulty swallowing or breathing), and urinary retention.

Rare side effects (occurring in at least 1 in 10,000 patients) are bronchospasm (chest tightness, wheezing, or shortness of breath), paradoxical bronchospasm (bronchial wall constriction due to inhalation), laryngeal spasm, pharyngeal edema (throat swelling), throat dryness, visual accommodation disorder (difficulty focusing), urticaria, increased heart rate, and atrial fibrillation.

If you experience any side effect that you think is serious or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Atrovent

Keep this medicine out of the sight and reach of children.

The pressurized container should not be punctured or exposed to temperatures above 50°C.

Do not use this medicine after the expiry date stated on the container and on the label of the inhaler after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Place the containers and medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Atrovent

• The active substance is ipratropium bromide. Each spray contains 21 micrograms of ipratropium bromide monohydrate (equivalent to 20 micrograms of anhydrous ipratropium bromide).

• The other components are anhydrous citric acid, purified water, ethanol (15% w/w), and HFA 134a (1,1,1,2-tetrafluoroethane).

This medicine contains fluorinated greenhouse gases.

Each inhaler contains 12.33 g of HFA 134a, which corresponds to 0.01763 tons of CO2 equivalent (global warming potential GWP = 1430).

Appearance and packaging of the product

Atrovent is an inhalation solution in a pressurized container, presented in 10 ml containers of solution (200 sprays) for oral inhalation.

Chlorofluorocarbon propellants can damage the ozone layer in the atmosphere. Atrovent does not contain this type of propellant and only contains the non-chlorofluorocarbon propellant HFA 134a, which does not contribute to the depletion of the ozone layer.

Marketing authorization holder

Boehringer Ingelheim España, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona)

Spain

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse, 173

55216 Ingelheim am Rhein

Germany

Date of last revision of this leaflet: January 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.