PATIENT INFORMATION LEAFLET

Atrovent 20 micrograms solution for inhalation in a pressurised container

bromide of ipratropium

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

- Keep this leaflet, as you may need to read it again.

- If you have any questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6. Contents of the container and additional information

Atrovent belongs to a group of medications called anticholinergic bronchodilators, which act by relaxing the bronchial muscle, thereby facilitating air passage and breathing.

Atroventpertenece al grupo de medicamentos denominados broncodilatadores por inhalación.

Atroventse utiliza para el tratamiento de mantenimiento del broncoespasmo asociado a enfermedades pulmonares obstructivas crónicas (EPOC).La EPOC es una enfermedad de los pulmones donde hay una obstrucción al paso de aire por los bronquios y que causa dificultad para respirar.

No use Atrovent

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Atrovent:

• If you have cystic fibrosis (a disease that alters the secretions of mucous and sweat glands affecting various organs), as you may be more prone to gastrointestinal motility disorders.
• If you experience acute difficulty breathing that worsens rapidly. You should consult your doctor immediately.
• Immediate allergic reactions may occur, such as urticaria, angioedema (swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing), skin rash, coughing, wheezing, and difficulty breathing (bronchospasm), swelling of the mouth and throat (oropharyngeal edema), and generalized allergic reaction (anaphylaxis).
• If you have benign prostatic hyperplasia (prostate enlargement) or urinary tract obstruction (if the urethral canal through which urine is expelled is blocked).
• If you are predisposed to glaucoma (narrow-angle glaucoma).
• If you spray the solution in your eyes, complications may occur, such as pupil dilation, increased intraocular pressure (narrow-angle glaucoma), eye pain, so it is essential to follow your doctor's instructions strictly for administration. The risk of the spray penetrating the eye is limited, given that inhalation occurs with a mouthpiece and is manually controlled.
• If you experience a combination of eye symptoms, such as eye pain or discomfort, blurred vision, halos (diffuse lights), or colored images along with eye redness, they may be signs of narrow-angle glaucoma, so you should consult a doctor immediately.
• As with other inhaled medications, Atrovent may cause paradoxical bronchospasm, which can put your life at risk. In the event of this occurring, you should immediately stop treatment and inform your doctor to substitute with an alternative treatment.

Other medications and Atrovent

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

Simultaneous administration of Atrovent with other anticholinergic medications for a long period is not recommended.

Beta-adrenergics (e.g., salbutamol) and xanthine derivatives (e.g., theophylline) are other bronchodilators and may potentiate the bronchodilating effect. Atrovent may enhance the anticholinergic effects of other medications.

Atrovent can be administered concurrently with other medications commonly used in the treatment of chronic obstructive pulmonary disease (COPD), including beta-adrenergics, methylxanthines (e.g., theophylline), corticosteroids, and cromoglicic acid, without the appearance of harmful interactions.

Pregnancy, breastfeeding, and fertility

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

The safety of the medication during pregnancy has not been established. The potential risk to the fetus should be carefully weighed against the benefits of using the medication, so standard precautions should be observed during this period.

The passage of ipratropium bromide into breast milk is unknown. However, it is unlikely to be ingested by the infant in significant quantities, especially since the preparation is administered via inhalation. Nevertheless, it should be administered with caution to breastfeeding women.

Driving and operating machinery

No studies are available on the effects on the ability to drive and operate machinery. However, it is warned that adverse effects such as dizziness, eye focusing difficulties, pupil dilation, and blurred vision may occur during treatment with Atrovent. Therefore, caution is recommended when driving and operating machinery.

Atrovent contains ethanol

This medication contains approximately 8 mg of alcohol (ethanol) in each puff.

The amount in each puff of this medication is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol contained in this medication does not produce any noticeable effect.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to use your medication.

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 activated 1 or 2 times after shaking it.

Before each application, follow the following instructions:

(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 way indicated in figure 1 and press firmly the mouthpiece with your lips. The arrow and the base of the container must be directed upwards.
2. Perform a deep inspiration (taking of air) as forcefully as possible and, at the same time, press strongly 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 air) slowly. If you cannot breathe deeply due to difficulty breathing, you can facilitate breathing by applying a spray of inhalation solution to the mouth before applying the medication.
3. Once used, replace the protective cap.
4. If you have not used the inhaler for a period of 3 days, the valve will need to be activated again.

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

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

Clean the mouthpiece at least once a week. It is essential to keep the mouthpiece always clean to ensure that the medication does not accumulate and block the spray. To clean it, remove the protective cap and the container from the mouthpiece. Rinse by passing hot water through the mouthpiece until any remaining medication or visible 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 designed specifically for use with Atrovent, to ensure that the correct amount of the preparation is always obtained. The mouthpiece should never be used with another inhalation solution in a pressurized container, nor should Atrovent be used with a different mouthpiece than the one provided with the product.

If you estimate that the action of Atrovent is too strong or too weak, inform your doctor or pharmacist.

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

The dosage (number of inhalations per day) should be adapted to the needs of each patient. Foradults 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 increasing doses suggests that additional treatment with another medication may be necessary, in general, a total daily dose of 12 inhalations (240 micrograms of anhydrous ipratropium bromide) should not be exceeded.

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. Also, consult your doctor immediately in case of significant difficulty breathing or when breathing difficulty rapidly worsens.

Atrovent should only be administered to children under the guidance of a doctor and always under adult supervision.

Your doctor will indicate the duration of your treatment with Atrovent. Do not stop treatment before, as your doctor is the only one who can give you the precise instructions.

If you use more Atrovent than you should

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

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

If you forgot to use Atrovent

Do not use a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The frequent adverse 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 habit, gastroesophageal reflux, dyspepsia (indigestion)).

The infrequent adverse 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 or colored images associated with eye redness (glaucoma), eye pain, halos or diffuse lights, eye redness, corneal edema (corneal swelling), palpitations, supraventricular tachycardia, constipation, diarrhea, vomiting, stomatitis (inflammation of the mouth), oral edema (swelling of the mouth), rash, pruritus (itching), angioedema (swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing), and urinary retention.

The rare adverse effects (occurring in at least 1 in 10,000 patients) are bronchospasm (chest tightness, wheezing, or shortness of breath), paradoxical bronchospasm (narrowing of the bronchial walls due to the inhalation itself), laryngeal spasm, pharyngeal edema (throat swelling), dry throat, visual accommodation disorder (difficulty focusing the eye), urticaria, increased heart rate, and atrial fibrillation.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not use this medication after the expiration date that appears on the container and on the inhaler label after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

Composition of Atrovent

• The active ingredient is ipratropium bromide. Each inhalation 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 medication 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 PCG = 1430).

Appearance of the product and contents of the packaging

Atrovent is a pressurized inhalation solution, presented in 10 ml solution (200 inhalations) for oral inhalation.

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

Marketing authorization holder

Boehringer Ingelheim España, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona)

Spain

Responsible for manufacturing

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse, 173

55216 Ingelheim am Rhein

Germany

Last review date of this leaflet: January 2025

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