Prospect: Information for the User

Ipratropium Bromide Cipla20 micrograms solution for inhalation in a pressurized container

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Ipratropio bromuro Ciplabelongs to a group of medicines called anticholinergic bronchodilators, which work by relaxing the muscle tissue of the bronchi, thereby facilitating airflow and breathing.

This medicine belongs to a group of medicines called inhalation bronchodilators.

Ipratropio bromuro Ciplais used for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary diseases (COPD). COPD is a lung disease where there is an obstruction to airflow through the bronchi, causing difficulty breathing.

Do not useIpratropio bromuro Cipla:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ipratropio bromuro Cipla:

• If you have a predisposition to develop increased pressure inside the eye (narrow-angle glaucoma).
• When you have benign prostatic hyperplasia (enlargement of the prostate) or obstruction of the urethral neck (if the urethral passage through which urine is expelled is blocked).
• 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.
• When you experience acute difficulty breathing that worsens rapidly. You must consult your doctor immediately.
• If you experience immediate allergic reactions, such as urticaria, angioedema (swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing), skin rash, coughing, wheezing when breathing, difficulty breathing (bronchospasm), swelling of the mouth and throat (oropharyngeal edema), and generalized allergic reaction (anaphylaxis).
• If you spray the solution in your eyes, complications may occur, such as pupil dilation, increased pressure inside the eye (narrow-angle glaucoma), and eye pain, so it is essential to follow your doctor's instructions for administration strictly. The risk of the spray penetrating the eye is limited, given that inhalation is done 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, these may be signs of narrow-angle glaucoma, in which case, you must consult a doctor immediately.

Use ofIpratropio bromuro Ciplawith other medications

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

Beta-adrenergics (e.g., salbutamol) and xanthine derivatives (e.g., theophylline) are other bronchodilator medications that may potentiate the dilating effect on the bronchi. Ipratropio bromuro Cipla may accentuate the anticholinergic effects of other medications.

Ipratropio bromuro Cipla 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), steroids, and cromoglic acid, without the appearance of harmful interactions.

Pregnancy, lactation, and fertility

Pregnancy:
If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

The safety of this medication during pregnancy has not been established. The benefits of using this medication must be weighed against the potential risk to the fetus, so usual precautions should be taken when using medications during this period.

Lactation:
The passage of Ipratropio bromuro Cipla into breast milk is unknown. However, it is unlikely that the infant will ingest significant amounts of Ipratropio bromuro Cipla, especially since the preparation is administered via inhalation. However, since many medications can pass into breast milk, this medication should be administered with caution to breastfeeding women.

Fertility:

The effect of Ipratropio bromuro Cipla on fertility has not been studied, and no data are available. Therefore, if you are planning to become pregnant, this medication should be used with caution and only after consulting your doctor.

Driving and operating machinery

No studies are available on the effects on the ability to drive and operate machinery. You may feel dizzy, have difficulty concentrating, dilated pupils, or blurred vision during the use of Ipratropio bromuro Cipla. If this occurs, do not drive or operate tools or machinery.

Important information about some of the components ofIpratropio bromuro Cipla

This medication contains 15% ethanol in the final product. Each inhalation contains 0.0084 g of ethanol, which may pose a risk to children, pregnant women, and patients with liver disease, alcoholism, epilepsy, or brain damage. It may modify or potentiate the effect of other medications.

Follow exactly the administration instructions for Ipratropio bromuro Cipla as indicated by your doctor. Consult with your doctor, nurse or pharmacist if you have any doubts.

The recommended dose is:

Adults and children over 6 years old with COPD

• 2inhalations four times a day
• In some cases, up to 4 inhalations may be used at the same time at the beginning of treatment. Since the need for increasing doses suggests that additional treatment with another medication may be necessary, a daily total dose of 12 inhalations (240 micrograms of ipratropium bromide monohydrate) should not be exceeded.

Use in children

Ipratropio bromuro Cipla should only be administered to children following the doctor's recommendations and under adult supervision, as there is not enough information available on its use in children.

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

Checking the inhaler

When using the inhaler for the first time, you should check if it is working correctly.

Also check its function if you have not used it for 3 or more days. Before each application, follow the following instructions:

• Remove the cap from the mouthpiece by gently pressing the sides with your thumb and index finger.
• Point the mouthpiece away from you and press the inhaler twice (once each time) to release two sprays into the air.

Using the inhaler

FIGURE 1

1. Stand upright or sit while using Ipratropio bromuro Cipla.
2. Remove the protective cap from the mouthpiece.
3. Before inhaling, check the inside and outside of the mouthpiece of the inhaler to ensure it is clean, free of dust or dirt, and without loose objects.
4. Hold the inhaler in a vertical position between your thumb at the base of the mouthpiece and your index finger at the top of the inhaler (the arrow at the base of the container should be pointing upwards), perform a long, deep, and slow exhalation as possible.
5. Immediately after exhalation, place the mouthpiece in your mouth, between your teeth, and close your lips around it, but do not bite it.
6. Breathe slowly and deeply through your mouth and, immediately after starting to inhale, press firmly on the top of the inhaler to release a spray of inhalation solution and continue breathing constantly and deeply.
7. Hold your breath, remove the inhaler from your mouth, and remove your finger from the top of the inhaler. Hold your breath for as long as possible, for 10 seconds if possible.
8. Exhale slowly through your nose. Do not exhale into the inhaler.
9. If a second inhalation is required, wait at least one minute and then repeat steps 4 to 8.
10. Replace the protective cap after use.

IMPORTANT

• Do not inhale too quickly, start breathing as slowly and continuously as possible before pressing the inhaler.
• Do not rush to complete the entire procedure.
• Patients with advanced age and weak hands may use the inhaler with both hands.

The mouthpiece has been designed specifically for use with this product. Do not use any other mouthpiece with the product and do not use the mouthpiece of this inhaler with any other product.

Practice in front of a mirror the first few times. If you see "fog" coming out of the top of your inhaler or from the sides of your mouth, start over.

If you find it difficult to breathe and press the inhaler at the same time (step 6), consult your doctor or pharmacist, as you may use a spacer (Aerochamber plusTM) with your inhaler. A spacer is a device designed to make step 6 easier. A spacer is generally a plastic container with a mouthpiece at one end and an opening for inserting the mouthpiece of the inhaler at the other end. The dose of medication from the inhaler is sprayed into the spacer and the medication spray remains inside the spacer until you breathe it in with the mouthpiece of the spacer in your mouth and with your lips closed around it. This means you do not have to worry about breathing and pressing the inhaler at the same time.

When usingIpratropio bromuro Ciplabe careful not to spray it into your eyes.
Please see section 4 on possible side effects that may occur if this medication is accidentally sprayed into your eyes.

Cleaning the inhaler

To prevent the inhaler from blocking, it should be cleaned at least once a week.

• Remove the container from the inhaler and the protective cap
• Wash and clean the white mouthpiece in warm soapy water
• Wash with warm water and let it air dry without using any drying system
• Make sure the small hole in the mouthpiece is thoroughly cleaned
• Once the mouthpiece is dry, replace it in the container and place the protective cap.

Do not place the metal container in the water.

Do not use more medication than prescribed by your doctor

Consult your doctor immediately if:

• You think your inhaler is not working as well as usual.
• If you need to use the inhaler more than your doctor has recommended.
  Your doctor may need to check if the medication is working correctly. In some cases, your doctor may need to change medication.

Make sure you do not run out ofIpratropio bromuro Cipla

The inhaler has been designed to provide 200 sprays of medication. However, it is not possible to know when the inhaler is empty and when the 200 sprays have been used. When all have been used, there may still be a small amount of liquid left in the container. Please make sure to replace the inhaler after inhaling 200 sprays (usually after 3-4 weeks of regular use) to ensure you receive the correct dose of medication with each spray.

If you use moreIpratropio bromuro Ciplathan you should

If you use the inhaler more than you should, consult your doctor or go to the hospital immediately. Bring the inhaler and any other medication you are using (in its original packaging if possible) with you. If you take more Ipratropio bromuro Cipla or too many sprays, you may experience dry mouth, tachycardia (increased heart rate), or blurred vision.

If you have used more Ipratropio bromuro Cipla than you should, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

Ifyou forget to useIpratropio bromuro Cipla

• If you forget a dose, take it as soon as you remember.
• However, if it is close to the time of the next dose, do not take the missed dose.
• Do not take a double dose to compensate for the missed doses.

Consult your doctor or pharmacist if you have any doubts.

If you stop usingIpratropio bromuro Cipla

Do not stop using Ipratropio bromuro Cipla unless your doctor tells you to. If you have any other doubts about the use of this medication, consult your doctor or pharmacist.

Like all medications, Cipla Ipratropium Bromide may cause adverse effects, although not everyone will experience them.

Theadverseeffectsfrequent(occurringinlessthan1in100patients)withtheadministrationofCipla Ipratropium Bromide are headache, dizziness, cough, throat irritation, nausea, dry mouth, and gastrointestinal motility disorders (e.g., change in bowel habits, gastroesophageal reflux, indigestion).

Theadverseeffectsinfrequent(occurringinatleast1in1,000patients)arehypersensitivity, 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 blurred vision, eye redness, corneal edema (corneal swelling), palpitations, supraventricular tachycardia, constipation, diarrhea, vomiting, stomatitis (mouth inflammation), oral edema (oral swelling), rash, pruritus (itching), angioedema (facial, lip, mouth, tongue, or throat swelling that may cause difficulty swallowing or breathing), and urinary retention.

Theadverseeffectsrare(occurringinatleast1in10,000patients)arebronchospasm (chest tightness, wheezing, or shortness of breath), paradoxical bronchospasm (bronchiole constriction due to inhalation), laryngeal spasm, pharyngeal edema (throat swelling), dry throat, visual accommodation disorder (difficulty focusing the eye), urticaria, increased heart rate, and atrial fibrillation.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, evenifitisapossibleadverseeffectnotlistedinthisleaflet.YoucanalsoreportthemdirectlytotheSpanish Medicines Vigilance System: 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.

Do not use Ipratropium bromide Cipla after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Protect from direct sunlight, heat, and frost.

If the inhaler has been exposed to low temperatures, the patient must remove the metal container from the plastic box and warm it in their hands for a minimum of two minutes.

The container contains a pressurized liquid. Do not expose to temperatures above 50°C. Do not attempt to open, pierce, or burn the container, even when it appears to be empty.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition ofIpratropio bromuro Cipla

• The active ingredient is bromide of ipratropium. Each inhalation (ex-valve) contains 20 micrograms of bromide of ipratropium (as monohydrate). This is equivalent to a dose supplied (ex-pulsator) of 17 micrograms of bromide of ipratropium (as monohydrate). Each package contains 200 inhalations, each inhalation contains 20 micrograms of bromide of ipratropium (as monohydrate).
• The other components are: non-CFC propellant, HFC-134a propellant (norflurane), anhydrous citric acid, anhydrous ethanol, and purified water. Ipratropio bromuro Cipla does not contain chlorofluorocarbon (CFC) propellants.
• This medication contains fluorinated greenhouse gases.
• Each inhaler contains 12.3 g of HFC-134a (norflurane) corresponding to 0.018 tons of CO2equivalent (global warming potential PCG = 1430).

Appearance ofIpratropio bromuro Ciplaand contents of the packaging.

Ipratropio bromuro Cipla consists of an aluminum pressure vessel containing the pressurized solution for inhalation closed with a dosing valve and a plastic pulsator, composed of a white nozzle provided with a protective cap. Each package contains an inhaler.

Holder of the marketing authorization and responsible for manufacturing

Cipla Europe NV

De Keyserlei 60C, Bus-1301,

2018 Antwerp

Belgium

Local representative

Cipla Europe NV subsidiary in Spain,

C/ Guzmán el Bueno, 133 Edif Britannia-28003- Madrid, Spain

Revision dateofthisleaflet: 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.es/