IPRATROPIUM BROMIDE CIPLA 20 micrograms SOLUTION FOR INHALATION IN A PRESSURIZED CONTAINER

2. What you need to know before starting to use Ipratropium bromide Cipla

Do not useIpratropium bromide 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 medications similar to ipratropium, such as atropine or its derivatives.
• If you experience 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 Ipratropium bromide Cipla:

• If you have a predisposition to increased intraocular pressure (narrow-angle glaucoma).
• 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 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.
• If you experience acute difficulty breathing that worsens rapidly. You should consult your doctor immediately.
• If you experience 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, difficulty breathing (bronchospasm), swelling of the mouth and throat (oropharyngeal edema), and generalized allergic reaction (anaphylaxis).
• If you spray the solution into your eyes, complications such as pupil dilation, increased intraocular pressure (narrow-angle glaucoma), and eye pain may occur, so it is essential to follow your doctor's instructions for administration carefully. The risk of the spray penetrating the eye is limited, as the 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, and you should consult your doctor immediately.

UsingIpratropium bromide Ciplawith other medications

Tell 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 bronchodilators and may enhance the bronchodilatory effect. Ipratropium bromide Cipla may increase the anticholinergic effects of other medications.

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

Pregnancy,breastfeedingandfertility

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

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

Breastfeeding:It is not known if Ipratropium bromide Cipla can pass into breast milk. However, it is unlikely that Ipratropium bromide Cipla can be ingested by the infant in significant amounts, especially since the preparation is administered by inhalation. Nevertheless, since many medications can pass into breast milk, it should be administered with caution to breastfeeding women.

Fertility:

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

Driving and using machines

There are no studies on the effects on the ability to drive and use machines. You may feel dizzy or have difficulty concentrating, dilated pupils, or blurred vision during the use of Ipratropium bromide Cipla. If this occurs, do not drive or operate tools or machines.

Important information about some of the components ofIpratropium bromide Cipla

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

3. How to use Ipratropium bromide Cipla

Follow your doctor's instructions for administering Ipratropium bromide Cipla exactly. Consult your doctor, nurse, or pharmacist if you have any questions.

The recommended dose is:

Adults and children over 6 years old with COPD

• 2 inhalations four times a day
• Sometimes, at the start of treatment, up to 4 inhalations can be used at the same time. Since the need for higher doses suggests that additional treatment with another medication may be necessary, the total daily dose should not usually exceed 12 inhalations (240 micrograms of ipratropium bromide monohydrate).

Use in children

Since there is not enough information about the use of Ipratropium bromide Cipla in children, it should only be administered to children following the doctor's recommendations and under adult supervision.

You should 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 your doctor immediately if you experience significant difficulty breathing (acute dyspnea) or if your difficulty breathing worsens rapidly.

Checking the inhaler

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

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

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

Using the inhaler

FIGURE 1

1. Stand or sit upright while using Ipratropium bromide Cipla.
2. Remove the protective cap from the mouthpiece.
3. Before inhaling, check the inside and outside of the inhaler mouthpiece to ensure it is clean, free of dust, dirt, or 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), and perform a long, deep, and slow exhalation.
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 in slowly and deeply through your mouth, and immediately after starting to inhale, press the top of the inhaler firmly to release a spray of inhalation solution, and continue breathing constantly and deeply.
7. Hold your breath, remove the inhaler from your mouth, and release your finger from the top of the inhaler. Hold your breath for as long as you can, 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 through the procedure.
• Older patients with weak hands may use the inhaler with both hands.

The mouthpiece has been specially designed for use with this product only. 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 "mist" coming out of the top of your inhaler or the sides of your mouth, you should start again.

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 be able to use a spacer device (Aerochamber plusTM) with your inhaler. A spacer is a device designed to make step 6 easier. A spacer is usually a plastic container with a mouthpiece at one end and an opening for the insertion of the inhaler mouthpiece at the other end. The medication dose from the inhaler is sprayed into the spacer, and the medication spray remains inside the spacer until you inhale it with the spacer mouthpiece in your mouth and your lips closed around it. This means you do not have to worry about breathing and pressing the inhaler at the same time.

When usingIpratropium bromide Cipla, be careful not to get the spray in your eyes.Please see section 4 for possible side effects that may occur if this medication is accidentally sprayed into the eyes.

Cleaning the inhaler.

To prevent the inhaler from becoming blocked, 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 with warm soapy water
• Rinse 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, put it back on the container and replace the protective cap.

Do not put the metal container in water.

Do not use more medication than indicated 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 often than your doctor has recommended. Your doctor may need to review if the medication is working correctly. In some cases, your doctor may need to change the medication.

Make sure you do not run out ofIpratropium bromide Cipla

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

If you use moreIpratropium bromide Ciplathan you should

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

If you have used more Ipratropium bromide 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.

If youforget to useIpratropium bromide Cipla

• If you forget a dose, take it as soon as you remember.
• However, if it is almost time for your next dose, do not take the missed dose.
• Do not take a double dose to make up for missed doses.

If you have any doubts, consult your doctor or pharmacist.

If you stop usingIpratropium bromide Cipla

Do not stop using Ipratropium bromide Cipla unless your doctor tells you to. If you have any other questions about using this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, Ipratropium bromide Cipla can cause side effects, although not everyone experiences them.

The frequent side effects (occurring in at least 1 in 100 patients) of Ipratropium bromide Cipla are headache, dizziness, cough, throat irritation, nausea, dry mouth, and gastrointestinal motility disorders (e.g., change in bowel habits, gastroesophageal reflux, dyspepsia).

The 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.

The rare side 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 contraction, pharyngeal edema (throat swelling), throat dryness, visual accommodation disorder (difficulty focusing), urticaria, increased heart rate, and atrial fibrillation.

Reporting side effects

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

5. Storage of Ipratropium bromide Cipla

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

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

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

If the inhaler has been exposed to low temperatures, the patient should remove the metal container from the plastic box and warm it in their hands for at least two minutes.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofIpratropium Bromide Cipla

• The active ingredient is ipratropium bromide. Each actuation (ex-valve) contains 20 micrograms of ipratropium bromide (as monohydrate). This is equivalent to a delivered dose (ex-actuator) of 17 micrograms of ipratropium bromide (as monohydrate). Each container contains 200 actuations, each actuation contains 20 micrograms of ipratropium bromide (as monohydrate).
• The other components are: CFC-free propellant, HFC-134a (norflurane) propellant, anhydrous citric acid, anhydrous ethanol, and purified water. Ipratropium Bromide Cipla does not contain chlorofluorocarbon (CFC) propellants.
• This medication contains fluorinated greenhouse gases.
• Each inhaler contains 12.3 g of HFC-134a (norflurane) which corresponds to 0.018 tons of CO2 equivalent (global warming potential GWP = 1430).

Appearance ofIpratropium Bromide Ciplaand Package Contents.

Ipratropium Bromide Cipla consists of a pressurized aluminum container containing the pressurized inhalation solution, closed with a metering valve and a plastic actuator, composed of a white mouthpiece with a protective cap. Each package contains one inhaler.

Marketing Authorization Holder and Manufacturer

Cipla Europe NV

De Keyserlei 60C, Bus-1301,

2018 Antwerp

Belgium

Local Representative

Cipla Europe NV branch in Spain,

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

Dateofthelastrevisionofthisleaflet: January 2025

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