Leaflet: information for the user

Ipratropium Bromide Aldo-Union 250 micrograms/ml, solution for inhalation by nebulizer

(Ipratropium bromide)

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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.

1. What is Ipratropium Bromide Aldo-Union and what it is used for

2. What you need to know before using Ipratropium Bromide Aldo-Union

3. How to use Ipratropium Bromide Aldo-Union

4. Possible side effects

5. Storage of Ipratropium Bromide Aldo-Union

6. Contents of the pack and additional information

Aldo-Union Ipratropium Bromide belongs to a group of medications called”bronchodilators” that act by relaxing the bronchial muscle, thereby facilitating breathing.

This medication helps patients with asthma and other respiratory difficulties such as Chronic Obstructive Pulmonary Disease breathe better.

Aldo-Union Ipratropium Bromide may be administeredalong withbronchodilator beta2-agonists, such as salbutamol.

Do not use Aldo-Union Ipratropium Bromide:

• If you are allergic to ipratropium bromide or to substances similar to atropine or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to use Aldo-Union Ipratropium Bromide:

• If you have cystic fibrosis.
• If your urine flow is obstructed.
• If you have increased intraocular pressure (glaucoma), as you will need to ensure that the mist does not come into contact with your eyes.
• If you have prostate problems.

Using Aldo-Union Ipratropium Bromide with other medications:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Inform your doctor if you are using or have used recently any of the following medications, as they may interact with Aldo-Union Ipratropium Bromide:

• Xanthine-derived medications, such as theophylline.
• Other medications containing bronchodilators (which help you breathe more easily), such as salbutamol or terbutaline.

Pregnancy and breastfeeding

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

If you become pregnant while being treated with this medication, consult your doctor as soon as possible.

Driving and operating machinery

Aldo-Union Ipratropium Bromide has no effect on your ability to drive and operate machinery.

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

Your doctor may instruct you to use your nebulizer regularly, daily or only when you have difficulty breathing.

Adults, elderly, and children over 12 years:

The recommended dose is 250-500 micrograms (1-2 ml of solution) 3 to 4 times a day. In case of acute asthma attacks, 500 micrograms (2 ml) of solution may be administered.

Use in children

Children from 6 to 12 years:

The recommended dose is 250 micrograms (1 ml). The time interval between dose administration should be determined by your doctor.

Children up to 5 years:

This medication should only be administered in case of acute asthma attacks in children up to 5 years.

The recommended dose is 125 to 250 micrograms (0.5-1 ml). The time interval between dose administration should be determined by your doctor, but it should never be less than 6 hours.

In case you do not experience significant improvement or your condition worsens, you should consult your doctor.

General instructions

Bromuro de Ipratropio Aldo-Unión should be used with suitable nebulizer devices. The mist produced is inhaled through the mask or mouthpiece. Your doctor will indicate which nebulizer is suitable and how to use it.

The solution of Bromuro de Ipratropio Aldo-Unión may be inhaled using an intermittent positive pressure ventilation device, in which case the treatment should be initiated by a doctor.

Usage instructions

1. Prepare your nebulizer following the instructions given by the manufacturer and/or your doctor. Make sure the nebulizer device is clean.
2. Take a plastic strip with ampoules out of the box, open it, and take one or two ampoules (depending on the dose) (Figure 1). Leave the rest of the ampoules on the strip and return it to the box. Never use an ampoule that is already open or if the solution is discolored.

Figure 1Figure 2

1. Take the ampoule and twist the top to open it (Figure 2).
2. Unless your doctor tells you otherwise, add the entire liquid from the ampoule to the nebulizer container.
3. Dispose of the empty plastic ampoule.

1. If your doctor has instructed you to dilute the solution, this should only be done using a sterile sodium chloride 0.9% solution. Use the amount indicated by your doctor.

1. Use the nebulizer according to your doctor's instructions. Breathe slowly and deeply, making sure the mask or mouthpiece is correctly positioned and that the nebulization is not directed at your eyes, as it may cause pain if it comes into contact.

This is especially important if you have glaucoma. If a significant amount of mist enters your eyes or you start to experience headache or eye discomfort after using this medication, you should consult your doctor or pharmacist.

1. The time it takes for the device to convert the solution and form a fine mist or spray that will then be inhaled will depend on the type of device used. Administration will be complete when the mist has disappeared.

1. After using the nebulizer, mask, or mouthpiece, clean it with warm soapy water and rinse it thoroughly.

Consult your doctor immediately if:

• You do not experience relief after administering the recommended dose.
• Difficulty breathing worsens.
• You experience chest tightness.

The above conditions are indicative of your symptoms not being controlled and may require different or additional treatment.

If you use more Bromuro de Ipratropio Aldo-Unión than you should:

You may feel that your heart is beating faster than usual or that your breathing rate is accelerated. You may experience high fever, restlessness, confusion, or hallucinations.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount administered. Contact your doctor or nearest Emergency Hospital Service. Bring this leaflet or an ampoule of this medication with you, so that the doctor treating you knows what you are taking.

If you forget to use Bromuro de Ipratropio Aldo-Unión.

If you forget to use Bromuro de Ipratropio Aldo-Unión, use the next dose when it is due or before if you start to experience difficulty breathing.

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

If you interrupt treatment withBromuro de Ipratropio Aldo-Unión.

If you stop treatment with Bromuro de Ipratropio Aldo-Unión, your condition may worsen. Do not stop treatment unless your doctor tells you to.

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

All medications can cause allergic reactions, although severe allergic reactions are very rare. Inform your doctor immediately if you suddenly experience "buzzing," difficulty breathing, eyelid, tongue, lip, or face swelling, rash, or itching (especially if it affects your entire body).This is known as "angioedema."

In very rare cases, effects such as acute dyspnea and/or difficulty breathing have occurred during treatment with Bromuro de Ipratropio Aldo-Unión. If this happens, discontinue the treatment with this medication immediately and consult with your doctor.

The following adverse effects have been reported:

Frequent(affect 1 in 10 people)

• Headache
• Cough
• Local irritation of the nose and mouth
• Dry mouth
• Nausea, and/or vomiting, constipation, diarrhea

Infrequent(affect less than 1 in 100 people)

• Skin rash and pruritus (itching)
• Increased heart rate
• Blurred vision, difficulty with visual accommodation, and other eye problems
• Glaucoma (increased intraocular pressure)

Rare(affect less than 1 in 1000 people)

• Increased intraocular pressure
• Irregular heart rhythm
• Urinary retention
• Eyelid pain
• Pupil dilation

If the solution or nebulized spray accidentally comes into contact with your eyes, it may cause redness, pain, blurred vision, and halos or colored images.

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 Medicinal Products for Human Use: https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above25ºC. Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging (ampoule, blister, and box). The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the solution is cloudy. Discard the solution and clean the nebulizer reservoir before reusing it.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Aldo-Unión Ipratropium Bromide

• The active ingredient is Ipratropium Bromide 250 micrograms (0.025% w/v).
• The other components are: sodium chloride, water for injection preparations, and hydrochloric acid.

Appearance of the product and contents of the packaging

The medication is presented in the form of plastic ampoules containing a water-based solution for inhalation via nebulizer (produces a fine mist for inhalation).

Other presentations:

Ampoules containing 2ml of solution (500 micrograms of Ipratropium Bromide/2 ml)

The ampoules are packaged in strips of 10 within the blister, and within the cardboard packaging. The available packaging sizes are 20 and 60 ampoules.

Not all formats may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder:

Aldo-Unión, S.L

C/Baronessa de Maldà nº 73

Esplugues del Llobregat

08950 Barcelona

Manufacturer:

Unither Laboratory

Espace Industriel Nord 151

Rue André Durouchez - CS 28028 Amiens

Cedex 2, 80084 France

Last review date of this leaflet:April 2016