IPRATROPIUM BROMIDE ALDO-UNION 250 micrograms/ml SOLUTION FOR NEBULIZER INHALATION

Introduction

Package Leaflet: Information for the User

Ipratropium Bromide Aldo-Union 250 micrograms/ml, Solution for Inhalation by Nebulizer

(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

1. What is Ipratropium Bromide Aldo-Union and what is it used for
2. What you need to know before you use 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 other information

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

Ipratropium bromide belongs to a group of medicines called “bronchodilators” that work by relaxing the muscle of the bronchi, making it easier to breathe.

This medicine helps patients with asthma and other breathing difficulties, such as Chronic Obstructive Pulmonary Disease (COPD), to breathe more easily.

Ipratropium Bromide Aldo-Union may be administered together with beta2-agonist bronchodilator medicines, such as salbutamol.

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

Do not use Ipratropium Bromide Aldo-Union:

• If you are allergic to ipratropium bromide or to atropine-like substances or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

• If you suffer from 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 Ipratropium Bromide Aldo-Union with other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

• Xanthine derivatives, such as theophylline.
• Other medicines that contain bronchodilators (which help you breathe more easily), such as salbutamol or terbutaline.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

Driving and using machines

Ipratropium Bromide Aldo-Union has no effects on the ability to drive and use machines.

3. How to use Ipratropium Bromide Aldo-Union

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are in 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 attacks of shortness of breath, 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 doses should be determined by the doctor.

Children up to 5 years:

This medicine should only be administered in case of acute attacks of shortness of breath in children up to 5 years.

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

If you do not achieve significant improvement or if your condition worsens, you should consult your doctor.

General instructions

Ipratropium Bromide Aldo-Union should be used with suitable nebulizers. 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 Ipratropium Bromide Aldo-Union can be inhaled using an intermittent positive pressure ventilation device, in which case the treatment should be initiated by a doctor.

Instructions for use

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

Drawing 1 Drawing 2

1. Take the ampoule and open it by twisting the top (Drawing 2).
2. Unless your doctor has given you other instructions, add all the liquid from the ampoule to the nebulizer reservoir.
3. Discard the empty plastic ampoule.

1. If your doctor has instructed you to dilute the solution, this should only be done using a sterile 0.9% sodium chloride 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 in place and that the nebulization is not directed at your eyes, as it may cause pain in case of contact.

This is especially important if you have glaucoma. If a significant amount of mist comes into contact with your eyes or if you start to experience headache or eye discomfort after using this medicine, 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. The complete administration will take place when the mist has disappeared.

1. After using the nebulizer, mask or mouthpiece, wash it with warm soapy water and rinse it well afterwards.

Consult your doctor immediately if:

• You do not feel relief after administering the recommended dose.
• Your breathing difficulties worsen.
• You feel chest tightness.

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

If you use more Ipratropium Bromide Aldo-Union than you should:

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

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

If you forget to use Ipratropium Bromide Aldo-Union.

If you forget to use Ipratropium Bromide Aldo-Union, use the next dose when it is due or before if you start to have difficulty breathing.

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

If you stop using Ipratropium Bromide Aldo-Union.

If you stop using Ipratropium Bromide Aldo-Union, your condition may worsen. Do not stop treatment unless your doctor tells you to.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor immediately if you suddenly experience “wheezing”, difficulty breathing, swelling of the eyelids, face, lips or tongue, rash or itching (especially if it affects the whole body). This is known as “angioedema”.

Very rarely, effects such as acute shortness of breath and/or difficulty breathing have occurred during treatment with Ipratropium Bromide Aldo-Union. If this happens, stop treatment with this medicine immediately and consult your doctor.

The following side 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

Uncommon(affect less than 1 in 100 people)

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

Rare(affect less than 1 in 1000 people)

• Increased eye pressure
• Irregular heart rhythm
• Urinary retention
• Eye pain
• Pupil dilation

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects 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. Storage of Ipratropium Bromide Aldo-Union

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

Do not store above 25°C. Store in the original packaging to protect from light.

Do not use this medicine after the expiry date which is stated on the packaging (ampoule, blister and carton). The expiry date is the last day of the month stated.

Do not use this medicine if you notice that the solution is cloudy. Discard the solution and wash the nebulizer reservoir before using it again.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ipratropium Bromide Aldo-Union

• The active substance is Ipratropium Bromide 250 micrograms (0.025% w/v).
• The other ingredients are: sodium chloride, water for injections and hydrochloric acid.

Appearance and packaging

The medicine is presented as a solution for inhalation by nebulizer (producing a fine mist for inhalation) in plastic ampoules.

Other presentations:

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

The ampoules are packaged in strips of 10 in the blister pack, and in the carton. The available pack sizes are 20 and 60 ampoules.

Not all formats may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorio Aldo-Unión, S.L.

C/Baronessa de Maldà nº 73

Esplugues del Llobregat

08950 Barcelona

Manufacturer:

Laboratoire Unither

Espace Industriel Nord 151

Rue André Durouchez - CS 28028 Amiens

Cedex 2, 80084 France

Date of last revision of this leaflet:April 2016