Package Insert: Information for the User

Budesonide Aldo-Union 0.5 mg/ml Suspension for Inhalation by Nebulizer

Budesonide

Read this package insert carefully before starting to take the medication because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you 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 package insert. See section 4.

Budesonide belongs to a group of steroid compounds called glucocorticoids that are used to reduce or prevent inflammatory reactions (inflammation) in the lungs.

This medication is used for the treatment of asthma. It is used in patients in whom other types of inhalers, such as pressurized canister inhalers or inhalers containing a powder formulation, have not provided satisfactory results or are not appropriate.

This medication may also be used in hospitals for the treatment of severe cases ofpseudocroup(a throat disease that can cause difficulty breathing).

No use Budesonida Aldo-Unión:

If you are allergic to budesonide or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Budesonida Aldo-Unión if any of the following situations affect you:

• If you have or have had tuberculosis
• If you have or have had a liver disease or liver problems.
• If you have a fungal, viral, or any other respiratory tract infection, e.g. a cold or a lung infection.

Notify your doctor if you experience blurred vision or other visual disturbances.

If you are changing from oral corticosteroid treatment (such as prednisolone) to inhaled budesonide, you may feel unwell during the change. You may also experience symptoms that were suppressed by oral corticosteroids, such as allergic rhinitis (itching, nasal congestion, or runny nose), eczema (dry skin, skin itching), muscle and joint pain. Inform your doctor if this happens.

Budesonide inhalation suspension is not suitable for use in acute asthma attacks. A sudden asthma attack should be treated with a short-acting bronchodilator.

If you experience more wheezing and/or breathing difficulty immediately after using Budesonida, inhalation suspension, discontinue use immediately and consult your doctor.

To reduce the risk of oral candidiasis (white patches on the tongue or in the mouth), rinse your mouth with water (spit out the water, do not swallow it) and brush your teeth after using Budesonida, inhalation suspension. Inform your doctor if you develop oral candidiasis.

Children and adolescents

In rare cases, long-term treatment with budesonide may delay normal growth in children and adolescents. If your child uses this medication for a prolonged period, it is normal for your doctor to monitor their height periodically.

Budesonide is a steroid. Be aware that, as a result of using this medication, you may test positive in doping control tests. If this concerns you, consult your doctor.

Use of Budesonida Aldo-Unión with other medications:

Inform your doctor if you are taking any of the following medications that may interact with this product:

• Antifungal medications such as ketoconazole or itraconazole
• Medications for HIV treatment called ritonavir or saquinavir
• Erythromycin and clarithromycin antibiotics
• Other medications to help you breathe.
• Estradiol and steroid contraceptives.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking a medication. If you become pregnant while using this medication, contact your doctor as soon as possible.

Driving and operating machinery

The influence of inhaled budesonide on the ability to drive and operate machinery is negligible or insignificant.

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

Your doctor will indicate the correct dose depending on the severity of your asthma.

Asthma

You may notice that your asthma improves within 3 days, but for the complete effect to be achieved, it may take 2 to 4 weeks. It is essential to continue taking the medication as prescribed by your doctor, even if you feel better.

Adults (including elderly) and adolescents 12 years or older:

The usual dose is 0.5 to 2 mg of budesonide per day. This dose will be administered normally divided into two doses, although if your asthma is stable and not severe, your doctor may advise you to take it once a day. Your doctor will advise you on how and when to take the medication, and you should always follow their instructions.

Children from 6 months to 11 years:

The usual dose is 0.25 to 1.0 mg of budesonide per day. Your doctor will advise you when your child should use the medication, but normally it will be in two daily administrations. However, if your asthma is stable and not severe, your doctor may advise you to take the medication once a day.

Pseudocroup:

The usual dose in infants and children with pseudocroup is 2 mg. It can be administered in a single dose or in two doses of 1 mg separated by a 30-minute interval. It can be repeated every 12 hours until improvement is observed, for a maximum of 36 hours.

Form of use

The medication must be used with a nebulizer. The mist produced is inhaled through a mouthpiece or a mask. This medication should not be used with ultrasonic nebulizers.

To take the medication, follow these steps:

6. Gently shake the container again and start the nebulization. During nebulization, breathe the mist of the nebulized suspension deeply and slowly.

7. When no more mist comes out of the mouthpiece or mask, the treatment will be finished.

8. When finished, rinse your mouth with water (do not swallow the water) and brush your teeth. If you used a mask, wash your face thoroughly. It is essential to do this to reduce the risk of some side effects associated with this medication.

1. After each use, wash the nebulizer thoroughly. Wash the nebulizer container and mouthpiece or mask with warm water using a mild detergent following the manufacturer's instructions. The nebulizer must be thoroughly cleaned and dried by connecting the container to the compressor or air outlet.

It is essential to always follow the manufacturer's instructions that come with the nebulizer. If you are unsure how to use the nebulizer, consult your doctor or pharmacist.

Your doctor may prescribe the following:

• Your doctor may also consider adding oral steroids to your treatment during critical periods (such as if you have an infection), before surgery, or if you have been taking a high dose of an inhaled steroid for a prolonged period.
• If you have been taking oral steroids for your asthma, your doctor will reduce the amount you need to take once you start using Budesonida suspension for inhalation by nebulizer. As a result, you may notice some symptoms such as nasal congestion or runny nose, lack of energy, depression, eczema, and muscle or joint pain. If any of these symptoms persist and are very bothersome, consult your doctor.
• Your doctor may advise you to mix this medication with other suspensions containing other active substances that act on the respiratory system, such as salbutamol, terbutaline, cromoglic acid, and ipratropium bromide. If so, follow their instructions carefully. Do not mix this medication unless your doctor has specifically instructed you to do so.

If you have taken more Budesonida Aldo-Unión than you should

Contact your doctor or pharmacist as soon as possible. Remember to bring the package and remaining ampoules with you.It is essential that you take the dose indicated on the label by the pharmacist or the dose recommended by your doctor. Do not increase or decrease the dose without medical consent.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service immediately. Phone: 91 562 04 20, indicating the medication and the amount taken.

If you forgot to use Budesonida Aldo-Unión

Do not take a double dose to compensate for the missed doses. Simply take the next dose at the scheduled time.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

All medicines can cause allergic reactions, although severe allergic reactions are very rare. Inform your doctor immediately if you suddenly experience wheezing, difficulty breathing, eyelid swelling, facial or lip swelling, rash or itching (especially if it affects the entire body).

Rarely, inhaled medicines like budesonide can cause sudden wheezing and/or difficulty breathing. If this occurs, stop using the medicine immediately and consult your doctor..

The following side effects have been reported:

Common:may affect up to 1 in 10 people:Muscle pain and/or mouth irritation (including oral ulcers or mouth sores), hoarseness, throat irritation, difficulty swallowing, and cough.

Uncommon:may affect fewer than 1 in 100 people

Cataracts (lens opacity in the eye), depression or anxiety, muscle spasms, tremors, blurred vision.

Rare:may affect up to 1 in 1,000 people:Dermatological reactions*, including itching, rash, bruising, inflammation, redness, and/or skin eruptions, swelling, growth delay in children and adolescents, hypersensitivity* (an allergy to the medicine) and bronchospasm (constriction of the airway muscles that causes wheezing). Voice problems.

Suppression of the adrenal gland (a small gland near the kidney) may occur. The main symptoms of adrenal suppression include headache, fatigue, nausea and vomiting, weight loss, stomach pain, and loss of appetite.

Restlessness, nervousness, overexcitement, or irritability (these effects are more likely to occur in children)

Very rare:may affect up to 1 in 10,000 people:Bone mineral density decrease (bone thinning).

Unknown frequency:cannot be estimated from available data

Glaucoma (increased eye pressure), aggression, increased motor activity (difficulty remaining still), sleep disorders.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date indicated on the box or the package after CAD.The expiration date is the last day of the month indicated.

Store the ampoules in their aluminum foil and in their original packaging to protect them from light and moisture.

Once an ampoule is opened, it must be used within a maximum period of 12 hours. Any unused amount should be discarded after this time.

Once a package is opened, the ampoules can be stored for up to 3 months (it is recommended to note the date of opening on the package to help you remember it)

Medications should not be thrown away through the drains or in the trash. Dispose of the containers and medications you no longer need at the Punto Sigreof your usual pharmacyor any other medication waste collection system. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Budesonide Aldo-Unión Composition

• The active ingredient is Budesonide
• The other components are edetate disodium, sodium chloride, polisorbate 80, citric acid, sodium citrate, and purified water.

Budesonide Aldo-Unión 0.5 mg/ml, suspension for inhalation by nebulizer contains 1.0 mg of budesonide (0.5 mg/ml) as active ingredient in each 2 ml ampule.

Appearance of Budesonide Aldo-Unión and packaging contents

Budesonide Aldo-Unión is presented in plastic ampules with 2 ml of white or off-white suspension to be nebulized (converted into a fine mist to be inhaled).

The ampules are packaged in strips of 4, 5, 8, 10, or 12 ampules in an aluminum foil pouch that is further packaged in cardboard boxes. Packaging is available in boxes containing 5, 20, 24, 40 (2 x 20), or 60 ampules. Only some packaging sizes may be commercially available.

Marketing Authorization Holder:

Aldo-Unión, S.L. c/ Baronesa de Malda nº 73, Esplugues de Llobregat, 08950 Barcelona (Spain)

Responsible for Manufacturing:

UNITHER PHARMACEUTICALS 151 Rue Andre Durouchez, Espace Industriel Nord Amiens Cedex 2. 80084 France

This medicinal product is authorized in the Member States of the EEA with the following names:

DenmarkBudesonid Arrow

BelgiumBudesonide Sandoz 0.5 mg/ml nebulisationssuspensie

GermanyBUDENOBRONCH 1.0mg/2ml Suspension für einen Vernebler

SpainBudesonida Aldo-Unión 0.5mg/ml suspension for inhalation by nebulizer

ItalyBudesonide Sandoz 0.5mg/ml sospensione per nebulizzatore

LuxembourgBudesonid „Arrow“ 0.5mg/ml Suspension für einen Vernebler

NetherlandsBudesonide Sandoz 0.5mg/ml vernevelsuspensie in ampul, 2ml.

NorwayBudesonid Arrow inhalation liquid for nebulizer, suspension 0.5mg/ml

SwedenBudesonid Arrow 0.5mg/ml suspension for nebulizer

United KingdomBudesonide 1mg Nebuliser Suspension

Last review date of this leaflet:May2016

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/