Budesonide Aldo-Union 0.5 mg/ml suspension for inhalation by nebulizer

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Budesonida Aldo-Unión 0.5 mg/ml Inhalation Suspension for Nebuliser

Budesonide

Read the entire 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 should not give it to other people, even if they have the same symptoms as you, since it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Budesonida Aldo-Unión is and what it is used for.
2. What you need to know before using Budesonida Aldo-Unión.
3. How to use Budesonida Aldo-Unión.
4. Possible adverse effects.
5. How to store Budesonida Aldo-Unión.
6. Contents of the pack and other information.

1. What Budesonida Aldo-Unión is and what it is used for

Budesonide belongs to a group of steroid compounds known as glucocorticoids, which are used to reduce or prevent inflammatory reactions (inflammation) in the lungs.

This medicine is used for the treatment of asthma. It is used in patients in whom other types of inhalers, such as pressurized metered-dose inhalers or inhalers containing a powder formulation, have not provided satisfactory results or are not suitable.

This medicine may also be used in hospitals for the treatment of severe cases of pseudocroup (a throat condition that can cause breathing difficulties).

2. What you need to know before using Budesonida Aldo-Unión

Do not use Budesonida Aldo-Unión:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Budesonida Aldo-Unión if any of the following apply to 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 infection of the airways, e.g. a cold or a lung infection.

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

If you are switching from oral corticosteroid treatment (such as prednisolona) to inhaled Budesonida via nebulizer, you may normally feel unwell during the transition. You may also experience symptoms previously suppressed by oral corticosteroids, such as allergic rhinitis (nasal itching, congestion, or runny nose), eczema (dry skin, skin itching), or muscle and joint pain. You should inform your doctor if this occurs.

Budesonida, suspension for inhalation by nebulizer is not suitable for use during acute episodes of breathlessness. A sudden attack of dyspnea (difficulty breathing) should be treated with a short-acting bronchodilator.

If you experience increased wheezing and/or difficulty breathing immediately after using Budesonida, suspension for inhalation by nebulizer, stop using Budesonida, suspension for inhalation by nebulizer immediately and consult your doctor.

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

Children and adolescents

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

Budesonida is a steroid. Please be aware that the use of this medicine may result in a positive doping test. If you are concerned, you should consult your doctor.

Use of Budesonida Aldo-Unión with other medicines:

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

• Medicines for fungal infections such as ketoconazole or itraconazole
• HIV treatments known as ritonavir or saquinavir
• The antibiotics erythromycin and clarithromycin
• Other medicines to help you breathe.
• Estrogens and steroid contraceptives.

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking any medicine. If you become pregnant while using this medicine, contact your doctor as soon as possible.

Driving and use of machines

The effect of inhaled budesonide on the ability to drive and operate machinery is negligible or none.

3. How to use Budesonide Aldo-Unión

Follow exactly the instructions for use given by your doctor. If in doubt, consult your doctor again.

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

Asthma

You may notice that your asthma improves within 3 days, but it may take 2 to 4 weeks to achieve the full effect. It is important that you continue taking the medicine as prescribed by your doctor, even if you feel better.

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

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

Children from 6 months to 11 years of age:

The usual dose is 0.25 to 1.0 mg of budesonide per day. Your doctor will advise you when your child should take the medicine, but it is usually administered in two doses per day. However, if the asthma is stable and not severe, your doctor may advise taking the medicine once daily.

Pseudocroup:

The usual dose in infants and children with pseudocroup is 2 mg. This may be administered as a single dose or as two doses of 1 mg given 30 minutes apart. Administration may be repeated every 12 hours until improvement is observed, for a maximum of 36 hours.

Method of use

The medicine must be used with a nebulizer. The mist produced is inhaled through a mouthpiece or a face mask. Ultrasonic nebulizers must not be used with this medicine.

To take the medicine, follow these steps:

1. Gently shake the reservoir once again and begin nebulization. During nebulization, breathe in the mist from the nebulized suspension deeply and slowly.
2. When no more mist comes out from the mouthpiece or mask, the treatment is complete.
3. After finishing, 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 important to do this to reduce the risk of certain side effects associated with this medicine.
   1. After each use, clean the nebulizer thoroughly. Wash the nebulizer reservoir and mouthpiece or mask with lukewarm water using a mild detergent, following the manufacturer's instructions. The nebulizer should be thoroughly rinsed and dried by connecting the reservoir to the compressor or air outlet.

Always follow the manufacturer's instructions provided with the nebulizer. If you are unsure about how to use the nebulizer, consult your doctor or pharmacist.

Your doctor may also prescribe the following:

• Your doctor may also consider adding oral steroids to your treatment during critical periods (such as during 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 gradually reduce your dose once you start using Budesonide inhalation suspension for nebulization. Because of this, you may experience certain symptoms such as nasal congestion or runny nose, lack of energy, depression, eczema, or muscle or joint pain. If any of these symptoms persist and become troublesome, consult your doctor.
• Your doctor may advise you to mix this medicine with other suspensions containing different active substances acting on the respiratory system, such as salbutamol, terbutaline, sodium cromoglicate, or ipratropium bromide. If so, follow their instructions carefully. Do not mix this medicine unless specifically instructed by your doctor.

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

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medication and the amount taken.

If you forget to use BudesonidaAldo-Unión

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

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

4. Possible adverse effects

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

All medicines can cause allergic reactions, although serious allergic reactions are very rare. Immediately inform your doctor if you suddenly develop whistling sounds, difficulty breathing, swelling of the eyelids, face or lips, rash or itching (especially if affecting the whole body).

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

The following adverse effects have been reported:

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

Uncommon: may affect up to 1 in 100 people: Cataracts (clouding of the eye's lens), depression or feeling anxious, muscle spasms, tremors, blurred vision.

Rare: may affect up to 1 in 1,000 people: Skin reactions*, including itching, rash, bruising, swelling, redness and/or skin eruptions, swelling, growth retardation in children and adolescents, hypersensitivity* (an allergy to the medicine), and bronchospasm (contraction of the muscles in the airways causing wheezing). Voice problems.

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

Feeling restless, nervousness, over-excitement, or irritability (these effects are more likely to occur in children).

Very rare: may affect up to 1 in 10,000 people: Decreased bone mineral density (thinning of the bones).

Frequency not known: cannot be estimated from available data: Glaucoma (increased pressure inside the eye), aggression, increased motor activity (difficulty remaining still), sleep disorders.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Budesonide Aldo-Unión

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

Do not use this medicine after the expiry date stated on the box or sachet, following EXP. The expiry date refers to the last day of the month indicated.

Store the ampoules in their aluminium sachet and in the original packaging to protect them from light and moisture.

Once an ampoule has been opened, it must be used within a maximum of 12 hours. After this time, any unused portion must be discarded.

Once a sachet has been opened, the ampoules may be stored for up to 3 months (it is advisable to write the opening date on the sachet to help you remember it).

Medicines must not be disposed of via wastewater drains or household waste. Dispose of containers and unused medicines at the Sigre Point located at your usual pharmacy, or through any other medicine waste collection system. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Budesonida Aldo-Unión

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

Budesonida Aldo-Unión 0.5 mg/ml, inhalation suspension for nebulizer contains 1.0 mg of budesonide (0.5 mg/ml) as the active substance in each 2 ml ampoule.

Appearance of Budesonida Aldo-Unión and contents of the pack

Budesonida Aldo-Unión is supplied as plastic ampoules containing 2 ml of white or almost white suspension for nebulization (to be converted into a fine mist for inhalation).

The ampoules are packed in strips of 4, 5, 8, 10 or 12 ampoules in an aluminum foil pouch, which is then packaged into cardboard packs. Packs containing 5, 20, 24, 40 (2 x 20) or 60 ampoules are available. Only certain pack sizes may be marketed.

Marketing Authorization Holder:

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

Manufacturer:

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

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

Denmark: Budesonid Arrow
Belgium: Budesonide Sandoz 0.5 mg/ml vernevelsuspensie
Germany: BUDENOBRONCH 1.0 mg/2 ml Suspension für einen Vernebler
Spain: Budesonida Aldo-Unión 0.5 mg/ml suspension for inhalation by nebulizer
Italy: Budesonide Sandoz 0.5 mg/ml sospensione per nebulizzatore
Luxembourg: Budesonid „Arrow“ 0.5 mg/ml Suspension für einen Vernebler
Netherlands: Budesonide Sandoz 0.5 mg/ml vernevelsuspensie in ampul, 2 ml
Norway: Budesonid Arrow inhalasjonsvæske til nebulisator, suspensjon 0.5 mg/ml
Sweden: Budesonid Arrow 0.5 mg/ml suspension för nebulisator
United Kingdom: Budesonide 1 mg Nebuliser Suspension

Date of the most recent review of this leaflet: May 2016

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/