Leaflet: information for the user

BUDESONIDE ALCON 100 micrograms/dose nasal spray suspension

Budesonide

Read this leaflet carefully before you start using the medicine, because 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; do 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.

1. What is BUDESONIDE ALCON 100 micrograms/dose and what it is used for

2. What you need to know before using BUDESONIDE ALCON 100 micrograms/dose

3. How to use BUDESONIDE ALCON 100 micrograms/dose

4. Possible side effects

5. Storage of BUDESONIDE ALCON 100 micrograms/dose

6. Contents of the pack and additional information

This medication contains budesonide, with anti-inflammatory and antiallergic activity when applied to the nasal mucosa.

It is indicated for the relief of congestion, irritation, and localized discomfort in the nasal mucosa (rhinitis), which are consequences of seasonal and chronic allergic processes. Also in vasomotor rhinitis and in the treatment of nasal polyps and their prevention after a polypectomy.

Do not use BUDESONIDA ALCON 100 micrograms/dose

If you are allergic (hypersensitive) to budesonide or to any of the other components of BUDESONIDA ALCON 100 micrograms/dose (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use BUDESONIDA ALCON 100 micrograms/dose.

• Patients with pulmonary tuberculosis or fungal or viral respiratory tract infections, or those previously treated with systemic corticosteroids (oral or injectable), should be treated with special caution and under the supervision of a doctor.
• In long-term treatments, a nasal mucosa review should be performed at least once a year.
• The use of the inhaler by more than one person may lead to contagion.
• During treatment with this preparation, it should be taken into account that there is a potential risk of masking a local infection.
• After the treatment period, it is recommended to discard the remaining preparation, even if it has not been fully consumed.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children

Children should use BUDESONIDA ALCON 100 micrograms/dose only under the supervision of an adult to ensure correct administration and that the dose corresponds to the one prescribed by the doctor.

Use of BUDESONIDA ALCON 100 micrograms/dose with other medications

No interactions have been described, although it is recommended to inform your doctor or pharmacist if you are using, or have recently used, any other medication, including those acquired without a prescription.

In some cases, simultaneous administration of an antihistamine eye drop may be useful to counteract the ocular effects produced by the allergy.

Pregnancy and breastfeeding

This medication will only be used during pregnancy and breastfeeding when the doctor considers it necessary. Consult your doctor or pharmacist before using any medication.

Driving and operating machineryNo effects on the ability to drive and operate machinery have been described.

This medication contains potassium sorbate

This medication may cause local skin reactions (such as contact dermatitis) because it contains potassium sorbate as an excipient.

It is reported to athletes that this medication contains budesonide, which may lead to a positive result in doping control tests.

Follow exactly the administration instructions for BUDESONIDA ALCON 100 micrograms/dose as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

The dosage should be individualized and may be modified according to medical criteria.

In adults and children aged 6 years and above, the recommended dose is two applications (200 mcg) in each nasal fossa once a day, in the morning (total 400 mcg).

When symptoms start to subside, the dose can be reduced to one application (100 mcg) in each nasal fossa (total 200 mcg).

For symptoms to completely disappear, several days are required, using the recommended doses and intervals.

The treatment of seasonal rhinitis should be initiated, whenever possible, before exposure to the allergen.

In the treatment of nasal polyps, the daily dose may be increased to 800 mcg.

The total daily dose may be divided, administered in the morning and evening, according to medical criteria.

Instructions for correct administration of the preparation

Before the first application:

• Remove the protective cap.
• Shake the combination bottle-sprayer.
• Operate the trigger as many times as necessary to fill the valve mechanism and produce a correct spraying.

Repeat the same process in the other nasal fossa.

After use, place the protective cap.

The use of the sprayer by more than one person may lead to contagion.

If you use more BUDESONIDA ALCON 100 micrograms/dose than you should

Although no toxic symptoms are expected from overdose or accidental ingestion, in such cases, consult the Toxicological Information Service. Phone 91 562 04 20.

If, in any special circumstance, symptoms of edema, facial swelling, or full moon face, etc., are observed, inform your doctor so that appropriate measures can be applied.

If you forgot to use BUDESONIDA ALCON 100 micrograms/dose

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

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

Like all medications, BUDESONIDA ALCON 100 micrograms/dose may produce adverse effects, although not all people will experience them.

Occasionally, sneezing fits may occur immediately after using the spray.

Mild nasal bleeding, nasal dryness, and throat irritation or blurred vision may rarely occur.

Exceptionally, cases of skin allergic reactions associated with the use of the preparation have been described. Extremely rare cases of nasal septum perforation have been reported after the use of nasal corticosteroids.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this leaflet, consult your doctor or pharmacist.

No special conservation conditions are required.

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

Do not use BUDESONIDA ALCON 100 micrograms/dose after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Budesonide Alcon 100 micrograms/dose Composition

- Each 100 ml contains 0.2 g of budesonide (DCI).

- Each dose provides 100 mcg of budesonide. A bottle contains 200 doses.

- Excipients: glucose, potassium sorbate, disodium edetate, cellulose, and sodium carboxymethylcellulose, polysorbate 80, and purified water.

Product Appearance and Packaging Contents

Budesonide Alcon 100 micrograms/dose is a nasal spray suspension, presented in glass bottles with 10 ml (200 doses of 100 mcg/dose).

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

M4 PHARMA, S.L.

C/ Tánger, 86

08018 Barcelona (Spain)

Responsible Manufacturer

LABORATORIO REIG JOFRE, S.A.

Gran Capita, 10.

Sant Joan Despi, Barcelona – Spain

This leaflet was revised in June 2017

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/