Budesonide Alcon 50 micrograms/dose nasal spray suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

BUDESONIDE ALCON 50 micrograms/dose nasal spray suspension

Budesonide

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet.

Contents of the leaflet:

1. What BUDESONIDE ALCON 50 micrograms/dose is and what it is used for
2. What you need to know before using BUDESONIDE ALCON 50 micrograms/dose
3. How to use BUDESONIDE ALCON 50 micrograms/dose
4. Possible side effects
5. How to store BUDESONIDE ALCON 50 micrograms/dose
6. Contents of the pack and other information

1. What BUDESONIDE ALCON 50 micrograms/dose is and what it is used for

This medicinal product contains budesonide, which has 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) resulting from seasonal and chronic allergic conditions. It is also indicated for vasomotor rhinitis and for the treatment of nasal polyps and their prevention following polypectomy.

2. What you need to know before using BUDESONIDE ALCON 50 micrograms/dose

Do not use BUDESONIDE ALCON 50 micrograms/dose

If you are allergic (hypersensitive) to budesonide or to any of the other components of BUDESONIDE ALCON 50 micrograms/dose (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use BUDESONIDE ALCON 50 micrograms/dose.

• Patients with pulmonary tuberculosis or fungal or viral respiratory tract infections, as well as those previously treated with systemic corticosteroids (oral or injectable), should be treated with special caution and under medical supervision.
• During long-term treatment, the nasal mucosa should be examined at least once a year.
• Using the spray by more than one person may lead to transmission of infections.
• During treatment with this preparation, it should be considered that there is a potential risk of masking a local infection.
• After completion of the treatment period, any remaining medication should be discarded, even if not completely used up.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children

Children should use BUDESONIDE ALCON 50 micrograms/dose only under adult supervision to ensure correct administration and that the dose corresponds to that prescribed by the doctor.

Using BUDESONIDE ALCON 50 micrograms/dose with other medicines

No interactions have been reported. However, it is recommended to inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Occasionally, simultaneous administration of an antihistamine eye drop may be useful to counteract ocular effects caused by allergy.

Pregnancy and breastfeeding

This medicine should only be used during pregnancy and breastfeeding if considered necessary by your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

No effects on the ability to drive or operate machinery have been reported.

This medicine contains potassium sorbate

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

Athletes are advised that this medicine contains budesonide, which may lead to a positive result in doping control tests.

3. How to use BUDESONIDE ALCON 50 micrograms/dose

Follow exactly the administration instructions for BUDESONIDE ALCON 50 micrograms/dose provided by your doctor. If in doubt, consult your doctor or pharmacist.

The dosage should be individualized and may be adjusted at the physician's discretion.

In adults and children aged 6 years and older, the usual recommended dose is two sprays (100 mcg) in each nostril in the morning and evening (total 400 mcg).

When symptoms begin to improve, the dose may be reduced to one spray (50 mcg) in each nostril in the morning and evening (total 200 mcg).

Several days of treatment at the recommended doses and intervals are needed for symptoms to completely resolve.

Treatment for seasonal rhinitis should be started, whenever possible, before exposure to the allergen.

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

Instructions for correct administration of the preparation:

Repeat the same process in the other nostril.

After use, replace the protective cap.

Using the spray by more than one person may lead to transmission of infections.

If you use more BUDESONIDE ALCON 50 micrograms/dose than you should

Although no toxic symptoms are expected following overdose or accidental ingestion, in such cases consult the Toxicology Information Service. Telephone 91 562 04 20.

If, under any very unusual circumstances, symptoms such as edema, facial swelling, or moon face appear, inform your doctor promptly so that appropriate measures can be taken.

If you forget to use BUDESONIDE ALCON 50 micrograms/dose

Do not use a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, BUDESONIDE ALCON 50 micrograms/dose may produce adverse effects, although not everyone experiences them.

Occasionally, episodes of sneezing may occur immediately after using the spray.

Rarely, mild nasal bleeding, nasal dryness, throat irritation, or blurred vision may occur.

Very rarely, cases of skin allergic reactions associated with the use of this preparation have been reported. Extremely rare cases of nasal septum perforation have been reported following the use of corticosteroids administered by the nasal route.

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

5. Storage of BUDESONIDE ALCON 50 micrograms/dose

No special storage conditions are required.

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

Do not use BUDESONIDE ALCON 50 micrograms/dose after the expiry date stated on the container. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Information for the user

Composition of BUDESONIDE ALCON 50 micrograms/dose

• Each 100 ml contains 0.1 g of budesonide (INN).
• Each dose delivers 50 mcg of budesonide. A spray bottle contains 200 doses.
• Excipients: glucose, potassium sorbate, disodium edetate, sodium carboxymethylcellulose, polysorbate 80, and purified water.

Appearance of the medicine and contents of the pack

BUDESONIDE ALCON 50 micrograms/dose is a nasal spray suspension presented in glass bottles containing 10 ml (200 doses of 50 mcg/dose).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

M4 PHARMA, S.L.
C/ Tánger, 86
08018 Barcelona (Spain)

Manufacturer

LABORATORIO REIG JOFRE, S.A.
Gran Capita, 10.
Sant Joan Despi, Barcelona - Spain

Local representative

Laboratorios ERN, S.A.
C/Perú, 228
08020 Barcelona, Spain

This leaflet was last reviewed in June 2017

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/