Budesonide Alcon 100 micrograms/DOSE nasal spray suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

BUDESONIDE ALCON 100 micrograms/dose nasal spray suspension

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, 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 may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet.

Contents of the leaflet

1. What BUDESONIDE ALCON 100 micrograms/dose is 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. How to store BUDESONIDE ALCON 100 micrograms/dose
6. Contents of the pack and other information

1. What BUDESONIDE ALCON 100 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 100 micrograms/dose

Do not use BUDESONIDE ALCON 100 micrograms/dose

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use BUDESONIDE ALCON 100 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.
• Sharing the spray among 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 preparation 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 100 micrograms/dose only under adult supervision to ensure correct administration and that the dose corresponds to that prescribed by the doctor.

Use of BUDESONIDE ALCON 100 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 helpful 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 result in a positive doping test.

3. How to use BUDESONIDE ALCON 100 micrograms/dose

Follow exactly the administration instructions for BUDESONIDE ALCON 100 micrograms/dose provided by your doctor. If in doubt, consult your doctor or pharmacist.

The dosage should be individualized and may be adjusted according to medical judgment.

In adults and children aged 6 years and older, the usual recommended dose is two sprays (200 mcg) in each nostril once daily in the morning (total 400 mcg).

When symptoms begin to improve, the dose may be reduced to one spray (100 mcg) in each nostril (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.

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

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

Instructions for correct administration of the preparation

Before first use:

• Remove the protective cap.
• Shake the bottle-applicator assembly.
• Prime the pump by pressing the nozzle several times until the spray mechanism is filled and a fine mist is produced.

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 100 micrograms/dose than you should

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

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

If you forget to use BUDESONIDE ALCON 100 micrograms/dose

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

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 100 micrograms/dose may cause 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 following the use of intranasal corticosteroids have been reported.

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

5. Storage of BUDESONIDE ALCON 100 micrograms/dose

No special storage conditions are required.

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

Do not use BUDESONIDE ALCON 100 micrograms/dose after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, please consult your pharmacist on how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional information

Composition of BUDESONIDE ALCON 100 micrograms/dose

• Each 100 ml contains 0.2 g of budesonide (INN).
• Each dose delivers 100 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 medicinal product and contents of the pack

BUDESONIDE ALCON 100 micrograms/dose is a medicinal product in the form of a nasal suspension for spray, supplied in 10 ml glass bottles (200 doses of 100 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 medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/