BUDESONIDE 64 Aqueous Nasal Spray Ref.[6670] Active ingredients: Budesonide

Posology

For nasal use only.

The dosage should be determined individually. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.

The duration of the therapy with Budesonide nasal spray should be restricted to the period of allergen exposure and depends on the nature and the characteristics of the allergen. For a full therapeutic benefit regular use is essential.

Allergic rhinitis

Initial dose

Adults, adolescents and children from 6 years of age:

The recommended initial dose of 256 micrograms may be administered once daily in the morning or divided into two administrations, in the morning and in the evening.

2 actuations into each nostril once daily in the morning or 1 actuation into each nostril in the morning and in the evening

Children should be treated under guidance of an adult.

Treatment of seasonal allergic rhinitis should be initiated, if possible, before the patient is exposed to allergens.

Concomitant therapy may sometimes be necessary to treat the symptoms affecting the eye caused by the allergy.

Maintenance dose

The desired clinical effect appears within about 1-2 weeks.

Afterwards, the lowest dose should be chosen that keeps the patient just without symptoms. No better efficacy is to be expected with a dose greater than 256 micrograms.

Nasal polyps

Adults, adolescents and children from 6 years of age:

The recommended dose for the treatment of nasal polyps is 256 micrograms. The dose may be administered once daily in the morning or divided into two administrations, in the morning and in the evening.

2 actuations into each nostril once daily in the morning or

1 actuation into each nostril in the morning and in the evening

Children should be treated under guidance of an adult.

After the desired clinical effect has appeared, the lowest dose should be chosen that keeps the patient without symptoms.

Method of administration

1. Gently blow your nose to clean the nostrils, if necessary.

2. Shake the bottle (figure 1). Remove the protective cap.

Figure 1:

3. Hold the bottle as shown in figure 2. Before using Budesonide nasal spray suspension for the first time you must prime the nozzle (i.e. fill it with medicine). Pump the nozzle up and down several times (5-10 times), spraying into the air until an even mist is seen. The priming effect remains for approximately 24 hours. If a longer period of time passes before the next dose is taken, the nozzle must be primed (filled with medicine) again. If Budesonide nasal spray suspension is used at shorter intervals it is sufficient to spray just once into the air.

Figure 2:

4. Insert the tip of the nozzle into your nostril as shown in figure 3 and spray once (or more if your doctor has told you to). Use the spray into the other nostril in the same way. Note, it is not necessary to breathe in at the same time as you spray.

Figure 3:

5. Wipe the nozzle with a clean tissue and replace the protective cap.

6. Store the bottle in an upright position.

Cleaning your Budesonide nasal spray suspension

You should clean the plastic nozzle of Budesonide nasal spray suspension regularly, and at any time the spray of medicine is not coming out as it should. If this happens, first check if the nozzle is primed with medicine (see earlier). If after priming the nozzle again the pump is still not working, clean the nozzle by using the following instructions:

• Remove the plastic nozzle with a clean tissue and wash in warm – not hot – water.
• Rinse the nozzle thoroughly, dry it and then replace onto the top of the bottle.
• Never try to unblock the nozzle by using a pin or other sharp object.

After cleaning the nozzle must be primed (filled with medicine) again before use.

An acute overdose with Budesonide nasal spray suspension is unlikely even if all the sprays contained in the bottle are administered all at once. Administration of doses higher than recommended (see section 4.2) for a longer period (over months) may result in suppression of hypothalamic-pituitary-adrenal axis.

2 years.

After first opening: 3 months.

Do not store above 30°C.

Do not freeze.

For storage conditions after first opening of the medicinal product, see section 6.3

Amber type III glass bottle fitted with a plastic nasal spray pump and polypropylene nasal applicator: pack size of 1 x120 (1 × 10 ml) doses, 3 × 120 (3 × 10 ml) doses, 10 × 120 (10 × 10 ml) doses

Not all pack sizes may be marketed.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.