Vividrin Nasal Spray

Active

Sodium cromoglycate EP 2.00% w/v.

Nasal spray.

For the prevention and relief of seasonal and perennial allergic rhinitis.

Route of Administration

For intra-nasal use.

Adults, Children and the Elderly

One spray into each nostril four to six times daily.

Note: Due to the prophylactic nature of sodium cromoglycate the patient should be encouraged to continue use even when symptoms have ceased.

Known hypersensitivity to benzalkonium chloride, sodium cromoglycate or other constituents.

Addition of Vividrin Nasal spray to existing sodium cromoglycate or steroid controlled asthma therapy may exaggerate the effects of that therapy.

It may be possible to reduce concomitant antihistamine therapy.

Use in Pregnancy: Vividrin Nasal Spray should be used cautiously during pregnancy and lactation. The widespread use of sodium cromoglycate has yet to reveal any adverse effects to mother or child during pregnancy.

Use in Lactation: It is not known whether sodium cromoglycate is excreted in human breast milk but on the basis of its physicochemical properties, this is considered unlikely. There is no information to suggest that the use of sodium cromoglycate has any undesirable effects on the baby

None known.

Occasional irritation of the nasal mucosa may occur during the first days of use. In rare cases wheezing or tightness of the chest have been reported by patients.

As sodium cromoglycate is absorbed only to a very limited extent in overdose, no action other than medical observation should be necessary.

Sodium cromoglycate has neither anti-histaminic or anti-inflammatory activity. Evidence suggests that sodium cromoglycate inhibits the release of mediators of the allergic reaction by stabilising the membranes of sensitised mast cells.

Sodium cromoglycate is poorly absorbed from the gastrointestinal tract. (Following inhalation as a fine powder only about 8% of a dose is reported to be deposited in the lungs from where it is rapidly absorbed and excreted unchanged in the urine and bile). Less than 7% of an intranasal dose is absorbed. The majority of an inhaled or an intranasal dose is swallowed, rapidly absorbed and excreted unchanged in the faeces.

The results of the studies do not add to the information needed by the prescriber, consequently, they are not repeated in the SPC.

Benzalkonium Chloride

Edetic Acid Disodium Salt 2H₂O

Polysorbate 80

Sorbitol

Sodium Hydroxide

Purified Water

Sodium cromoglycate forms insoluble complexes with metal ions resulting in solution turbidity.

36 months.

Store below 25ºC, out of direct sunlight.

15ml polyethylene bottles fitted with integral nasal spray pump and cap.

Pharma Global Limited

Hudson Road

Sandycove

Co Dublin

Republic of Ireland

PL 11185/0003

13^th December 1996/21^st November 2000

12^th June 1996

25^th January 2007