Otrivine^® Adult Nasal Spray

Xylometazoline Hydrochloride 0.1% w/v

For excipients see section 6.1

Nasal spray, solution

The spray is a clear, colourless solution

For the treatment of nasal congestion, perennial and allergic rhinitis (including hay fever), sinusitis.

Adults, children over 12 years and the elderly: One application in each nostril 2 or 3 times daily

Route of administration: Nasal use

Known hypersensitivity to Otrivine.

Patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater.

Patients are advised not to take decongestants for more than seven consecutive days. Otrivine, like other preparations belonging to the same class of active substances, should be used only with caution in patients showing a strong reaction to sympathomimetic agents as evidenced by signs of insomnia, dizziness etc.

• Do not exceed the recommended dosage

• Decongestants should not be used for more than seven consecutive days. If symptoms persist consult your doctor

• If you are pregnant or taking other medicines or are under a doctor's care consult him before using Otrivine

• The adult spray should not be used for infants or children under 12 years

• Each Otrivine pack should be used by one person only to prevent any cross infection

• Some patients who have sensitive nasal passages may feel some local discomfort when applying nasal drops. Other side effects are very rare

• Keep medicines out of reach of children

None

No foetal toxicity or fertility studies have been carried out in animals. In view of its potential systemic vasoconstrictor effect, it is advisable to take the precaution of not using Otrivine during pregnancy.

Label warning: If you are pregnant or taking any other medicines or are under a doctor's care, consult him before using Otrivine.

None

The following side effects have occasionally been encountered: A burning sensation in the nose and throat, local irritation, nausea, headache, and dryness of the nasal mucosa.

Systemic cardiovascular effects have occurred, and this should be kept in mind when giving Otrivine to people with cardiovascular disease.

No cases of overdosage in adults have yet been reported. In rare instances of accidental poisoning in children, the clinical picture has been marked chiefly by signs such as acceleration and irregularity of the pulse, elevated blood pressure, drowsiness, respiratory depression or irregularity. There is no specific treatment and appropriate supportive treatment should be initiated.

Otrivine Adult Nasal Spray is a sympathomimetic agent with marked alpha-adrenergic activity, and is intended for use in the nose. It constricts the nasal blood vessels, thereby decongesting the mucosa of the nose and neighbouring regions of the pharynx. This enables patients suffering from colds to breathe more easily through the nose. The effect of Otrivine Adult Nasal Spray begins within a few minutes and lasts for up to 10 hours. Otrivine Adult Nasal Spray is generally well tolerated and does not impair the function of ciliated epithelium.

In a double-blind, saline solution (Otrisal) controlled study in patients with common cold, the

decongestant effect of Otrivine was significantly superior (p<0.0001) to Otrisal saline solution based on rhinomanometry measurement at 1 hour after administration of the study drugs.

Systemic absorption may occur following nasal application of xylometazoline hydrochloride solutions. It is not used systemically.

There are no findings in the preclinical testing which are of relevance to the prescriber.

Benzalkonium chloride

Disodium phosphate dodecahydrate (Sodium phosphate)

Disodium edetate

Sodium dihydrogen phophate dihydrate (Sodium acid phosphate)

Sodium chloride

Purified water

None

Unopened: 36 months

After the container is opened for the first time: 28 days

Do not store above 25°C.

Bottle: Low density polyethylene

Cap: High density polyethylene

Spray valve and capillary: Low density polyethylene

Carton: Cardboard

Pack size: 10 ml

Keep all medicines out of the reach of children

Novartis Consumer Health UK Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

Trading as: Novartis Consumer Health

PL 00030/0116

Date of first authorisation: 1 October 1997

22 December 2009.

Legal category: GSL