Otrivine Adult Measured Dose Sinusitis Spray

1. Name Of The Medicinal Product

Otrivine^® Adult Measured Dose Sinusitis Spray

Otrivine^® Adult Metered Dose 0.1% Nasal Spray

2. Qualitative And Quantitative Composition

Active ingredient: 0.1% w/v Xylometazoline Hydrochloride

For excipients see 6.1

3. Pharmaceutical Form

Nasal spray, solution

A clear, colourless solution

4. Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Posology And Method Of Administration

Adults and elderly: One application in each nostril 1 to 3 times daily.

Not suitable for children under 12 years.

Route of administration: Application to the nasal passages.

4.3 Contraindications

Known hypersensitivity to xylometazoline.

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

4.4 Special Warnings And Precautions For Use

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.

Label warnings and precautions

• Do not exceed the stated dose

• Do not use continuously 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 your doctor before using Otrivine

• Not to be used for infants or children under 12 years

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

• For reasons of hygiene do not use this bottle for more than 28 days after first opening it

• Keep medicines out of the reach of children

Additional leaflet warnings and precautions

• Do not use if you are sensitive to any of the ingredients of Otrivine

• Do not use if you have had recent neurosurgery

• Consult your doctor before using Otrivine if you have heart or circulatory disease

• Some patients who have sensitive nasal passages may feel some local discomfort when applying the product. Other side effects such as palpitations, nausea and headache are very rare

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None

4.6 Pregnancy And Lactation

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.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

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.

4.9 Overdose

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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Otrivine Adult Measured Dose Sinusitis 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 Measured Dose Sinusitis Spray begins within a few minutes and lasts for up to 10 hours. Otrivine Adult Measured Dose Sinusitis 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 Otrivin was significantly superior (p<0.0001) to Otrisal saline solution based on rhinomanometry measurement at 1 hour after administration of the study drugs.

5.2 Pharmacokinetic Properties

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

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Benzalkonium chloride

Disodium phosphate dodecahydrate (Sodium phosphate)

Disodium edetate

Sodium dihydrogen phosphate dihydrate (Sodium acid phosphate)

Sodium chloride

Sorbitol

Hypromellose

Purified water

6.2 Incompatibilities

None

6.3 Shelf Life

Unopened: 36 months

Opened: 28 days

6.4 Special Precautions For Storage

No special precautions.

6.5 Nature And Contents Of Container

High density polyethylene bottle with a polypropylene/polyethylene metered dose pump in a cardboard carton.

Pack size 10 ml.

6.6 Special Precautions For Disposal And Other Handling

Medicines should be kept out of the reach of children.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

Trading as: Novartis Consumer Health

8. Marketing Authorisation Number(S)

PL 00030/0117

9. Date Of First Authorisation/Renewal Of The Authorisation

First Authorisation: 1^st October 1997

10. Date Of Revision Of The Text

4 March 2010

LEGAL STATUS

GSL