Otrivine Adult Menthol Nasal Spray

1. Name Of The Medicinal Product

Otrivine ® Adult Menthol Nasal Spray

2. Qualitative And Quantitative Composition

Active ingredient: 0.1% w/v Xylometazoline Hydrochloride

3. Pharmaceutical Form

Nasal spray, 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 the elderly: One application in each nostril 2 to 3 times daily.

Not suitable for children under 12 years of age.

Route of administration: Nasal use.

4.3 Contraindications

Known sensitivity to xylometazoline. Patients with trans-phenoidal hypophysectomy or surgery exposing the dura mater.

4.4 Special Warnings And Precautions For Use

Precautions: 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 suitable for 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 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 patients 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 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 begins within a few minutes and lasts for up to 10 hours. Otrivine is generally well tolerated and does not impair the function of ciliated epithelium.

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 solution

Disodium phosphate dodecahydrate

Disodium edetate

Sodium dihydrogen phosphate

Sodium chloride

Menthol

Eucalyptol

Sorbitol

Macrogol glycerol hydroxystearate

Purified water

6.2 Incompatibilities

None.

6.3 Shelf Life

Unopened: 30 months

Opened: 28 days

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Squeeze bottle of high density polyethylene and polypropylene, with a polyethylene nose piece.

Pack size: 10ml

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 Ltd

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

Trading as: Novartis Consumer Health

8. Marketing Authorisation Number(S)

PL 00030/0118

9. Date Of First Authorisation/Renewal Of The Authorisation

1 October 1997

10. Date Of Revision Of The Text

12 February 2003

Legal category: GSL