Otrivine® Child Nasal Drops

Xylometazoline Hydrochloride 0.05% w/v

For excipients see 6.1.

Nasal drops, solution

The product is a clear, colourless solution.

For the relief of nasal congestion associated with the common cold, perennial and allergic rhinitis (including hay fever), sinusitis.

Adults and elderly: Not applicable.

Otrivine Child Nasal Drops are contra-indicated in children under 6 years of age.

Children between 6 and 12 years (all indications):

1 or 2 drops, in each nostril 1 or 2 times daily.

Not to be used for more than 5 days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment.

Not more than 2 doses should be given in any 24 hours.

Route of administration: Nasal use

Do not exceed the stated dose

Keep out of the reach and sight of children.

• Known hypersensitivity to Otrivine or any of the excipients

• Concomitant use of other sympathomimetic decongestants

• Cardiovascular disease including hypertension

• Diabetes mellitus

• Phaeochromocytoma

• Hyperthyroidism

• Closed angle glaucoma

• Monoamine oxidase inhibitors (MAOIs, or within 14 days of stopping treatment, see section 4.5)

• Beta-blockers – (see section 4.5)

• Inflammation of the skin and/or mucosa of the nasal vestibule

• Trans-sphenoidal hypophysectomy or nasal surgery exposing the dura mater

• Not to be used in children under the age of 6 years

Patients are advised not to take decongestants for more than five 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 stated dose

• Do not take with any other cough and cold medicine.

• Do not use continuously for more than five consecutive days. If symptoms persist consult your doctor

• If your child is receiving medication or is under a doctor's care, consult him before giving Otrivine

• 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

• Some patients who have sensitive nasal passages may feel some local discomfort when applying nasal drops.

• Other side effects such as palpitations, nausea and headache are very rare

• Occasionally small children may show restlessness or sleep disturbance when Otrivine is used. If this occurs Otrivine should be stopped

• Keep medicines out of reach and sight of children

• Expectant mothers should consult their doctors before using Otrivine for themselves

As for all sympathomimetics, a reinforcement of the systemic effects of xylometazoline by concomitant use of monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants, cannot be excluded, especially in case of overdose.

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: Expectant mothers should consult their doctor before using Otrivine Child Nasal Drops for themselves.

No evidence of any adverse effect on the breast-fed infant. However, it is not known if xylometazoline is excreted in breast milk, therefore caution should be exercised and Otrivine should be used only on the advice of a doctor whilst breastfeeding.

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. In isolated cases, systemic allergic reactions and transient visual disturbances.

Oral agents

Cardiovascular effects

• Tachycardia/palpitations

• Other cardiac dysrhythmias and hypertension

• CNS effects

• Irritability

• Anxiety

• Restlessness

• Excitability

• Insomnia

• Hallucinations and paranoid delusions

Skin reactions including rash

Hypersensitivity reactions – including that cross-sensitivity may occur with other sympathomimetics

Other reactions

• Nausea and/or vomiting

• Headache

• Urinary retention

Topical agents

• Local effects – irritation and dryness

• Nausea

• Headache

• Rebound congestion (rhinitis medicamentosa) – especially with prolonged and/or heavy use

• Tolerance with diminished effect – especially with prolonged and/or heavy use

• Cardiovascular effects (as with oral agents) particularly with prolonged and/or excessive use

• CNS effects (as with oral agents) particularly with prolonged and/or excessive use

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 and sometimes consciousness clouding.

There is no specific treatment. Appropriate supportive measures should be initiated.

Otrivine Child Nasal Drops 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 Child Nasal Drops begins within a few minutes and lasts for up to 10 hours. Otrivine Child Nasal Drops 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 phosphate dihydrate (Sodium acid phosphate)

Sodium chloride

Sorbitol 70% (non-crystallising)

Hypromellose

Purified water

None

Unopened: 36 months

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

Protect from heat.

Bottle: High density polyethylene

Cap: Polypropylene

Pipette rod: Low density polythene

Pipette bulb: Halogenated butyl elastomer

Carton: Cardboard

The pipette forms an integral part of the cap.

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 00030/0114

15^th November 2003

05/04/2012

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