Otrivine Child Nasal Drops

1. Name Of The Medicinal Product

Otrivine^® Child Nasal Drops

2. Qualitative And Quantitative Composition

Xylometazoline Hydrochloride 0.05% w/v

For excipients see 6.1

3. Pharmaceutical Form

Nasal drops, solution

The product is a clear, colourless solution

4. Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Posology And Method Of Administration

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.

4.3 Contraindications

• 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

4.4 Special Warnings And Precautions For Use

Patients are advised not to take decongestants for more than five consecutive days, without the advice of a doctor. Otrivine Child Nasal Drops 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

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

• Decongestants should not be used 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 Child Nasal Drops

• Each Otrivine Child Nasal Drops 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

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

• Keep medicines out of reach and sight of children

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

• Use with caution in occlusive vascular disease

• Keep away from the eyes

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

MAOIs and /or RIMAs: should not be given to patients treated with MAOIs or within 14 days of stopping treatment: increased risk of hypertensive crisis

•Moclobemide: risk of hypertensive crisis

•Antihypertensives (including adrenergic neurone blockers & beta-blockers):

Otrivine Child Nasal Drops may block the hypotensive effects

•Cardiac glycosides: increased risk of dysrhythmias

•Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism

•Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension

•Oxytocin– risk of hypertension

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 Child Nasal Drops during pregnancy.

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

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 Child Nasal Drops to people with cardiovascular disease.

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

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 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.

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

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

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

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

6.4 Special Precautions For Storage

Protect from heat

6.5 Nature And Contents Of Container

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

6.6 Special Precautions For Disposal And Other Handling

Keep all medicines 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 00030/0114

9. Date Of First Authorisation/Renewal Of The Authorisation

15 November 2003

10. Date Of Revision Of The Text

22 December 2009

Legal Category: P