This information is intended for use by health professionals

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 relief of nasal congestion associated with the common cold, 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 under adult supervision (all indications): 1 or 2 drops, in each nostril up to 2 times a day.

Not to be used for more than 5 days without the advice of a doctor. (see warnings and precautions)

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

Prostatic hypertrophy

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

Rhinitis sicca or atrophic rhinitis

4.4 Special warnings and precautions for use

Patients are advised not to take decongestants for more than five consecutive days. Prolonged or excessive use may cause rebound congestion and/or atrophy of the nasal mucosa.

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, tremor, cardiac arrhythmias or elevated blood pressure.

Use with caution in occlusive vascular disease

If any of the following occur, Otrivine should be stopped

• Hallucinations

• Restlessness

• Sleep disturbances

Keep away from eyes.

Keep medicines out of the sight and reach of children.

Otrivine 0.05% is contraindicated in children aged less than 6 years old

Information concerning excipients

Otrivine contains benzalkonium chloride. This may cause irritation of the nasal mucosa.

4.5 Interaction with other medicinal products and other forms of interaction

The concomitant use of xylometazoline with monoamine oxidase (MAO) inhibitors, reversible inhibitors of monoamine oxidase (RIMAs) or tri- and tetra-cyclic antidepressants, may cause an increase in blood pressure due to the cardiovascular effects of these substances (see Contraindications).

Moclobemide: risk of hypertensive crisis.

Antihypertensives (including adrenergic neurone blockers & beta-blockers): Otrivine may block the hypotensive effects.

Cardiac glycosides: increased risk of dysrhythmias

Ergot alkaloids (ergotamine & methylsergide): increased risk of ergotism

Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension

Oxytocin – risk of hypertension

4.6 Fertility, 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.

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.

4.7 Effects on ability to drive and use machines

Otrivine has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

The adverse effects listed below are classified by system organ class and frequency according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000).

MeDRA SOC

Adverse reaction

Frequency

Immune System Disorders

Hypersensitivity reaction (angioedema, rash, pruritus)

Very rare

Nervous System Disorders

Headache

Common

Irritability, Anxiety, Restlessness, Excitability, Insomnia, Hallucinations and Paranoid Delusions - particularly with prolonged and/or excessive use

Unknown

Eye Disorders

Transient visual impairment

Very rare

Cardiac Disorders

Heart rate irregular, Heart rate increased - particularly with prolonged and/or excessive use

Very rare

Other cardiac dysrhythmias and hypertension- particularly with prolonged and/or excessive use

Unknown

Respiratory, thoracic and mediastinal disorders

Nasal Dryness, Nasal Discomfort

Common

Gastrointestinal disorders

Nausea

Common

General disorders and administration site

Application site burning

Common

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

Unknown

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

Unknown

Irritation & dryness

Unknown

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.

4.9 Overdose

Symptoms and Signs

Excessive administration of topical xylometazoline hydrochloride or accidental ingestion may cause severe dizziness, perspiration, severely lowered body temperature, headache, bradycardia, hypertension, respiratory depression, coma and convulsions. Hypertension may be followed by hypotension. Small children are more sensitive to toxicity than adults.

Treatment

Appropriate supportive measures should be initiated in all individuals suspected of an overdose, and urgent symptomatic treatment under medical supervision is indicated when warranted. This would include observation of the individual for several hours.

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 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

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 70% (non-crystallising)

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 10ml

6.6 Special precautions for disposal and other handling

Keep all medicines out of the reach of children

7. Marketing authorisation holder

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

8. Marketing authorisation number(s)

PL 44673/0147

9. Date of first authorisation/renewal of the authorisation

15 November 2003/ 19 August 2010

10. Date of revision of the text

1st December 2020