Otrivine Child Nasal Drops

Nasal drops, solution The product is a clear, colourless solution.

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 rhinitis4.4 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 and in patients taking tri or tetra-cyclic antidepressant treatment (see Interactions). 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 hypertension4.6 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 Epistaxis | Common Common Uncommon | | 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.

5.1 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.

6.1 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 water6.2 Incompatibilities None6.3 Shelf life Unopened: 36 months After the container is opened for the first time: 28 days6.4 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 10ml6.6 Special precautions for disposal and other handling Keep all medicines out of the reach of children