OTRIVINE CHILD NASAL

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.

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 Headache CommonNervous System Disorders Irritability, Anxiety, Restlessness, Excitability, Insomnia, Hallucinations and Paranoid Delusions - particularly with prolonged and/or excessive use Unknown Eye Disorders Transient visual impairment Very rare Heart rate irregular, Heart rate increased - particularly with prolonged and/or excessive use Very rareCardiac Disorders 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 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 General disorders and administration site 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.

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. 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.

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