4.1. Therapeutic indications

This product is indicated for the symptomatic relief of nasal congestion associated with the common cold, influenza, sinusitis, allergic and non-allergic rhinitis, and other upper respiratory tract allergies.

4.2. Posology and method of administration

Posology

Adults and children 12 years and over:

One spray to be expressed into each nostril 2-3 times daily, as necessary.

Maximum daily dose: 3 sprays in 24 hours.

Use for more than seven consecutive days is not recommended, [See section 4.4].

Children under 12 years:

Do not give to children under 12 years of age.

The Elderly

Experience has indicated that normal adult dosage is appropriate, [See section 5.2].

Hepatic/renal dysfunction

Normal adult dosage is appropriate, [See section 5.2].

Method of administration

Nasal

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Children under 12 years of age.

This product is contraindicated in individuals who are taking or have taken monoamine oxidase inhibitors within the preceding two weeks.

This product is contraindicated in individuals with hypophysectomy or surgery exposing dura mater.

4.4. Special warnings and precautions for use

There is minimal systemic absorption with topically applied imidazoline sympathomimetics such as xylometazoline, however, this product should be used with caution in patients suffering coronary artery disease, hypertension, hyperthyroidism or diabetes mellitus. Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias.

This medicine is intended for short term use only. Prolonged treatment may lead to reactive hyperemia of the nasal mucosa.

This rebound effect may lead to nasal congestion or nasal obstruction during continued use or after discontinuation, resulting in repeated or even continuous use of the medicine by the patient (see section 4.8).

This medicine contains 1.96 mg benzalkonium chloride in each 10 ml, and 2.94 mg benzalkonium chloride in each 15 ml, which is equivalent to 0.196 mg/ml of product. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time. Long-term use may cause oedema of the nasal mucosa.

4.5. Interaction with other medicinal products and other forms of interaction

Due to the low systemic absorption of xylometazoline when administered intra-nasally, interaction with drugs administered via other routes is considered unlikely.

No interaction studies have been performed.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no adequate and well-controlled studies in pregnant women. This product should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs the possible risks to the developing foetus.

Lactation

It is not known whether xylometazoline or its metabolites are excreted in human milk. This product should not be used during lactation unless the potential benefit to the mother outweighs the possible risks to the nursing infant.

4.7. Effects on ability to drive and use machines

It is not known if xylometazoline has an effect on the ability to drive and use machines.

4.8. Undesirable effects

Adverse Drug Reactions (ADRs) identified during clinical trials and post-marketing experience with xylometazoline are listed below by System Organ Class (SOC). The frequencies are defined in accordance with current guidance, as:

Very common ≥1/10

Common ≥1/100 and < 1/10

Uncommon ≥1/1,000 and <1/100

Rare ≥1/10,000 and <1/1,000

Very rare <1/10,000

Not known (cannot be estimated from the available data)

ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available or 2) when incidence is unavailable, frequency category is listed as Not known.

System Organ Class (SOC)

Frequency

Adverse Drug Reaction

(Preferred Term)

Nervous System Disorders

Rare

Not known

Headache

Burning sensation mucosal

Respiratory, Thoracic and Mediastinal Disorders

Uncommon

Epistaxis

Not known

Nasal discomfort

Nasal dryness

Nasal pruritus

Rhinalgia

Sneezing

Gastrointestinal Disorders

Rare

Nausea

General Disorders and Administration Site Conditions

Not known

Rebound effect

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

Systemic action is unlikely when applied nasally due to the local vasoconstriction that inhibits absorption. If systemic absorption does occur xylometazoline as an α2-adrenergic agonist could be expected to produce effects similar to those of clonidine with a short lived rise in blood pressure, followed by more prolonged hypotension and sedation.

Management

Treatment of overdose should be supportive.