Sudafed Sinus-Ease 0.1% Nasal Spray

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.

By intranasal administration using nasal spray.

Posology

Adults and children 12 years and above:

1 spray into each nostril 1-3 times a day as required, for a maximum of 5 days.

Maximum daily use: no more than 3 doses should be given in any 24 hours.

Leave at least 8 hours between doses, unless otherwise advised by your healthcare professional.

Do not exceed the recommended dose.

Do not use for more than 5 consecutive days.

Continuous use of the product for more than 5 days can lead to an increased risk of side effects (see section 4.4).

Medical advice should be sought if symptoms of nasal congestion persist or worsen or do not improve after 5 days as alternative treatment may be required.

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).

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.

Do not take with other sympathomimetic decongestants.

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.

Repeated and/or prolonged administration can cause appreciable systemic exposure to the active substance and increases the risk of side effects.

Tachyphylaxis – a rapidly diminishing response to the drug after a few doses.

Using more of this product and/or using it for longer than recommended may also lead to reduced effect of a dose (due to repetitive drug exposure) and rebound congestion (see section 4.8).

Prolonged or excessive use may result in reactive hyperaemia, chronic swelling of the nasal mucosa known as rhinitis medicamentosa, and atrophy of the nasal mucosa. Increasing the dose and/or frequency of xylometazoline spray at onset of rebound congestion and/or rhinitis medicamentosa, will worsen the nasal congestion. Patients must stop treatment rather than increasing the dose or prolonging the treatment. It is necessary to ensure that the treatment period does not exceed 5 days of continuous use. Alternative treatment may be required if nasal congestion persists beyond the recommended treatment period (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.

Labelling (outer pack):
The label will state (To be displayed prominently on the front of the outer pack):
- 'For 5 days use only'

The label will also state:
- 'Leave at least 8 hours between doses'
- 'For short-term use only'
- 'Do not use for more than 5 days in a row. Do not use more medicine than the label tells you to. If your symptoms worsen or you do not feel better after 5 days, stop treatment and seek medical advice.'

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.

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.

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

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.

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.

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.

Pharmacotherapeutic group: Nasal preparations, sympathomimetics, plain; ATC code: R01AA07

It acts directly on α₂-adrenoreceptors but does not act on ß‑receptors. When used topically as a nasal decongestant, xylometazoline acts rapidly and provides long-lasting relief. Onset of action is within minutes, the decongestant effect being prolonged and lasting for up to 10 hours.

Absorption, Distribution, Biotransformation and Elimination

Little information is available concerning the absorption, distribution, Biotransformation and elimination of xylometazoline in man. Absorption into the nasal mucosal tissues is rapid.

Pharmacokinetics in Renal/Hepatic Impairment

There have been no specific studies of this product or xylometazoline in hepatic or renal impairment.

Pharmacokinetics in the Elderly

There have been no specific clinical studies of this product or xylometazoline in the elderly.

Mutagenicity

There is insufficient information available to determine whether xylometazoline has mutagenic potential.

Carcinogenicity

There is insufficient information available to determine whether xylometazoline has carcinogenic potential.

Teratogenicity

There is insufficient information available to determine whether xylometazoline has teratogenic potential.

Fertility

No studies have been conducted in animals to determine whether xylometazoline has the potential to impair fertility. There is no information on the effects of this product on fertility.

Benzalkonium chloride solution

Disodium edetate

Sodium dihydrogen phosphate dihydrate

Sodium monohydrogen phosphate dihydrate

Sodium chloride

Sorbitol solution, 70% (Non crystalline)

Purified water

Not applicable

Unopened: 3 years.

Opened: 20 weeks after first opening, discard the bottle even if there is solution remaining.

Do not store above 25°C.

Amber glass bottle of either 10 ml or 15 ml nominal fill volume.

The bottle is sealed with an integral snap-on metered 0.14 ml pump consisting of a white plastic actuator and natural polyethylene pull-off overcap.

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.