This information is intended for use by health professionals

1. Name of the medicinal product

Sudafed Congestion Relief 0.1% Nasal Spray, solution

2. Qualitative and quantitative composition

Xylometazoline Hydrochloride 1 mg /1ml of solution

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Nasal spray, solution (nasal spray)

4. Clinical particulars
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).

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

Not known

Nasal discomfort

Nasal dryness

Nasal pruritus

Rhinalgia

Sneezing

Gastrointestinal Disorders

Rare

Nausea

General Disorders and Administration Site Conditions

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.

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.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Nasal preparations, sympathomimetics, plain; ATC code: R01AA07.It acts directly on α-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.

Hyaluronic acid (as sodium hyaluronate), together with glycerol and sorbitol, acts as a humectants to moisturise the nasal mucosa.

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

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.

6. Pharmaceutical particulars
6.1 List of excipients

Sodium hyaluronate

Sorbitol

Glycerol

Disodium phosphate dihydrate

Sodium dihydrogen phosphate dihydrate

Sodium chloride

Water for injections

6.2 Incompatibilities

Not applicable

6.3 Shelf life

2 years.

This product should not be used longer than 6 months after opening.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

White HDPE bottle, with 3K pump system, plastic cover, carton box.

10ml nasal spray.

6.6 Special precautions for disposal and other handling

No special requirements.

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

7. Marketing authorisation holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom.

8. Marketing authorisation number(s)

PL 15513/0368

9. Date of first authorisation/renewal of the authorisation

28 March 2012

10. Date of revision of the text

03 January 2019