Summary of medicine characteristics - SUDAFED CONGESTION RELIEF 0.1% NASAL SPRAY SOLUTION
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
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 | Uncommon | Epistaxis |
| 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 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 a2-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.
Treatment of overdose should be supportive.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Nasal preparations, sympathomimetics, plain; ATC code: R01AA07.
It acts directly on □ -adrenoreceptors but does not act on B-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 Pharmacokinetics propertiesAbsorption, 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.
There have been no specific studies of this product or xylometazoline in hepatic or renal impairment.
There have been no specific clinical studies of this productor xylometazoline in the elderly.
5.3 Preclinical safety data
5.3 Preclinical safety dataMutagenicity
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 PHARMACEUTICAL PARTICULARS
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
6.6 Special precautions for disposalNo special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.