Sudafed Congestion Relief 0.1% Nasal Spray Solution
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 4.8]. Children under 12 years:
This product is not recommended for 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. 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.
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 fetus.
Lactation
It is not known whether xylometazoline or its metabolites are excreted in the human milk.
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
Xylometazoline nasal preparations are generally well tolerated following short-term use and local side effects are mild and infrequent. Localised burning, stinging, itching, soreness, dryness or irritation and sneezing may occur occasionally. Rarely, nausea and headache may occur.
Rebound congestion has been reported occasionally, particularly following longer-term use of xylometazoline. 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 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.
Management
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 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 productor 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 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.
Special precautions for disposal
6.6
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
30/03/2016