Care Decongestant Nasal Spray
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Care Decongestant Nasal Spray
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The nasal solution contains Oxymetazoline (as hydrochloride) 0.05% w/v.
For full list of excipients, see 6.1.
3. PHARMACEUTICAL FORM Nasal spray, solution.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Care Decongestant Nasal Spray is recommended for the relief of nasal congestion in such conditions as the common cold, catarrh and hayfever.
4.2 Posology and method of administration Adults, the Elderly and children over 12 years of age
While holding upright the spray nozzle should be inserted into each nostril in turn and squeezed firmly twice while breathing in. The application may be repeated up to 2 times a day, or used at bedtime to give relief through the night.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Children under 12 years of age.
Concomitant use of other sympathomimetic nasal decongestants.
Patients who are receiving monoamine oxidase inhibitors or within 14 days of stopping such treatments; or patients who are receiving beta-blockers (see section 4.5).
Patients suffering from porphyria, closed angle glaucoma, cardiovascular disease, cardiac arrhythmias, cardiomyopathy and peripheral vascular disease, hypertension, hyperthyroidism, phaeochromocytoma or diabetes.
Care Decongestant Nasal Spray should not be used after nasal or sinus surgery.
4.4 Special warnings and precautions for use
If symptoms persist, consult your doctor.
Prolonged use may result in rebound congestion (rhinitis medicamentosa) and should therefore be avoided.
Treatment should be limited to a maximum of seven days.
Use with caution in patients with renal impairment, patients with prostatic hypertrophy (as there is a risk of acute urinary retention) and the elderly.
This medicinal product contains thiomersal (an organomercuric compound) and benzalkonium chloride as preservatives. Thiomersal may cause local skin reactions (e.g. contact dermatitis) and discolouration. Benzalkonium chloride may cause bronchospasm. (see section 4.8).
Labels state: Do not give to children under 12 years.
Do not use for longer than 7 days.
Do not exceed the stated dose.
Keep out of the sight and reach of children.
Keep away from eyes.
4.5 Interaction with other medicinal products and other forms of interaction
If you are taking other medicines, you should see your doctor for advice before taking this medicine.
Since oxymetazoline is absorbed through the mucosa, interactions may follow topical administration. These interactions are those of the sympathomimetics in general and can include antagonism of the hypotensive effects of antihypertensives (including adrenergic neurone blockers and beta-blockers), increased risk of hypertension with oxytocin, appetite suppressants and amphetamine-like psychostimulants; and increased risk of ergotism with ergotamine and methysergide. There is an increased risk of dysrhythmias with cardiac glycosides. Caution is required if used with thyroid hormones.
Oxymetazoline should not be given to patients treated with MAOIs and/or RIMAs within 14 days of stopping treatment, including moclobemide and rasagiline as there is a risk of hypertensive crisis if these types of drug are taken at the same time as oxymetazoline.
4.6. Pregnancy and lactation
The safety of use in pregnancy has not been established and administration of oxymetazoline during pregnancy should be avoided.
4.7. Effects on ability to drive and use machines
None
4.8 Undesirable effects
Oxymetazoline can give rise to tolerance and rebound congestion (rhinitis medicamentosa) after frequent or prolonged use. Transient local irritation and dryness may occur after local topical use.
The following undesirable effects have been reported following use of oxymetazoline and may arise following use of Care Decongestant Nasal Spray. The frequency of adverse effects cannot be estimated from available data, but adverse effects may be minimised by avoiding prolonged or excessive use (see section 4.4).
Nervous system disorders: anxiety, fear, confusion, restlessness, irritability, tremors, headache, tolerance with diminished effect, insomnia, dizziness, and psychotic states
Cardiac disorders: arrhythmias, tachycardia, palpitations
Vascular disorders: vasoconstriction with hypertension, impaired circulation to the extremities (cold extremities), vasodilation in rebound congestion
Respiratory, thoracic and mediastinal disorders: dyspnoea; bronchospasm (as this product contains benzalkonium chloride)
Gastrointestinal disorders: nausea, dry mouth, anorexia, vomiting
Skin and Subcutaneous tissue disorders: Local skin reactions (e.g. contact dermatitis) and discolouration (as this product contains thiomersal)
Musculoskeletal and connective tissue disorders: weakness
General disorders and administration site conditions: transient local irritation and dryness, pain, rebound congestion and drug-induced rhinitis.
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
Provided this product is used as directed, overdose is considered unlikely; however, overdosage or accidental exposure by mouth may result in CNS depression with marked reduction of body temperature and bradycardia, sweating, drowsiness and coma, particularly in children. Hypertension may be followed by rebound hypotension. Treatment of adverse effects is symptomatic.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group (ATC code): S01G A04 Sympathomimetics used as decongestants
Oxymetazoline is an alpha-adrenoceptor agonist which causes local vasoconstriction when applied to nasal membrane.
5.2. Pharmacokinetic properties
When applied locally to nasal mucosa, oxymetazoline acts within a few minutes and its effects last for up to 12 hours.
5.3. Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Benzalkonium chloride
Thiomersal
Sodium chloride
Levomenthol
Cineole
Camphor
Methyl salicylate
Poloxamer 188
Sodium citrate (dihydrate) (E331)
Citric acid (anhydrous) (E330)
Purified water.
6.2. Incompatibilities
None
6.3. Shelf life
2 years
6.4. Special precautions for storage
None
6.5. Nature and contents of container
White, low density polyethylene/polypropylene copolymer 15ml bottle. White, high density polyethylene 15ml and 20ml bottle.
6.6 Instructions for use and handling
None
7. MARKETING AUTHORISATION HOLDER
Thornton & Ross Limited
Linthwaite
Huddersfield
West Yorkshire
HD75QH
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 00240/0343
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20/12/2010
10 DATE OF REVISION OF THE TEXT
31/12/2014