Otrivine Congestion Relief 0.1% Nasal Spray
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Otrivine Congestion Relief 0.1% Nasal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Otrivine Congestion Relief 0.1% Nasal Spray, nasal solution contains 1 mg/ml of xylometazoline hydrochloride. Each metered-dose spray delivers 0.14 mg of xylometazoline hydrochloride.
Excipients with known effect: polyoxyl hydrogenated castor oil (2.750 mg/ml) For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, (solution)
Metered-dose spray: opalescent, white solution, with menthol and eucalyptol (cineole) odour.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the symptomatic relief of nasal congestion, perennial and allergic rhinitis (including hay fever), sinusitis
4.2 Posology and method of administration
Posology
Paediatric population
Otrivine Congestion Relief 0.1% Nasal Spray should not be used in children aged less than 12 years old.
Method of administration
|
Stre ngth |
Age |
Posology |
|
0.1 |
Adults and |
1 spray into each nostril, 1 to 3 times daily as |
|
% |
adolescents over |
needed. Do not exceed 3 applications daily into |
|
12 years of age |
each nostril. |
The metered-dose spray permits accuracy of dosage and ensures that the solution is well distributed over the surface of the nasal mucosa. It precludes the possibility of unintentional overdose.
Before the first application, prime the pump by actuating 4 times. Once primed the pump will normally remain charged throughout regular daily treatment periods. Should the spray not be ejected during the full actuation stroke, the pump will need to be reprimed with the same number of actuations as initially performed.
Be careful not to spray in the eyes.
1. Blow the nose gently.
2. Remove protective cap.
3. Do not cut the nozzle. The metered dose spray is ready to prime before use.
4. Hold the bottle upright with thumb under base and nozzle between two fingers.
5. Lean forward slightly and insert the nozzle into a nostril.
6. Spray and breathe in gently through the nose at the same time.
7. Repeat in the other nostril
8. Clean and dry the nozzle before replacing back the cap right after use.
To avoid possible spread of infection, the spray should only be used by one person.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Like other vasoconstrictors,
Otrivine Congestion Relief 0.1% Nasal Spray should not be used in patients with trans-sphenoidal hypophysectomy or surgery exposing the dura mater.
4.4 Special warnings and precautions for use
Otrivine Congestion Relief 0.1% Nasal Spray, like other sympathomimetic agents, should be used with caution in patients showing a strong reaction to adrenergic substances, as manifested by signs of insomnia, dizziness, tremor, cardiac arrhythmias or elevated blood pressure.
Otrivine Congestion Relief 0.1% Nasal Spray should not be used for more than seven consecutive days.
Caution is recommended in patients with hypertension, cardiovascular disease, hyperthyroidism, narrow angle glaucoma or diabetes mellitus.
Label warnings and precautions
• Do not exceed the stated dose
• Do not use continuously for more than seven consecutive days. If symptoms persist consult your doctor
• If you are pregnant or taking other medicines or are under a doctor’s care consult your doctor before using Otrivine
• Not to be used for infants or children under 12 years
• Each Otrivine pack should be used by one person only to prevent any cross infection
• Keep medicines out of the sight and reach of children
Additional leaflet warnings and precautions
• Do not use if you are sensitive to any of the ingredients of Otrivine
• Do not use if you have had recent neurosurgery
• Consult your doctor before using Otrivine if you have heart or circulatory disease
• Some patients who have sensitive nasal passages may feel some local discomfort when applying nasal drops.
• Other side effects such as palpitations, nausea and headache are very rare Information concerning excipients
This medicine contains polyoxyl hydrogenated castor oil (2.750 mg/ml) which may cause skin reactions.
4.5 Interaction with other medicinal products and other forms of interaction
Like for all sympathomimetics, a reinforcement of the systemic effects of xylometazoline by concomitant use of monoamine oxidase inhibitors, tricyclic or tetracyclic antidepressants, cannot be excluded, especially in case of overdose.
4.6 Fertility, Pregnancy and lactation
Pregnancy
No foetal toxicity or fertility studies have been carried out in animals. In view of its potential systemic vasoconstrictor effect, it is advisable to take the precaution of not using Otrivine Congestion Relief 0.1% Nasal Spray during pregnancy.
Breastfeeding
No evidence of any adverse effect on the breast-fed infant. However, it is not known if xylometazoline is excreted in breast milk, therefore caution should be exercised and Otrivine should be used only on the advice of a doctor whilst breastfeeding.
Label warning: If you are pregnant or taking any other medicines or are under a doctor’s care, consult your doctor before using Otrivine.
4.7 Effects on ability to drive and use machines
Otrivine Congestion Relief 0.1% Nasal Spray has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Systemic cardiovascular effects have occurred, and this should be kept in mind when giving this product to people with cardiovascular disease.
Adverse reactions are listed below, by system organ class and frequency.
Frequencies are defined as: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000) or very rare (<1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Adverse reactions
|
Immune system disorders | |
|
Very rare: |
Hypersensitivity reaction (angioedema, rash, pruritus) |
|
Nervous system disorders | |
|
Common: |
Headache |
|
Eye disorders | |
|
Very rare: |
Transient visual impairment |
|
Cardiac Disorders | |
|
Very rare: |
Heart rate irregular and heart rate increased |
|
Respiratory, thoracic and mediastinal disorders | |
|
Common: |
Nasal dryness or discomfort, burning sensation |
|
Gastrointestinal disorders | |
|
Common: |
Nausea |
|
General disorders and administration site conditions | |
|
Common |
Application site burning |
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 Yellow Card Scheme, Website: www.mhra.gov .uk/yellowcard
4.9 Overdose
In rare instances of accidental poisoning in children, the clinical picture has been marked chiefly by signs such as acceleration and irregularity of the pulse, elevated blood pressure and sometimes clouding of consciousness.
There is no specific treatment. Appropriate supportive measures should be initiated and symptomatic treatment under medical supervision is indicated.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: decongestants for topical use, sympathomimetics, plain. ATC Code: R01A A07
Mechanism of action and pharmacodynamic effects
Xylometazoline is a sympathomimetic agent acting on alpha-adrenergic receptors in the nasal mucosa. Administered in the nose, it constricts the nasal blood vessels, thereby decongesting the mucosa of the nose and neighbouring regions of the pharynx. This decongests nasal passages and enables patients suffering from blocked nose to breathe more easily through the nose. The effect of Otrivine begins within a few minutes and lasts for up to 10 hours.
In a double-blind, saline solution controlled study in patients with common cold, the decongestant effect of Otrivine 0.1% nasal solution was significantly superior (p<0.0001) to saline solution based on rhinomanometry measurement. Relief of blocked nose developed twice as fast in the Otrivine group compared to saline solution as of 5 minutes post treatment (p= 0.047).
Otrivine is well tolerated, even by patients with a sensitive mucosa, and does not impair the mucociliary function.
5.2 Pharmacokinetic properties
Plasma concentrations of xylometazoline in man after local nasal application of the product are very low and close to the limit of detection.
5.3 Preclinical safety data
Xylometazoline has no mutagenic effect. No teratogenic effects were shown in a study where xylometazoline was given subcutaneously in mice and rats.
6.1 List of excipients
Sodium dihydrogen phosphate dihydrate
Disodium phosphate dodecahydrate
Sodium chloride
Disodium edetate
Levomenthol
Cineole
Sorbitol
Polyoxyl hydrogenated castor oil (macrogol glycerol hydroxystearate) Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
30 months
Do not use the bottle for more than 28 days after opening.
6.4 Special precautions for storage
Do not store above 25°C.
Store in the original package.
6.5 Nature and contents of container
High density polyethylene bottle with a metered dose pump (materials in contact with product: low density polyethylene, stainless steel, compound PE/butyl) polypropylene nozzle with cap.
Content: 10 ml.
6.6 Special precautions for disposal
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 44673/0151
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10/07/2014
10 DATE OF REVISION OF THE TEXT
03/04/2016