- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Use during pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
Vicks Sinex Decongestant Nasal Spray
2. Qualitative and quantitative composition
|Oxymetazoline hydrochloride||0.050% w/v||Ph. Eur|
3. Pharmaceutical form
Non-pressurised, aqueous nasal spray solution.
4. Clinical particulars
4.1 Therapeutic indications
The symptomatic relief of congestion of the upper respiratory tract due to the common cold, hay fever and sinusitis.
4.2 Posology and method of administration
Adults and children over 12 years: 1-2 sprays per nostril every 6-8 hours unless otherwise advised by your doctor. Topical application as a nasal spray.
Hypersensitivity to oxymetazoline or any of the other ingredients.Inflammation or lesions of the skin around the nostrils or nasal mucosa.Trans-sphenoidal hypophysectomy or nasal surgery exposing the dura materConcomitant use of other sympathomimetic decongestantsPhaeochromocytoma Children under 12 years of age.
4.4 Special warnings and precautions for use
Consult a doctor before taking this medicine in case of:• High blood pressure, heart disease including angina, diabetes mellitus, hyperthyroid disease, hepatic and renal disorders and prostatic hypertrophy. • Patients currently taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs in the last 14 days.• Use with caution in occlusive vascular disease• If any of the following occur, Vicks Sinex Micromist should be stopped;
• Patients who have narrow angle glaucoma.Patients are advised to use for a maximum of 7 consecutive days to avoid rebound effect and drug induced rhinitis.If symptoms persist consult a doctorKeep away from eyesKeep out of the reach and sight of children
|o .Sleep disturbances|
4.5 Interaction with other medicinal products and other forms of interaction
Hypertensive interactions may occur between sympathomimetic amines such as oxymetazoline and monoamine oxidase inhibitors (MAOIs) (see Section 4.4) and/or reversible inhibition of monoamine oxidase (RIMA) and Moclobemide.Oxymetazoline may reduce the efficacy of beta-blocking drugs, methyl dopa or other anti-hypertensive drugs including adrenergic neurone blockers.There is a possible increased risk of hypertension and arrhythmias when tricyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants are given with sympathomimetics such as oxymetazoline.Possible additive cardiovascular toxicity may occur when sympathomimetics are given with antiparkinsonian drugs such as bromocriptineThere is an increased risk of dysrhythmias when cardiac glycosides are given with sympathomimetics such as oxymetazoline.There is an increased risk of ergotism when ergot alkaloids (ergotamine & methysergide) are given with sympathomimetics such as oxymetazoline.
4.6 Use during pregnancy and lactation
Due to insufficient evidence on the use of the product in pregnancy and lactation, use of the product should be avoided unless on the advice of a physician.
4.7 Effects on ability to drive and use machines
No effects on ability to drive and use machines have been observed..
4.8 Undesirable effects
In general no severe undesirable effects are expected.
Prolonged and/or heavy use of Vicks Sinex may lead to reduced effect and/or rebound congestion (rhinitis medicamentosa), cardiovascular effects and/or CNS effects.
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.
|Rare:||Eye disorders: Eye irritation, dryness, discomfort or redness Respiratory : Discomfort or irritation in the nose, mouth or throat; Sneezing|
|Very rare:||Cardiovascular : Tachycardia, palpitations, increased blood pressure CNS : Insomnia, nervousness, tremor, anxiety, restlessness, irritability, headache Gastrointestinal: Nausea|
4.9.1 SymptomsThe symptoms of moderate or acute overdosage can include mydriasis, nausea, cyanosis, fever, tachycardia, cardiac arrhythmia, hypertension, dyspnoea, and cardiovascular failure. CNS depression with symptoms such as decreased body temperature, bradycardia, hypotension, apnoea or loss of consciousness is possible.
4.9.2 Treatment of overdoseSymptomatic treatment of the overdosage is required. In serious cases, intubation and artificial ventilation are required.
5. Pharmacological properties
5.1 Pharmacodynamic properties
|Oxymetazoline hydrochloride:||α-Adrenergic imidazoline derivative, providing localised nasal vasoconstriction.|
5.2 Pharmacokinetic properties
Not applicable. The product provides purely local action.
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
Menthol Eucalyptol Sodium citrate dihydrate Tyloxapol Citric acid anhydrous Chlorhexidine digluconate Benzalkonium chloride Camphor Disodium edetate Sodium hydroxide Purified water
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
15ml or 20ml polyethylene/polypropylene copolymer bottle with L. D polyethylene dip tube to spray orifice. Green polypropylene screw cap.
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
Procter & Gamble (Health & Beauty Care) Limited The Heights, Brooklands, Weybridge,Surrey KT13 0XP
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
12th June 1990
10. Date of revision of the text
Procter & Gamble (Health & Beauty Care) Ltd.
The Heights, Brooklands, Weybridge, Surrey, KT13 0XP, UK
+44 (0)191 297 6295
Customer Care direct line
+44 (0) 8000 850367 (UK)
+44 (0)191 297 5000
Customer Care direct line
+353 (1) 800 509 301 (Ireland)