VICKS SINEX DECONGESTANT NASAL SPRAY
Active substance: OXYMETAZOLINE HYDROCHLORIDE
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Vicks Sinex Decongestant Nasal Spray
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENT Oxymetazoline hydrochloride Percentage quantity 0.050% w/v Specification EP
3.
PHARMACEUTICAL FORM Non-pressurised, aqueous nasal spray solution.
4 4.1.
CLINICAL PARTICULARS 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.
4.3
Contraindications 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 mater Concomitant use of other sympathomimetic decongestants Phaeochromocytoma
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; o Hallucinations o Restlessness o Sleep disturbances 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 doctor Keep away from eyes Keep out of the reach and sight of children
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 bromocriptine There 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
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 . 4.8
Effects on ability to drive and use machines
No effects on ability to drive and use machines have been observed.
Undesirable effects In general no severe undesirable effects are expected. 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 Prolonged and/or heavy use of Vicks Sinex may lead to reduced effect and/or rebound congestion (rhinitis medicamentosa), cardiovascular effects and CNS effects.
4.9
4.9.1
Overdose
Symptoms The 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 overdose
Symptomatic treatment of the overdosage is required. In serious cases, intubation and artificial ventilation are required.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Oxymetazoline hydrochloride: -Adrenergic imidazoline derivative, providing localised nasal vasoconstriction.
5.2.
Pharmacokinetic Properties Not applicable. The product provides purely local action.
5.3.
Preclinical Safety Data Not applicable.
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
6.2.
Incompatibilities None known.
6.3.
Shelf Life 3 years.
6.4.
Special Precautions for Storage None.
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.
Instruction for Use, Handling and Disposal Not applicable.
7.
MARKETING AUTHORISATION HOLDER Procter & Gamble (Health & Beauty Care) Limited The Heights Brooklands Weybridge Surrey KT13 0XP
8.
MARKETING AUTHORISATION NUMBER PL 00129/5011R
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01/12/2010
10
DATE OF REVISION OF THE TEXT
20/03/2012
1
NAME OF THE MEDICINAL PRODUCT
Vicks Sinex Decongestant Nasal Spray
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENT Oxymetazoline hydrochloride Percentage quantity 0.050% w/v Specification EP
3.
PHARMACEUTICAL FORM Non-pressurised, aqueous nasal spray solution.
4 4.1.
CLINICAL PARTICULARS 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.
4.3
Contraindications 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 mater Concomitant use of other sympathomimetic decongestants Phaeochromocytoma
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; o Hallucinations o Restlessness o Sleep disturbances 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 doctor Keep away from eyes Keep out of the reach and sight of children
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 bromocriptine There 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
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 . 4.8
Effects on ability to drive and use machines
No effects on ability to drive and use machines have been observed.
Undesirable effects In general no severe undesirable effects are expected. 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 Prolonged and/or heavy use of Vicks Sinex may lead to reduced effect and/or rebound congestion (rhinitis medicamentosa), cardiovascular effects and CNS effects.
4.9
4.9.1
Overdose
Symptoms The 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 overdose
Symptomatic treatment of the overdosage is required. In serious cases, intubation and artificial ventilation are required.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Oxymetazoline hydrochloride: -Adrenergic imidazoline derivative, providing localised nasal vasoconstriction.
5.2.
Pharmacokinetic Properties Not applicable. The product provides purely local action.
5.3.
Preclinical Safety Data Not applicable.
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
6.2.
Incompatibilities None known.
6.3.
Shelf Life 3 years.
6.4.
Special Precautions for Storage None.
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.
Instruction for Use, Handling and Disposal Not applicable.
7.
MARKETING AUTHORISATION HOLDER Procter & Gamble (Health & Beauty Care) Limited The Heights Brooklands Weybridge Surrey KT13 0XP
8.
MARKETING AUTHORISATION NUMBER PL 00129/5011R
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01/12/2010
10
DATE OF REVISION OF THE TEXT
20/03/2012
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
