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
Percentage quantity
0.050% w/v

Oxymetazoline hydrochloride

3.

Specification
EP

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.

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

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.
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

Overdose

4.9.1

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

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
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

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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