Vicks Sinex Micromist 0.05% w/v Nasal Spray, Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxymetazoline hydrochloride

Available from:

WICK Pharma - Zweigniederlassung der Procter & Gamble GmbH

ATC code:

R01AA; R01AA05

INN (International Name):

Oxymetazoline hydrochloride

Dosage:

0.05 percent weight/volume

Pharmaceutical form:

Nasal spray, solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Sympathomimetics, plain; oxymetazoline

Authorization status:

Marketed

Authorization date:

1998-07-13

Patient Information leaflet

PATIENT INFORMATION LEAFLET
VICKS SINEX MICROMIST 0.05% W/V NASAL SPRAY SOLUTION
OXYMETAZOLINE HYDROCHLORIDE
IN THIS LEAFLET:
1. WHAT VICKS SINEX MICROMIST IS AND WHAT IT IS USED FOR
2. BEFORE YOU USE VICKS SINEX MICROMIST
3. HOW TO USE VICKS SINEX MICROMIST
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE VICKS SINEX MICROMIST
6. FURTHER INFORMATION
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use Vicks Sinex Micromist
carefully to get the best results from it.
▪
KEEP THIS LEAFLET.
You may need to read it again.
▪
Ask your pharmacist if you need more information or advice.
▪
You must contact your pharmacist if your symptoms worsen or do not
improve after 7 days.
▪
If any of the side effects gets serious or you notice any side effects
not listed in this leaflet,
please tell your doctor or pharmacist.
1. WHAT VICKS SINEX MICROMIST IS AND WHAT IT IS USED FOR
Vicks Sinex Micromist is a nasal spray used for localised relief of
the symptoms of a blocked nose in
association with a cold, hay fever or sinusitis (inflammation of the
passages leading to the nose).
The effect of the spray starts after several minutes and lasts for 6-8
hours. The active substance is
oxymetazoline hydrochloride.
2. BEFORE YOU USE VICKS SINEX MICROMIST
DO NOT USE VICKS SINEX MICROMIST IF YOU:
•
are allergic (hypersensitive) to the active substance oxymetazoline
hydrochloride or any of
the other ingredients of Vicks Sinex Micromist (see section 6)
•
have inflamed skin or mucous membranes of your nostrils or have scabs
in your nose.
DO NOT GIVE VICKS SINEX MICROMIST TO CHILDREN UNDER 12 YEARS OF AGE
TAKE SPECIAL CARE WITH VICKS SINEX MICROMIST
Before using tell your doctor if you have:
•
difficulty urinating due to an enlarged prostate gland
•
high blood pressure
•
heart disease including angina
•
diabetes
•
disturbance in your thyroid function
•
hepatic or renal disorder
•
suffer from increased eyeball-pressure

Summary of Product characteristics

Health Products Regulatory Authority
27 March 2024
CRN00F4H9
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vicks Sinex Micromist 0.05% w/v Nasal Spray, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient:
% w/v
Oxymetazoline hydrochloride
0.05
Excipients:
% w/v
Benzalkonium chloride solution (50%)
0.04
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal Spray, Solution (Nasal Spray)
Non-pressurised, metered dose, aqueous nasal spray solution. Solution
is a clear liquid with a slight yellowish colouration.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The symptomatic relief of acute rhinitis in allergic or upper
respiratory tract infection, including the common cold or influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Topical application as a nasal spray.
Adults and children over 12 years: 1-2 sprays per nostril every 6-8
hours unless otherwise advised by your doctor.
Not to be used for children under 12 years of age.
4.3 CONTRAINDICATIONS
Hypersensitivity to oxymetazoline or any of the other ingredients.
Where there is inflammation or lesions of the skin around the nostrils
or nasal mucosa.
Not to be used for children under 12 years of age.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients are advised to consult their doctor before taking this
medicine if they:
Have high blood pressure, heart disease including angina, diabetes,
thyroid disease, hepatic or renal disorders.
Are currently taking (or have taken during the last two weeks)
monoamine oxidase inhibitors (MAOIs).
Have narrow angle glaucoma.
Are a male patient with difficulty urinating due to enlarged prostate
gland.
Sympathomimetic-containing products should be used with great care in
patients receiving phenothiazines or tricyclic
antidepressants.
Health Products Regulatory Authority
27 March 2024
CRN00F4H9
Page 2 of 4
Sympathomimetic-containing products should be used with caution in
patients receiving digitalis, beta-adrenergic blockers,
methyldopa or other anti-hyper