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VICKS SINEX SOOTHER NASAL SPRAY

Active substance: OXYMETAZOLINE HYDROCHLORIDE

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Vicks Sinex Soother 0.5mg/ml nasal spray solution Oxymetazoline Hydrochloride
Patient information leaflet
In this leaflet:
1. What Vicks Sinex Soother is and
what it is used for
2. Before you use Vicks Sinex Soother
3. How to use Vicks Sinex Soother
4. Possible side effects
5. How to store Vicks Sinex Soother
6. Further information

1. What Vicks Sinex Soother is and
what it is used for
Vicks Sinex Soother is a nasal spray used for
localised relief of the symptoms of a blocked nose
in association with a cold or rhinitis.
The effect of the spray starts after several minutes
and lasts for 6-8 hours.
2. Before you use Vicks Sinex Soother
Do not use Vicks Sinex Soother if you:
• are allergic (hypersensitive) to the active substance
oxymetazoline hydrochloride or any of the other
ingredients of Vicks Sinex Soother (see section 6)
• are taking (or have taken during the last 2 weeks)
monoamine oxidase inhibitors (MAO inhibitors are
used in the treatment of Parkinson's disease and
depression)
• suffer from acute heart disease or cardiac asthma
• suffer from increased eyeball-pressure (narrowangle glaucoma)
• have had an operation to remove your pituitary
gland

Vicks Sinex Soother (Sinex
Pump) Nasal Spray 0.5mg 15ml
(P) UK v2
223
5-1-15

KA
Leaflet
205x145mm

IPMS: 97128532
MPMS: 60063006.005
Tech Drw No: 60007538.004
Region: Europe
Manf. Plant: GG
Substrate:
Printing process: letterpress
Printer: Eukerdruck
Laetus: 749
SGS File Reference: H26913

Guide
Black

Futura bold, Univers 57
cond/67 bold cond/57 cond
obl
Body copy: 8.7pts
Min font size used: 8.7pts

Illustrator CS6

Do not give Vicks Sinex Soother to children
under 12 years of age







Take special care with Vicks Sinex Soother
Before using ask your doctor for advice if you have:
high blood pressure
heart disease, including angina
diabetes
thyroid problems
enlarged prostate gland (prostatic hypertrophy)

Taking other medicines
Please inform your doctor or pharmacist before using
Vicks Sinex Soother if you are taking, or have recently
taken, any other medicines, even those obtained
without a prescription.
• monoamine oxidase inhibitors (MAOIs) are
used in the treatment of Parkinson's disease and
depression). Do not use Vicks Sinex Soother if you
have taken MAOIs during the last two weeks.
• tricyclic antidepressants - inform your doctor if
you are taking drugs used in the treatment of
depression such as amitriptyline and imipramine.

• Beta blockers or high blood pressure
medicines – inform your doctor before use if you
are taking any of these.
• Parkinson's disease medicine (bromocriptine)
– inform your doctor before use if you are taking
this medicine.
Pregnancy and Breast-feeding
Ask your doctor or pharmacist for advice before
using Vicks Sinex Soother. The spray should be
used with caution during pregnancy or if breast
feeding.
Driving and using machines
No effect on ability to drive or use machines has
been observed.
Important information about some of the
ingredients of Vicks Sinex Soother
Benzalkonium chloride (a preservative) is an
ingredient in Vicks Sinex Soother which might
cause swelling of nasal mucosa, especially during
long-term use.

19-1-15
YA

initial: KA

Always use Vicks Sinex Soother exactly as your
pharmacist or doctor has told you. You should
check with your doctor or pharmacist if you are
not sure.
Dosage: The recommended dose is
Adults and children over 12 years: 1-2 sprays
in each nostril no more than 2-3 times daily.
Children under 12 years - Do not use.
Do not exceed the recommended dose.
Do not use for longer than 5-7 days in a row.
If used over a longer period, Vicks Sinex Soother
may cause a blocked nose.
Contact your doctor if symptoms worsen or do not
improve after 3 days.
Administration:
1. Remove the cap. Keep the bottle upright with the
nasal applicator just into the nostril. Hold the
other nostril closed.
2. Spray and breathe in deeply through your nose at
the same time. Repeat for the other nostril.
3. Adults and children over 12 years may repeat
steps 1 and 2 once if necessary.
4. Wipe the nasal applicator with a clean, wet tissue
and replace the cap immediately after application.
If you use more Vicks Sinex Soother than
you should
If you use too much Vicks Sinex Soother and you
experience any unwanted effects or symptoms,
seek medical advice immediately and take the
bottle or pack with you.

Version 1.4

• have inflamed skin or mucous membranes of your
nostrils or have scabs in your nose.

– Keep this leaflet. You may need to read it again.
– Ask your pharmacist if you need more
information or if you get any side effects, talk to
your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.
– You should contact a doctor if your symptoms
worsen or do not improve after 3 days.

2

3. How to use Vicks Sinex Soother

REG0149827

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
Soother carefully to get the best results from it.

Approved

If you forget to use Vicks Sinex Soother
Do not take a double dose if you forget to take the
previous dose; instead, continue using according
to the administration instructions.
If you have any further questions on the use of this
product, ask your pharmacist.
4. Possible side effects
Like all medicines, Vicks Sinex Soother can cause
side effects, although not everybody gets them.
Uncommon (occurring in less than 1 in 100
people): Sneezing, dryness or irritation in the nose,
mouth or throat.
Rare (occurring in less than 1 in 1000 people):
Anxiety, fatigue, irritability, disturbed sleep in
children, rapid heartbeat, palpitations, raised
blood pressure, blocked nose, swelling of the
nasal lining, headache, nausea, flushing, rash
and visual disturbances.
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the Yellow
Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Vicks Sinex Soother
Keep out of the reach and sight of children.
Do not store above 25˚C.
Do not use Vicks Sinex Soother after the expiry
date which is printed on the carton.The expiry
date refers to the last day of the month stated.

Page 1 of 3

Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
6. Further information
What Vicks Sinex Soother contains
The active substance is: Oxymetazoline
hydrochloride 0.5 mg/ml.
The other ingredients are: sorbitol, sodium
citrate dihydrate, tyloxapol, chlorhexidine
digluconate solution, citric acid anhydrous, aloes
dry extract, benzalkonium chloride solution,
acesulfame potassium, menthol (levo), cineole,
disodium edetate (dihydrate), carvone (levo),
sodium hydroxide, purified water. (See end of
section 2 for benzalkonium chloride).
What Vicks Sinex Soother looks like and
contents of the pack
Vicks Sinex Soother is a metered dose nasal pump
spray. The pack contains an amber glass bottle
with a white pump on top. The bottle is filled with
10 ml or 15 ml of product.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Procter & Gamble(Health & Beauty Care) Limited,
Weybridge, Surrey KT13 0XP United Kingdom
Manufacturer:
Procter & Gamble, Manufacturing GmbH
Procter & Gamble Strasse 1, 64521 Gross-Gerau,
Germany
This leaflet was last updated in 01/2015.
PGT223
97128532

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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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