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VICKS SINEX SOOTHER 0.5 MG/ML NASAL SPRAY SOLUTION

Active substance: OXYMETAZOLINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Vicks Sinex Soother 0.5 mg/ml, nasal spray solution
oxymetazoline hydrochloride

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
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 should contact a doctor if your symptoms worsen or do not improve after 3 days.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Vicks Sinex is and what it is used for
2. Before you use Vicks Sinex
3. How to use Vicks Sinex
4. Possible side effects
5. How to store Vicks Sinex
6. Further information

1.

WHAT VICKS SINEX IS AND WHAT IT IS USED FOR

Vicks Sinex 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

Do not use Vicks Sinex if you:
-

are allergic (hypersensitive) to the active substance Oxymetazoline hydrochloride
or any of the other ingredients of Vicks Sinex (see section 6)
are taking (or have taken during the last two 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 (narrow-angle glaucoma)
have had an operation to remove your pituitary gland
have inflamed skin or mucous membranes of your nostrils or have scabs in your
nose

Do not give Vicks Sinex to children under 6 years of age.
Take special care with Vicks Sinex:

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 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 if you have taken MAOIs during
the last two weeks.
tricyclic antidepressants – inform you 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.
The spray should be used with caution during pregnancy or if breast-feeding.
Driving and using machines
No effect on the ability to drive or use machines has been observed.
Important information about some of the ingredients of Vicks Sinex
Benzalkonium chloride (a preservative) is an ingredient in Vicks Sinex which might cause
swelling of nasal mucosa, especially during long-term use.

3.

HOW TO USE VICKS SINEX

Always use Vicks Sinex 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 10 years: 1-2 sprays in each nostril no more than 2-3 times daily.
Children 6-10 years: 1 spray in each nostril no more than 2-3 times daily.
Children under 6 years – Do not use
Do not exceed the recommended dose.

Do not use for longer than 7 days in a row. If used over a longer period, Vicks Sinex may
cause 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 deeply through your nose at the same time. Repeat in the other nostril.
3. Adults and children over 10 years may repeat steps 1 and 2 once if necessary.
4. Wipe the nasal applicator with a wet and clean tissue and replace the dust cover
immediately after application.
If you use more Vicks Sinex than you should
If you use too much Vicks Sinex and experience any unwanted effects or symptoms, seek
medical advice immediately and take the bottle or pack with you.
If you forget to use Vicks Sinex
Do not take a double dose if you forgot 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 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 1,000 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.
If any of the side effects becomes serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.

5.

HOW TO STORE VICKS SINEX

Keep out of the reach and sight of children.
Store below 25°C.
Do not use Vicks Sinex after the expiry date which is printed on the carton. The expiry date
refers to the last day of the month stated.
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 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 looks like and contents of the pack
Vicks Sinex 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
or 15 ml of product. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Procter and Gamble (Health & Beauty Care) Limited
The Heights
Brooklands
Weybridge
Surrey KT13 0XP
Manufacturer
Procter and Gamble Manufacturing GmbH
Procter & Gamble Strasse 1
64521 Gross-Gerau
Germany
This medicinal product is authorised in the Member States of the EEA under the
following names:
Sweden: Vicks Sinex, 0,5 mg/ml, nässpray, lösning
Austria: WICK SinexAloe Nasenspray
Belgium: Vicks SinexAloe
Czech Republic: Sinex Vicks Aloe a Eucalyptus

Denmark: Vicks Sinex
Finland: Vicks Sinex
Germany: WICK Sinex avera Nasenspray 0,5 mg/ml Lösung
Greece: Vicks Sinex Spray
Hungary: Sinex Wick Eukaliptusz 0.5mg/ml oldatos orrspray
The Netherlands: Vicks Sinex Aloë
Norway:
Poland: Vicks Sinex Aloes I Eukaliptus
Portugal: Sinexsensi
Spain: Sinexsensi
UK: Vicks Sinex Soother
This leaflet was last updated October 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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