Vicks Sinex Soother Nasal Spray
Package leaflet: Information for the user
What is in this leaflet:
1. What Vicks Sinex Soother is and what it is used for
2. What you need to know 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. Contents of the pack and other information
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. This medicine is available without prescription. However, you still need to use Vicks Sinex Soother 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.
I f 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 must talk to a doctor if you do not feel better or if you feel worse after 3 days.
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.
Do not use Vicks Sinex Soother:
if you are allergic (hypersensitive) to the active substance oxymetazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6) if you 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) if you suffer from acute heart disease or cardiac asthma
if you suffer from increased eyeball-pressure (narrow-angle glaucoma) if you have had an operation to remove your pituitary gland
• if you have inflamed skin or mucous membranes of your nostrils or have scabs in your nose
O Do not give this medicine to children under 12 years of age.
O Warnings and precautions Talk to your doctor or pharmacist before using Vicks Sinex Soother if you have:
• high blood pressure
• heart disease, including angina
• diabetes
• thyroid problems
• enlarged prostate gland (prostatic hypertrophy)
O Other medicines and Vicks Sinex Soother
Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines
• 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.
O Pregnancy and Breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
The spray should be used with caution during pregnancy or if breast feeding.
O Driving and using machines
Vicks Sinex Soother has no influence on the ability to drive or use machines.
O Vicks Sinex Soother contains Benzalkonium chloride
Benzalkonium chloride (a preservative) is an ingredient in Vicks Sinex Soother which might cause swelling of nasal mucosa, especially during longterm use.
nal use NLY
Always use this medicine exactly as described in this leaflet or as your doctor or your pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
O 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.
1 Method of 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.
O 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.
O If you forget to use Vicks Sinex Soother
Do not take a double dose to make up for a forgotten dose; instead, continue using according to the administration instructions.
If you have any further questions on the use of thismedicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Uncommon (may affect up to 1 in 100 people): Sneezing, dryness or irritation in the nose, mouth or throat.
• Rare (may affect up to 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.
O 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.
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the carton and label of the bottle after EXP The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
What Vicks Sinex Soother contains The active substance is: oxymetazoline hydrochloride 0.5 mg/ml. One spray (equivalent to 0.05 ml) contains approximately 25 micrograms oxymetazoline hydrochloride.
The other ingredients are: sorbitol, sodium citrate, polysorbate 80, benzyl alcohol, citric acid anhydrous, benzalkonium chloride solution, acesulfame potassium, levomenthol, cineole, disodium edetate, aloes dry extract, levocarvone, water, purified.
(See section 2 Vicks Sinex Soother contains Benzalkonium chloride).
What Vicks Sinex Soother looks like and contents of the pack Vicks Sinex Soother nasal spray solution 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 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:
Teva Czech Industries s.r.o.
Ostravska 29, indication number 305, Opava-Komarov, Postal code 747 70,
Czech Republic
PL 00129/0356
This leaflet was last revised in 06/2015.
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What is in this leaflet:
1. What Vicks Sinex Soother is and what it is used for
2. What you need to know 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. Contents of the pack and other information
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.
Do not use Vicks Sinex Soother:
if you are allergic (hypersensitive) to the active substance oxymetazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6) if you 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) if you suffer from acute heart disease or cardiac asthma
if you suffer from increased eyeball-pressure (narrow-angle glaucoma) if you have had an operation to remove your pituitary gland
Read all of this leaflet carefully bef start using this medicine because important information for you.
Always use this medicine exactly as leaflet or as your doctor or pharmacist h This medicine is available without pre
ore you - Keep this leaflet. You may need to read it again.
it contains - Ask your pharmacist if you need more information
or advice.
cribed in this - I f you get any side effects, talk to your doctor or ave told you. pharmacist. This includes any possible side effects scription. not listed in this leaflet. See section 4.
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However, you still need to use Vicks Sinex Soother carefully to get the best results from it
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
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• if you have inflamed skin or mucous membranes of your nostrils or have scabs in your nos
O Do not give this medicine to children under 12 years of age.
O Warnings and precautions Talk to your doctor or pharmacist before Vicks Sinex Soother if you have:
• high blood pressure
• heart disease, including angina
• diabetes
• thyroid problems
• enlarged prostate gland (prostatic hyp
O Other medicines and Vicks Sinex
Tell your doctor or pharmacist if you an or have recently taken or might take an medicines
• monoamine oxidase inhibitors (MAI used in the treatment of Parkinson's depression). Do not use Vicks Sinex have taken MAOIs during the last two
• tricyclic antidepressants - inform if you are taking drugs used in the tre depression such as amitriptyline and
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• Beta blockers or high blood pressure medicines - inform your doctor before use if you are taking any of there.
• Parkinson's disease medicine (bromocriptine)
- inform your doctor before use if you are taking this medicine.
O Pregnancy and Breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
The spray should be used with caution during pregnancy or if breast feeding.
O Driving and using machines
Vicks Sinex Soother has no influence on the ability to drive or use machines.
O Vicks Sinex Soother contains Benzalkonium chloride
Benzalkonium chloride (a preservative) is an ingredient in Vicks Sinex Soother which might cause swelling of nasal mucosa, especially during longterm use.
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Always use this medicine exactly as described in this leaflet or as your doctor or your pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
O 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.
If you have any further questions on tl thismedicine, ask your doctor or pharm
he u
e use of acist.
Like all medicines, this medicine can c effects, although not everybody gets Uncommon (may affect up to 1 in 100 Sneezing, dryness or irritation in the no or throat. 186
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people): se, mouth
What Vicks Sinex Soother contains The active substance is: oxymetazoline hydrochloride 0.5 mg/ml. One spray (equivalent to 0.05 ml) contains approximately 25 micrograms oxymetazoline hydrochloride.
The other ingredients are: sorbitol, sodium citrate, polysorbate 80, benzyl alcohol, citric acid anhydrous, benzalkonium chloride solution, acesulfame
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.
1 Method of 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.
O 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.
O If you forget to use Vicks Sinex Soother
Do not take a double dose to make up for a forgotten dose; instead, continue using according to the §- administration instructions.
• Rare (may affect up to 1 in 1000 peop e):
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.
O 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 Scoe me at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
potassium, levomenthol, cineole, disodium edetate, aloes dry extract, levocarvone, water, purified.
(See section 2 Vicks Sinex Soother contains Benzalkonium chloride).
What Vicks Sinex Soother looks like and contents of the pack
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the exp ry date which is stated on the carton and label of the bottle after EXP The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Vicks Sinex Soother nasal spray solution 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 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:
Teva Czech Industries s.r.o.
Ostravska 29, indication number 305,
Opava-Komarov, Postal code 747 70,
Czech Republic
PL 00129/0356
This leaflet was last revised in 06/2015.
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148
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REG0149827 Version 3.2 Approved Page 4 of 5