Vicks Sinex Soother 0.5 Mg/Ml Nasal Spray Solution
Package leaflet: Information for the user Vicks Sinex 0.5 mg/ml, nasal spray solution
Oxymetazoline hydrochloride
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 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.
- 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 must talk to a doctor if you do not feel better or if you feel worse after 3 days.
What is in this leaflet:
1. What Vicks Sinex is and what it is used for
2. What you need to know before you use Vicks Sinex
3. How to use Vicks Sinex
4. Possible side effects
5. How to store Vicks Sinex
6. Contents of the pack and other 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. What you need to know 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 this medicine (listed in section 6)
- if you 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).
- 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.
Do not give this medicine to children under 6 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using Vicks Sinex if you have:
• high blood pressure,
• heart disease including angina,
diabetes
• thyroid problems
• enlarged prostate gland [prostatic hypertrophy]
Other medicines and Vicks Sinex
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 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
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.
Driving and using machines
Vicks Sinex has no influence on the ability to drive or use machines.
Vicks Sinex contains Benzalkonium chloride
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 this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
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 5-7 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.
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 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 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 this medicine, ask your doctor or pharmacist.
4. Possible side effects
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 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any 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
Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Do not use this medicineafter 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.
6. Contents of the pack and other information What Vicks Sinex 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 contains Benzalkonium chloride).
What Vicks Sinex looks like and contents of the pack
Vicks Sinex 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.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Procter & Gamble (Health & Beauty Care) Ltd
The Heights
Weybridge
Brooklands
Surrey
KT13 0XP
Manufacturer
Teva Czech Industries s.r.o.
Ostravska 29, indication number 305 747 70 Opava-Komarov Czech Republic
This leaflet was last revised in
[To be completed upon approval]
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