Vicks Sinex

Document: Vicks Sinex nasal spray, solution ENG PL change

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

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.

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 medicineto 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.

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 national reporting system listed in Appendix V*. 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

Manufacturer

Teva Czech Industries s.r.o.

Ostravska 29, indication number 305

747 70 Opava-Komarov

Czech Republic

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: WICK SinexAloe Nasenspray Nasenspray 0,5 mg/ml Lösung

Belgium: Vicks SinexAloe 0,5 mg/ml neusspray oplossing

Bulgaria: Викс Синекс Алое и Евкалипт 0,5 mg/mlспрей за нос, разтвор

Czech Republic: Sinex Vicks Aloe a Eukalyptus 0,5mg/ml, nosni sprej, roztok

Estonia: Sinex

Finland: Vicks Sinex

Germany: WICK Sinex avera Nasenspray 0,5 mg/ml Lösung

Greece: Vicks Sinex nasal spray solution 0,5mg/ml

Hungary: Wick Sinex Aloe Vera és Eukaliptusz 0.5 mg/ml oldatos orrspray

Lithuania: Sinex 0,5 mg/ml nosies purškalas (tirpalas)

Latvia: Sinex 0,5 mg/ml deguna aerosols, šķīdums

The Netherlands: Vicks Sinex Aloë 0,5 mg/ml neusspray oplossing

Poland: Vicks Sinex Aloes I Eukaliptus

Portugal: Sinexsensi 0,5 mg/ml solução para pulverização nasal

Romania: Vicks Sinex 0,5 mg/ml spray nazal, soluție.

Spain: Sinexsensi 0,5 mg/ml solución para pulverización nasal

Sweden: Vicks Sinex, 0,5 mg/ml, nässpray, lösning

UK: Vicks Sinex Soother 0,5 mg/ml Nasal Spray Solution

This leaflet was last revised in 2016-01-27