WICK

WICK Sinex Avera metered dose spray

Important notes (mandatory information)

Wick Sinex avera Nasal Spray. Active ingredient: Oxymetazoline hydrochloride. Areas of application: for local relief of symptoms of a blocked nose in connection with a cold or runny nose.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Wick Sinex avera Nasal Spray 0.5 mg/ml solution
Active ingredient: Oxymetazoline hydrochloride

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist. This medicine is available without a prescription. However, to achieve the best possible treatment results, Wick Sinex avera Nasal Spray must be used as prescribed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after 3 days, contact your doctor.

What this package leaflet contains

1. WHAT IS WICK SINEX AVERA NASAL SPRAY AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING WICK SINEX AVERA NASAL SPRAY?
3. HOW IS WICK SINEX AVERA NASAL SPRAY USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD WICK SINEX AVERA NASAL SPRAY BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS WICK SINEX AVERA NASAL SPRAY AND WHAT IS IT USED FOR?

Wick Sinex avera is a nasal spray for local relief of symptoms of a blocked nose in connection with a cold or runny nose. The spray starts working after a few minutes and lasts for 6 - 8 hours.

2. WHAT SHOULD YOU CONSIDER BEFORE USING WICK SINEX AVERA NASAL SPRAY?

Wick Sinex avera Nasal Spray must not be used:

• if you are allergic (hypersensitive) to oxymetazoline hydrochloride, levomenthol, cineole or any of the other ingredients of this medicine listed in section 6.
• if you are taking or have taken monoamine oxidase inhibitors (MAO inhibitors) in the last two weeks (MAO inhibitors are used to treat Parkinson's disease and depression).
• if you suffer from an acute heart condition or cardiac asthma.
• if you suffer from increased eye pressure (narrow-angle glaucoma).
• if you have undergone surgery to remove your pituitary gland.
• if you suffer from inflammation of the skin or mucous membranes of your nostrils or have crusts in your nose.

Wick Sinex avera Nasal Spray must not be used in children under 6 years of age.

Warnings and precautions

Please talk to your doctor or pharmacist before using Wick Sinex avera Nasal Spray if you have:

• High blood pressure,
• Heart disease including angina pectoris,
• Diabetes,
• Thyroid problems,
• Prostate enlargement (prostate hypertrophy).

Use of Wick Sinex avera Nasal Spray together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

• Monoamine oxidase inhibitors (MAO inhibitors) are used to treat Parkinson's disease and depression — Do not use Wick Sinex avera Nasal Spray if you have taken MAO inhibitors in the last two weeks.
• Tricyclic antidepressants – tell your doctor before using if you are taking medicines to treat depression, such as amitriptyline and imipramine.
• Beta-blockers or other blood pressure lowering medicines – tell your doctor before using if you are taking such medicines.
• Medicines for Parkinson's disease (bromocriptine) – tell your doctor before using if you are taking such medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. The spray should only be used with caution during pregnancy or breast-feeding.

Driving and using machines

Wick Sinex avera Nasal Spray has no influence on the ability to drive and use machines.

Wick Sinex avera Nasal Spray contains benzalkonium chloride

The preservative (benzalkonium chloride) contained in Wick Sinex avera Nasal Spray can, especially with prolonged use, cause swelling of the nasal mucosa. If such a reaction is suspected (persistent blocked nose), a nasal medicine without preservatives should be used if possible. If such medicines are not available, a different dosage form should be considered.

3. HOW IS WICK SINEX AVERA NASAL SPRAY USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

• Adults and children over 10 years: 1 – 2 sprays into each nostril, no more than 2 – 3 times a day.
• Children aged 6 – 10 years: 1 spray into each nostril, no more than 2 – 3 times a day.
• Not for children under 6 years.

Do not exceed the recommended dosage. Do not use continuously for more than 5 - 7 days. If used for a longer period of time, Wick Sinex avera Nasal Spray can cause a blocked nose. Please talk to your doctor if symptoms worsen or do not improve after 3 days.

Method of administration

1. Remove the cap. Hold the bottle upright and hold the spray nozzle into the nostril. Close the other nostril.
2. Spray and inhale deeply through the nose at the same time. Repeat the process with the other nostril.
3. Adults and children over 10 years can repeat steps 1 and 2 once if necessary.
4. Wipe the spray nozzle with a clean, damp paper towel and replace the cap immediately after use.

If you have used more Wick Sinex avera Nasal Spray than you should

If you have used too much Wick Sinex avera Nasal Spray and side effects occur, you should seek medical advice immediately and take the bottle or packaging with you.

If you forget to use Wick Sinex avera Nasal Spray

Do not use a double dose to make up for a forgotten dose, but continue using as directed in the dosage instructions.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• Occasionally (may affect up to 1 in 100 people): Sneezing, dryness or irritation in the nose, mouth or throat.
• Rarely (may affect up to 1 in 1,000 people): Anxiety, tiredness, irritability, sleep disorders in children, palpitations, heart palpitations, increased blood pressure, blocked nose, swelling of the nasal mucosa, headache, nausea, skin redness, rash and blurred vision.

In appropriately sensitised patients, Wick Sinex avera Nasal Spray can trigger hypersensitivity reactions (including shortness of breath).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD WICK SINEX AVERA NASAL SPRAY BE STORED?

Keep this medicine out of the 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 after "Use by". The expiry date refers to the last day of the month indicated. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Wick Sinex avera Nasal Spray contains

The active ingredient is: 0.5 mg/ml oxymetazoline hydrochloride. One spray (corresponding to 0.05 ml) contains approximately 25 micrograms of oxymetazoline hydrochloride. The other ingredients are: Sorbitol, sodium citrate (Ph.Eur.), polysorbate 80, benzyl alcohol, anhydrous citric acid, benzalkonium chloride solution, acesulfame potassium, levomenthol, cineole, sodium edetate (Ph.Eur.), aloe dry extract, L-carvone, purified water. (For benzalkonium chloride see end of section 2.)

What Wick Sinex avera Nasal Spray looks like and contents of the pack

Wick Sinex avera Nasal Spray is a nasal spray with a metered dose pump. The pack contains a brown glass bottle with a white pump nozzle. The bottle contains 15 ml of solution.

Pharmaceutical entrepreneur

Wick Pharma
Zweigniederlassung der Procter & Gamble GmbH
D-65823 Schwalbach
Tel: 0800-9425847

Manufacturer

Teva Czech Industries s.r.o.
Ostravska 29, indication number 305
747 70 Opava-Komarov
Czech Republic

This leaflet was last revised in January 2016.

Source: Information from the package leaflet
Status: 11/2017
Active ingredient: Oxymetazoline hydrochloride. Areas of application: for local relief of symptoms of a blocked nose in connection with a cold or runny nose.