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Vicks Sinex Decongestant Nasal Spray

Oxymetazoline hydrochloride 0.05% w/v

Patient Information Leaflet

In this leaflet:

1.    What Vicks Sinex Decongestant Nasal Spray is and what it is used for

2.    Before you use Vicks Sinex Decongestant Nasal Spray

3.    How to use Vicks Sinex Decongestant Nasal Spray

4.    Possible side effects

5.    How to store Vicks Sinex Decongestant Nasal Spray

6.    Further information

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 Decongestant Nasal Spray 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 7 days.

1. What Vicks Sinex Decongestant Nasal Spray is and what it is used for

Vicks Sinex Decongestant Nasal Spray is used for localised relief of the symptoms of a blocked nose in association with a cold, hay fever or sinusitis (inflammation of the passages leading to the nose). The effect of the spray starts after several minutes and lasts for 6-8 hours.

The active substance is oxymetazoline hydrochloride.

2. Before you use Vicks Sinex Decongestant Nasal Spray

Do not use Vicks Sinex Decongestant Nasal Spray if you:

are allergic (hypersensitive) to the active substance oxymetazoline hydrochloride or any of the other ingredients of Vicks Sinex Decongestant Nasal Spray (see section 6) are taking (or have taken during the last 14 days) 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

•    are taking other medications containing decongestants

•    have had nasal surgery

•    suffer from a tumour of the adrenal glands.

O Do not give Vicks Sinex Decongestant Nasal Spray to children under 12 years of age O Take special care with Vicks Sinex Decongestant Nasal Spray

Before using tell your doctor if you have:

•    high blood pressure

•    heart disease

•    diabetes

•    disturbance in your thyroid function

•    an enlarged prostate gland

•    hepatic or renal disorder

•    occlusive vascular disease.

If any of the following occur, Vicks Sinex Decongestant Nasal Spray should be stopped;

•    hallucinations

•    restlessness

•    sleep disturbances.

Keep away from eyes.

O Taking other medicines

Please inform your doctor or pharmacist 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 Decongestant Nasal Spray if you have taken MAOIs during the last 14 days tricyclic antidepressants - inform your doctor if you are taking drugs used in the treatment of depression such as amitriptyline and imipramine high blood pressure medicines - inform your doctor before use if you are taking bethanidine, debrisoquine, guanethidine or any other medicine for high blood pressure as their effect may be reduced beta blockers - inform your doctor before use if you are taking these, as their effect may be reduced Parkinson's disease medicine (bromocriptine) -treatment with Vicks Sinex Decongestant Nasal Spray may be affected if it is used at the same time. appetite suppressants and amphetamine-like psychostimulants - inform your doctor before use if you are taking drugs for obesity

cardiac glycosides - inform your doctor before use as it can cause irregular heart beat (dysrhythmias) if it is taken at the same time

ergot alkaloids (ergotamine and methysergide)

- inform your doctor before use if you are taking these treatments for migraines as they can cause increased side effects.

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¹ Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before using Vicks Sinex Decongestant Nasal Spray. The spray should be used with caution during pregnancy or if breastfeeding. O Driving and using machines

No effect on ability to drive or use of machinery has been observed.

Important information about some of the ingredients of Vicks Sinex Decongestant Nasal Spray Benzalkonium chloride (a preservative) is an ingredient in Vicks Sinex Decongestant Nasal Spray which might cause swelling of nasal mucosa, especially during longterm use.

3. How to use Vicks Sinex Decongestant Nasal Spray

3. Wipe the nasal applicator with a clean, wet tissue and replace the cap immediately after application.

If you use more Vicks Sinex Decongestant Nasal Spray than you should

If you use too much Vicks Sinex Decongestant Nasal Spray you should contact your doctor or go to a hospital immediately and take the bottle or pack with you.

If you forget to use Vicks Sinex Decongestant Nasal Spray

Do not take a double dose if you forget to take 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 doctor or pharmacist.

4. Possible side effects

5. How to store Vicks Sinex Decongestant Nasal Spray

Keep out of the reach and sight of children.

This medicinal product does not require any special storage conditions.

Do not use Vicks Sinex Decongestant Nasal Spray 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 protect the environment.

6. Further information

Always use Vicks Sinex Decongestant Nasal Spray exactly as your pharmacist or doctor has told you. You should check with your doctor or pharmacist if you are not sure. Vicks Sinex Decongestant Nasal Spray is for use in your nose only.

O Dosage: The recommended dose is

Adults and Children over 12 years: 1 or 2 sprays per nostril every 6 to 8 hours unless advised otherwise by your doctor.

Children under 12 years: Do not use Do not exceed the recommended dose Do not use for more than 7 days in a row.

If used over a longer period or more than the recommended dose, Vicks Sinex Decongestant Nasal Spray may cause a blocked nose.

Contact your doctor if symptoms worsen or do not improve after 7 days.

¹ Administration:

1.    Remove the cap. Keep the bottle upright with the nasal applicator just into the nostril. Hold the other nostril closed.

2.    Lightly squeeze the bottle and breathe in deeply through your nose at the same time. Repeat for the other nostril.

Like all medicines, Vicks Sinex Decongestant Nasal Spray 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. Eye irritation, discomfort or redness.

•    Rare (occurring in less than 1 in 1,000 people):

Anxiety, fatigue, irritability, nervousness, tremor, sleep disturbance, rapid heartbeat, palpitations, raised blood pressure, blocked nose, swelling of the nasal lining, headache, nausea, flushing, rash and visual disturbances.

•    Prolonged and/or heavy use beyond the recommended use of 7 days, may in rare instances lead to cardiovascular and/or CNS effects.

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 (see details below).

United Kingdom: via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard Malta: ADR Reporting www.medicinesauthority.gov.mt/adrportal By reporting side effects you can help provide more information on the safety of this medicine.

What Vicks Sinex Decongestant Nasal Spray contains

The active substance is: oxymetazoline hydrochloride 0.5 mg/ml

The other ingredients are: sodium citrate dihydrate, tyloxapol, citric acid anhydrous, chlorhexidine digluconate, menthol, benzalkonium chloride, camphor, disodium edetate, eucalyptol, sodium hydroxide and purified water. What Vicks Sinex Decongestant Nasal Spray looks like and contents of the pack Vicks Sinex Decongestant Nasal Spray is a nasal spray solution in a plastic bottle with a spray nozzle and protective cap. It is available in a 15ml or 20ml bottle. Marketing authorisation holder:

Procter & Gamble (Health & Beauty Care) Limited,

The Heights, Brooklands, Weybridge, Surrey,

KT13 0XP, UK (send all enquiries to this address). Manufacturer:

Procter & Gamble Manufacturing GmbH,

Procter & Gamble Strasse 1, 64521 Gross Gerau, Germany PL00129/5011R Text Revised: 05/2015

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