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Oxymetazoline Decongestant Nasal Spray 0.05%W/V

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PL 16431/0123

WHAT YOU SHOULD KNOW ABOUT

OXYMETAZOLINE DECONGESTANT NASAL SPRAY 0.05% w/v

Intended for adults and children over 5 years old

Please read this leaflet carefully before you start to use this nasal spray, and keep it somewhere handy for reference. If you have any questions or are not sure about anything ask your doctor or pharmacist.

What is in the nasal spray?

The name of this medicine is Oxymetazoline Decongestant Nasal Spray 0.05% w/v. It contains Oxymetazoline HydrochlorideUSP. 0.05% w/v as the active ingredient. It also contains benzalkonium chloride 0.015% w/v as the preservative, disodium edetate, sodium phosphate dihydrate, citric acid monohydrate and water.

How does the nasal spray work?

This spray contains a nasal decongestant. Nasal decongestants help clear blocked noses associated with a number of conditions including head colds and hay fever.

A blocked nose, such as occurs with a cold, is caused by excessive nasal secretions and the swelling up of many tiny blood vessels that line the nose. The air passages become narrower and the nasal secretions may block the nose completely.

The nasal decongestant in this product helps to open up the nasal passages by reducing the excessive nasal secretions and reducing the swollen blood vessels to their normal size. It will help you breathe more easily and so feel better. The effects start within minutes and last for up to about 12 hours.

What is the nasal spray used for?

It is used to relieve the discomfort and symptoms of head colds and hay fever.

Check before you use the spray

• Do not use the spray:- If you are allergic to oxymetazoline hydrochloride or any of the other ingredients

-    If you are pregnant or breast feeding

-    For children under 5 years

-    If you have vasomotor rhinitis or atropic rhinitis

-    If you have had a trans-sphenoidal hypophysectomy or surgery exposing the dura mater

•    See your doctor before using the spray if:- You have heart disease, raised blood pressure, diabetes, an overactive thyroid

gland, or are under a doctor's care for another illness.

-    You have experienced a strong reaction (for example difficulty in sleeping or dizziness) with similar medicines.

•    Ask your doctor or pharmacist before using this spray if you are using any other medicines including any that you can buy without a prescription. Use with medicines known as " sympathomimetics ", such as ephedrine or phenylephrine, may increase the risk of side effects. Do not use this nasal spray if you are taking or have taken within the last 2 weeks a medicine known as a " monoamine oxidase inhibitor".

How to use the spray

For Adults and children over 5 years of age:

Two - three sprays to be instilled into each nostril in the morning and at bedtime.

1.    Clear the nose.

2.    Shake the bottle gently and remove the cap.

3.    Hold the spray with your forefinger and middle finger either side of the nozzle and your thumb underneath the bottle as shown in the diagram below.

4.    Close one nostril and put the nozzle in the other nostril. Tilt you head forward slightly and keep the spray upright.

5.    Start to breathe in through your nose and while breathing in press down with your fingers once to release a spray.

6.    Repeat Steps 4 and 5 with the other nostril.

7.    Wipe the nozzle with a clean tissue or handkerchief and replace the cap.

Consult your doctor if you think you have used too much spray or have taken it accidentally by mouth.

This nasal spray, like other nasal decongestants, should not be used for more than 7 consectutive days. If symptoms persist, consult your doctor.

To avoid possible spread of infection, this spray should be used by one person only.

Will the nasal spray suit me?

Some people with sensitive nasal passages may experience a burning or stinging sensation when applying the spray. It may also occasionally cause sneezing, dryness in the nose and throat and headaches in a few people.

If you think you are reacting badly in any way, stop using the spray and see your doctor. Storing the nasal spray

Use by date: Do not use the spray if it is past the expiry date on the bottle.

For reasons of hygiene do not use the spray more than 28 days after first opening it. Keep the spray in a cool place below 30°C.

The product provides upto 120 doses. It is available in bottles of 15ml

Product licence holder:-

Ayrton Saunders Ltd

9 Arkwright Road

Astmoor Industrial Estate

Runcorn

Cheshire

WA7 1NU


Manufacturer:-

INyX Pharma Ltd

9 Arkwright Road

Astmoor Industrial Estate

Runcorn

Cheshire

WA7 1NU


Remember:    Keep all medicines out of the reach of children

WARNING: DO NOT EXCEED THE RECOMMENDED DOSAGE


Date of last revision: August 2006