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OXYMETAZOLINE DECONGESTANT NASAL SPRAY 0.05%W/V

Active substance(s): OXYMETAZOLINE HYDROCHLORIDE

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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

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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.

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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 30ºC.
The product provides upto 120 doses. It is available in bottles of 15ml
Product licence holder:-

Manufacturer:-

Ayrton Saunders Ltd
9 Arkwright Road
Astmoor Industrial Estate
Runcorn
Cheshire
WA7 1NU

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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