NON-DROWSY SUDAFED DECONGESTANT NASAL SPRAY

Active substance: XYLOMETAZOLINE HYDROCHLORIDE

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PROPOSED LEAFLET - ALTERNATIVE
position only

2 Before taking this medicine
0.1% NASAL SPRAY Xylometazoline Hydrochloride
medicine is used to help clear the stuffy, blocked up feeling in your nose and sinuses caused by colds and allergies such as hay fever. This medicine is for use by adults and children aged 12 years and over. Do not take this medicine: There are some people who should not take this medicine. To find out if you are one of them see section 2 c If you have ever had a bad reaction to any of the ingredients. For the list of ingredients see section 6 c Speak to your doctor: If you suffer from any of the conditions mentioned in section 2. See section 2 c Follow the dosage instructions carefully. These are shown in the table. See section 3 c Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again.
This

3 How to use this medicine
Follow the instructions and study the pictures below to ensure that you use Sudafed Mucus Relief 0.1% Nasal Spray correctly:


This medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.

Do not take this medicine
If you have ever had a bad reaction (e.g. rash, swelling of the face and throat, difficulty breathing) to any of the ingredients. If you are taking, or have taken in the last two weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs). If you have recently had neurosurgery. If you have had your pituitary gland removed. If you are pregnant. If any of these apply to you, get advice from a doctor or pharmacist without taking Sudafed Mucus Relief 0.1% Nasal Spray.


Step 1. Remove the plastic cap from the nozzle. Step 2. When using the spray for the first time, press the plunger downwards while supporting the base with your thumb as shown in the diagram and release until a single spray is delivered. Step 3. Hold the bottle upright and place the nozzle into one nostril. Press the plunger downwards and at the same time breathe in through your nose. Release the plunger and remove the nozzle from the nostril. Repeat this process for the other nostril. Step 4. Wipe the nozzle and replace the plastic cap after use.



Talk to your doctor or pharmacist
If you have high blood pressure or heart disease. If you have diabetes. If you have an overactive thyroid gland.


If any of these bullet points apply to you now or in the past, talk to a doctor or pharmacist.

1 What the medicine is for
Sudafed Mucus Relief 0.1% Nasal Spray is a medicine which is used to help clear the stuffy, blocked up feeling in your nose and sinuses caused by colds and allergies such as hay fever. The spray contains xylometazoline hydrochloride, which is a topical decongestant that relieves nasal and sinus congestion. This medicine is for use in adults and children aged 12 years and over.

If you are pregnant or breast-feeding


Do not take this medicine if you are pregnant. If you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.

Some of the ingredients can cause problems


Benzalkonium chloride is an irritant which may cause skin reactions.



turn over c

Check the table that follows to see how much medicine to use.


4 Possible side-effects
Sudafed Mucus Relief 0.1% Nasal Spray can have side-effects, like all medicines, although these don't affect everyone and are usually mild. Occasionally people may experience local irritation such as burning, soreness, dryness, stinging, itching or sneezing. Nausea and headache may rarely occur. If this medicine is used continuously for long periods, congestion symptoms may return. If you experience any side-effects not included in this leaflet or are not sure about anything, talk to your doctor or pharmacist.

6 Further information
Whats in this medicine?
The active ingredient in Sudafed Mucus Relief 0.1% Nasal Spray is: Xylometazoline hydrochloride 0.1% w/v. Other ingredients are: Benzalkonium chloride, disodium edetate, sodium dihydrogen phosphate, sodium monohydrogen phosphate, sodium chloride, sorbitol solution, purified water.

Do not use more than the stated dose shown in the table.

Children under 12 years
Do not give to children under 12 years old.

Adults and Children aged 12 years and over
Age Adults and children aged 12 years and over


Dose One spray into each nostril 2 or 3 times a day

What the medicine looks like
Sudafed Mucus Relief 0.1% Nasal Spray is a clear colourless solution in a 15 ml bottle. Product Licence holder: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK. Manufacturer: Famar Orlans, 5 avenue de Concyr, 45071 Orleans, Cedex 2, France. This leaflet was revised May 2011. Sudafed is a registered trade mark.

Do not take more than 3 doses in 24 hours. Do not use continuously for more than 7 days. If symptoms persist talk to your doctor.

5 Storing this medicine
Do not store above 25C. Keep the product out of the reach and sight of children. Do not use your medicine after the end of the month shown as an expiry date on the packaging. 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 to protect the environment.

If anyone has too much
If anyone has too much contact a doctor or your nearest Accident & Emergency Department (Casualty) taking this leaflet and pack with you.

If you forget to take the medicine
If you forget to take a dose, take the next dose when needed provided that you do not take more than 3 doses in 24 hours. Do not take a double dose.

F XXXXXX 11-0131 position only

CURRENT LEAFLET - alternative

2 Before taking this medicine
This medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.

3 How to use this medicine
Follow the instructions and study the pictures below to ensure that you use Sudafed Blocked Nose Spray correctly:


Xylometazoline hydrochloride
medicine is used to help clear the stuffy, blocked up feeling in your nose and sinuses caused by colds and allergies such as hay fever. This medicine is for use by adults and children aged 12 years and over. Do not take this medicine: There are some people who should not take this medicine. To find out if you are one of them see section 2 c If you have ever had a bad reaction to any of the ingredients. For the list of ingredients see section 6 c Speak to your doctor: If you suffer from any of the conditions mentioned in section 2. See section 2 c Follow the dosage instructions carefully. These are shown in the table. See section 3 c Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again.
This

Do not take this medicine
If you have ever had a bad reaction (e.g. rash, swelling of the face and throat, difficulty breathing) to any of the ingredients. If you are taking, or have taken in the last two weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs). If you have recently had neurosurgery. If you have had your pituitary gland removed. If you are pregnant. If any of these apply to you, get advice from a doctor or pharmacist without taking Sudafed Blocked Nose Spray.


Step 1. Remove the plastic cap from the nozzle. Step 2. When using the spray for the first time, press the plunger downwards while supporting the base with your thumb as shown in the diagram and release until a single spray is delivered. Step 3. Hold the bottle upright and place the nozzle into one nostril. Press the plunger downwards and at the same time breathe in through your nose. Release the plunger and remove the nozzle from the nostril. Repeat this process for the other nostril. Step 4. Wipe the nozzle and replace the plastic cap after use.



Talk to your doctor or pharmacist
If you have high blood pressure or heart disease. If you have diabetes. If you have an overactive thyroid gland.


If any of these bullet points apply to you now or in the past, talk to a doctor or pharmacist.

1 What the medicine is for
Sudafed Blocked Nose Spray is a medicine which is used to help clear the stuffy, blocked up feeling in your nose and sinuses caused by colds and allergies such as hay fever. The spray contains xylometazoline hydrochloride, which is a topical decongestant that relieves nasal and sinus congestion. This medicine is for use in adults and children aged 12 years and over.

If you are pregnant or breast-feeding


Do not take this medicine if you are pregnant. If you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.

Some of the ingredients can cause problems


Benzalkonium chloride is an irritant which may cause skin reactions.



turn over c

F307456 - Leaflet SUDAFED BLOCKED NOSE SPRAY 15mlv4.4.indd 1

09/02/10 09:17

Check the table that follows to see how much medicine to use.


4 Possible side-effects
Sudafed Blocked Nose Spray can have side-effects, like all medicines, although these don't affect everyone and are usually mild. Occasionally people may experience local irritation such as burning, soreness, dryness, stinging, itching or sneezing. Nausea and headache may rarely occur. If this medicine is used continuously for long periods, congestion symptoms may return. If you experience any side-effects not included in this leaflet or are not sure about anything, talk to your doctor or pharmacist.

6 Further information
Whats in this medicine?
The active ingredient in Sudafed Blocked Nose Spray is: Xylometazoline hydrochloride 0.1% w/v. Other ingredients are: Benzalkonium chloride, disodium edetate, sodium dihydrogen phosphate, sodium monohydrogen phosphate, sodium chloride, sorbitol solution, purified water.

Do not use more than the stated dose shown in the table.

Children under 12 years
Do not give to children under 12 years old.

Adults and Children aged 12 years and over
Age Adults and children aged 12 years and over


Dose One spray into each nostril 2 or 3 times a day

What the medicine looks like
Sudafed Blocked Nose Spray is a clear colourless solution in a 15 ml bottle. Product Licence holder: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK. Manufacturer: Famar Orlans, 5 avenue de Concyr, 45071 Orleans, Cedex 2, France. This leaflet was revised February 2010. Sudafed is a registered trade mark.

Do not take more than 3 doses in 24 hours. Do not use continuously for more than 7 days. If symptoms persist talk to your doctor.

5 Storing this medicine
Do not store above 25C. Keep the product out of the reach and sight of children. Do not use your medicine after the end of the month shown as an expiry date on the packaging. 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 to protect the environment.

If anyone has too much
If anyone has too much contact a doctor or your nearest Accident & Emergency Department (Casualty) taking this leaflet and pack with you.

If you forget to take the medicine
If you forget to take a dose, take the next dose when needed provided that you do not take more than 3 doses in 24 hours. Do not take a double dose.

F307456-43 09/0599

F307456 - Leaflet SUDAFED BLOCKED NOSE SPRAY 15mlv4.4.indd 2

09/02/10 09:17

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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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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