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1. Sudafed Mucus Relief 0.1% Nasal Spray
2. Sudafed Mucus Relief 0.1% Nasal Spray

SVDAFED

BLOCKED NOSE

Spray

Xylometazoline hydrochloride

■    This 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:

i There are some people who should not take this medicine. To find out if you are one of them see section 2 c

i 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:

i 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.

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.

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.

□ 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.

^^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.

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.

^Wsome of the ingredients can cause problems

■    Benzalkonium chloride is an irritant which may cause skin reactions.

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

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

O Children under 12 years

Do not give to children under 12 years old.

O Adults and Children aged 12 years and over

Age    Dose

Adults and    One spray into each nostril

children aged 12    2 or 3 times a day

years and over

■    Do not take more than 3 doses in 24 hours.

■    Do not use continuously for more than 7 days.

■    If you do not get better, talk to your doctor.

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.

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.

Reporting of side-effects

If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side-effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

By reporting side-effects you can help provide more information on the safety of this medicine.

5    Storing this medicine

Do not store above 25°C.

Keep the product out of the sight and reach 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.

6 Further information

What's 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.

What the medicine looks like

Sudafed Blocked Nose Spray is a clear colourless solution in a 15 ml bottle.

Marketing Authorisation holder: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK. Manufacturer: Famar Orleans, 5 avenue de Concyr, 45071 Orleans, Cedex 2, France.

This leaflet was revised September 2013.

Sudafed is a registered trade mark.

F309822-57

13/0068

CRR: 318992 Ref: F309822-57 13/0068 v5 01/10/13

Dimensions: 148 x210mm

SUDAFED'

MUCUS RELIEF

0.1% Nasal Spray

Xyiometazoiine hydrochloride

■    This 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.

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.

mi

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.

□ 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.

^Xlalk 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.

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.

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

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

O Children under 12 years

Do not give to children under 12 years old.

O Adults and Children aged 12 years and over

Age    Dose

Adults and    One spray into each nostril

children aged 12    2 or 3 times a day

years and over

■    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.

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.

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.

Reporting of side-effects

If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side-effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

By reporting side-effects you can help provide more information on the safety of this medicine.

5    Storing this medicine

Do not store above 25°C.

Keep the product out of the sight and reach 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.

6 Further information

What's 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.

What the medicine looks like

Sudafed Mucus Relief 0.1% Nasal Spray is a clear colourless solution in a 15 ml bottle.

Marketing Authorisation holder: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK. Manufacturer: Famar Orleans, 5 avenue de Concyr, 45071 Orleans, Cedex 2, France.

This leaflet was revised October 2013.

Sudafed is a registered trade mark.

CRR: 320512 Ref: F309825-17 13-0071 v2 Date: 09/10/13 Dimensions:148 x 210mm

PACKAGELEAFLET

NON-DROWSY SUDAFED DECONGESTANT NASAL SPRAY Xylometazoline

■    This 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 >

■    If you have ever had a bad reaction to any of the ingredients. For the list of ingredients see section 6 >

■    Speak to your doctor:^

■    If you suffer from any of the conditions mentioned in section 2. See section 2 >

■    Follow the dosage instructions carefully.

These are shown in the table. See section 3 >

■    ■ Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again.

1    What the medicine is for

Non-Drowsy Sudafed Decongestant 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.

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.

X 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 Non-Drowsy Sudafed Decongestant Nasal Spray.

! 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.

! 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.

3 How to use this Medicine

Follow the instructions and study the pictures below to ensure that you use Non-Drowsy Sudafed Decongestant Nasal Spray correctly:

■ 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.

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

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

i Children under 12 years

This medicine is not recommended for children under 12 years.

i Adults and Children 12 years and over

Age    Dose

Adults and    One spray into each nostril

children 12    2 or 3 times a day

years and over

■    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.

! 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.

4    Possible side-effects

Non-Drowsy Sudafed Decongestant 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5    Storing this medicine

Do not store above 25°C.

Keep the product out of the sight and reach of children.

Do not use your medicine after the end of the month shown as an expiry date on the packaging

6 Further information

What’s in this medicine?

The active ingredient in Non-Drowsy Sudafed Decongestant 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.

What the medicine looks like

Non-Drowsy Sudafed Decongestant Nasal Spray is a clear colourless solution in a 15 ml bottle.

Product Licence holder: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.

Manufacturer: McNeil Manufacturing, 5 avenue de Concyr, 45071 Orleans, Cedex 2, France.

This leaflet was revised March 2016

Sudafed is a registered trade mark.