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SUDAFED MUCUS RELIEF 0.1% NASAL SPRAY

Active substance(s): XYLOMETAZOLINE HYDROCHLORIDE

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Transcript
2 Before taking this
medicine

3 How to use 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.

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

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:
■ 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 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.

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.

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

F309822 - Leaflet SUDAFED BLOCKED NOSE SPRAY 15ml UKv5.0.indd 1

01/10/13 14:32

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


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

4 Possible side-effects

6 Further information

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.

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.

Age

Dose

Reporting of side-effects

What the medicine looks like

Adults and
children aged 12
years and over

One spray into each nostril
2 or 3 times a day

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.

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 Orléans, 5 avenue de Concyr,
45071 Orleans, Cedex 2, France.
This leaflet was revised September 2013.
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 you do not get better, talk to your doctor.



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

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.

5 Storing this medicine
Do not store above 25ºC.
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.

F309822-57
13/0068

CRR: 318992
Ref: F309822-57
13/0068 v5
01/10/13
Dimensions: 148 x 210mm

F309822 - Leaflet SUDAFED BLOCKED NOSE SPRAY 15ml UKv5.0.indd 2

01/10/13 14:32

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:
■ 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.

2 Before taking this
medicine

3 How to use 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.

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

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.

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

F309825-PIL SUDAFED NS Mucus Relief 15ml UKV2.1.indd 1

09/10/13 16:33

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


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

Dose

Adults and
children aged 12
years and over

One spray into each nostril
2 or 3 times a day

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.



4 Possible side-effects

6 Further information

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.

What’s in this medicine?

Reporting of side-effects

What the medicine looks like

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.

If anyone has too much

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

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

5 Storing this medicine

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.

CRR: 320512
Ref: F309825-17
13-0071 v2
Date: 09/10/13
Dimensions:148 x 210mm
F309825-PIL SUDAFED NS Mucus Relief 15ml UKV2.1.indd 2

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.

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 Orléans, 5 avenue de Concyr,
45071 Orleans, Cedex 2, France.
This leaflet was revised October 2013.
Sudafed is a registered trade mark.

Do not store above 25ºC.
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.

F309825-17
13-0071

09/10/13 16:33

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

! 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 25ºC.
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.

Expand view ⇕

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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