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SUDAFED CONGESTION RELIEF 0.1% NASAL SPRAY SOLUTION

Active substance(s): XYLOMETAZOLINE HYDROCHLORIDE

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This medicine is for use in adults and children aged
12 years and over.

NIGHT 0.1%
ALLERGY
This medicine is used to help clear the stuffy,
blocked up feeling in your nose and sinuses
caused by allergies, such as hay fever, and colds.
n This medicine is for use by adults and children
aged 12 years and over.
n Do not take this medicine:
n There are some people who should not take
this medicine. To find out if you are one of
them see section 2
n If you have ever had a bad reaction to any of
the ingredients. For the list of ingredients see
section 6
n Speak to your doctor:
n If you suffer from any of the conditions
mentioned in section 2. See section 2
n 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.
n

1 What the medicine is for
Sudafed Congestion 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 allergies, such as hay fever, and colds.
The spray contains xylometazoline hydrochloride,
which is a topical decongestant that relieves
nasal and sinus congestion.

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
Congestion Relief 0.1% Nasal Spray correctly:

Step 1. Remove the
plastic cap from the
nozzle from Sudafed
Do not take this medicine…
Congestion Relief
n If you have ever had a bad reaction (e.g.
0.1% Nasal Spray.
rash, swelling of the face and throat, difficulty
n Step 2. When using the
breathing) to any of the ingredients.
spray for the first time,
n If you are taking, or have taken in the last
press the plunger
two weeks, drugs for depression known as
downwards while
Monoamine Oxidase Inhibitors (MAOIs).
supporting the base with
n If you have recently had neurosurgery.
your thumb as shown in
n If you have had your pituitary gland removed.
the diagram and release
n If you are pregnant.
until a single spray
If any of these apply to you, get advice from
is delivered.
a doctor or pharmacist without taking
n Step 3. Hold the bottle
Sudafed Congestion Relief 0.1% Nasal Spray.
upright and place the
nozzle into one nostril.
Talk to your doctor or pharmacist…
Press the plunger
n If you have high blood pressure or heart
downwards and at the
disease.
same time breathe in
n If you have diabetes.
through your nose.
n If you have an overactive thyroid gland.
Release the plunger and
If any of these bullet points apply to you now or in
remove the nozzle from
the past, talk to a doctor or pharmacist.
the nostril. Repeat this
process for the other
If you are pregnant or breast-feeding
nostril.
n Do not take this medicine if you are pregnant. n Step 4. Wipe the nozzle
n If you are breast-feeding, ask your doctor
and replace the plastic
or pharmacist for advice before taking this
cap after use.
medicine.
n

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

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

Children under 12 years
This medicine is not recommended for
children under 12 years.



Adults and Children aged 12 years and
over

Age

Dose

Adults and
children aged 12
years and over

One spray into each
nostril 2 to 3 times daily,
as necessary.

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

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.



I f 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.

If you forget to take the medicine

4 Possible side-effects

6 Further information

Sudafed Congestion Relief 0.1% Nasal Spray can
have side-effects, like all medicines, although
these don't affect everyone and are usually mild.
n Occasionally people may experience local
irritation such as burning, soreness,
dryness, stinging, itching or sneezing.
n Nausea and headache may rarely occur.
n If this medicine is used continuously for
long periods, congestion symptoms may
return.

What’s in this medicine?

Reporting of side effects

Sudafed Congestion Relief 0.1% Nasal Spray is a
clear colourless solution in a 10 ml bottle.
Product Licence holder: McNeil Products Ltd,
Maidenhead, Berkshire. SL6 3UG.
Manufacturer: Famar Health Care Services
Madrid, S.A.U. Avda. Leganés, 62, Alcorcón,
28923 Madrid, Spain.
This leaflet was revised November 2014.
Sudafed is a registered trade mark.

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

The active ingredient in Sudafed Congestion
Relief 0.1% Nasal Spray is: Xylometazoline
hydrochloride 1 mg in 1 ml.
Other ingredients are: Sodium hyaluronate,
sorbitol, glycerol, disodium phosphate dihydrate,
sodium dihydrogen phosphate dihydrate, sodium
chloride and water for injections.

What the medicine looks like

Keep the product out of the sight and reach of
children.
Do not store above 25°C.
Do not use your medicine after the end of the
month shown as an expiry date on the packaging.
Discard the product 6 months after first opening.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer
required. These measures will help protect the
environment.
14-0082
11504121-00

Reference: 14-0082 v13
Dimensions:148 x 210mm
Font size of main body text:
8pts
Famar

NIGHT 0.1%
ALLERGY

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Reference 14-0119 v10
Dimensions: 148x210mm
Font size main body text: 8pt
Ursapharm

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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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