UKPAR Sudafed 0.
1% Nasal Spray PL 15513/0368
SUDAFED 0.1% NASAL SPRAY
(xylometazoline hydrochloride)
PL 15513/0368
UKPAR
TABLE OF CONTENTS
Lay Summary Page 2
Scientific discussion Page 3
Steps taken for assessment Page 11
Steps taken after authorisation – summary
Summary of Product Characteristics
Page 12
Patient Information Leaflet Page 15
Labelling Page 17
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UKPAR Sudafed 0.1% Nasal Spray PL 15513/0368
Sudafed 0.1% Nasal Spray
(xylometazoline hydrochloride)
PL 15513/0368
LAY SUMMARY
The Medicines and Healthcare products Regulatory Agency (MHRA) granted McNeil
Products Limited a Marketing Authorisation for the medicinal product Sudafed 0.1%
Nasal Spray (PL 15513/0368) on 28 March 2012. This is a General Sales List (GSL)
medicine, which can be purchased at pharmacies, supermarkets and other retail outlets
without the supervision of a pharmacist.
Sudafed 0.1% Nasal Spray is used, in adults and children aged 12 years and over, to
help clear the stuffy, blocked-up feeling in the nose and sinuses caused by colds and
allergies such as hay fever.
Sudafed 0.1% Nasal Spray contains the active ingredient xylometazoline
hydrochloride, which is a topical decongestant that relieves nasal and sinus
congestion.
No new or unexpected safety concerns arose from this application and it was,
therefore, judged that the benefits of taking Sudafed 0.1% Nasal Spray outweigh the
risks and a Marketing Authorisation has been granted.
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UKPAR Sudafed 0.1% Nasal Spray PL 15513/0368
Sudafed 0.1% Nasal Spray
(xylometazoline hydrochloride)
PL 15513/0368
SCIENTIFIC DISCUSSION
TABLE OF CONTENTS
Introduction Page 4
Pharmaceutical assessment Page 5
Non-clinical assessment Page 8
Clinical assessment Page 9
Overall conclusions and risk assessment Page 10
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UKPAR Sudafed 0.1% Nasal Spray PL 15513/0368
INTRODUCTION
Based on the review of the data on quality, safety and efficacy, the MHRA granted
McNeil Products Limited a Marketing Authorisation for the medicinal product
Sudafed 0.1% Nasal Spray (PL 15513/0368) on 28 March 2012. The product is
available as a General Sales List (GSL) medicine and does not require a prescription.
Sudafed 0.1% Nasal Spray is indicated for the symptomatic relief of nasal congestion
associated with the common cold, influenza, sinusitis, allergic and non-allergic
rhinitis, and other upper respiratory tract allergies.
This is a national abridged application submitted under Article 10(1) of Directive
2001/83/EC, as amended, claiming to be a generic medicinal product of Otrivine
Adult Formula Spray (Novartis Consumer Healthcare UK Limited), which was first
authorised in the UK on 26 September 1988.
Xylometazoline hydrochloride, the active substance, is an imidazole α-adrenergic
agonist which causes local vasoconstriction when applied topically. When a 0.1%
xylometazoline hydrochloride solution is applied to the nasal mucosa the capillaries
within the nasal vasculature are constricted which reduces congestion and associated
symptoms of mucus hypersecretion as well as facilitating drainage of blocked
secretions.
No new non-clinical or clinical data have been submitted, which is acceptable given
that the application was based on being a generic medicinal product of an originator
products that have been in clinical use for over 10 years.
No new or unexpected safety concerns arose during review of information provided
by the Marketing Authorisation Holder and it was, therefore, judged that the benefits
of taking Sudafed 0.1% Nasal Spray outweigh the risks, and a Marketing
Authorisation was granted.
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UKPAR Sudafed 0.1% Nasal Spray PL 15513/0368
PHARMACEUTICAL ASSESSMENT
ACTIVE SUBSTANCE
INN: Xylometazoline hydrochloride
Chemical Name: 2-[4-(1,1-Dimethylethyl)-2,6-dimethylbenzyl]-4,5-dihhydro-
1H-imidazole hydrochloride
Molecular Formula: C16H24N2, HCl
Structure
Molecular weight: 280.8
Appearance: A white or almost white crystalline powder
Solubility Freely soluble, in ethanol (96 per cent) and in methanol,
practically insoluble in ether, chloroform and benzene
Xylometazoline hydrochloride is the subject of a European Pharmacopoeia
monograph.
All aspects of the manufacture and control of the active substance xylometazoline
hydrochloride are covered by a European Directorate for the Quality of Medicines
(EDQM) Certificate of Suitability.
DRUG PRODUCT
Other Ingredients
Other ingredients consist of the pharmaceutical excipients sodium hyaluronate,
sorbitol, glycerol, disodium phosphate dihydrate, sodium dihydrogen phosphate
dihydrate, sodium chloride and water for injections.
Appropriate justification for the inclusion of each excipient has been provided.
All excipients comply with their respective European Pharmacopoeia monograph.
Satisfactory Certificates of Analysis have been provided for all excipients.
None of the excipients contain materials of animal or human origin.
No genetically modified organisms (GMO) have been used in the preparation of these
excipients.
Pharmaceutical Development
The objective of the development programme was to formulate a safe, efficacious,
stable preservative-free sterile solution containing 0.1% (w/v) xylometazoline
hydrochloride, which could be considered a generic medicinal product of Otrivine
Adult Formula Spray (Novartis Consumer Healthcare UK Limited), in an innovative
multi-dose/metered spray device so designed that the reservoir of product solution
remains uncontaminated.
Suitable pharmaceutical development data have been provided for this application.
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UKPAR Sudafed 0.1% Nasal Spray PL 15513/0368
Comparative impurity profiles have been provided for this product and the reference
product.
Manufacturing Process
A satisfactory batch formula has been provided for the manufacture of the product,
along with an appropriate account of the manufacturing process. The manufacturing
process has been validated at production scale and has shown satisfactory results.
Control of Finished Product
The finished product specification is satisfactory. Test methods have been described
and adequately validated, as appropriate. Batch data have been provided and comply
with the release specification. Certificates of Analysis have been provided for any
working standards used.
Container Closure System
The nasal spray is packaged in a white high-density polyethylene bottle, with a 3K
pump system and a plastic cover. The product is packed into a cardboard carton with a
Patient Information Leaflet in a pack size of one 10 ml nasal spray.
Satisfactory specifications and Certificates of Analysis have been provided for all
packaging components. All primary packaging complies with the current European
regulations concerning materials in contact with food.
Stability
Finished product stability studies were performed in accordance with current
guidelines on batches of finished product packed in the packaging proposed for
marketing. Based on the results, a shelf-life of 3 years for the product in the unopened
bottle has been set. A shelf-life of 6 months has been set once the bottle has been first
opened. The product requires no special storage conditions.
Suitable post approval stability commitments have been provided to continue stability
testing on batches of finished product.
Bioequivalence/Bioavailability
A bioequivalence study was not necessary to support this application for a nasal
spray.
Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL)
and Labelling
The SmPC, PIL and labelling are satisfactory from a pharmaceutical perspective.
A user consultation with target patient groups (‘user test’) on the package information
leaflet has been performed on the basis of a bridging report making reference to the
successful user-testing of the ‘parent’ PIL for Non-Drowsy Sudafed Dual Relief Max
(PL 15513/0126, McNeil Products Limited). The text, content and layout of the
proposed PIL are considered to be sufficiently similar to the approved ‘parent’ PIL.
Hence, the bridging is accepted, without the need for further testing.
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UKPAR Sudafed 0.1% Nasal Spray PL 15513/0368
MAA Form (Marketing Authorisation Application)
The MAA form is pharmaceutically satisfactory.
Expert Report (Quality Overall Summary)
The quality overall summary is written by an appropriately qualified person and is a
suitable summary of the pharmaceutical aspects of the dossier.
Conclusion
The grant of Marketing Authorisation is recommended.
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UKPAR Sudafed 0.1% Nasal Spray PL 15513/0368
NON-CLINICAL ASSESSMENT
PHARMACODYNAMICS, PHARMACOKINETICS AND TOXICOLOGY
As the pharmacodynamic, pharmacokinetic and toxicological properties of
xylometazoline hydrochloride are well-known, no further non-clinical studies are
required and none have been provided.
NON-CLINICAL EXPERT REPORT (NON-CLINICAL OVERVIEW)
The applicant’s non-clinical overview has been written by an appropriately qualified
person and is satisfactory, providing an appropriate review of the relevant non-clinical
pharmacology, pharmacokinetics and toxicology.
ENVIRONMENTAL RISK ASSESSMENT
The Marketing Authorisation Holder has submitted an acceptable Environmental Risk
Assessment, prepared in accordance with the “Guideline on the Environmental Risk
Assessment of Medicinal Products for Human Use” (EMEA/CHMP/SWP/4447/00).
In the Phase I study, the exposure of the environment was evaluated. The predicted
environmental concentration (PEC) in surface water was calculated as less than
0.01microgram/L, which is below the PEC action limit. Hence, the results of Phase I
study, indicates that the therapeutic use of Sudafed 0.1% Nasal Spray is unlikely to
pose a risk to the environment following prescribed usage.
CONCLUSION
The grant of a Marketing Authorisation is recommended.
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UKPAR Sudafed 0.1% Nasal Spray PL 15513/0368
CLINICAL ASSESSMENT
CLINICAL PHARMACOLOGY
The clinical pharmacology of xylometazone hydrochloride is well-known.
No new clinical pharmacology data have been submitted and none are required for
this type of application. A bioequivalence study was not necessary to support this
application for a nasal spray. According to CPMP guidelines, bioequivalence studies
are not generally required if the test product is of the same type of solution and
contains the same concentration of the same active substance as the medicinal product
currently approved (CPMP/QWP/EWP/1401/98 Rev.1).
EFFICACY
The efficacy of xylometazoline hydrochloride is well-known. No new efficacy data
have been submitted and none are required for this type of application.
SAFETY
The safety profile of xylometazoline hydrochloride is well-known. No new safety data
have been submitted with this application and none are required.
PHARMACOVIGILANCE SYSTEM AND RISK MANAGEMENT PLAN
The Pharmacovigilance System, as described by the applicant, fulfils the requirements
and provides adequate evidence that the applicant has the services of a qualified
person responsible for pharmacovigilance, and has the necessary means for the
notification of any adverse reaction suspected of occurring either in the Community or
in a third country.
Suitable justification has been provided for not submitting a Risk Management Plan
for this product.
SUMMARY OF PRODUCT CHARACTERISTICS (SmPC), PATIENT
INFORMATION LEAFLET (PIL) AND LABELLING
The SmPC, PIL and labelling are acceptable from a clinical perspective. The SmPC is
consistent with that for the reference product. The PIL is consistent with the details in
the SmPC and in-line with the current guidelines. The labelling is in-line with the
current guidelines.
CLINICAL EXPERT REPORT (CLINICAL OVERVIEW)
The clinical overview is written by an appropriately qualified physician and is a
suitable summary of the clinical aspects of the dossier.
CONCLUSION
The grant of a Marketing Authorisation is recommended.
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UKPAR Sudafed 0.1% Nasal Spray PL 15513/0368
OVERALL CONCLUSION AND BENEFIT/RISK ASSESSMENT
QUALITY
The important quality characteristics of Sudafed 0.1% Nasal Spray are well-defined
and controlled. The specifications and batch analytical results indicate consistency
from batch to batch. There are no outstanding quality issues that would have a
negative impact on the benefit/risk balance.
NON-CLINICAL
No new non-clinical data were submitted. As the pharmacokinetics,
pharmacodynamics and toxicology of xylometazoline hydrochloride are well-known,
no additional data were required.
EFFICACY
No new clinical data were submitted for this application. A bioequivalence study was
not necessary to support this application for a nasal spray.
SAFETY
The safety profile of xylometazoline hydrochloride is well-known. No new safety data
were submitted and none were required for this application.
PRODUCT LITERATURE
The SmPC, PIL and labelling are acceptable. The SmPC is consistent with that for the
reference product. The PIL is consistent with the details in the SmPC and in-line with
the current guidelines. The labelling is in-line with current guidance.
BENEFIT/RISK ASSESSMENT
The quality of the product is acceptable, and no new non-clinical or clinical safety
concerns have been identified. Extensive clinical experience with xylometazoline
hydrochloride is considered to have demonstrated the therapeutic value of the product.
The benefit/risk balance is, therefore, considered to be positive.
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UKPAR Sudafed 0.1% Nasal Spray PL 15513/0368
Sudafed 0.1% Nasal Spray
(xylometazoline hydrochloride)
PL 15513/0368
STEPS TAKEN FOR ASSESSMENT
1 The MHRA received the Marketing Authorisation application on 26 February
2010.
2 Following standard checks and communication with the applicant the MHRA
considered the application valid on 11 March 2010.
3 Following assessment of the application the MHRA requested further information
relating to the clinical dossier on 29 July 2010and the quality dossier on 10
August 2010, 19 August 2010, 30 March 2011, 05 September 2011 and 20
January 2012.
4 The applicant responded to the MHRA’s requests, providing further information
on the clinical dossier 21 January 2011 and the quality dossier on 24 February
2011, 28 July 2011, 22 December 2011, 03 February 2012 and 14 February 2012.
5 The application was determined and granted on 28 March 2012.
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UKPAR Sudafed 0.1% Nasal Spray PL 15513/0368
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sudafed 0.1% Nasal Spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Xylometazoline Hydrochloride 1 mg /1ml of solution
For full list of excipients see 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
This product is indicated for the symptomatic relief of nasal congestion associated with the
common cold, influenza, sinusitis, allergic and non-allergic rhinitis, and other upper
respiratory tract allergies.
4.2 Posology and method of administration
Adults and children 12 years and over:
Nasal. One spray to be expressed into each nostril 2-3 times daily, as necessary.
Maximum daily dose: 3 sprays.
Use for more than seven consecutive days is not recommended, [See section 4.8].
Children under 12 years:
This product is not recommended for children under 12 years of age.
The Elderly
Experience has indicated that normal adult dosage is appropriate, [See section 5.2].
Hepatic/renal dysfunction
Normal adult dosage is appropriate, [See section 5.2].
4.3 Contraindications
This product is contraindicated in individuals with known hypersensitivity to the product or
any of its constituents.
This product is contraindicated in individuals who are taking or have taken, monoamine
oxidase inhibitors within the preceding two weeks.
This product is contraindicated in individuals with hypophysectomy or surgery exposing dura
mater.
4.4 Special warnings and precautions for use
There is minimal systemic absorption with topically applied imidazoline sympathomimetics
such as xylometazoline, however, this product should be used with caution in patients
suffering coronary artery disease, hypertension, hyperthyroidism or diabetes mellitus.
4.5 Interaction with other medicinal products and other forms of interaction
Due to the low systemic absorption of xylometazoline when administered intra-nasally,
interaction with drugs administered via other routes is considered unlikely.
4.6 Fertility, pregnancy and lactation
No foetal toxicity or fertility studies have been carried out in animals. In view of its potential
vasoconstrictor effect, it is advisable to take the precaution of not using this product during
pregnancy.
4.7 Effects on ability to drive and use machines
No special comment - unlikely to produce an effect
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UKPAR Sudafed 0.1% Nasal Spray PL 15513/0368
4.8 Undesirable effects
Xylometazoline nasal preparations are generally well tolerated following short-term use and
local side effects are mild and infrequent. Localised burning, stinging, itching, soreness,
dryness or irritation and sneezing may occur occasionally. Rarely, nausea and headache may
occur.
Rebound congestion has been reported occasionally, particularly following longer-term use of
xylometazoline
4.9 Overdose
Symptoms and signs
Systemic action is unlikely when applied nasally due to the local vasoconstriction that inhibits
absorption. If systemic absorption does occur xylometazoline as an α2-adrenergic agonist
could be expected to produce effects similar to those of clonidine with a short lived rise in
blood pressure, followed by more prolonged hypotension and sedation.
Treatment
Treatment of overdose should be supportive
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Xylometazoline is a sympathomimetic amine of the imidazoline class.
It acts directly on α-adrenoreceptors but does not act on ß-receptors. When used topically as a
nasal decongestant, xylometazoline acts rapidly and provides long-lasting relief. Onset of
action is within minutes, the decongestant effect being prolonged and lasting for up to
10 hours.
Hyaluronic acid (as sodium hyaluronate), together with glycerol and sorbitol, acts as a
humectants to moisturise the nasal mucosa.
5.2 Pharmacokinetic properties
Absorption, Distribution, Metabolism and Elimination
Little information is available concerning the absorption, distribution, metabolism and
elimination of xylometazoline in man. Absorption into the nasal mucosal tissues is rapid.
Pharmacokinetics in Renal/Hepatic Impairment
There have been no specific studies of this product or xylometazoline in hepatic or renal
impairment.
Pharmacokinetics in the Elderly
There have been no specific clinical studies of this productor xylometazoline in the elderly.
5.3 Preclinical safety data
Mutagenicity
There is insufficient information available to determine whether xylometazoline has
mutagenic potential.
Carcinogenicity
There is insufficient information available to determine whether xylometazoline has
carcinogenic potential.
Teratogenicity
There is insufficient information available to determine whether xylometazoline has
teratogenic potential.
Fertility
No studies have been conducted in animals to determine whether xylometazoline has the
potential to impair fertility. There is no information on the effects of this product on fertility.
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UKPAR Sudafed 0.1% Nasal Spray PL 15513/0368
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium hyaluronate
Sorbitol
Glycerol
Disodium phosphate dihydrate
Sodium dihydrogen phosphate dihydrate
Sodium chloride
Water for injection
6.2 Incompatibilities
None known
6.3 Shelf life
3 years.
This product should not be used longer than 6 months after opening.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
White HDPE bottle, with 3K pump system, plastic cover, carton box.
10ml nasal spray.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire SL6 3UG
United Kingdom.
8 MARKETING AUTHORISATION NUMBER(S)
PL 15513/0368
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28/03/2012
10 DATE OF REVISION OF THE TEXT
28/03/2012
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UKPAR Sudafed 0.1% Nasal Spray
PATIENT INFORMATION LEAFLET
The leaflet text below is that agreed.The Marketing Authorisation Holder is
required to submit the mock-up leaflet to the regulatory authorities before
marketing the product.
SUDAFED 0.1% NASAL SPRAY
Xylometazoline hydrochloride
• This medicine is used to help clear the stuffy, blocked nose 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:
o There are some people who should not take this medicine. To find out if you are one
of them see section 2 >
o 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:
o 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
Sudafed 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
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 Sudafed 0.1%
Nasal Spray.
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UKPAR Sudafed 0.1% 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.
3 How to use this medicine
Follow the instructions to ensure that you use Sudafed 0.1% Nasal Spray correctly:
• Step 1. Remove the plastic cap from the nozzle from Sudafed 0.1% Nasal Spray.
• 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 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.
! 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 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.
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UKPAR Sudafed 0.1% Nasal Spray
• 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.
5 Storing this medicine
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 waste water or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help protect the environment.
6 Further information
What’s in this medicine?
The active ingredient in Sudafed 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
Sudafed 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: Ursapharm Arzneimittel GmbH, Industriestraße, D‐66129 Saarbrücken, Germany.
This leaflet was revised May 2012.
Sudafed is a registered trade mark.
McNeil Products Ltd.
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UKPAR Sudafed 0.1% Nasal Spray PL 15513/0368
LABELLING
The labelling text below is the agreed The Marketing Authorisation Holder is required to submit the
mock-up labelling to the regulatory authorities before marketing the product.
CARTON
FRONT & BACK PANELS:
SUDAFED 0.1% NASAL SPRAY
Xylometazoline hydrochloride
• Targets nasal mucus directly
• Works in minutes
• Lasts up to 10 hours
SIDE PANEL 1:
SUDAFED 0.1% NASAL SPRAY
How does this product help?
Sudafed 0.1% Nasal Spray with xylometazoline hydrochloride, works in minutes to help clear
stuffy noses and relieve sinus pressure caused by colds and hay fever. It also moisturises and
soothes a dry nose. The metered spray gives an exact dose that lasts for up to 10 hours.
Preservative free.
How to Use?
Adults and children aged 12 years and over:
1 spray into each nostril, 2 or 3 times daily.
Not recommended for children under 12 years old.
Do not use more than 3 doses in 24 hours.
Remove the plastic cap, insert nozzle into the nostril. Depress the pump by placing the fingers on
either side of the nozzle. At the same time breathe in deeply through the nose. Repeat for the
other nostril.
Keep out of reach and sight of children
10ml e
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UKPAR Sudafed 0.1% Nasal Spray PL 15513/0368
SIDE PANEL 2:
SUDAFED 0.1% NASAL SPRAY
Do not use if you are pregnant or breast‐feeding. If you are taking any other medicine consult
your doctor or pharmacist before using this product.
Continuous use for over 7 days is not recommended.
If symptoms persist discontinue use and consult your doctor.
This solution contains: Xylometazoline hydrochloride 1 mg/1 ml.
Other ingredients include: Sodium hyaluronate, sorbitol, glycerol, disodium phosphate
dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, water for injections.
See leaflet for further information and full directions.
Product Licence holder:
McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.
PL 15513/0368
McNeil Products Ltd
Sudafed is a registered trade mark.
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