Patient leaflet - Sudafed Congestion Relief 0.1% nasal spray solution
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.
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 use this medicine…
n If you have ever had a bad reaction (e.g.
rash, swelling of the face and throat, difficulty breathing) to any of the ingredients. n If you are taking, or have taken in the last
two weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs). n If you have recently had neurosurgery. n If you have had your pituitary gland removed. n For a child under 12 years old.
If any of these apply to you, get advice from a doctor or pharmacist without taking Sudafed Congestion Relief 0.1% Nasal Spray.
Talk to your doctor or pharmacist…
n If you have high blood pressure or heart disease. n If you have diabetes.
n If you have an overactive thyroid gland. n If you have a heart disease (e.g. long QT syndrome).
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
n If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. turn over
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:
n Step 1. Remove the
plastic cap from the
nozzle from Sudafed
Congestion Relief
0.1% Nasal Spray.
n 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.
n 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.
n Step 4. Wipe the nozzle and replace the plastic cap after use.
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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
Do not give to children under 12 years old.
Adults and Children aged 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
Like all medicines, Sudafed Congestion Relief 0.1% Nasal Spray can have side-effects, although not everybody gets them.
n Uncommon - Nosebleeds
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.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the safety of this medicine.
5 Storing this medicine
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.
6 Further information What’s in 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
Sudafed Congestion Relief 0.1% Nasal Spray is a clear colourless solution in a 10 ml bottle. Marketing Authorisation holder: McNeil Products Ltd, High Wycombe, Buckinghamshire, HP12 4EG.
Manufacturer: Famar Health Care Services Madrid, S.A.U. Avda. Leganés, 62, Alcorcón, 28923 Madrid, Spain.
This leaflet was last revised in April 2021.
Sudafed is a registered trade mark.
| Age |
Adults and children aged 12 years and over
| Dose |
One spray into each nostril 2 to 3 times a day.
n Do not take more than 3 doses in 24 hours.
n Do not use continuously for more than 7 days.
n If symptoms persist or worsen, talk to your
doctor or pharmacist.
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