Sudafed Congestion Relief 0.1% Nasal Spray Solution
CONGESTIONRELIEF
0.1% Nasal Spray
Xylometazoline hydrochloride
■ 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.
■ 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
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 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 Congestion Relief 0.1% Nasal Spray.
.^klalk 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 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 Congestion Relief 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.
11504121-00 turn over ►
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
This medicine is not recommended for children under 12 years.
O Adults and Children aged 12 years and over
Age Dose
Adults and One spray into each
children aged 12 nostril 2 to 3 times daily,
years and over as necessary.
■ 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 Congestion 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
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. Product Licence holder: McNeil Products Ltd, Maidenhead, Berkshire. SL6 3UG.
Manufacturer: Famar Health Care Services Madrid, S.A.U. Avda. Leganes, 62, Alcorcon, 28923 Madrid, Spain.
This leaflet was revised November 2014.
Sudafed is a registered trade mark.
14-0082
11504121-00
Reference: 14-0082 vl3 Dimensions: 14 8 x 21 Omni Font size of main body text: 8pts Famar
■Ill SUDAFED
CONGESTIONRELIEF
0.1% Nasal Spray
Xylometazoline hydrochloride
m This medicine is used to help dear the stuffy, blocked up feeling in your nose and sinuses caused by allergies, such as hay fever, and colds.
■ 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
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 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 Congestion Relief 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.
^klf 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 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 Congestion Relief 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.
turn over ►
E
E
■ Do not use more than the stated dose shown in the table.
o
Age Dose
Adults and One spray into each
children aged 12 nostril 2 to 3 times daily,
years and over as necessary.
■ 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 contact a doctor or your nearest Accident & Emergency Department (Casualty) taking this leaflet and pack with you.
A
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 Congestion 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
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.
Product Licence holder: McNeil Products Ltd, Maidenhead, Berkshire. SL6 3UG.
Manufacturer: Ursapharm Arzneimittel GmbH, IndustriestrafSe, D-66129 Saarbrucken, Germany. This leaflet was revised November 2014. Sudafed is a registered trade mark.
14-0119
90.0509
Reference 14-0119 vlO Dimensions: 148x210mm Font size main body text: 8pt Ursapharm