Non-Drowsy Sudafed Congestion Relief Capsules
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to
E
CD
SlIDAFED
BLOCKED NOSE
Capsules
Phenylephrine hydrochloride
• This medicine is used to dear stuffy noses associated with colds and 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 use 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. Forthefull list of ingredients see section 6 ►
■ Speak to your doctor:
If you suffer from any of the conditions mentioned in section 2. Seesection2 ►
If you are taking any other medicines. See section 2 ►
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 Capsules are used to help clear stuffy noses associated with colds and hay fever.
The capsules contain phenylephrine hydrochloride which is a decongestant.
This medicine is for use in adults and children aged 12 years and over.
2 Before using this medicine
This medicine is suitable for most people but some 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 to any of the ingredients in Sudafed Blocked Nose Capsules.
■ If you have diabetes mellitus.
■ If you suffer from heart disease.
■ If you have closed-angle glaucoma (increased pressure in the eye).
■ If you have an overactive thyroid gland.
■ If you have prostate problems (difficulty with passing water or needing to pass water often).
■ If you are taking, or have taken in the last two weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs).
■ If you are taking alcohol.
■ If you are taking drugs used to treat high blood pressure such as vasodilators and beta-blockers.
■ If you have phaeochromocytoma (a tumour of the adrenal gland that can effect blood pressure).
If any of these apply to you, get advice from a doctor or pharmacist without taking Sudafed Blocked Nose Capsules.
^kTalk to your doctor or pharmacist...
■ If you suffer from circulation problems such as Raynaud's Phenomenon.
■ If you are taking any other medicines including:
Anticholinergic drugs such as tricyclic antidepressants (used to treat mood disorders).
Sympathomimetic drugs such as decongestants (used to treat congestion).
Cardiac glycosides (drugs used to control heart rhythms or contractions) e.g. digoxin.
If you are not sure about any of the medicines you are taking, show the bottle or pack to your pharmacist.
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 use this medicine if you are pregnant or breast-feeding.
Some of the ingredients can cause problems
■ If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
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3 How to take this medicine
Check the table that follows to see how much medicine to take.
■ For oral use only.
Children under 12 years old
Do not give to children under 12 years old.
O Adults and children aged 12 years and over '
Age Dosage
Adults and Take 1 capsule up to
children aged 4 times a day
12 years and over
■ Do not take more medicine than the label tells you to.
■ If symptoms persist for more than 7 days, talk to a doctor.
If anyone has too much
If anyone has taken too many capsules contact a doctor or your nearest Accident and 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 one when needed. Do not take a double dose.
4 Possible side-effects
Sudafed Blocked Nose Capsules can have side-effects, like all medicines, but these are rare and are usually mild.
If you experience any of the following stop using this medicine and talk to your doctor: ~
■ Increased heart rate.
■ Irregular or changes to heartbeat.
■ Increase in blood pressure.
■ A few men, especially men with prostate problems, may have trouble passing water.
Other effects which may occur include:
■ Nausea and vomiting.
■ Headache.
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 25°C.
Store in the original package.
Keep all medicines out of the sight and reach of children.
Do not use after the end of the month shown as the 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.
6 Further information
What's in this medicine?
The active ingredient in this medicine is:
Phenylephrine hydrochloride 12 mg.
Other ingredients are: Lactose monohydrate, dried maize starch, pregelatinised maize starch, and magnesium stearate. Gelatin Capsule: Gelatin, Quinoline yellow (E104) and titanium dioxide (E171). Printed Ink: Black iron oxide (E172), shellac, propylene glycol and ammonium hydroxide.
What the medicine looks like
Sudafed Blocked Nose Capsules are hard capsules with a yellow cap and body and are printed with 'Sudafed 0593' in black ink. They are available in packs of 12 and 24 capsules.
Marketing Authorisation holder:
McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer: Janssen-Cilag, Domaine de Maigremont, 27100Valde Reuil, France.
PL 15513/0125
Text revised November 2013.
Sudafed is a registered trade mark.
365009A
12-0022
LEAFLET - SIZE 145 X 210 MM
Technical requirement for the back side of the leaflet
right margin 14 mm
O)
3
3
Reference: 12-0022 v5
3
3
SUDAFED
BLOCKED NOSE capsules
Phenylephrine hydrochloride
■ This medicine is used to clear stuffy noses associated with colds and 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 use 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 full 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
■ If you are taking any other medicines. See section 2c
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 Capsules are used to help clear stuffy noses associated with colds and hay fever.
The capsules contain phenylephrine hydrochloride which is a decongestant.
This medicine is for use in adults and children aged 12 years and over.
2 Before using this medicine
This medicine is suitable for most people but some 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 to any of the ingredients in Sudafed Blocked Nose Capsules.
■ If you have diabetes mellitus.
■ If you suffer from heart disease.
■ If you have closed-angle glaucoma (increased pressure in the eye).
■ If you have an overactive thyroid gland.
■ If you have prostate problems (difficulty with passing water or needing to pass water often).
■ If you are taking, or have taken in the last two weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs).
■ If you are taking alcohol.
■ If you are taking drugs used to treat high blood pressure such as vasodilators and beta-blockers.
■ If you have phaeochromocytoma (a tumour of the adrenal gland that can effect blood pressure).
If any of these apply to you, get advice from a doctor or pharmacist without taking Sudafed Blocked Nose Capsules.
Talk to your doctor or pharmacist.
■ If you suffer from circulation problems such as Raynaud's Phenomenon.
■ If you are taking any other medicines including:
■ Anticholinergic drugs such as tricyclic antidepressants (used to treat mood disorders).
■ Sympathomimetic drugs such as decongestants (used to treat congestion).
■ Cardiac glycosides (drugs used to control heart rhythms or contractions) e.g. digoxin.
If you are not sure about any of the medicines you are taking, show the bottle or pack to your pharmacist.
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 use this medicine if you are pregnant or breast-feeding.
Some of the ingredients can cause problems
■ If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3 How to take this medicine
Check the table that follows to see how much medicine to take.
■ For oral use only.
Children under 12 years old
Do not give to children under 12 years old.
turn over►
I I I I I I I I
Adults and children aged 12 years and over
|
Age |
Dose |
|
Adults and children |
Take 1 capsule up to |
|
aged 12 years and |
4 times a day |
|
over | |
|
■ Do not exceed the stated dose. ■ If symptoms persist for more than 7 days, talk to | |
|
a doctor. | |
If anyone has too much
If anyone has taken too many capsules contact a doctor or your nearest Accident and Emergency Department (Casualty) taking this leaflet and pack with you.
HL If you forget to take the medicine
If you forget to take a dose, take the next one when needed. Do not take a double dose.
4 Possible side-effects
Sudafed Blocked Nose Capsules can have side-effects, like all medicines, but these are rare and are usually mild.
If you experience any of the following stop using this medicine and talk to your doctor:
■ Increased heart rate.
■ Irregular or changes to heartbeat.
■ Increase in blood pressure.
■ A few men, especially men with prostate problems, may have trouble passing water.
Other effects which may occur include:
■ Nausea and vomiting.
■ Headache.
5 Storing this medicine
Do not store above 25°C.
Store in the original package.
Keep all medicines out of the reach and sight of children.
Do not use after the end of the month shown as the 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.
6 Further information
What's in this medicine?
The active ingredient in this medicine is:
Phenylephrine hydrochloride 12 mg.
Other ingredients are:Lactose monohydrate, dried maize starch, pregelatinised maize starch, and magnesium stearate. Gelatin Capsule: Gelatin, Quinoline yellow (E104) and titanium dioxide (E171). Printed Ink: Black iron oxide (E172), shellac and propylene glycol.
What the medicine looks like
Sudafed Blocked Nose Capsules are hard capsules with a yellow cap and body and are printed with 'Sudafed 0593' in black ink.They are available in packs of 12 and 24 capsules.
Product Licence holder: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer: Hamol Limited,Thane Road, Nottingham, NG90 2DB.
PL 15513/0125
Text revised January 2010.
Sudafed is a registered trade mark.
McNeil
PmkittxLtd.
reference: 09-0551 v3