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Non-Drowsy Sudafed Congestion Relief Capsules

Document: leaflet MAH BRAND 2_PL 15513-0125 change

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CONGESTION RELIEF capsules

phenylephrine

■    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

■    If you have ever had a bad reaction to any of the ingredients. For the full 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

■    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

Non-Drowsy Sudafed Congestion Relief Capsules are used to help clear stuffy noses associated with colds and hay fever.

The tablets 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 Non-Drowsy Sudafed Congestion Relief 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

Non-Drowsy Sudafed Congestion Relief

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

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


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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.


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

Non-Drowsy Sudafed Congestion Relief 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.

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

Non-Drowsy Sudafed Congestion Relief 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 June 2008.

Sudafed is a registered trade mark.


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