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SVDAFED

DECONGESTANT

LIQUID

Pseudoephedrine hydrochloride

■    This medicine is used to provide relief from the symptoms of blocked nose or sinuses and catarrh associated with colds.

■    This medicine is for use by children aged

6 years and over and can also be used by adults.

■    Do not take this medicine:

i There are some people who should not take this medicine. To find out if you are one of them see section 2 c

i If you have ever had a bad reaction to any of the ingredients. For the list of ingredients see section 6 c

■    Speak to your doctor:

i 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 2 c

■    Follow the dosage instructions carefully. Children and adults need different amounts. These are shown in the tables. See section 3 c

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 Decongestant Liquid is a medicine which is used to provide relief from the symptoms of blocked nose or sinuses and catarrh associated with colds.

The syrup contains pseudoephedrine hydrochloride, which is a decongestant that relieves nasal and sinus congestion.

This medicine is for use in children aged 6 years and over and adults.

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...

■    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 have high blood pressure or heart disease.

■    If you have diabetes.

■    If you have a phaeochromocytoma (rare tumour that affects your heart rate and blood pressure).

■    If you have an overactive thyroid.

■    If you have closed angle glaucoma (increased pressure in the eye).

■    If you have severe kidney problems.

■    If you are taking beta blockers (used to treat high blood pressure).

■    If you are taking, or have taken in the last two weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs) or Reversible Inhibitors of Monoamine Oxidase (RIMAs).

■    If you are taking any other cough and cold medicine.

■    For children under 6 years old.

If any of these apply to you, get advice from a doctor or pharmacist without using Sudafed Decongestant Liquid.

^Xlalk to your doctor or pharmacist.

■    If you have kidney problems.

■    If you have blocked arteries or veins (occlusive vascular disease).

■    If you have been diagnosed with an intolerance to some sugars.

■    If you are taking any other medicines,

including:

■    Antimuscarinic /anticholinergic drugs e.g.:

■ Tricyclic antidepressants (drugs to treat mood disorders).

■ Atropine (used to treat some eye conditions and occasionally bowel conditions).

■    Antihypertensives (drugs used to treat high blood pressure including alpha and beta blockers).

■    Sympathomimetic drugs (stimulants or appetite suppressants and drugs used to treat congestion and asthma).

■    Moclobemide (used to treat mood disorders).

■    Cardiac glycosides (drugs used to control heart rhythms or contractions) e.g. digoxin.

■    Ergot alkaloids (drugs used to treat migraine such as ergotamine and methysergide).

■    Oxytocin (drug used to help contractions during childbirth).

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

■    Ask your doctor or pharmacist for advice before taking any medicine in pregnancy or whilst breast-feeding.

Some of the ingredients can ' cause problems

■    Each 5 ml of this medicine contains

3.5 g of sucrose. This may be harmful to your teeth. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

■    Methyl hydroxybenzoate may cause allergic reactions such as skin rash; this may occur after a few days.

■    The colouring Ponceau 4R (E124) in this medicine may cause allergic reactions.

turn over ►

Check the table that follows to see how much medicine to take.

■    For oral use only.

■    Always shake the bottle thoroughly before use.

■    Do not use more than the stated dose shown in the table.

■    Do not overfill the spoon.

There is a double-ended spoon in the pack.

O Children under 6 years

Do not use this medicine in children under 6 years of age.

o Children from 6 years and adults

■    Leave at least 4 hours between doses.

■    Do not take more than 4 doses in 24 hours.

■    If symptoms persist or worsen talk to your doctor.

■    Do not give to a child under 12 years old for more than 5 days without the advice of a 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 the last dose was taken at least 4 hours ago. Do not take a double dose.

4    Possible side-effects

Sudafed Decongestant Liquid can have side-effects, like all medicines, although these don't affect everyone and are usually mild.

If anyone experiences any of the following stop using this medicine and seek immediate help:

■    Allergic reactions including skin rashes (which may be severe and include blistering and peeling of the skin) and itching.

■    Allergic reactions to other medicines containing sympathomimetic drugs (stimulants or appetite suppressants and drugs used to treat congestion and asthma).

■    Hallucinations and paranoid delusions.

If anyone experiences any of the following, stop using this medicine and talk to your doctor:

■    An increased or irregular heartbeat, an increased awareness of the heartbeat (palpitations), high blood pressure.

■    Restlessness and sleep disturbances.

Other effects which may occur include:

■    Irritability, anxiety, excitability, nausea and sickness.

■    Headache, difficulty in passing urine.

5    Storing this medicine

Store below 25°C. Protect from light.

Keep the product out of the reach and sight of children.

Keep the container tightly closed.

Do not use after the end of the month shown as an 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 Sudafed Decongestant Liquid is:

Pseudoephedrine hydrochloride 30 mg per 5 ml. Other ingredients are: Citric acid monohydrate, sucrose, glycerol, methyl hydroxybenzoate (E218), sodium benzoate (E211), Ponceau 4R (E124), raspberry flavour and water.

What the medicine looks like

Sudafed Decongestant Liquid is a clear red liquid available in 100 ml amber glass bottles.

The Product Licence holder:

McNeil Products Ltd, Maidenhead, Berkshire,

SL6 3UG, UK.

Manufacturer:

Famar Orleans, 5 avenue de Concyr, 45071 Orleans, Cedex 2, France

This leaflet was revised February 2010.

Sudafed is a registered trade mark.

7    Information about treating cough and cold in children

It's normal for children to get 8 or more colds in a year. Because colds are caused by viruses, not bacteria, antibiotics don't help.

Here are simple steps to help your child who has a cough or cold.

If they are hot/feverish: Increase the amount of fluid your child normally drinks. Lower their temperature with a paracetamol or ibuprofen medicine which has doses for children.

For coughs: Coughing serves a purpose, it helps clear phlegm and mucus. Give the child plenty of warm clear fluids to drink.

To help with breathing: Plain saline nose drops / sprays can help with blocked noses.

McNeiT} ^f307466

.    Products UtL    09/0604

1_1 1_1
Component Number	Component type	Dimens	ons	Code descriptif generique
| F307466 |	Notice bobine / Rolled Leaflet	| 160 x 210 mm NOTC010 |			V7.3

Safety code	Job Bag Number
| DATA MATRIX |	| 09/0604 |
FRONT Col	jurs REAR
NOIR	NOIR
■ PMS 300	■ PMS 300

SUDAFED

DECONGESTANT _A

Liquid

Pseudoephedrine hydrochloride

■    This medicine is used to provide relief from the symptoms of blocked nose or sinuses and catarrh associated with colds.

■    This medicine is for use by children aged

6 years and over and can also be used by adults.

■    Do not take this medicine:

i There are some people who should not take this medicine. To find out if you are one of them see section 2 c

i If you have ever had a bad reaction to any of the ingredients. For the list of ingredients see section 6 c

■    Speak to your doctor:

i 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 2 c

■    Follow the dosage instructions carefully. Children and adults need different amounts. These are shown in the tables. See section 3 c

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 Decongestant Liquid is a medicine which is used to provide relief from the symptoms of blocked nose or sinuses and catarrh associated with colds. The syrup contains pseudoephedrine hydrochloride, which is a decongestant that relieves nasal and sinus congestion.

This medicine is for use in children aged 6 years and over and adults.

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...

■    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 have high blood pressure or heart disease.

■    If you have diabetes.

■    If you have a phaeochromocytoma (rare tumour that affects your heart rate and blood pressure).

■    If you have an overactive thyroid.

■    If you have closed angle glaucoma (increased pressure in the eye).

■    If you have severe kidney problems.

■    If you are taking beta blockers (used to treat high blood pressure).

■    If you are taking, or have taken in the last two weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs) or Reversible Inhibitors of Monoamine Oxidase

^Xlalk to your doctor or pharmacist.

■    If you have kidney problems.

■    If you have blocked arteries or veins (occlusive vascular disease).

■    If you have been diagnosed with an intolerance to some sugars.

■    If you are taking any other medicines,

including:

■    Antimuscarinic /anticholinergic drugs e.g.:

■    Tricyclic antidepressants (drugs to treat mood disorders).

■    Atropine (used to treat some eye conditions and occasionally bowel conditions).

■    Antihypertensives (drugs used to treat high blood pressure including alpha and beta blockers).

■    Sympathomimetic drugs (stimulants or appetite suppressants and drugs used to treat congestion and asthma).

■    Moclobemide (used to treat mood disorders).

■    Cardiac glycosides (drugs used to control heart rhythms or contractions) e.g. digoxin.

■    Ergot alkaloids (drugs used to treat migraine such as ergotamine and methysergide).

■    Oxytocin (drug used to help contractions during childbirth).

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

■ Ask your doctor or pharmacist for advice before taking any medicine in pregnancy or whilst breast-feeding.

Some of the ingredients can ' cause problems

■    Each 5 ml of this medicine contains

3.5 g of sucrose. This may be harmful to your teeth. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

■    Methyl hydroxybenzoate may cause allergic reactions such as skin rash; this may occur after a few days.

■    The colouring Ponceau 4R (E124) in this medicine may cause allergic reactions.

turn over ►

Check the table that follows to see how much medicine to take.

■    For oral use only.

■    Always shake the bottle thoroughly before use.

■    Do not use more than the stated dose shown in the table.

■    Do not overfill the spoon.

There is a double-ended    ^

spoon in the pack.    ^

O Children under 6 years

Do not use this medicine in children under 6 years of age.

o Children from 6 years and adults

Age	Dose
Children	One large 5 ml spoonful
6-12 years	every 4 - 6 hours, up to
	4 times a day
Adults and	Two large 5 ml spoonfuls
children aged 12	every 4 - 6 hours, up to
years and over	4 times a day

■    Leave at least 4 hours between doses.

■    Do not take more than 4 doses in 24 hours.

■    If symptoms persist or worsen talk to your doctor.

■    Do not give to a child under 12 years old for more than 5 days without the advice of a 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 the last dose was taken at least 4 hours ago. Do not take a double dose.

4    Possible side-effects

Sudafed Decongestant Liquid can have side-effects, like all medicines, although these don't affect everyone and are usually mild.

If anyone experiences any of the following stop using this medicine and seek immediate help:

■    Allergic reactions including skin rashes (which may be severe and include blistering and peeling of the skin) and itching.

■    Allergic reactions to other medicines containing sympathomimetic drugs (stimulants or appetite suppressants and drugs used to treat congestion and asthma).

■    Hallucinations and paranoid delusions.

If anyone experiences any of the following, stop using this medicine and talk to your doctor:

■    An increased or irregular heartbeat, an increased awareness of the heartbeat (palpitations), high blood pressure.

■    Restlessness and sleep disturbances.

Other effects which may occur include:

■    Irritability, anxiety, excitability, nausea and sickness.

■    Headache, difficulty in passing urine.

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

Store below 25°C. Protect from light.

Keep the product out of the sight and reach of children. Keep the container tightly closed.

Do not use after the end of the month shown as an 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 Sudafed Decongestant Liquid is:

Pseudoephedrine hydrochloride 30 mg per 5 ml.

Other ingredients are: Citric acid monohydrate, sucrose, glycerol, methyl hydroxybenzoate (E218), sodium benzoate (E2l1), Ponceau 4R (E124), raspberry flavour and water.

What the medicine looks like

Sudafed Decongestant Liquid is a clear red liquid available in 100 ml amber glass bottles.

Marketing Authorisation holder:

McNeil Products Ltd, Maidenhead, Berkshire,

SL6 3UG, UK.

Manufacturer:

Famar Orleans, 5 avenue de Concyr, 45071 Orleans, Cedex 2, France

This leaflet was revised September 2013.

Sudafed is a registered trade mark.

7    Information about treating cough and cold in children

It's normal for children to get 8 or more colds in a year. Because colds are caused by viruses, not bacteria, antibiotics don't help.

Here are simple steps to help your child who has a cough or cold.

If they are hot/feverish: Increase the amount of fluid your child normally drinks. Lower their temperature with a paracetamol or ibuprofen medicine which has doses for children.

For coughs: Coughing serves a purpose, it helps clear phlegm and mucus. Give the child plenty of warm clear fluids to drink.

To help with breathing: Plain saline nose drops / sprays can help with blocked noses.

McNeh

Component number	Component type	Dimensions	Client Version
F309806	Rolled leaflet	160 x 210 mm	v8.0
Safety code	Technical specification	Job bag n°	Minimum font size
DM	NOTC010	13-0074	-

Colours

Recto 1    Verso 1    Recto 2    Verso 2

■	BLACK	■	BLACK		NA		NA
	PMS 3005		PMS 3005

pseudoephedrine

■    This medicine is used to provide relief from the symptoms of blocked nose or sinuses and catarrh associated with colds.

■    This medicine is for use by children aged 6 years and over and can also be used by adults.

■    Do not give this medicine:

There are some people who should not take this medicine. To find out if your child is one of them see section 2 c

If your child has ever had a bad reaction to any of the ingredients. For the list of ingredients see section 6 c

■    Speak to your doctor:

If your child suffers from any of the conditions mentioned in section 2. See section 2 c If your child is taking any other medicines.

.See section 2 c

■    Follow the dosage instructions carefully. Children and adults need different amounts. These are shown in the table. See section 3 c

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 Children's Syrup is a medicine which is used to provide relief from the symptoms of blocked nose or sinuses and catarrh associated with colds. The syrup contains pseudoephedrine hydrochloride, which is a decongestant that relieves nasal and sinus congestion. This medicine is for use in children aged 6 years and over and adults.

2 Before giving the medicine to your child

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. If you are an adult taking this product you need to follow the same precautions as listed below for children.

Do not give this medicine...

■    If your child has ever had a bad reaction (e.g. rash, swelling of the face and throat, difficulty breathing) to any of the ingredients.

■    If your child has high blood pressure or heart disease.

■    If your child has diabetes.

■    If your child has a phaeochromocytoma (rare tumour that affects your heart rate and blood pressure).

■    If your child has an overactive thyroid.

■    If your child suffers from or has had closed angle glaucoma (increased pressure in the eye).

■    If your child has severe kidney problems.

■    If your child is taking beta blockers (used to treat high blood pressure).

■    If your child is taking, or has taken in the last two weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs) or Reversible Inhibitors of Monoamine Oxidase (RIMAs).

■    If your child is taking any other cough and cold medicine.

■    If your child is under 6 years old.

If any of these apply to your child, get advice from a doctor or pharmacist without giving Non-Drowsy Sudafed Children's Syrup.

Talk to your doctor or pharmacist.

■    If your child has kidney problems.

■    If your child has blocked arteries or veins (occlusive vascular disease).

■    If your child has been diagnosed with an intolerance to some sugars.

■    If your child is taking any other medicines, including:

■ Antimuscarinic / anticholinergic drugs e.g.: ■ tricyclic antidepressants (drugs to treat mood disorders).

■ atropine (used to treat some eye conditions and occasionally bowel conditions).

■    Antihypertensives (drugs used to treat high blood pressure including alpha and beta blockers).

■    sympathomimetic drugs (stimulants or appetite suppressants and drugs used to treat congestion and asthma).

■    moclobemide (used to treat mood disorders).

■    Cardiac glycosides (drugs used to control heart rhythms or contractions) e.g.

digoxin.

■    Ergot alkaloids (drugs used to treat migraine such as ergotamine and methysergide).

■    Oxytocin (drug used to help contractions during childbirth).

If you are not sure about any of the medicines your child is taking, show the bottle or pack to your pharmacist.

If any of these bullet points apply to your child now or in the past, talk to a doctor or pharmacist.

If you are pregnant or breast-feeding

■    Ask your doctor or pharmacist for advice before taking any medicine in pregnancy or whilst breast-feeding.

Some of the ingredients can ' cause problems

■    Each 5 ml of this medicine contains

3.5 g of sucrose. This may be harmful to your child's teeth. If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before giving this medicine.

■    Methyl hydroxybenzoate may cause allergic reactions such as skin rash; this may occur after a few days.

■    The colouring Ponceau 4R (E124) in this medicine may cause allergic reactions.

turn over ►

Check the table that follows to see how much medicine to use.

■    For oral use only.

■    Always shake the bottle thoroughly before use.

■    Do not use more than the stated dose shown in the table.

■    Do not overfill the spoon.

There is a double-ended spoon in the pack.

o Children under 6 years

Do not give to children under 6 years old.

o Children from 6 years and adults

Age	Dose
Children	One large 5 ml spoonful
6-12 years	every 4 - 6 hours, up to
	4 times a day
Adults and	Two large 5 ml spoonfuls
children aged 12	every 4 - 6 hours, up to
years and over	4 times a day

■    Leave at least 4 hours between doses.

■    Do not give more than 4 doses in 24 hours.

■    If symptoms persist or worsen talk to your doctor.

■    Do not give to a child under 12 years old for more than 5 days without the advice of a 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, even if the child seems well.

.^klf you forget to give the medicine

If you forget to give a dose, give the next dose when needed provided that the last dose was given at least 4 hours ago. Do not give a double dose.

4    Possible side-effects

Non-Drowsy Sudafed Children's Syrup can have side-effects, like all medicines, although these don't affect everyone and are usually mild.

If anyone experiences any of the following stop using this medicine and seek immediate help:

■    Allergic reactions including skin rashes (which may be severe and include blistering and peeling of the skin) and itching.

■    Allergic reactions to other medicines containing sympathomimetic drugs (stimulants or appetite suppressants and drugs used to treat congestion and asthma).

■    Hallucinations and paranoid delusions.

If anyone experiences any of the following, stop using this medicine and talk to your doctor:

■    An increased or irregular heartbeat, an increased awareness of the heartbeat (palpitations), high blood pressure.

■    Restlessness and sleep disturbances.

Other effects which may occur include:

■    Irritability, anxiety, excitability, nausea and sickness.

■    Headache, difficulty in passing urine.

If your child experiences any side-effects not included in this leaflet, or you are not sure about anything, talk to your doctor or pharmacist.

5    Storing this medicine

Store below 25°C. Protect from light.

Keep the product out of the reach and sight of children.

Keep the container tightly closed.

Do not use after the end of the month shown as an 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 Non-Drowsy Sudafed Children's Syrup is:

Pseudoephedrine hydrochloride 30 mg per 5 ml. Other ingredients are: Citric acid monohydrate, sucrose, glycerol, methyl hydroxybenzoate (E218), sodium benzoate (E211), Ponceau 4R (E124), raspberry flavour and water.

What the medicine looks like

Non-Drowsy Sudafed Children's Syrup is a clear red liquid available in 100 ml amber glass bottles.

The Product Licence holder:

McNeil Products Ltd, Maidenhead, Berkshire,

SL6 3UG, UK.

Manufacturer:

Famar Orleans, 5 avenue de Concyr,

45071 Orleans, Cedex 2, France

This leaflet was revised January 2010.

Sudafed is a registered trade mark.

7    Information about treating cough and cold in children

It's normal for children to get 8 or more colds in a year. Because colds are caused by viruses, not bacteria, antibiotics don't help.

Here are simple steps to help your child who has a cough or cold.

If they are hot/feverish: Increase the amount of fluid your child normally drinks. Lower their temperature with a paracetamol or ibuprofen medicine which has doses for children.

For coughs: Coughing serves a purpose, it helps clear phlegm and mucus. Give the child plenty of warm clear fluids to drink.

To help with breathing: Plain saline nose drops / sprays can help with blocked noses.

McNeil

F307800 - Leaflet SUDAFED Children's Syrup 100mlv5.0.indd 3 05/01/10 13:13