Sudafed Congestion & Headache Relief Max Strength capsules

Main information

  • Trade name:
  • Sudafed Congestion & Headache Relief Max Strength capsules
  • Dosage:
  • 25mg ; 6.1mg ; 500mg
  • Pharmaceutical form:
  • Capsule
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Never Valid To Prescribe As A VMP
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Sudafed Congestion & Headache Relief Max Strength capsules
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 03090200; GTIN: 3574661162249

Other information

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 12063/0067
  • Last update:
  • 18-02-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Sudafed Congestion & Headache Relief Max Strength

Capsules with food, drink and alcohol

Do not drink alcohol (beer, wine, spirits etc) while taking this product.

3

How to take this medicine

Check the table below to see how much medicine to take.

For oral use only.

Do not take more medicine than the label tells you to.

Take with a glass of water. Do not chew.

Children and adolescents

Do not give to children under 16 years.

Adults, the elderly and children aged 16 years and

over

Age

Dosage

Adults, the elderly and children

Two capsules every 4

aged 16 years and over

to 6 hours as required.

Do not take more than eight capsules (4 doses) in any 24

hours period.

Leave at least 4 to 6 hours between doses.

If you do not get better, talk to your doctor or pharmacist.

Do not take for more than 3 days unless advised by your doctor.

Taking this medicine with food and drink:

You should avoid too much caffeine in drinks like coffee and tea.

If you are also consuming other medicines or food that contains

caffeine (coffee, tea, cola drinks, chocolate) you may have a high

caffeine intake and might have difficulty sleeping, start shaking

and/or an uncomfortable feeling in the chest.

If anyone has too much

Talk to a doctor at once if you take too much of this medicine even

if you feel well. This is because too much paracetamol can cause

delayed, serious liver damage. Go to your nearest hospital casualty

department. Take your medicine and this leaflet 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 Congestion & Headache Relief Max Strength Capsules can

have side-effects, like all medicines, although these don't affect

everyone and are usually mild.

Unknown side-effects are:

bronchospasm

restlessness, anxiety, nervousness, irritability, agitation

Rare side-effects are:

allergic reactions such as skin rash

nausea (feeling sick) or vomiting (being sick) or diarrhoea

Read all of this leaflet carefully before you take this medicine

because it contains important information you need to know.

This medicine is available without prescription, however, you still

need to use this product carefully to get the best results from it.

Keep this leaflet as you may need to read it again

Ask your pharmacist if you need more information or advice

If you get any side-effects, talk to your doctor or pharmacist.

This includes any possible side-effects not listed in this leaflet.

You must talk to a doctor if you do not feel better or if you feel

worse after 3 days

What is in this leaflet?

1.

What is Sudafed Congestion & Headache Relief Max

Strength Capsules and what is it used for

2.

What you need to know before you take Sudafed

Congestion & Headache Relief Max Strength Capsules

3.

How to take Sudafed Congestion & Headache Relief Max

Strength Capsules

4.

Possible side-effects

5.

How to store Sudafed Congestion & Headache Relief Max

Strength Capsules

6.

Contents of the pack and other information

1

What is Sudafed Congestion &

Headache Relief Max Strength

Capsules and what is it used for

Sudafed Congestion & Headache Relief Max Strength Capsules help

relieve the symptoms of pain and congestion caused by sinusitis, which

include stuffy nose, blocked sinuses, headache, fever, aches and pains.

The capsules contain paracetamol, an analgesic and antipyretic which

helps to relieve pain and fever, caffeine, a stimulant to help combat

tiredness and to help increase the pain relief, and phenylephrine

hydrochloride, which is a decongestant.

This medicine is for use by adults, the elderly and children aged 16 years

and over.

2

What you need to know before you

take Sudafed Congestion & Headache

Relief Max Strength Capsules

This medicine is suitable for most adults and children aged

16 years and over 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 are allergic to paracetamol, caffeine, phenylephrine

or any of the other ingredients listed in section 6

turn over

AB261QMJ1

If you have high blood pressure.

If you have severe heart disease or circulatory problems.

If you have an overactive thyroid.

If you have a history of stomach ulcers.

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 tricyclic antidepressants, such

as imipramine, amitriptyline.

In children under 16 years old.

If any of these apply to you, get advice from a doctor or

pharmacist without using Sudafed Congestion & Headache

Relief Max Strength Capsules.

Please see your doctor or pharmacist before taking

this medicine if you:

are pregnant or breast-feeding

suffer from kidney or liver problems, including alcoholic liver

disease or have alcohol dependence

have diabetes

have circulatory disorders such as a condition called

Raynaud’s Phenomenon, which results from poor circulation

in the fingers and toes.

Other medicines and Sudafed Congestion &

Headache Relief Max Strength Capsules

Tell your doctor or pharmacist if you are taking, have

recently taken or might take any other medicines

medicines to treat high cholesterol levels which reduce

the amount of fat in the blood such as colestyramine

medicines to control feeling sick or being sick such as

metoclopramide or domperidone

medicines called anti-coagulants, which are used to thin

the blood such as warfarin or other coumarins - you may

take occasional doses of paracetamol but should consult

your doctor if you need to take it on a regular basis

barbiturates (for epilepsy or to help you sleep), such as

phenobarbitone

medicines to treat migraines such as ergotamine or methysergide

medicines to lower blood pressure, treat heart or

circulatory problems such as beta blockers (e.g. atenolol)

or vasodilators (e.g. hydralazine)

other decongestant drugs such as ephedrine or xylometazoline.

If you are pregnant or breast-feeding:

Ask your doctor or pharmacist for advice before taking this

medicine if you are pregnant or breast-feeding.

Sudafed Congestion & Headache Relief Max Strength

Capsules contains paracetamol.

Do not take anything else containing

paracetamol while taking this medicine.

headache, tremor, dizziness

difficulty sleeping (insomnia)

fast, slow or irregular heart beat (palpitations)

high blood pressure

glaucoma

problems or pain passing urine

sudden weight loss, loss of appetite and yellowing of the eyes and skin

More rarely, the following side-effects can happen:

you may become more prone to bleeding, bruising, fever and infections,

such as sore throat and ulcers, due to changes in your blood.

Very rare cases of serious skin reactions have been reported.

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

How to store Sudafed Congestion &

Headache Relief Max Strength Capsules

Do not store above 25ºC.

Keep this medicine out of the sight and reach of children.

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

Contents of the pack and other

information

What’s in this medicine?

The active ingredients in Sudafed Congestion & Headache Relief

Max Strength Capsules are: 500 mg Paracetamol, 25 mg Caffeine

and 6.1 mg Phenylephrine hydrochloride per capsule.

Other ingredients are: Maize starch, croscarmellose sodium, sodium

laurilsulfate, magnesium stearate, talc, gelatin, titanium dioxide (E171),

quinoline yellow (E104), Patent Blue V (E131), erythrosine (E127) and

indigo carmine (E132).

What the medicine looks like

Sudafed Congestion & Headache Relief Max Strength Capsules are

red/blue capsules available in packs of 16 capsules.

Marketing Authorisation holder and Manufacturer:

Wrafton Laboratories Limited, Braunton, North Devon, EX33 2DL, UK.

Distributor: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.

This leaflet was revised January 2017.

Sudafed is a registered trade mark.

17-0017

CONGESTION

&

HEADACHE RELIEF

345 >>>

345 >>>

Sudafed Congestion & Headache Relief Max Strength

Capsules with food, drink and alcohol

Do not drink alcohol (beer, wine, spirits etc) while taking this product.

3

How to take this medicine

Check the table below to see how much medicine to take.

For oral use only.

Do not take more medicine than the label tells you to.

Take with a glass of water. Do not chew.

Children and adolescents

Do not give to children under 16 years.

Adults, the elderly and children aged 16 years and

over

Age

Dosage

Adults, the elderly and children

Two capsules every 4

aged 16 years and over

to 6 hours as required.

Do not take more than eight capsules (4 doses) in any 24

hours period.

Leave at least 4 to 6 hours between doses.

If you do not get better, talk to your doctor or pharmacist.

Do not take for more than 3 days unless advised by your doctor.

Taking this medicine with food and drink:

You should avoid too much caffeine in drinks like coffee and tea.

If you are also consuming other medicines or food that contains

caffeine (coffee, tea, cola drinks, chocolate) you may have a high

caffeine intake and might have difficulty sleeping, start shaking

and/or an uncomfortable feeling in the chest.

If anyone has too much

Talk to a doctor at once if you take too much of this medicine even

if you feel well. This is because too much paracetamol can cause

delayed, serious liver damage. Go to your nearest hospital casualty

department. Take your medicine and this leaflet 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 Congestion & Headache Relief Max Strength Capsules can

have side-effects, like all medicines, although these don't affect

everyone and are usually mild.

Unknown side-effects are:

bronchospasm

restlessness, anxiety, nervousness, irritability, agitation

Rare side-effects are:

allergic reactions such as skin rash

nausea (feeling sick) or vomiting (being sick) or diarrhoea

Read all of this leaflet carefully before you take this medicine

because it contains important information you need to know.

This medicine is available without prescription, however, you still

need to use this product carefully to get the best results from it.

Keep this leaflet as you may need to read it again

Ask your pharmacist if you need more information or advice

If you get any side-effects, talk to your doctor or pharmacist.

This includes any possible side-effects not listed in this leaflet.

You must talk to a doctor if you do not feel better or if you feel

worse after 3 days

What is in this leaflet?

1.

What is Sudafed Congestion & Headache Relief Max

Strength Capsules and what is it used for

2.

What you need to know before you take Sudafed

Congestion & Headache Relief Max Strength Capsules

3.

How to take Sudafed Congestion & Headache Relief Max

Strength Capsules

4.

Possible side-effects

5.

How to store Sudafed Congestion & Headache Relief Max

Strength Capsules

6.

Contents of the pack and other information

1

What is Sudafed Congestion &

Headache Relief Max Strength

Capsules and what is it used for

Sudafed Congestion & Headache Relief Max Strength Capsules help

relieve the symptoms of pain and congestion caused by sinusitis, which

include stuffy nose, blocked sinuses, headache, fever, aches and pains.

The capsules contain paracetamol, an analgesic and antipyretic which

helps to relieve pain and fever, caffeine, a stimulant to help combat

tiredness and to help increase the pain relief, and phenylephrine

hydrochloride, which is a decongestant.

This medicine is for use by adults, the elderly and children aged 16 years

and over.

2

What you need to know before you

take Sudafed Congestion & Headache

Relief Max Strength Capsules

This medicine is suitable for most adults and children aged

16 years and over 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 are allergic to paracetamol, caffeine, phenylephrine

or any of the other ingredients listed in section 6

turn over

AB261QMJ1

If you have high blood pressure.

If you have severe heart disease or circulatory problems.

If you have an overactive thyroid.

If you have a history of stomach ulcers.

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 tricyclic antidepressants, such

as imipramine, amitriptyline.

In children under 16 years old.

If any of these apply to you, get advice from a doctor or

pharmacist without using Sudafed Congestion & Headache

Relief Max Strength Capsules.

Please see your doctor or pharmacist before taking

this medicine if you:

are pregnant or breast-feeding

suffer from kidney or liver problems, including alcoholic liver

disease or have alcohol dependence

have diabetes

have circulatory disorders such as a condition called

Raynaud’s Phenomenon, which results from poor circulation

in the fingers and toes.

Other medicines and Sudafed Congestion &

Headache Relief Max Strength Capsules

Tell your doctor or pharmacist if you are taking, have

recently taken or might take any other medicines

medicines to treat high cholesterol levels which reduce

the amount of fat in the blood such as colestyramine

medicines to control feeling sick or being sick such as

metoclopramide or domperidone

medicines called anti-coagulants, which are used to thin

the blood such as warfarin or other coumarins - you may

take occasional doses of paracetamol but should consult

your doctor if you need to take it on a regular basis

barbiturates (for epilepsy or to help you sleep), such as

phenobarbitone

medicines to treat migraines such as ergotamine or methysergide

medicines to lower blood pressure, treat heart or

circulatory problems such as beta blockers (e.g. atenolol)

or vasodilators (e.g. hydralazine)

other decongestant drugs such as ephedrine or xylometazoline.

If you are pregnant or breast-feeding:

Ask your doctor or pharmacist for advice before taking this

medicine if you are pregnant or breast-feeding.

Sudafed Congestion & Headache Relief Max Strength

Capsules contains paracetamol.

Do not take anything else containing

paracetamol while taking this medicine.

headache, tremor, dizziness

difficulty sleeping (insomnia)

fast, slow or irregular heart beat (palpitations)

high blood pressure

glaucoma

problems or pain passing urine

sudden weight loss, loss of appetite and yellowing of the eyes and skin

More rarely, the following side-effects can happen:

you may become more prone to bleeding, bruising, fever and infections,

such as sore throat and ulcers, due to changes in your blood.

Very rare cases of serious skin reactions have been reported.

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

How to store Sudafed Congestion &

Headache Relief Max Strength Capsules

Do not store above 25ºC.

Keep this medicine out of the sight and reach of children.

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

Contents of the pack and other

information

What’s in this medicine?

The active ingredients in Sudafed Congestion & Headache Relief

Max Strength Capsules are: 500 mg Paracetamol, 25 mg Caffeine

and 6.1 mg Phenylephrine hydrochloride per capsule.

Other ingredients are: Maize starch, croscarmellose sodium, sodium

laurilsulfate, magnesium stearate, talc, gelatin, titanium dioxide (E171),

quinoline yellow (E104), Patent Blue V (E131), erythrosine (E127) and

indigo carmine (E132).

What the medicine looks like

Sudafed Congestion & Headache Relief Max Strength Capsules are

red/blue capsules available in packs of 16 capsules.

Marketing Authorisation holder and Manufacturer:

Wrafton Laboratories Limited, Braunton, North Devon, EX33 2DL, UK.

Distributor: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.

This leaflet was revised January 2017.

Sudafed is a registered trade mark.

17-0017

CONGESTION

&

HEADACHE RELIEF

345 >>>

345 >>>