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Proposed Leaflet for Sudafed Decongestant & Pain Tablets

Decongestant & Pain Tablets
Diphenhydramine, Paracetamol and Pseudoephedrine
 This medicine is used to relieve the symptoms of cold and flu.
 This medicine is for use by adults and children aged 12 years and over.
 This pack contains 2 different coloured tablets, for use at different times of the day. Read
the leaflet carefully to ensure that you take the correct tablet at the appropriate time of day.
 The white tablets contain paracetamol and pseudoephedrine and are for daytime
 The blue tablets contain paracetamol and diphenhydramine and are for night-time
use only.
 Follow the dosage instructions carefully. There are different tablets for day and nighttime doses. See section 3 
 Do not use 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 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
Sudafed Decongestant & Pain Tablets are used for the relief of cold and flu symptoms.
The white daytime tablets contain paracetamol, an analgesic and antipyretic which helps to
relieve pain and fever and pseudoephedrine hydrochloride, a decongestant which unblocks
stuffy noses.
The blue night-time tablets contain paracetamol and diphenhydramine hydrochloride, an
antihistamine which helps clear catarrh and so aids sleep.
This medicine is for use in adults and children aged over 12 years.

2 Before taking this medicine
This medicine is suitable for most adults and children aged over 12 years but a few people
should not use it. If you are in any doubt, talk to your doctor or pharmacist.
X Do not use this medicine…
 If you have very high blood pressure or severe heart disease.
 If you have ever had a bad reaction to paracetamol or any of the other ingredients.
 If you are taking any other medicines containing paracetamol or a decongestant.
 If you are taking, or have taken in the last two weeks, drugs for depression known as
Monoamine Oxidase Inhibitors (MAOIs).
 If you are pregnant or breast-feeding.
If any of these apply to you, get advice from a doctor or pharmacist without using
Sudafed Decongestant & Pain Tablets.

! Talk to your doctor or pharmacist…
 If you have liver or kidney problems.
 If you have heart disease or mild to moderate high blood pressure.
 If you have diabetes.
 If you have an overactive thyroid gland.
 If you have glaucoma (increased pressure in the eye).
 If you have prostate problems (difficulty with passing water or needing to pass water
 If you are taking alcohol.
 If you are taking any other medicines, including:
 anticholinergic drugs e.g.:
 tricyclic antidepressants (drugs used to treat mood disorders).
 barbiturates (a kind of sleeping tablet).
 antidepressants (drugs used to treat mood disorders).
 sympathomimetic drugs (stimulants or appetite suppressants and drugs used to treat
congestion and asthma).
 antihypertensives (drugs used to treat high blood pressure).
 colestyramine (used to lower blood cholesterol).
 metoclopramide or domperidone (used to treat nausea and vomiting).
 anticoagulants (drugs used to thin the blood, such as warfarin).
 anticonvulsants (drugs used to treat epilepsy).
 oral contraceptives ("the pill").
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 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 this medicine if you are pregnant or
! Special warnings about this medicine
 You can use this medicine while you are taking oral contraceptives (“the pill”) or
anticonvulsant tablets used to treat epilepsy, but the medicine may not work so well on your
pain or fever.
 Night-time tablets may cause drowsiness. If affected, do not drive or operate machinery.
Avoid alcoholic drink.
turn over 

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 than the stated dose shown below.
 Take with a glass of water.

! Children under 12 years old
This medicine is not recommended for children under 12 years old.
! Adults and children aged 12 years and over

Adults and children
aged 12 years and over

1 white tablet every 4 - 6 hours, up to 3
times a day (one tablet in the morning, at
mid-day and in the afternoon).
1 blue tablet to be taken at night.

 Do not take more than 3 white tablets a day.
 Take only 1 tablet at a time and only at the times of day described in this table.
 Do not take the night-time tablets during the day.
 If symptoms persist, talk to your doctor.
! If anyone has too much
Immediate medical advice should be sought in the event of an overdose, even if you feel well,
because of the risk of delayed, serious liver damage.
! If you forget to take the medicine
You should only take this medicine as required following the dosage instructions above
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 & Pain Tablets can have side-effects, like all medicines, although
these don't affect everyone and are usually mild.
If you experience any of the following, stop using the medicine and seek immediate help:
 Allergic reactions including skin rashes (which may be severe and include blistering
or peeling of the skin) and itching.
If you experience any of the following, stop using the medicine and talk to your doctor:
 A few people have had hallucinations but this is rare.
 There have been rare reports of blood disorders although these were not necessarily related
to paracetamol.
 A few men, especially men with prostate problems, may have trouble passing water.
Other effects which may occur include:
 Having trouble getting to sleep.
 Drowsiness, dizziness, blurred vision.
 Dry mouth, nose and throat.
 Upset stomach.
If you experience any side-effects not included in this leaflet or are not sure about anything,
talk to your doctor or pharmacist.

5 Storing this medicine
Do not store above 25ºC.
Store in the original package.
Keep the product out of the reach and sight 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 Further information
What’s in this medicine?
The active ingredients in Sudafed Decongestant & Pain Tablets are: Day Tablets: 500 mg
Paracetamol and 60 mg Pseudoephedrine hydrochloride.
Night Tablets: 500 mg Paracetamol and 25 mg Diphenhydramine hydrochloride.
Other ingredients are:
Day Tablets: Pregelatinised maize starch, povidone, crospovidone, stearic acid,
microcrystalline cellulose, croscarmellose sodium and magnesium stearate.
Night Tablets: Microcrystalline cellulose, maize starch, sodium starch glycollate,
pregelatinised maize starch, hydroxypropylcellulose, croscarmellose sodium, stearic acid,
magnesium stearate and are coated with hypromellose, indigo carmine (E132), titanium
dioxide (E171) and propylene glycol.
What the medicine looks like
Sudafed Decongestant & Pain Tablets come in a carton containing 12 white oblong day-time
tablets and 4 blue round night-time tablets.
Marketing Authorisation holder: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG,
Manufacturer: Janssen Cilag S.A., Domaine de Maigremont, 27100 Val de Reuil.
This leaflet was revised February 2016.
Sudafed is a registered trade mark.
McNeil Products Ltd. Logo
09-1019 364867A

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.