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SUDAFED DRY COUGHS WITH DECONGESTANT LIQUID

Active substance(s): DEXTROMETHORPHAN HYDROBROMIDE / PSEUDOEPHEDRINE HYDROCHLORIDE

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PACKAGE LEAFLET
Sudafed Dry Coughs with Decongestant Liquid
Dextromethorphan & Pseudoephedrine
■ This medicine is used to provide relief from dry tickly coughs and help clear the stuffy,
blocked up feeling in your nose and sinuses.
■ 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 take 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 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 2 c
■ Follow the dosage instructions carefully. 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
Sudafed Dry Coughs with Decongestant Liquid is a medicine which is used to provide relief
from dry tickly coughs and help clear the stuffy, blocked up feeling in your nose and sinuses.
The liquid contains pseudoephedrine hydrochloride, which is a decongestant that relieves
nasal and sinus congestion and dextromethorphan, which is a cough suppressant
that helps soothe dry tickly coughs. This medicine is for use in adults and children aged
12 years and over.
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 take 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 very high blood pressure or severe heart disease.
■ If you are taking, or have taken in the last two weeks, drugs for depression known as
Monoamine Oxidase Inhibitors (MAOIs).
■ If you have had a cough for a few weeks, or a cough which brings up any blood or a lot
of mucus that may be caused by asthma or emphysema.
■ If you have breathing problems.
■ If you are taking any other cough and cold medicine.

If any of these apply to you, get advice from a doctor or pharmacist without taking
Sudafed Dry Coughs with Decongestant Liquid.
Talk to your doctor or pharmacist…
■ If you have liver or kidney problems.
■ If you have high blood pressure or heart disease.
■ If you have diabetes or have been diagnosed with an intolerance to some sugars.
■ 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
often).
■ If you have alcohol dependence.
■ If you are taking any other medicines,
including:
■ Antihypertensives (drugs to treat high blood pressure such as guanethidine,
methyldopa,alpha and beta blockers, debrisoquine,bretylium and betanidine).
■ Sympathomimetic drugs (stimulants or appetite suppressants and drugs used to treat
congestion and asthma).
■ Tricyclic antidepressants (used to treat mood disorders).
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 this medicine if you are pregnant
or breast-feeding.
Some of the ingredients can cause problems
■ This medicine contains sucrose (2.8 g per 5 ml) and sorbitol solution. 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 happen
after a few days.
■ The colouring, Ponceau 4R (E124), in this medicine may cause allergic reactions.
■ This medicine contains 5% v/v ethanol (alcohol), which is up to 190 mg per 5 ml,
equal to 5 ml beer or 2 ml wine per 5 ml.This can be harmful for those suffering from
alcoholism. The ethanol content should be taken into account in pregnant or breastfeeding
women, children and high-risk groups such as patients with liver disease or epilepsy.

Driving and using machines
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Do not drive while taking this medicine until you know how it affects you.
It may be an offence to drive when taking this medicine.
However, you would not be committing an offence if:
o The medicine has been taken to treat a medical or dental problem and
o You have taken it according to the information provided with the medicine and
o It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while
taking this medicine. Details regarding a new driving offence concerning driving after drugs
have been taken in the UK may be found here:
https://www.gov.uk/drugdrivinglaw
3 How to take this medicine
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.
Children under 12 years
Do not give to children under 12 years old.
Adults and children aged 12 years and over
Age
Adults and children aged 12 years and over

Dose
Two large 5 ml spoonfuls every 4 - 6 hours,
up to 4 times a day

■ Leave at least 4 hours between doses.
■ Do not take more than 4 doses in 24 hours.
■ If symptoms persist talk to your 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 Dry Coughs with Decongestant Liquid 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 talk to your doctor:
■ A few people have had hallucinations, but this is rare.
■ A few men, especially men with prostate problems, may have trouble passing water.
■ Occasionally people get skin rashes that are sometimes itchy.

Other effects which may occur include:
■ Restlessness, having trouble getting to sleep or bad dreams.
■ Nausea, vomiting or 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.
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 25ºC.
Protect from light.
Keep the product out of the reach and sight of children.
Do not use your medicine 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 Dry Coughs with Decongestant Liquid are: 30 mg
Pseudoephedrine hydrochloride and 10 mg
Dextromethorphan hydrobromide in each 5 ml spoonful.
Other ingredients are: Sucrose, sorbitol solution, sodium benzoate (E211), methyl
hydroxybenzoate (E218), ethanol, blackcurrant flavour, L-menthol,
Ponceau 4R (E124) and purified water.
What the medicine looks like
Sudafed Dry Coughs with Decongestant Liquid is a clear red liquid in a glass bottle.
Product Licence holder: McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer: Famar Orléans, 5 avenue de Concyr,
45071 Orleans, Cedex 2, France.
This leaflet was revised June 2015
Sudafed is a registered trade mark.

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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.

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