NON-DROWSY SUDAFED LINCTUS

Active substance: PSEUDOEPHEDRINE HYDROCHLORIDE

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Transcript
1 What the medicine is for

with DECONGESTANT
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.

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.

turn over c

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.


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

If anyone has too much

5 Storing this medicine

If anyone has too much contact a doctor or
your nearest Accident & Emergency Department
(Casualty) taking this leaflet and pack with you.

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.

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.


Do not give to children under 12 years old.

Other effects which may occur include:

Adults and children aged 12 years
and over

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.

Age

Dose

Adults and children
aged 12 years and
over

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.




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 January 2010.
Sudafed is a registered trade mark.



F307460
09/0595

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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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