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SUDAFED DECONGESTANT TABLETS

Active substance(s): PSEUDOEPHEDRINE HYDROCHLORIDE

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12 mm

6 mm

6 mm

1 What the medicine is for

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 you are taking any other medicines,
including:
■ Antihypertensives (drugs used 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.


Pseudoephedrine hydrochloride
■ This

medicine is used to help clear cold, flu
and allergy symptoms such as blocked sinuses,
stuffy nose and catarrh.
■ 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.
See section 3 c
Now read this whole leaflet carefully before you
use this medicine. Keep the leaflet: you might need
it again.

Sudafed Decongestant Tablets is a medicine used to
provide relief from cold, flu and allergy symptoms such as
blocked sinuses, stuffy nose and catarrh. The tablets
contain pseudoephedrine hydrochloride, which is a
decongestant that relieves nasal and sinus congestion.
This medicine is for use by 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.

x 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 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 OxidaseInhibitors (MAOIs).
If any of these apply to you, get advice from a
doctor or pharmacist without using
Sudafed Decongestant Tablets.




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.

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14 mm

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spot = 12 x 2 centered in
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Distance between cutted line/middel of the spot = 83.6 mm

Barcodes placed at 14 mm
Hight for bars : 10 mm
reading way

14
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If you forget to take the medicine

Some of the ingredients can cause
problems


This medicine contains lactose. If you have been
told by your doctor that you have an intolerance
to some sugars, contact your doctor before
taking this medicine.

4 Possible side-effects

3 How to take this
medicine

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

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




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

For oral use only.
Do not take more than the stated dose shown.
Take with a glass of water.

i

Children under 12 years old
Adults and children aged 12 years and
over

Age

Dose

Adults and
children aged
12 years and over

Swallow 1 tablet every
4 - 6 hours up to 4 times a
day





A few people have had hallucinations, but this
is rare..
■ Occasionally people get skin rashes that
are sometimes itchy.
■ A few men, especially men with prostate
problems, may have trouble passing water.


Do not give to children under 12 years old.

i

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.

Other effects which may occur include:


Leave at least 4 hours between doses.
Do not take more than 4 tablets in 24 hours.
If symptoms persist talk to your doctor.

Restlessness, having trouble getting to sleep
or bad dreams.

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

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
Tablets is: Pseudoephedrine hydrochloride 60 mg
per tablet.
Other ingredients are: Lactose, microcrystalline
cellulose, maize starch, silica, magnesium stearate,
hypromellose, polyethylene glycol, talc and red iron
oxide (E172).

What the medicine looks like
Sudafed Decongestant Tablets are reddish brown
film-coated tablets, available in packs of 12 tablets.
Product Licence holder: McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer: Janssen-Cilag, Domaine de Maigremont,
27100 Val de Reuil, France.
This leaflet was revised July 2012.
Sudafed is a registered trade mark.

5 Storing this medicine

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

Store below 30˚C in the original package to protect
from moisture.
Keep the product out of the reach and sight
of children.

365218C
12-0087

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14 mm
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COLOURS:
Job Bag No.
Version

Product

Description
Country
Date

12-0087
1
Sudafed Decongestant

BLACK

PMS
300

PROFILE

Pil
UK
10/07/12

SIZE:
145 x 210 mm

Main body text
(PIL’s only)

7.5 pts

A print out of this image s
not be used for exact colour matching but to check if the layout,
spelling, text and colour references are correct. Please check thoroughly.

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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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