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PSEUDOEPHEDRINE 60MG TABLETS

Active substance(s): PSEUDOEPHEDRINE HYDROCHLORIDE / PSEUDOEPHEDRINE HYDROCHLORIDE / PSEUDOEPHEDRINE HYDROCHLORIDE

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Artwork No.

231211/36

Colours Used

Customer

Ennogen

Black

Description

Pseudoephedrine 60mg Leaflet

Keyline

Market

UK

Language

English

Size

160 x 270 mm

Min. Font Size

9 pt

Page No.

1 of 1

Version No.

8

Date

04-04-17

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

3. HOW TO TAKE PSEUDOEPHEDRINE
TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER

Pseudoephedrine 60mg Tablets
[Pseudoephedrine Hydrochloride]

Always take Pseudoephedrine Tablets exactly as
described in this leaflet or as your doctor or
pharmacist has told you.
Taking this medicine

Changes in your heart beat
!
Skin rashes
!
Urinary retention (inability to completely
!
empty the bladder)

Rarely, the following adverse effect has
been seen:
!
Hallucinations

!
Take this medicine by mouth
!
Swallow the tablets whole with a glass of water.
Reporting of side effects

Read all of this leaflet carefully before you start
Warnings and precautions
Do not crush or chew your tablets.
If you get any side effects, talk to your doctor,
taking this medicine because it contains
Talk to your doctor or pharmacist before taking
pharmacist
or nurse. This includes any possible side
important information for you.
Pseudoephedrine Tablets if you have:
Age
Dose
effects not listed in this leaflet. You can also report
!
Always take this medicine exactly as described in
An overactive thyroid gland
Adults and children
Swallow 1 tablet every 4-6
side effects directly via the Yellow Card Scheme at:
!
this leaflet or as your doctor or pharmacist have told
Diabetes
aged 12 years and over hours up to 4 times a day
www.mhra.gov.uk/yellowcard
!
Leave at least 4 hours between doses.
!
you.
Heart disease
By reporting side effects you can help provide more
!
Do not take more than 4 tablets in 24 hours
!
!
Keep this leaflet. You may need to read it again.
Glaucoma (increased pressure in the eye)
information on the safety of this medicine.
!
If symptoms persist talk to your doctor
!
!
Ask your pharmacist if you need more
Prostate problems (difficulty with passing water
5. HOW TO STORE PSEUDOEPHEDRINE
information or advice.
or needing to pass water often)
Children under 12 years: not recommended
TABLETS
!
!
If you get any side effects, talk to your doctor or
Liver or kidney problems
!
pharmacist. This includes any possible side
Mild to moderately high blood pressure
Elderly: the same dose as adult dose
Keep this medicine out of the sight and reach of
Been told by your doctor that you have a rare
!
effects not listed in this leaflet. See section 4.
children.
If you take more Pseudoephedrine Tablets than
hereditary disease called Lapp lactase
!
You must talk to a doctor if you do not feel better
Check the expiry date printed on the label or side of
you should
the box. Do not use after the expiry date stated on the
deficiency or glucose-galactose malabsorption
or if you feel worse.
This medicine is to be taken at regular intervals. If
label.
as this medicine contains lactose.
you take too many tablets by mistake contact your
Do not store above 25°C. Store in the original
What is in this leaflet:
nearest hospital casualty department or tell your
package.
1. What are Pseudoephedrine Tablets and what
Other medicines and Pseudoephedrine Tablets
doctor immediately. Take your tablet pack with you.
In case of any visible signs of deterioration, you
are they used for
Tell your doctor or pharmacist if you are taking, have
should discard the package.
If you forget to take Pseudoephedrine Tablets
2. What you need to know before you take
recently taken or might take any other medicines,
Medicines should not be disposed of via waste water
If you forget to take a dose, take the next dose when
or household waste. Ask your pharmacist how to
Pseudoephedrine Tablets
especially any of the following:
needed provided that the last dose was taken at least
dispose of medicines no longer required. These
!
3. How to take Pseudoephedrine Tablets
Monoamine-oxidase inhibitors (MAOIs) drugs
measures
help to protect the environment.
4
hours
ago.
Do
not
take
a
double
dose.
4. Possible side effects
used to treat depression e.g phenelzine.
5. How to store Pseudoephedrine Tablets
Pseudoephedrine Tablets should not be taken at
6. CONTENTS OF THE PACK AND OTHER
4. POSSIBLE SIDE EFFECTS
6. Contents of the pack and other information
the same time as or within 2 weeks of stopping
INFORMATION
taking a MAOI
Like all medicines, this medicine can cause side
What Pseudoephedrine Tablets contain:
!
1. WHAT ARE PSEUDOEPHEDRINE TABLETS
Antihypertensives (drugs used to treat high blood
effects, although not everyone gets them.
Pseudoephedrine Tablets contain pseudoephedrine
AND WHAT ARE THEY USED FOR
pressure), such as guanethidine, methyldopa,
hydrochloride. Each tablet contains 60mg of
If you experience any of the following then STOP
alpha and betablockers, debrisoquine, bretylium
pseudoephedrine hydrochloride.
taking the medicine and contact a doctor
This medicine contains pseudoephedrine
and betanidine
immediately
!
hydrochloride, a decongestant. It can be used to
Sympathomimetic drugs (stimulants or appetite
The other ingredients are: cellactose, magnesium
!
Allergic reactions may occur with symptoms
provide relief from cold, flu and allergy symptoms
suppressants) and drugs used to treat
stearate, colloidal anhydrous silica, lactose,
such as rash, itching, swelling of the face,
hypromellose, macrogol 4000, Ponceau 4R
such as a blocked nose, stuffy nose and blocked
congestion and asthma
wheeziness, shortness of breath, tightness in the
aluminium lake (E124), titanium dioxide (E171),
chest, fever, low blood pressure and feeling dizzy
!
sinuses to help you breathe more easily without
Tricyclic antidepressants (used to treat mood
sunset yellow aluminium lake (E110), macrogol
particularly when standing up.
causing drowsiness.
disorders) e.g imiprimine.
6000.
!
A few people have had hallucinations, but this is
rare
2. WHAT YOU NEED TO KNOW BEFORE YOU
Pregnancy and breast-feeding
What Pseudoephedrine Tablets look like and
!
A few men, especially men with prostate
TAKE PSEUDOEPHEDRINE TABLETS
Ask your doctor or pharmacist for advice if you are
contents of the pack
problems may have trouble passing water.
pregnant, planning on becoming pregnant or
Pseudoephedrine Tablets are packed in blisters
packs
in pack sizes of 12 tablets.
The
most
frequently
reported
adverse
effects
are:
Do not take Pseudoephedrine Tablets if you:
breastfeeding before taking this medicine. Your
!
Anxiety,
restlessness,
insomnia
!
Are hypersensitive (allergic) to pseudoephedrine
doctor will decide whether you should take this
Marketing Authorisation Holder
!
Headaches, dizziness and psychosis
or any of the ingredients
medicine.
Ennogen Pharma Limited
!
Chest pain and fast heart beat.
!
Have very high blood pressure
Unit G4, Riverside Industrial Estate,
These are especially common in the elderly.
Have coronary heart disease - a condition where
!
Pseudoephedrine Tablets contain lactose,
Riverside Way, Dartford, DA1 5BS, UK.
the arteries in the heart become narrowed and
sunset yellow (E110) and ponceau 4R (E124)
Occasionally, the following adverse effects have
Manufacturer:
been seen:
hard
If you have been told by your doctor that you have an
Quailphar NV
!
Tremor
!
intolerance to some sugars, contact your doctor
Are taking, or have taken in the last two weeks,
Rijksweg 9, B-2880 Bornem, Belgium
!
Dry
mouth,
nausea,
vomiting,
appetite
loss
and
before taking this medicinal product.
drugs for depression known as Monoamine
ischaemic colitis (abdominal pain and diarrhoea)
Sunset yellow and ponceau 4R may cause allergic
Oxidase Inhibitors (MAOIs).
This leaflet was last revised in April 2017.
!
High blood pressure
reactions.

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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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