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PSEUDOEPHEDRINE 60MG TABLETS

Active substance(s): PSEUDOEPHEDRINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Pseudoephedrine 60mg Tablets
[Pseudoephedrine Hydrochloride]
Read all of this leaflet carefully before you start
taking this medicine.
! Keep this leaflet. You may need to read it again.
! If you have any further questions, ask your doctor
or pharmacist.
! This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
! If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Take special care with Pseudoephedrine Tablets
Consult your doctor before taking Pseudoephedrine
Tablets if you have:
! An overactive thyroid gland
! Diabetes
! Heart disease
! Glaucoma (increased pressure in the eye)
! Prostate problems (difficulty with passing water
or needing to pass water often)
! Liver or kidney problems
! Mild to moderately high blood pressure.

In this leaflet:
1. What are Pseudoephedrine Tablets and what
are they used for
2. Before you take Pseudoephedrine Tablets
3. How to take Pseudoephedrine Tablets
4. Possible side effects
5. How to store Pseudoephedrine Tablets
6. Further information

Taking other medicines
Please tell your doctor or pharmacist if you are taking
any of the following medicines:! Monoamine-oxidase inhibitors (MAOIs) drugs
used to treat depression e.g phenelzine.
Pseudoephedrine Tablets should not be taken at
the same time as or within 2 weeks of stopping
taking a MAOI
! Antihypertensives (drugs used to treat high blood
pressure), such as guanethidine, methyldopa,
alpha and betablockers, 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) e.g imiprimine.

1. WHAT ARE PSEUDOEPHEDRINE TABLETS
AND WHAT ARE THEY USED FOR
This medicine contains pseudoephedrine
hydrochloride, a decongestant. It can be used to
provide relief from cold, flu and allergy symptoms
such as a blocked nose, stuffy nose and blocked
sinuses to help you breathe more easily without
causing drowsiness.
2. BEFORE YOU TAKE PSEUDOEPHEDRINE
TABLETS
Do not take Pseudoephedrine Tablets if you:
! Are hypersensitive (allergic) to pseudoephedrine
or any of the ingredients
! Have very high blood pressure
! Coronary heart disease - a condition where the
arteries in the heart become narrowed and hard
! Are taking, or have taken in the last two weeks,
drugs for depression known as Monoamine
Oxidase Inhibitors (MAOIs)
! Have been told by your doctor that you have a
rare hereditary disease called Lapp-lactase
deficiency or glucose-galactose malabsorption
as this medicine contains lactose.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice if you are
pregnant, planning on becoming pregnant or
breastfeeding before taking this medicine. Your
doctor will decide whether you should take this
medicine.
Important information about some of the
ingredients
This medicine contains lactose (a type of sugar), if
you have been told by your doctor that you have an
intolerance to some sugars talk to your doctor before
taking this medicine.
This medicine also contains sunset yellow (E110)
and ponceau (E124) which can cause allergic
reactions.

3. HOW TO TAKE PSEUDOEPHEDRINE
TABLETS
Always take PseudoephedrineTablets exactly as
your doctor has instructed you. You should check
with your doctor or pharmacist if you are unsure.
Taking this medicine
Take this medicine by mouth
Swallow the tablets whole with a glass of water.
Do not crush or chew your tablets.

!
!

Age
Dose
Adults and children
Swallow 1 tablet every 4-6
aged 12 years and over hours up to 4 times a day
! Leave at least 4 hours between doses.
! Do not take more than 4 tablets in 24 hours
! If symptoms persist talk to your doctor
Children under 12 years: not recommended

Occasionally, the following adverse effects
have been seen:
! Tremor
! Dry mouth, nausea, vomiting, appetite
loss and ischaemic colitis (abdominal
pain and diarrhoea)
! High blood pressure
! Changes in your heart beat
! Skin rashes.
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. HOW TO STORE PSEUDOEPHEDRINE
TABLETS

Elderly: the same dose as adult dose
Patient with liver and kidney problems: should be
treated with caution
If you take more PseudoephedrineTablets than
you should
This medicine is to be taken at regular intervals. If
you take too many tablets by mistake contact your
nearest hospital casualty department or tell your
doctor immediately. Take your tablet pack with you.
If you stop taking PseudoephedrineTablets
Keep taking your tablets until your doctor tells you to
stop. Do not stop taking your tablets just because
you feel better. If you stop taking this medicine your
symptoms may come back.
If you forget to take PseudoephedrineTablets
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
Like all medicines, Pseudoephedrine Tablets can
cause side effects, although not everyone gets them.
If you experience any of the following then STOP
taking the medicine and contact a doctor
immediately
! Allergic reactions may occur with symptoms
such as rash, itching, swelling of the face,
wheeziness, shortness of breath, tightness in the
chest, fever, low blood pressure and feeling dizzy
particularly when standing up.
! A few people have had hallucinations, but this is
rare
! A few men, especially men with prostate
problems may have trouble passing water.
The most frequently reported adverse effects are:
Anxiety, restlessness, insomnia
Headaches, dizziness, and psychosis
Chest pain and fast heart beat.
These are especially common in the elderly.

!
!
!

Check the expiry date printed on the label or side of
the box. Do not use after the expiry date stated on the
label.
Do not store above 25°C. Store in the original
package.
In case of any visible signs of deterioration, you
should discard the package.
Medicines should not be disposed of via waste water
or household waste. Ask you pharmacist how to
dispose of medicines no longer required. These
measures help to protect the environment.
Keep out of the reach and sight of children.
6. FURTHER INFORMATION
What PseudoephedrineTablets contain:
Pseudoephedrine Tablets contain pseudoephedrine
hydrochloride. Each tablet contains 60mg of
pseudoephedrine hydrochloride.
The other ingredients are: cellactose, magnesium
stearate, colloidal anhydrous silica, lactose,
hypromellose, macrogol 4000, Ponceau 4R
aluminium lake (E124), titanium dioxide (E171),
sunset yellow aluminium lake (E110), macrogol
6000.
What PseudoephedrineTablets look like and
contents of the pack
Pseudoephedrine Tablets are packed in blisters
packs in pack sizes of 12 tablets.
Marketing Authorisation Holder
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
Manufacturer:
Quailphar NV
Rijksweg 9, B-2880 Bornem, Belgium
This leaflet was last revised in June 2015.

SIZE : 160 X 270 (mm) Back

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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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