COLDREX TABLETS

Active substance: TERPIN HYDRATE

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Information for the User
COLDREX TABLETS
What should you know about Coldrex Tablets
Please read this leaflet carefully before you take Colrex Tablets, especially the section
headed “check before you take this medicine”. This leaflet provides information
available on your medicine. If you have any questions or are not sure about anything,
ask your doctor or pharmacist.
What is in the pack
This pack contains 12 or 24 tablets in a blister strip enclosed in an outer box.
What is in Coldrex Tablets?
Each tablet contains Paracetamol 500mg, Caffeine 25mg, Phenylephrine
Hydrochloride 5mg, Terpin Hydrate 20mg and Vitamin C (ascorbic Acid) as the
active ingredients.
The tablets also contain soluble starch, maize starch, talc, stearic acid, polyvinyl
pyrrolidone, potassium sorbate, sodium lauryl sulphate and colour sunset yellow
(E110).
Who makes Coldrex Tablets
The product licence holder is GlaxoSmithKline Consumer healthcare, Brentford,
TW8 9GS, UK and all enquiries should be sent to this address.
The manufacturer is GlaxoSmithKline Dungarvan Ltd., Knockbrack, Co. Waterford,
Ireland.

How do Coldrex Tablets work?
Coldrex tablets contain paracetamol is an analgesic (a pain killer) and antipyretic (it
reduces body temperature when you have a fever). Phenylephrine hydrdochloride is a
decongestant which unblocks your nose and sinuses helping you breathe more easily
without causing drowsiness. Caffeine is present as a mild stimulant and terpin hydrate
as an expectorant. Ascorbic acid (Vitamin C) is a common ingredient of flu and cold
products and is included to help replace the vitamin C which may be lost in the initial
stages of flu and colds.

What are Coldrex Tablets for?
Coldrex Tablets are recommended for the relief of the symptoms of influenza (flu)
and colds.
Check before you take this medicine
IMPORTANT:




Do not take with any other Paracetamol-containing products. Do not take
with any other flu, cold or decongestant products.
Avoid drinking too much coffee or tea when taking these tablets.
Do not take more than the recommended dose.

Do not take Coldrex Tablets if:


you are allergic to paracetamol, phenylephrine hydrochloride, caffeine, terpin
hydrate, vitamin C or any of the other ingredients listed above. Colour E110
can cause allergic reactions including asthma: reactions are more common in
people who are allergic to aspirin. Potassium sorbate (E202) can cause
irritation, including dermatitis.



you suffer from severe kidney or liver problems, overactive thyroid, diabetes
or are under the care of your doctor for high blood pressure or heart disease,
angle closure glaucoma or phaeochromocytoma.



you are taking tricyclic antidepressants (e.g. imipramine or amitriptyline) or
drugs for heart problems (including beta-blockers) or you are taking (or have
taken within the last two weeks) drugs called monoamine oxidase inhibitors
(MAOIs) prescribed by your doctor or hospital for depression.

Take special Care with Coldrex Tablets:
• This product may cause dizziness. If affected, do not drive or operate
machinery.
Ask your doctor before you take this medicine:
• if you have blood vessel disease (such as Raynaud’s Phenomenon).
• if you have an enlarged prostate.
If you are taking other medicines:
Talk to your doctor or pharmacist before taking Coldrex Tablets if you are taking any
prescribed medicines particularly metoclopramide or domperidone (for nausea
[feeling sick] or vomiting [being sick] or colestyramine (to lower blood cholesterol)
or drugs to lower blood pressure; appetite suppressants or stimulants; ergot alkaloids
(e.g. ergotamine or methylsergide); drugs to treat depression such as tricyclic
antidepressants (e.g. amitriptyline) or heart disease (e.g. digoxin); if you take blood
thinning drugs (anticoagulants e.g. warfarin) and you need to take a pain reliever on a
daily basis talk to your doctor because of the risk of bleeding. But you can still take
occasional doses of Coldrex Tablets at the same time as anticoagulants.

If you are pregnant or breast feeding:
Do not take Coldrex Tablets if you are pregnant.
This product should not be used while breast-feeding unless advised by a doctor.
How should you take Coldrex Tablets?
Adults and children aged 12 years and over:
1-2 tablets can be taken up to 4 times a day.
Do not exceed 8 tablets in 24 hours.
These doses should not be repeated more frequently than every four hours.
Do not take continuously for more than 7 days without medical advice.
Do not give to children under 12 years.
If symptoms persist consult your doctor.
What should you do if you take too much?
Taking Coldrex Tablets than recommended on the pack or in this leaflet may be
harmful. Immediate medical advice should be sought in the event of an overdose,
even if you feel well, because of the risk of delayed, serious liver damage.
What side effects can Coldrex Tablets have?
Like all medicines, Coldrex Tablets can have side effects but not everybody gets
them.
Stop taking this medicine and tell your doctor immediately if you experience:
• Allergic reactions which may be severe such as skin rash and itching
sometimes with swelling of the mouth or face or shortness of breath.
• Skin rash or peeling or mouth ulcers.
• Breathing problems. These are more likely if you have experienced them
before when taking other painkillers such as ibuprofen and aspirin.
• Unexplained bruising or bleeding.
• Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and
skin.
• Nervousness, irritability, restlessness and excitability.
• Headache, dizziness or insomnia.
• Raised blood pressure or an usually fast pulse rate or a sensation of an
unusually fast or irregular heartbeat.
• Nausea, diarrhoea or sickness.
• Unexplained bruising or bleeding.
These reactions are rare. If you do get any side effects, even those not mentioned in
this leaflet, tell your doctor or pharmacist.

Further information
Store in a dry place.
Do not use this medicine after the “Use by” date shown on the pack.
Keep out of the reach and sight of children.
Leaflet prepared: May 2013.
GSK (logo) GlaxoSmithKline
GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.
Coldrex 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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