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COLDREX HOTREM LEMON
Active substance(s): PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE / PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE / PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE
PATIENT INFORMATION LEAFLET
Information for the User
COLDREX HOTREM LEMON POWDERS
What you should know about Coldrex HotRem Lemon Powders
Please read this leaflet carefully before you start to take your medicine, 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?
Coldrex HotRem Lemon Powders
Each sachet contains 5 g powder for oral solution. Five* sachets are contained in a box.
What is in Coldrex HotRem Lemon Powders?
Each 5 g powder contains Paracetamol Ph Eur 750 mg and Phenylephrine Hydrochloride
Ph Eur 10 mg as the active ingredients.
The powder for oral solution also contains ascorbic acid, sugar, citric acid, saccharin
sodium, sodium citrate, aspartame, maize starch, lemon and honey flavours and caramel
Carbohydrate content 2.7 g per sachet. Sodium content 0.12 g per sachet.
How does Coldrex HotRem Lemon Powders work?
Paracetamol is an analgesic (a pain killer) and antipyretic (it reduces body temperature when
you have a fever). Phenylephrine hydrochloride is a sympathomimetic decongestant which
unblocks your nose and sinuses helping you breathe more easily.
Who makes Coldrex HotRem Lemon Powders?
The product licence holder is:
Omega Pharma Ltd, 32 Vauxhall Bridge Road, London, United
Kingdom SW1V 2SA.
and all enquiries should be sent to this address.
Manufactured on behalf of Omega Pharma Ltd by:
Sanofi Winthrop Limited, Newcastle upon Tyne, NE3 3TT, England.
SmithKline Beecham SA, 28806 Alcala de Henares, Madrid, Spain.
* (or Ten)
What are Coldrex HotRem Lemon Powders for?
Coldrex HotRem Lemon Powders is for the short term relief of the symptoms of influenza
(flu), colds and chills. These symptoms include headache, feverishness, aches and pains,
congested or blocked nose, painful sinuses and sore throat pain.
Check before you take this medicine
Remember: Coldrex HotRem contains a decongestant; do not take with other
flu, cold or decongestant products. Coldrex HotRem Lemon contains
paracetamol. Do not take with any other paracetamol-containing products.
Do not take Coldrex HotRem Lemon if :
you are allergic to paracetamol, ascorbic acid, phenylephrine hydrochloride
or any of the other ingredients listed above. The lemon flavours contain trace
amounts of soya oil, which may rarely cause severe allergic reactions.
you have kidney or liver disease including alcoholic liver disease, overactive
thyroid, diabetes or are under the care of your doctor for high blood pressure
or heart disease.
you are taking tricyclic antidepressants (eg. 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.
If you have glaucoma or phaeochromocytoma.
Each 5.0g sachet of this powder for oral solution contains 2.9g of sucrose.
When taken according to the dosage recommendations this supplies up to
11.6g of sucrose daily. Unsuitable in rare disorders of sugar metabolism
(hereditary fructose intolerance, glucose-galactose malabsorption or sucraseisomaltase deficiency).
Take special Care with Lemon Coldrex Powders:
This product may cause dizziness. If affected, do not drive or operate machinery.
Ask your doctor before you take this medicine:
If you have a blood vessel disease such as Raynaud’s Phenomenon.
If you have an enlarged prostate.
If you have diabetes mellitus. Each dose contains 2.9 g of sucrose.
If you are on a controlled-sodium diet. Each dose contains 0.12 g of sodium.
If you are taking other medicines:
Talk to your doctor or pharmacist before taking Lemon Coldrex Powders 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; 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 HotRem Lemon Powders at
the same time as anticoagulants.
If you are pregnant or breast feeding:
Do not take Blackcurrant Coldrex Powders if you are pregnant or breast feeding unless
advised by a doctor.
How should you take Coldrex HotRem Lemon Powders?
Empty contents of one sachet into a mug. Half fill with very hot water. Stir well. Add cold
water as necessary and sugar if desired.
Adults (including the elderly) and children aged 12 years and over:
The contents of one sachet to be taken every four to six hours as necessary. Do not take
more than four sachets in any 24 hours.
Do not give to children under 12 years of age unless your doctor tells you to.
Do not take for more than 5 days without asking your doctor.
If symptoms persist consult your doctor.
What should you do if you take too much?
It will be harmful to take more than the doses stated on the pack and in this leaflet.
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 HotRem Lemon Powders have?
Like all medicines, Blackcurrant Coldrex Powders can have side effects but not everybody
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.
Visual disturbances. This is rare but is more likely in those with glaucoma.
Usually fast pulse rate or a sensation of an unusually fast or irregular heartbeat
Difficulty passing water. This is more likely to occur in men with an enlarged
These reactions are rare.
The following side effects may occur. Tell your doctor if you get them:
Raised blood pressure, headache, dizziness, difficulty sleeping, nervousness,
diarrhoea or sickness.
If you do get any side effects, even those not mentioned in this leaflet, tell your doctor or
Do not use this medicine after the "Use by” date shown on the pack.
Remember: Keep all medicines safely away from children.
Leaflet Revised: November 2015
(logo) Omega Pharma
Omega Pharma Ltd, 32 Vauxhall Bridge Road,
London, United Kingdom SW1V 2SA.
Coldrex is a registered trade mark
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.