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GALPHARM FLU-MAX 4-IN-ONE RELIEF POWDER FOR ORAL SOLUTION

Active substance(s): CETYLPYRIDINIUM CHLORIDE / GUAIFENESIN / PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE / CETYLPYRIDINIUM CHLORIDE / GUAIFENESIN / PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE / CETYLPYRIDINIUM CHLORIDE / GUAIFENESIN / PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE

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1.3

PRODUCT INFORMATION

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SPC, LABELLING AND PACKAGE LEAFLET

Particulars to appear on the outer packaging
Package leaflet
Package leaflet: Information for the patient
Galpharm Flu-Max 4-In-One Relief powder for oral solution
Paracetamol, Guaifenesin, Phenylephrine, Cetylpyridinium
Read all of this leaflet carefully before you start taking this medicine because it
contains important information.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse.
What is in this leaflet
1.
What this medicine is and what it is used for
2.
What you need to know before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1) What this medicine is and what it is used for
This medicine contains:
• paracetamol which is a pain reliever (analgesic) and helps reduce your temperature
when you have a fever
• guaifenesin which is an expectorant to help loosen phlegm
• phenylephrine which is a decongestant to reduce swelling in the passages of the
nose to help you breathe more easily
• cetylpyridinium chloride which is an antibacterial, and relieves sore throats.
These sachets are used for the short term relief of the symptoms of colds and flu,
including aches and pains, headache, blocked nose, tickly sore throat and chesty
coughs.
2. What you need to know before you take this medicine
Do not take this medicine if you:

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SPC, LABELLING AND PACKAGE LEAFLET

• are allergic to paracetamol, guaifenesin, phenylephrine, cetylpyridinium chloride or
any of the other ingredients of this medicine (listed in section 6)
• have a serious heart condition or cardiovascular disorder(s)
• have high blood pressure (hypertension)
• have an overactive thyroid
• have glaucoma
• have difficulty passing urine
• are taking antidepressant drugs called monoamine oxidase inhibitors (MAOI’s), or
have taken them within the last 14 days - these are medicines such as phenelzine,
isocarboxazid and tranylcypromine
• are currently taking other decongestant drugs (e.g. ephedrine and xylometazoline) or
stimulants (e.g. dexamfetamine).
Warnings and precautions:
Talk to your doctor or pharmacist before taking this medicine, if you
• are pregnant or breastfeeding
• suffer from kidney or liver problems, including alcoholic liver disease
• have diabetes
• have circulatory disorders such as a condition called Raynaud’s Phenomenon, which
results from poor circulation in the fingers and toes
• have angina
• have an enlarged prostate gland, as this may cause more difficulty in passing urine
• suffer from phenylketonuria, a rare, inherited metabolic disorder.
Other medicines and Galpharm Flu-Max 4-In-One Relief powder for oral
solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, like
• medicines to treat high cholesterol levels which reduce the amount of fat in the
blood such as colestyramine
• medicines to control feeling sick or being sick such as metoclopramide or
domperidone
• medicines called anti-coagulants, which are used to thin the blood such as warfarin
or other coumarins – you may take occasional doses of paracetamol but should
consult your doctor if you need to take it on a regular basis
• barbiturates (for epilepsy or to help you sleep), such as phenobarbitones
• tricyclic antidepressants such as imipramine, amitriptyline
• medicines to treat heart or circulatory problems, or to lower blood pressure, (e.g.
digoxin, guanethidine, reserpine, methyldopa)
• beta blockers (e.g. atenolol) or vasodilators (e.g. hydralazine)
• phenothiazines used as sedatives (e.g. chlorpromazine, pericyazine and
fluphenazine)
• if you are going to have a general anaesthetic as this may cause changes in heart
rhythm.

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Contains paracetamol.
Do not take with any other paracetamol-containing products.
Other important information:
If you are taking medication or are under medical care, consult your doctor before
using this medicine.
Long term use of this product is not recommended.
Information about some of the ingredients in this medicine:
Contains aspartame (E951), a source of phenylalanine equivalent to 20 mg per
sachet. May be harmful for people with phenylketonuria.
Each sachet contains 117 mg sodium. To be taken into consideration by people on a
controlled sodium diet.
3) How to take this medicine
Pour the contents of 1 sachet into a standard mug. Fill the mug to below the brim with
approximately 250 ml (8 fluid oz) of hot, but not boiling, water. Stir until dissolved,
and allow to cool to a drinkable temperature.
Adults, the elderly and children 16 years and over:
1 sachet every 4 to 6 hours, as necessary, up to a maximum of 4 sachets (4 doses) in
any 24 hour period. Leave at least 4 to 6 hours between doses.
Do not give to children under 16 years of age.
Do not take more medicine than the label tells you to. If you do not get better, talk to
your doctor.
Do not take for longer than 3 days unless advised by your doctor.
If you take more of this medicine than you should
Talk to a doctor at once if you take too much of this medicine even if you feel well.
This is because too much paracetamol can cause delayed, serious liver damage. Go to
your nearest hospital casualty department. Take your medicine and this leaflet with
you.
4) Possible side effects
Most people do not have any side effects while taking this medicine. However, if you
experience any of the following side effects, or anything else unusual happens, stop
taking the medicine immediately, and see your doctor or pharmacist.

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Rare side effects are:
• allergic reactions such as skin rash
• stomach upsets, diarrhoea
• dizziness
• tingling and coolness of the skin
• difficulty sleeping (insomnia)
• nervousness, tremors or convulsions
• a rise in body temperature
• a rise in blood pressure with headache, vomiting (being sick) and fast, slow or
irregular heart beat (palpitations).
More rarely, the following side effects can happen:
• you may become more prone to bleeding, bruising, fever and infections, such as sore
throat and ulcers, due to changes in your blood.
Very rare cases of serious skin reactions have been reported.
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 this medicine
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and sachet.
The expiry date refers to the last day of that month.
Do not store above 25ºC.
6) Contents of the pack and other information
What this medicine contains
Each 4.1 g sachet of off-white powder, taken as a hot drink, contains the active
ingredients: paracetamol 1000 mg, guaifenesin 200 mg, phenylephrine hydrochloride
12.2 mg and cetylpyridinium chloride 3 mg.
The other ingredients are: maltodextrin, citric acid (anhydrous), tartaric acid, sodium
citrate, acesulfame potassium (E950), aspartame (E951), sucralose, powdered menthol
flavour, lemon flavour and the colour curcumin (E100).
This product is available in pack sizes of 5 or 10 sachets.

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Marketing Authorisation holder and manufacturer is Wrafton Laboratories
Limited, Braunton, Devon, EX33 2DL, UK.
Text Revised: August 2017
PL 12063/0108

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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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