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

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

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Pack Copy
Leaflet
Specification
Marketing
PL 12063/0108
Authorisation number
S:\Artwork\PROCESS\Validated Pack Copy Library\PL 12063-0108\PL 12063
0108 Leaflet- Reasons for change.doc

Patient Information Leaflet
Read all of this leaflet carefully before you take this medicine because it contains
important information you need to know.
This medicine is available without prescription, however, you still need to use this
product carefully to get the best results from it. Keep this leaflet as you may need to
read it again. Ask your pharmacist if you need more information or advice.

1) What is this medicine and what is it 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) Is this medicine suitable for you?
Do not take this medicine if you:
• are allergic to paracetamol, guaifenesin, phenylephrine, cetylpyridinium chloride or
any of the other ingredients
• 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).
Please see your doctor or pharmacist before taking this medicine if you:
• are pregnant or breastfeeding
• suffer from kidney or liver problems, including alcoholic liver disease

Pack Copy
Leaflet
Specification
Marketing
PL 12063/0108
Authorisation number
• 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.
If you are taking any of the following medicines please see your doctor:
• 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.
Contains paracetamol.
Do not take anything else containing paracetamol while taking this medicine.
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.

Pack Copy
Leaflet
Specification
Marketing
PL 12063/0108
Authorisation number
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 12 years and over:
1 sachet every 4 hours, as required. Do not take more than 4 sachets (4 doses) in any
24 hour period.
Do not give to children under 12 years.
Do not take more medicine than the label tells you to. If you do not get better, talk to
your doctor.
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.
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.

Pack Copy
Leaflet
Specification
Marketing
PL 12063/0108
Authorisation number
By reporting side effects you can help provide more information on the safety of this
medicine.

5) How to store your medicine
Keep all medicines out of the reach and sight 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) What is in this medicine?
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.

7) Who makes this medicine?
The Marketing Authorisation holder and manufacturer is Perrigo, Braunton, Devon,
EX33 2DL, UK.
Text Revised:
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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