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GALPHARM MAX STRENGTH COLD & FLU LEMON POWDER FOR ORAL SUSPENSION

Active substance(s): PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE / PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE / PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE

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Package leaflet: Information for the user
Benylin Cold and Flu Max Strength Sachets - Lemon
Paracetamol, Phenylephrine
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
have 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 after 3 days.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What this medicine is and what it is used for
What you need to know before you take this medicine
How to take this medicine
Possible side effects
How to store this medicine
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
• phenylephrine which is a decongestant to reduce swelling in the passages of the nose to
help you breathe more easily.
These sachets are used for the relief of the symptoms of colds and flu, including headache,
aches and pains, sore throat, nasal congestion (blocked nose) and feverishness (high
temperature).

2. What you need to know before you take this medicine

Do not take this medicine if you:
• are allergic to paracetamol, phenylephrine or any of the other ingredients
• have a serious heart condition
• have high blood pressure (hypertension)
• have diabetes
• have glaucoma
• have an overactive thyroid gland
• have an enlarged prostate
• have phaeochromocytoma
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 circulatory disorders such as a condition called Raynaud’s Phenomenon, which
results from poor circulation in the fingers and toes
• have an intolerance to some sugars
• suffer with phenylketonuria, a rare, inherited metabolic disorder.
Other medicines and this medicine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines specially:
• antidepressant drugs called monoamine oxidase inhibitors (MAOI’s) or have taken them
within the last 14 days – these are medicines such as phenelzine and isocarboxazid and
should not be taken at the same time as these sachets
• 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 lower blood pressure, treat heart or circulatory problems such as beta
blockers (e.g. atenolol),vasodilators (e.g. hydralazine) or cardiac glycosides (e.g. digoxin)
• other decongestant drugs such as ephedrine or xylometazoline.
Contains paracetamol.
Do not take anything else containing paracetamol while taking this medicine.
This medicine with food and alcohol
Do not drink alcohol (beer, wine, spirits etc) while taking this product.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
This medicine contains sucrose, aspartame (E951) & sodium
Contains 1.9 g sucrose (sugar) per sachet. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this medicinal
product. This should be taken into account in patients with diabetes.
Contains aspartame (E951), a source of phenylalanine equivalent to 14 mg per sachet. May
be harmful for people with phenylketonuria.

Each sachet contains 118 mg sodium. To be taken into consideration by patients 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 250ml (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 required. Do not take more than 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.
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 your doctor agrees.
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.
Rare side effects are:
• allergic reactions such as skin rash
• raised blood pressure
• changes in heart rate
• difficulty sleeping (insomnia)
• restlessness
• tremor
• anxiety
• problems passing water
• hallucinations.
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.

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 printed on the pack.
Do not store above 25°C.

6. Contents of the pack and other information

What this medicine contains
The active ingredients are paracetamol and phenylephrine hydrochloride. Each 5 g sachet
contains paracetamol 1000 mg and phenylephrine hydrochloride 12.2 mg.
The other ingredients are: sucrose, citric acid, natural lemon flavours, sodium citrate,
ascorbic acid (Vitamin C), acesulfame potassium (E950), aspartame (E951) and quinoline
yellow (E104).
What this medicine looks like and contents of the pack
Each 5 g sachet contains yellow powder.
This pack contains 5, 8 or 10 sachets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, UK.
Text revised: January 2017
PL 12063/0034

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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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