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PARACETAMOL GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE WRAFTON 500MG/100MG/6.1MG CAPSULES HARD

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

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Pack Copy
PGP Max Capsules - Leaflet
Specification
Marketing
PL 12063/0082
Authorisation number

Paracetamol, Guaifenesin, Phenylephrine
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.
These capsules are used for the relief of the symptoms of colds and flu and the pain
and congestion of sinusitis, including aches and pains, headache, blocked nose and
sore throat, chills and feverishness (high temperature). They can also loosen stubborn
mucus (phlegm) and provide relief from chesty coughs.

2) Is this medicine suitable for you?
Do not take this medicine if you:
• are allergic to paracetamol, guaifenesin, phenylephrine or any of the other
ingredients
• have a serious heart condition or cardiovascular disorder(s)
• have high blood pressure (hypertension)
• have diabetes
• have an overactive thyroid
• have glaucoma
• have difficulty passing urine, an enlarged prostate or other prostate problems
• have phaeochromocytoma (a rare tumour of adrenal gland tissue)
• suffer from liver or kidney problems
• have porphyria, which is a type of blood disorder that causes skin or nervous
system problems
• are pregnant or breastfeeding
• are taking tricyclic antidepressants such as imipramine or amitriptyline

Pack Copy
PGP Max Capsules - Leaflet
Specification
Marketing
PL 12063/0082
Authorisation number



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:
• suffer from alcoholic liver disease or alcohol dependence
• have circulatory disorders such as a condition called Raynaud’s Phenomenon,
which results from poor circulation in the fingers and toes
• have angina.
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
• 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:
Do not drink alcohol (beer, wine, spirits etc) while taking this product.
If you are taking medication, or are under medical care, consult your doctor before
using this medicine. Do not take with other flu, cold or decongestant products.
Long term use of this product is not recommended.

Pack Copy
PGP Max Capsules - Leaflet
Specification
Marketing
PL 12063/0082
Authorisation number
3) How to take this medicine
For oral use. Swallow the capsules whole with water. Do not chew.
Adults, the elderly and children 12 years and over:
2 capsules every 4 hours as required. Do not take more than 8 capsules 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:
• allergic reactions which may be severe such as skin rash, peeling of the skin,
itching, swollen red areas of the skin, sometimes with shortness of breath or
swelling of the mouth, lips, tongue, throat or face. Very rare cases of serious skin
reactions have been reported.
• breathing problems, these are more likely if you have experienced them before
when taking other painkillers such as aspirin or ibuprofen.
• stomach upsets, nausea, vomiting, diarrhoea
• tingling or coolness of the skin
• a faster or slower heart beat
• difficulty sleeping (insomnia)
• nervousness or tremors
• a rise in blood pressure with headache, and irregular heartbeat (palpitations)
• restlessness
• dizziness, headache
• anxiety, irritability
• problems or pain passing water
• hallucinations
• eye disorders
• pins and needles and cold feelings in your extremities.

Pack Copy
PGP Max Capsules - Leaflet
Specification
Marketing
PL 12063/0082
Authorisation number
You may become more prone to bleeding, bruising, fever and infections such as sore
throat and ulcers, due to changes in your blood.
If you have previously experienced an allergic reaction (hypersensitivity) when taking
decongestants, appetite suppressant and stimulants, you may be at increased risk of
developing an allergic reaction when taking this product.
Reporting 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 t he safety of this
medicine.

5) How to store your medicine
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister
foil. The expiry date refers to the last day of that month.
Do not store above 25ºC.

6) What is in this medicine?

Each blue /green hard capsule contains the active ingredients: paracetamol 500 mg,
guaifenesin 100 mg and phenylephrine hydrochloride 6.1 mg.
The other ingredients are: maize starch, croscarmellose sodium, sodium laurilsulfate,
magnesium stearate and talc. The capsule shell is made of gelatin and contains the
colours quinoline yellow (E104), indigo carmine (E132), erythrosine (E127) and
titanium dioxide (E171).
This product is available in pack sizes of 8 or 16 capsules.

7) Who makes this medicine?

The Marketing Authorisation holder and manufacturer is Wrafton Laboratories
Limited, Braunton, Devon, EX33 2DL, UK.
Text revised: October 2014
PL 12063/0082


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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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