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PERRIGO PARACETAMOL/GUAIFENESIN/PHENYLEPHRINE HYDROCHLORIDE 500MG/200MG/10MG POWDER FOR ORAL SOLN

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

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PACKAGE LEAFLET

Package leaflet: Information for the user

Perrigo Paracetamol/Guaifenesin/Phenylephrine Hydrochloride
500mg/200mg/10mg powder for oral solution
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 5 days.
The name of your medicine is Perrigo Paracetamol/Guaifenesin/Phenylephrine
Hydrochloride 500mg/200mg/10mg powder for oral solution. It will be referred to
as Perrigo Paracetamol/Guaifenesin/Phenylephrine throughout the remainder of
the leaflet.
What is in this leaflet
1. What Perrigo Paracetamol/Guaifenesin/Phenylephrine is and what it is used for
2. What you need to know before you take Perrigo
Paracetamol/Guaifenesin/Phenylephrine
3. How to take Perrigo Paracetamol/Guaifenesin/Phenylephrine
4. Possible side effects
5. How to store Perrigo Paracetamol/Guaifenesin/Phenylephrine
6. Contents of the pack and other information

1. What Perrigo Paracetamol/Guaifenesin/Phenylephrine 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.
These sachets are used for the short term symptomatic relief of colds and flu including
aches and pains, headache, blocked nose and sore throat, chills and fever, and for
relief from chesty coughs.
You must talk to a doctor if you do not feel better or if you feel worse after 5 days.

2. What you need to know before you take Perrigo
Paracetamol/Guaifenesin/Phenylephrine
Do not take this medicine if you:

• are allergic to paracetamol, guaifenesin, phenylephrine or any of the other
ingredients of this medicine (listed in section 6)
• are pregnant or breastfeeding
• have liver or kidney problems, including alcoholic liver disease
• have a serious heart condition or cardiovascular disorder(s) or blood problems such
as anaemia (low red blood cell count)
• have high blood pressure (hypertension)
• have an overactive thyroid
• have diabetes
• have phaeochromocytoma
• have glaucoma, including closed angle 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 and
isocarboxazid
• are taking tricyclic antidepressants
• are taking beta-blocking drugs
• are taking other paracetamol-containing products
• are currently taking other decongestant drugs or stimulants (e.g. ephedrine,
amfetamines and xylometazoline)
• are taking a medicine to suppress a dry cough.

Warnings and precautions
Talk to your doctor or pharmacist before taking Perrigo
Paracetamol/Guaifenesin/Phenylephrine:
• if you have a very bad cough or asthma. See your doctor if your cough lasts for more than 5
days or comes back, or if you have a fever, rash or a headache which won’t go away
• have circulatory disorders such as a condition called Raynaud’s Phenomenon, which results
from poor circulation in the fingers and toes

• if you have angina
• if you have an enlarged prostate gland, as this may cause more difficulty in passing
urine
• if you have severe stomach or intestinal problems
• if you have an intolerance to some sugars
• if you suffer with phenylketonuria, a rare, inherited metabolic disorder.
Children
Do not give this medicine to children under 12 years of age.
Other medicines and Perrigo Paracetamol/Guaifenesin/Phenylephrine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including medicines obtained without a prescription.
Perrigo Paracetamol/Guaifenesin/Phenylephrine may interact with certain
medicines:
• used to treat high cholesterol levels which reduce the amount of fat in the blood such
as colestyramine
• used to control feeling sick or being sick such as metoclopramide or domperidone

• 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)
• aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs)
• medicines to treat migraine (e.g. ergotamine and methylsergide)
• zidovudine as this might cause blood problems (low white blood cell count)
• phenothiazines used as sedatives (e.g. chlorpromazine, pericyazine and
fluphenazine)
• if you are going to have blood or urine tests as taking this medicine may affect the
results
• if you are going to have a general anaesthetic, as this may cause changes in heart
rhythm.

Other important information
• Do not use for longer than 5 days, except on medical advice
• This medicine should only be used if you have all of the following symptoms - pain
and/or fever, a blocked nose and a chesty cough
• Use medicines which will only treat the symptoms you have
• Do not take with other flu, cold or decongestant products.
Perrigo Paracetamol/Guaifenesin/Phenylephrine with alcohol
• Do not drink alcohol when using Perrigo
Paracetamol/Guaifenesin/Phenylephrine.
Pregnancy and breast-feeding
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.
Perrigo Paracetamol/Guaifenesin/Phenylephrine should not be used while
pregnant or breast-feeding.
Driving and using machines
• This product could cause dizziness. If affected do not drive or operate machinery.
Perrigo Paracetamol/Guaifenesin/Phenylephrine contains sucrose, aspartame
and sodium.
Perrigo Paracetamol/Guaifenesin/Phenylephrine:
• Contains 2.1 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. This may be harmful for
people with phenylketonuria.
• Contains 129 mg sodium per sachet. This should be taken into consideration by
patients on a controlled sodium diet.

3. How to take Perrigo Paracetamol/Guaifenesin/Phenylephrine
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you. Check with your doctor or pharmacist if you are not
sure.
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. Drink all of the solution within 1½
hours.
The recommended dose is:
Adults, the elderly and children 12 years and over:
1 sachet every 4 hours, as required. Do not use more than 4 sachets (4 doses) in any
24 hour period.
Do not give to children under 12 years.
If you use more Perrigo Paracetamol/Guaifenesin/Phenylephrine than you should
Perrigo Paracetamol/Guaifenesin/Phenylephrine contains paracetamol.
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.
If you forget to use Perrigo Paracetamol/Guaifenesin/Phenylephrine
Do not take more medicine than the label tells you to. If your symptoms persist for
more than 5 days or worsen, you must see a doctor or pharmacist.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
them.

Serious side effects
Very rare: may affect up to 1 in 10,000 people
• allergic reactions which may be severe such as skin rash, breathing difficulties,
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.
• you may become more prone to bleeding, bruising, fever and infections, such as sore
throat and ulcers, due to changes in your blood.

Other side effects
Common: may affect up to 1 in 10 people
• difficulty sleeping (insomnia)
• diarrhoea, nausea (feeling sick)
• nervousness, tremors, irritability, restlessness or excitability
• a rise in blood pressure with headache, dizziness, vomiting (being sick) and irregular
heart beat (palpitations).
Rare: may affect up to 1 in 1,000 people
• stomach pain or discomfort
• liver problems
• a faster or slower heart beat
• eye disorders
• problems passing water.

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 Perrigo Paracetamol/Guaifenesin/Phenylephrine
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 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.

6. Contents of the pack and other information
What Perrigo Paracetamol/Guaifenesin/Phenylephrine contains.
The active substances are paracetamol 500 mg, guaifenesin 200 mg and
phenylephrine hydrochloride 10 mg.

The other ingredients are: sucrose, citric acid (E330), tartaric acid (E334), sodium
cyclamate (E952), sodium citrate (E331), acesulfame potassium (E950), aspartame
(E951), powdered menthol flavour, lemon flavour, lemon juice flavour, quinoline
yellow (E104).
What Perrigo Paracetamol/Guaifenesin/Phenylephrine looks like and contents of
the pack.
The medicine is an off-white powder with a characteristic citrus/menthol odour, and is
packed into individual 4.4 g sachets.
This medicine is available in pack sizes of 5, 6 or 10 sachets although not all pack
sizes may be marketed.
Marketing Authorisation holder and Manufacturer
Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, UK.
This medicinal product is authorised in the Member States of the EEA under the
following names:
United Kingdom: Perrigo Paracetamol/Guaifenesin/Phenylephrine Hydrochloride
(500mg/200mg/10mg) powder for oral solution
Czech Republic: Paracetamol/Guaifenesin/Phenylephrine Hydrochloride Perrigo
500mg/200mg/10mg, prášek pro perorálni roztok
Hungary: Rubophen Thermo Plus por belsőleges oldathoz
Italy: Nirolex Flu Tripla Azione
Poland: Paracetamol + Guaifenesin + Phenylephrine Hydrochloride Perrigo.
This leaflet was last revised in February 2016.

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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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