BENYLIN FOUR FLU LIQUID

Active substance: PSEUDOEPHEDRINE HYDROCHLORIDE

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2 Before taking this
medicine
This medicine is suitable for most people but a few
people should not use it. If you are in any doubt, talk
to your doctor or pharmacist.

Do not use this medicine…
If you are taking any other medicines containing
paracetamol or sympathomimetic drugs (stimulants
or appetite suppressants and drugs used to treat
congestion and asthma) including those that are
not taken orally.
■ If you have ever had a bad reaction to any of the
ingredients.
■ If you have heart disease or high blood pressure.
■ If you have diabetes.
■ If you have an overactive thyroid.
■ If you have a phaeochromocytoma (rare tumour
which affects your heart rate and blood pressure).
■ If you are taking, or have taken in the last two
weeks, drugs for depression known as Monoamine
Oxidase Inhibitors (MAOIs) or Reversible Inhibitors
of Monoamine Oxidase (RIMAs).
■ If you suffer from or have had closed angle
glaucoma (increased pressure in the eye).
■ If you are taking beta blockers (used to treat high
blood pressure).
■ If you have severe kidney problems.
If any of these apply to you, now or in the past, get
advice from a doctor or pharmacist without
using Benylin 4 Flu Liquid.


diphenhydramine, paracetamol, pseudoephedrine

This medicine is used for the treatment of cold
and flu symptoms, including aches, pains and fever
(high temperature), cough and congestion.
■ This medicine is for use by adults and children aged
12 years and over.
■ Do not use this medicine:
■ There are some people who should not use this
medicine. To find out if you are one of them see
section 2 c
■ If you have ever had a bad reaction to any of the
ingredients. For the list of ingredients see section 6 c
■ Speak to your doctor:
■ If you suffer from any of the conditions
mentioned in section 2. See section 2 c
■ If you are taking any other medicines. See section 2 c
■ Follow the dosage instructions carefully.
These are shown in the table. See section 3 c
Now read this whole leaflet carefully before you
use this medicine. Keep the leaflet: you might need it
again.


1 What the medicine is for

Talk to your doctor or pharmacist…

Benylin 4 Flu Liquid is a medicine which is used to help
relieve cold and flu symptoms. The liquid contains
paracetamol, an analgesic which helps to relieve aches
and pains and fever (high temperature),
diphenhydramine, an antihistamine which helps dry
secretions and relieve coughing and pseudoephedrine, a
decongestant which helps unblock stuffy noses.
The medicine is for use in adults and children aged
12 years and over.

■ If

F307718 - Leaflet BENYLIN 4Flu 200mlv8.1.indd 1

you want to give this medicine to a child under
12 years old.
■ If you have kidney or liver problems, including
alcoholic liver disease.
■ If you have difficulty passing water (urinary
retention).
■ If you have prostate disease.
■ If you have blocked arteries or veins (occlusive
vascular disease).
■ If you have a persistent cough such as occurs
with asthma, have asthma, are suffering from an
asthma attack or a cough that produces a lot
of mucus (phlegm).

If you are taking any other medicines,
including:
■ Antimuscarinic drugs e.g.:
- tricyclic antidepressants (drugs to treat mood
disorders).
- atropine (used to treat some eye conditions
and occasionally bowel conditions).
■ CNS depressants e.g.:
- hypnotics (sleeping tablets including
barbiturates).
- minor tranquillisers (drugs used to relax
muscles or decrease anxiety).
- opioid analgesics (drugs used to relieve
pain e.g. codeine, tramadol, morphine).
- antipsychotics (drugs used to treat mood
disorders).
■ Antihypertensives (drugs used to treat high
blood pressure including alpha and beta
blockers).
■ Moclobemide (used to treat mood
disorders).
■ Cardiac glycosides (drugs used to control heart
rhythms or contractions) e.g. digoxin.
■ Ergot alkaloids (drugs used to treat migraine
such as ergotamine and methysergide).
■ Oxytocin (drug used to help contractions
during childbirth).
■ Oral contraceptives (“the pill”).
■ Metoclopramide or domperidone (used to treat
nausea and vomiting).
■ Colestyramine (used to treat high
cholesterol).
■ Anticoagulants (drugs that thin the blood,
such as warfarin).
■ Anticonvulsants (drugs to treat epilepsy).
If you are not sure about the medicine you are taking,
show the bottle or pack to your pharmacist.
If any of these bullet points apply, talk to a doctor
or pharmacist.


If you are pregnant or breast-feeding


Ask your doctor or pharmacist for advice
before taking this medicine if you might be
pregnant or are breast-feeding.

Special warnings about this medicine


You can use this medicine while you are taking
oral contraceptives (“the pill”) or anticonvulsant
tablets used to treat epilepsy, but the medicine
may not work so well on your pain or fever.

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This medicine may cause drowsiness. If affected,
do not drive or operate machinery. Avoid alcoholic
drink.

Some of the ingredients can cause
problems
Ponceau 4R (E124) may cause allergic type reactions.
This medicine contains 10 vol % of ethanol
(alcohol) i.e. up to 400 mg per 20 ml, which is
the same as 40 ml of beer or 17 ml of wine per
20 ml. This can be harmful for those suffering
from alcoholism. The ethanol content should be
taken into account for pregnant or breast-feeding
women, children or high risk groups such as
patients with liver disease or epilepsy.
■ This medicine contains sodium (26 mg per 20 ml).
This should be taken into account by patients on a
controlled sodium diet.
■ This medicine contains fructose. If you have been
told by your doctor that you have an intolerance
to some sugars contact your doctor before taking
this medicinal product.
■ Benylin 4 Flu Liquid contains soya oil. If you
are allergic to peanut or soya, do not use this
medicinal product.




3 How to take this
medicine
Check the table below to see how much
medicine to take.
For oral use only.
Do not take more than the stated dose shown below.
■ A measuring cup is included in the pack.



Children under 12 years
Not recommended for children under 12 years old.

Adults and children aged 12 years or over
Age
Adults and children
aged 12 years
or over

Dose
Take 20 ml (fill measuring
cup to 20 ml mark) up to
4 times a day if necessary

Leave at least 4 hours between doses.
Do not take more than 4 times a day.
■ If symptoms persist, talk to your doctor or pharmacist.



F307718 - Leaflet BENYLIN 4Flu 200mlv8.1.indd 2

If anyone has too much
Immediate medical advice should be sought in the
event of an overdose, even if you feel well, because
of the risk of delayed, serious liver damage.

If you forget to take the medicine
If you forget to take a dose, take the next dose
when needed provided that the last dose was taken
at least 4 hours ago. Do not take a double dose.

4 Possible side-effects
Benylin 4 Flu Liquid can have side-effects, like all medicines,
although these don’t affect everyone and are usually mild.

If you experience any of the following stop
using the medicine and seek immediate help:
Allergic reactions including skin rashes (which may
be severe and include blistering and peeling of the
skin) and itching.
■ Allergic reactions to other medicines containing
sympathomimetic drugs (stimulants or appetite
suppressants and drugs used to treat congestion
and asthma).
■ Becoming unusually tired, unexpected bruising
or bleeding and getting more infections (such as
colds) than usual. These are very rare effects in
people taking paracetamol.
■ Hallucinations and paranoid delusions.
■ People can experience fits.
■ Abnormal blood test results for liver function.


If you experience any of the following, stop
using the medicine and talk to your doctor:
Rarely people can have an increased heartbeat,
an increased awareness of the heartbeat
(palpitations) and high blood pressure.
■ Restlessness and sleep disturbances.


Other effects that may occur include:
Irritability, anxiety, excitability, nausea (feeling sick
or queasy) and vomiting (being sick).
■ Drowsiness, difficulty performing tasks, insomnia.
■ Headache, upset stomach, difficulty in passing
urine, stimulation, blurred vision, dry mouth,
thickened mucus.


Low blood pressure, tremor, shakiness, slurred
speech, dizziness, confusion, depression, blood
disorders.
If you experience any side-effects not included in this
leaflet, or are not sure about anything, talk to your
doctor or pharmacist.


5 Storing this medicine
Do not store this product above 30ºC. Keep the container
in the outer carton. Keep the container tightly closed.
Keep the product out of the reach and sight of children.
Do not use your medicine after the date shown as an expiry
date on the packaging.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6 Further information
What’s in this medicine?
The active ingredients in 20 ml of Benylin 4 Flu liquid
are: Paracetamol 1000 mg, Pseudoephedrine hydrochloride
45 mg, Diphenhydramine hydrochloride 25 mg.
Other ingredients are: Polyethylene glycol, glycerol,
propylene glycol, saccharin sodium, citric acid monohydrate,
sodium benzoate, eucalyptol, menthol, carmellose sodium,
sodium citrate, ethanol, quinoline yellow (E104), Ponceau
4R (E124), Patent Blue V (E131), flavourings (honey, lemon,
cream) and water.

What the medicine looks like
Benylin 4 Flu liquid is a clear orange to brown oral solution,
available in 200 ml glass bottles.
Marketing Authorisation holder:
McNeil Products Ltd, Maidenhead, Berkshire,
SL6 3UG, UK.
Manufacturer: Famar Orleans, 5 avenue de Concyr,
45071 Orleans, Cedex 2, France.
This leaflet was revised March 2010.
Benylin is a registered trade mark.
F307718
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24/03/10 12:18

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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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