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BENYLIN FOUR FLU TABLETS

Active substance(s): DIPHENHYDRAMINE HYDROCHLORIDE / PARACETAMOL / PSEUDOEPHEDRINE HYDROCHLORIDE / DIPHENHYDRAMINE HYDROCHLORIDE / PARACETAMOL / PSEUDOEPHEDRINE HYDROCHLORIDE

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Technical requirement for the front side of the leaflet

TABLETS

diphenhydramine, paracetamol, pseudoephedrine
Q This

medicine is used for the treatment of cold and flu
symptoms, including aches, pains and fever (high
temperature), cough and congestion.
medicine is for use by adults and children aged 10 years
and over.
Q Do not use this medicine:
 Q There are some people who should not use this medicine.
To find out if you are one of them see section 2
 Q If you have ever had a bad reaction to any of the
ingredients. For the list of ingredients see section 6
Q Speak to your doctor:
 Q If you suffer from any of the conditions mentioned in
section 2. See section 2
 Q If you are taking any other medicines. See section 2
Q Follow the dosage instructions carefully. Children and
adults need different amounts. See section 3
Q This

1 What the medicine is for
Benylin 4 Flu Tablets are used to help relieve cold and flu
symptoms. The tablets contain paracetamol which helps to
relieve aches and pains and fever (high temperature),
diphenhydramine, which is an antihistamine that helps relieve
coughing, sneezing and runny nose and pseudoephedrine,
which is a decongestant that helps unblock stuffy noses.
The medicine is for use in adults and children aged 10 years
and over.

2 Before using this medicine





Q

Special warnings about this medicine
Q You can use this medicine while you are taking oral
contraceptives (“the pill”) or anticonvulsants (drugs
used to treat epilepsy), but the medicine may not work
so well on your pain or fever.
Q This medicine may cause drowsiness. If affected, do
not drive or operate machinery. Avoid alcoholic drink.
Q This product may cause drowsiness. It should NOT be
used to sedate a child.
Some of the ingredients can cause problems
Q This medicine contains Sunset yellow (E110).
This may cause allergic reactions.
Q This medicine contains 1.2 mg sodium per tablet.
Q To be taken into consideration by patients on a
controlled sodium diet.

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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.

Talk to your doctor or pharmacist…
Q If you have kidney or liver problems, including
alcoholic liver disease.
Q If you have difficulty passing water (urinary retention).
Q If you have blocked arteries or veins (occlusive
vascular disease).
Q 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).
Q If you are taking any other medicines including:
 Q Antimuscarinic drugs e.g.:


Q tricyclic antidepressants (drugs to treat mood
disorders).


Q atropine (used to treat some eye conditions and
occasionally bowel conditions).
 Q CNS depressants e.g.:


Q hypnotics (sleeping tablets including barbiturates).


Q minor tranquillisers (drugs used to relax muscles
or decrease anxiety).


Q opioid analgesics (drugs used to relieve pain e.g.
codeine, tramadol, morphine).

Q antipsychotics (drugs used to treat mood
disorders).
Antihypertensives (drugs used to treat high blood
pressure including alpha and beta blockers).
 Q sympathomimetic drugs (stimulants or appetite
suppressants and drugs used to treat congestion
and asthma).
 Q moclobemide (used to treat mood disorders).
 Q Cardiac glycosides (drugs used to control heart
rhythms or contractions) e.g. digoxin.
 Q Ergot alkaloids (drugs used to treat migraine such
as ergotamine and methysergide).
 Q Oxytocin (drug used to help contractions during
childbirth).
 Q oral contraceptives ("the pill").
Q metoclopramide or domperidone (used to treat
nausea and vomiting).
 Q colestyramine (used to treat high cholesterol).
 Q anticoagulants (drugs that thin the blood, such as
warfarin).
 Q 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
Q Ask your doctor or pharmacist for advice before
taking this medicine if you might be pregnant or are
breast-feeding.


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Flu

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Four

Do not use this medicine…
Q If you are taking any other medicines containing
paracetamol.
Q If you have ever had a bad reaction to any of
the ingredients.
Q If you have heart disease or high blood pressure.
Q If you have diabetes.
Q If you have an overactive thyroid.
Q If you have phaeochromocytoma (rare tumour
which affects your heart rate and blood pressure).
Q 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).
Q If you suffer from or have had closed angle
glaucoma (increased pressure in the eye).
Q If you are taking beta blockers (used to treat high
blood pressure).
Q For a child under 10 years of age.
Q If you are taking any other cough and cold
medicine.
Q 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 Tablets.

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3 How to take this
medicine
Check the tables below to see how much medicine
to take.
Q For oral use only.
Q Do not take more than the stated dose shown below.
Children under 10 years
This medicine is not recommended for children under
10 years old.
Adults and children aged 10 years and over
Age
Adults and children
aged 16 years and over
Children 10 – 15 years

Dose
Take two tablets, up to 4 times
a day
Take one tablet, up to 4 times
a day
Q Leave at least 4 hours between doses.
Q Do not take more than 4 times a day.
Q If symptoms persist or worsen, talk to your doctor or
pharmacist.
Q Do not give to a child under 16 years of age for more than
5 days without consulting your doctor.
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
You should only take this medicine as required following
the dosage instructions above carefully. 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 Tablets 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:
Q Allergic reactions including skin rashes (which may be severe
and include blistering and peeling of the skin) and itching.

Q Allergic

reactions to other medicines containing
sympathomimetic drugs (stimulants or appetite suppressants
and drugs used to treat congestion and asthma).
Q 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.
Q Hallucinations and paranoid delusions.
Q Rarely people can experience fits.
Q Rarely abnormal blood test results for liver function.
If you experience any of the following, stop using the
medicine and talk to your doctor:
people can have an increased heartbeat, an increased
awareness of the heartbeat (palpitations) and high blood
pressure.
Q Restlessness and sleep disturbances.
Q Rarely

Other effects that may occur include:
Q Irritability, anxiety, excitability, nausea and sickness.
Q Commonly: drowsiness, including some difficulty performing

tasks, 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.

Q Rarely:

If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly in the UK via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
You can also report side effects directly in Malta via:
ADR Reporting at: www.medicinesauthority.gov.mt/adrportal

5 Storing this medicine
Do not store this product above 25ºC.
Store in the original packaging.
Keep the container in the outer carton.
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 after 'Expiry'. The expiry date refers to the last
day of that month.
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 Further information
What’s in this medicine?
The active ingredients in Benylin 4 Flu Tablets are:
500 mg Paracetamol, 22.5 mg Pseudoephedrine
hydrochloride, 12.5 mg Diphenhydramine hydrochloride.
Other ingredients are: Microcrystalline cellulose,
pregelatinised maize starch, povidone, crospovidone,
macrogol 6000, croscarmellose sodium, stearic acid,
magnesium stearate, hypromellose, titanium dioxide (E171),
quinoline yellow (E104), sunset yellow (E110) and talc.
What the medicine looks like
Benylin 4 Flu Tablets are orange film coated tablets,
available in packs of 24.
Marketing Authorisation holder:
McNeil Products Ltd, Maidenhead, Berkshire,
SL6 3UG, UK.
Manufacturer: Janssen Cilag, Domaine de Maigremont,
27100 Val de Reuil, France.
This leaflet was revised October 2016.
Benylin is a registered trade mark.

7 Information about treating
cough and cold in children
It's normal for children to get 8 or more colds in a year.
Because colds are caused by viruses, not bacteria,
antibiotics don't help. Here are simple steps to help your
child who has a cough or cold.
Q If they are hot/feverish: Increase the amount of fluid your
child normally drinks. Lower their temperature with a
paracetamol or ibuprofen medicine which has doses for
children.
Q For coughs: Coughing serves a purpose, it helps clear
phlegm and mucus. Give the child plenty of warm clear
fluids to drink.
Q To help with breathing: Plain saline nose drops / sprays
can help with blocked noses.

365304D
16-0538

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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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