Benylin Four Flu Film-Coated Tablets. Paracetamol 500mg Diphenhydramine hydrochloride 12.5mg Pseudoephedrine hydrochloride 22.5m

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Diphenhydramine; Pseudoephedrine; Paracetamol
Available from:
Imbat Limited
ATC code:
N02BE; N02BE51
INN (International Name):
Diphenhydramine; Pseudoephedrine; Paracetamol
Dosage:
500 12.5 22.5 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Anilides; paracetamol, combinations excl. psycholeptics
Authorization status:
Authorised
Authorization number:
PPA1151/130/001
Authorization date:
2009-09-25

Page 1 of 2

PATIENT INFORMATION LEAFLET

Benylin Four Flu

®

Film-Coated Tablets

(paracetamol 500mg / diphenhydramine hydrochloride

12.5mg / pseudoephedrine hydrochloride 22.5mg)

Your medicine is available using the above name but will be

referred to as Benylin Four Flu throughout the leaflet.

Read all of this leaflet carefully because it

contains important information for you.

This medicine is available without prescription. However you

still need to take Benylin Four Flu carefully to get the best

results from it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or

advice.

You must contact a doctor if your symptoms worsen or

do not improve.

If any of the side effects get serious or if you notice any

side effects not listed in this leaflet, please consult your

doctor or pharmacist.

In this leaflet

What Benylin Four Flu is and what it is used for.

Before you take Benylin Four Flu.

How to take Benylin Four Flu.

Possible side effects.

How to store Benylin Four Flu.

Contents of the pack and other information.

Information about treating cough and cold in children

1.

What Benylin Four Flu is and what it is

used for

Benylin Four Flu is 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 taking Benylin Four Flu

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.

If you have ever had an allergic (hypersensitivity)

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 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).

For a child under 10 years of age.

If you are taking any other cough and cold medicine.

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 Four

Flu.

Talk to your doctor or pharmacist…

If you have liver or kidney problems.

If you have difficulty passing water (urinary

retention).

If you have an enlarged prostate.

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).

Taking other medicines

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).

sympathomimetic drugs (stimulants or appetite

suppressants and drugs used to treat congestion and

asthma).

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.

Pregnancy and breast feeding

Ask your doctor or pharmacist for advice before taking

this medicine if you might be pregnant or are breast-

feeding.

Take special care with Benylin Four Flu

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.

There is a greater risk of overdose in patients with

alcoholic liver disease.

Driving and using machines

This medicine may cause drowsiness. If affected, do not

drive or operate machinery. Avoid alcoholic drink.

This product may cause drowsiness. It should NOT be

used to sedate a child.

Important information about some of the

ingredients of Benylin Four Flu

This medicine contains Sunset yellow (E110). This may

cause allergic reactions.

This medicine contains 1.2mg sodium per tablet. To be

taken into consideration by patients on a controlled

sodium diet.

3.

How to take Benylin Four Flu

Check the tables overleaf to see how much

medicine to take.

For oral use only.

Do not take more than the stated dose shown overleaf.

Children under 10 years

This medicine is not recommended for children under 10

years old.

Page 2 of 2

Adults and children aged 10 years and over

Age

Dose

Adults and children

aged 16 years and over

Take two tablets, up to

4 times a day

Children 10 – 15 years

Take one tablet, up to

4 times a day

Leave at least 4 hours between doses.

Do not take more than 4 times a day.

If symptoms persist or worsen, talk to your doctor or

pharmacist.

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 Four Flu 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.

Rarely people can experience fits.

Rarely abnormal blood test results for liver function.

An abnormal decrease in the number of platelets in the

blood.

High fever and/or a sharp drop in level of white blood

cells.

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 and vomiting.

Commonly: drowsiness, including some difficulty

performing tasks, headache, upset stomach, difficulty in

passing urine, stimulation, blurred vision, dry mouth,

thickened mucus.

Rarely: low blood pressure, tremor, shakiness, slurred

speech, dizziness, confusion and depression.

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

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2

Tel: +353 1 6764971 Fax: +353 1 6762517

Website: www.hpra.ie E-mail: medsafety@hpra.ie

By reporting side effects, you can help provide more

information on the safety of this medicine.

5.

How to store Benylin Four Flu

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Store in the original package. Keep container in the outer

carton.

Do not use this medicine after the expiry date (Exp) which is

marked on the blisters and outer carton. This 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

any medicines you no longer use. These measures will help

protect the environment.

6.

Contents of the pack and other

information

What’s in this medicine?

Each tablet contains the active ingredients:

12.5mg diphenhydramine hydrochloride, 500mg paracetamol,

and 22.5mg pseudoephedrine hydrochloride.

The tablets also contain: 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 Four Flu are orange, biconvex, film coated tablets

with no markings.

Benylin Four Flu is available in blister packs containing

24 tablets.

Manufacturer

Manufactured by: Janssen Cilag S.A.,

Domaine de Maigremont, 27100 Val de Reuil, France.

Procured from within the EU and repackaged by:

Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,

Doncaster, DN3 1QR, UK.

PPA holder: Imbat Ltd., Unit L2, North Ring Business Park,

Santry, Dublin 9.

Distributed by: Eurodrug Ltd., Unit L2, North Ring Business

Park, Santry, Dublin 9.

PPA No: 1151/130/1

Leaflet issue and revision date (ref): 14.03.17

Benylin

is a registered trademark of Johnson & Johnson

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.

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.

For coughs: Coughing serves a purpose, it helps clear

phlegm and mucus. Give the child plenty of warm clear

fluids to drink.

To help with breathing: Plain saline nose drops /

sprays can help with blocked noses.

Blind or partially sighted?

Is this leaflet hard to see or

read?

Call +44 (0) 1302 365000

(Regulatory)

Please be ready to give the

following information:

Product name: Benylin Four

Flu Film-Coated Tablets

Reference No: 1151/130/1

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Benylin Four Flu Film-Coated Tablets.

Paracetamol 500mg

Diphenhydramine hydrochloride 12.5mg

Pseudoephedrine hydrochloride 22.5mg

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Paracetamol 500mg

Diphenhydramine hydrochloride 12.5mg

Pseudoephedrine Hydrochloride 22.5mg

Excipients:Contains Sunset yellowing colouring (E110)

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film coated tablets

Product imported from the UK:

Orange, biconvex, film coated tablets with no markings

4 CLINICAL PARTICULARS

As per PA0823/034/002

5 PHARMACOLOGICAL PROPERTIES

As per PA0823/034/002

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Pregelatinized maize starch

Povidone

Crospovidone

Stearic acid

Microcrystalline cellulose

Croscarmellose sodium

Magnesium Stearate

Film-coating materials

Hypromellose

Macrogol 6000

Talc

Titanium Dioxide (E171)

Sunset Yellow (E110)

Quinoline Yellow (E104)

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6.2 Incompatibilities

Not applicable

6.3 Shelf life

The shelf-life expiry date of this product is the date shown on the blister strip and outer carton of the product as

marketed in the country of origin.

6.4 Special precautions for storage

Do not store above 25

Store in the original package. Keep container in the outer carton.

6.5 Nature and contents of container

Overlabelled outer container containing blister strips

Pack size: 24 tablets

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

No special requirements

7 PARALLEL PRODUCT AUTHORISATION HOLDER

Imbat Ltd

Unit L2, North Ring Business Park

Santry

Dublin 9.

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA 1151/130/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 25

September 2009

10 DATE OF REVISION OF THE TEXT

May 2017

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