BENYLIN CHILDREN’S CHESTY COUGH 50mg / 5ml N/A Syrup

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
GUAIFENESIN
Available from:
McNeil Healthcare (Ireland) Ltd
ATC code:
R05CA03
INN (International Name):
GUAIFENESIN
Dosage:
50mg / 5ml N/A
Pharmaceutical form:
Syrup
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Expectorants
Authorization status:
Authorised
Authorization number:
PA0823/031/001
Authorization date:
1998-07-27

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Packageleaflet: Informationfortheuser

Children’sChesty

Coughs

50mg/5mlSyrup

6-12years

Guaifenesin

.

Readallofthis leafletcarefully beforeyoustart taking this medicinebecauseit contains

important informationforyou.

Always takethis medicineexactlyas described in this leaflet or asyour doctor orpharmacist

havetoldyou.

- Keep this leaflet. You mayneed to read itagain.

- Askyour pharmacistifyou need moreinformation oradvice.

- Ifyour childgets anysideeffects,talk toyour doctor orpharmacist. This includes any

possible side effects notlisted in this leaflet. Seesection 4.

- You musttalk to a doctor ifyourchild does notfeel betteror feels worseafterafew

days.

Whatis inthisleaflet

1. What Benylin Children’s ChestyCoughs Syrup isand what it is used for

2. Whatyou need to knowbeforeyou takeBenylinChildren’s ChestyCoughs Syrup

3. Howtouse BenylinChildren’s ChestyCoughs Syrup

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4. Possible side effects

5. Howto storeBenylin Children’s ChestyCoughs Syrup

6. Contents of thepack andotherinformation

1.WhatBenylinChildren’s Chesty CoughSyrupis andwhatit is usedfor

BenylinChildren’sChestyCoughSyrupisamedicinewhichisusedtohelprelievechestycoughsin

children.Itcontainsguaifenesin(anexpectorant)tohelploosenmucus(phlegm)fromthelungsand

makeiteasiertocoughup.Themedicineisforuseinchildrenaged6-12years.

2. Whatyouneedto know beforeyouuseBenylinChildren’s Chesty Cough

Syrup

Thismedicineissuitableformostchildrenbutafewchildrenshouldnotuseit.Ifyouareinany

doubt,talktoyourdoctororpharmacist.

DonotuseBenylinChildren’sChestyCoughSyrup…

■Ifyourchildhaseverhadabadreactiontothisproductoranyoftheingredients.Seesection

6forfulllistofingredients.

■Ifyourchildistakinganyothercoughandcoldmedicine.

■Ifyourchildisagedunder6years.

Warnings andPrecautions

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Talktoyourdoctororpharmacistbeforeusing BenylinChildren’s Chesty Cough

Syrup…

■Ifyourchildsuffersfromliverorkidneyproblems.

■Ifyourchildhashadacoughforafewweeksthatmaybecausedbyasthma,oracough

whichbringsupalotofmucus(phlegm).

■Ifyourchild has a cough that tends to recuror is accompanied byafever, rash or

persistent headache

Ifanyoftheseapplynoworinthepast,talk toadoctororpharmacist.

Pregnancyandbreast-feeding

Thefollowingadviceisincludedincaseanolderchildoradultistakingthemedicine.

■Ifyouarepregnantorbreast-feedingornot takingcontraceptivemeasures,onlyusethis

medicineontheadviceofyourdoctor.

BenylinChildren’sChestyCough Syrup containssorbitol andsodium

■Ifyouhavebeentoldbyyourdoctorthatyouhaveanintolerancetosomesugars,contactyour

doctorbeforetakingthismedicinalproduct.

■This medicinal productcontains 14.9 mgsodium per5 ml. To betaken into

consideration bypatientson acontrolled sodium diet.

3.Howto usethisBenylinChildren’s Chesty Coughs Syrup

Checkthetable belowto seehowmuchmedicineto take.

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■Alwaysuse this medicineexactlyas described in this leaflet or asyour doctor or

pharmacisthas toldyou.Check withyour doctororpharmacistifyouarenot sure.

■Fororal use only.

■Do not givemorethanthe stated doseshownbelow.

■Thereis a double-endedspoon in this pack.<pictureof spoon>

Childrenundersix years old

This medicineis notrecommended forchildrenunder 6years old.

Children6-12 years

Age Dose

Children6-12 years Givetwo 5mlspoonfuls every6 to 8 hours. Do not

givemorethan eight 5ml spoonfuls in oneday.

■Useonlywhensimplemeasures havefailed toprovide adequate relief.

■Do not giveto achildunder 12years ofageformorethan 5 days without consulting

yourdoctor.

Ifanyonehas too much

Ifanyonehas taken toomuch, contactyourdoctor orpharmacistimmediately.

Ifyou taketoo much of this productyou maydevelop kidneystones.

Ifyouforget to give themedicine

You should onlygive this medicineasrequiredfollowingthe dosageinstructions above

carefully.

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Ifyou forget togiveadose, give thenext dosewhen needed.Do notgive adouble dose.

4.Possible side-effects

Likeallmedicines, this medicinecancause sideeffects although noteverybodygets

them.

Ifyouexperienceany of thefollowing stopusing themedicineandseekimmediate

help:

Allergicreactionsincludingskinrashes(which maybesevereand include blistering

and peelingof theskin)anditching.

Mildeffects thatmay occurinclude:

■Nauseaor vomiting.

■Stomach pain anddiarrhoea.

Reporting ofsideeffects

Ifyour childgets anysideeffects, talk toyour doctor, pharmacistor nurse. This includes

anypossible sideeffectsnot listed in this leaflet. You can also report sideeffects directly

via HPRA Pharmacovigilance, Earlsfort Terrace,IRL-Dublin 2;Tel:+3531 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie ; E-mail: medsafety@hpra.ie . Byreporting

side effectsyou can helpprovide moreinformation on the safetyof this medicine.

5.Howto storeBenylinChildren’s Chesty CoughSyrup

Do not storethis product above25ºC.

Storein theoriginal package.

Keepthismedicine outof thesightandreachofchildren.

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Do not usethis medicineaftertheexpirydate on thepackaging. Theexpirydate refersto

the last dayof that month.

■Do not useif bottleseal is broken when purchased.Keep bottle tightlyclosed in order

to protect frommoisture.

Do not throwawayanymedicinevia wastewaterorhousehold waste. Askyour

pharmacisthow tothrowawaymedicinesyou no longer use. Thesemeasures willhelp

protect theenvironment.

6.Contents ofthepackandotherinformation

WhatBenylinChildren’s Chesty CoughSyrupcontains

TheactivesubstanceisGuaifenesin.

Theotheringredients are:Glycerol, sorbitol liquid(E420),carmellosesodium, sodium

citrate, sodiumsaccharin,sodium benzoate (E211), citricacidmonohydrate, strawberry

flavourand water.

WhatBenylinChildren’s Chesty CoughSyruplooks likeandcontents ofthepack

Benylin Children's ChestyCough Syrup isaclearcolourless syrup, available in 125 ml,

glass bottles.

Marketing authorizationHolderandManufacturer

ProductAuthorisationholder:McNeilHealthcare

(Ireland)Limited, AirtonRoad, Tallaght, Dublin 24,Ireland.

Manufacturer:Famar Orleans, 5 avenuedeConcyr,45071Orleans, Cedex2, France.

This leafletwas revisedDecember2014.

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Benylin is a registered trademark.

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Benylin Children’s Chesty Cough 50mg/5ml Syrup

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml contains 50 mg guaifenesin.

Excipients with known effect:

sorbitol liquid (E420) 2.525g per 5ml.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Syrup

A colourless to slightly yellow, clear syrup.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Benylin Children's Chesty Cough is indicated for the symptomatic relief of productive coughs.

4.2 Posology and method of administration

Adults and children 12 years and over:

Not appropriate.

Children aged 6 to 12 years:

Oral.10 ml three or four times daily

Maximum daily dose: 40 ml

Use only when simple measures have failed to provide adequate relief.

Use for more than five consecutive days is not recommended.

Children under 6 years:

Not recommended. [See Section 4.3]

4.3 Contraindications

Use in patients hypersensitive to the active ingredients.

Use in patients at risk of developing respiratory failure.

Use in children under 6 years of age is contraindicated.

4.4 Special warnings and precautions for use

BENYLIN Children's Chesty Coughs should be not used for persistent or chronic cough, such as occurs with asthma, or

where cough is accompanied by excessive secretions, unless directed by a physician.

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If cough tends to recur or is accompanied by a fever, rash or persistent headache, a physician should be consulted.

Caution should be exercised in the presence of severe renal or severe hepatic impairment.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Not more than 4 doses should be given in any 24 hours. Do not exceed the stated dose.

Do not take with any other cough and cold medicine.

Consult a pharmacist or other healthcare professional before use in children aged 6 to 12 years.

4.5 Interaction with other medicinal products and other forms of interaction

If urine is collected within 24 hours of a dose of Benylin Children's Chesty Cough a metabolite of guaifenesin may

cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and

vanillylmandelic acid (VMA).

4.6 Fertility, pregnancy and lactation

This product has been formulated specifically for children, and would therefore not normally be taken during

pregnancy and lactation.

Pregnancy

There are no or limited amount of data from the use of guaifenesin in pregnant women.

Animal studies are insufficient

with respect to reproductive toxicity (see section 5.3).

BENYLIN Children’s Chesty Cough is not recommended during pregnancy and in women of childbearing potential not

using contraception.

Breastfeeding

Guaifenesin is excreted in breast milk in small amounts. There is insufficient information on the effects of Guaifenesin

in newborns/infants. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from

BENYLIN Children's Chesty Coughs therapy, taking into account the benefit of breast feeding for the child and the

benefit of therapy for the woman.

Fertility

There is insufficient information available to determine whether guaifenesin has the potential to impair fertility.

4.7 Effects on ability to drive and use machines

It is not expected that this product would interfere with the ability to drive or operate machinery.

4.8 Undesirable effects

Adverse drug reactions identified during post-marketing experience with guaifenesin are included in the table below.

The frequencies are provided according to the following convention:

Very common

1/10

Common

1/100 and <1/10

Uncommon

1/1,000 and <1/100

Rare

1/10,000 and <1/1,000

Very rare <1/10,000

Not known (cannot be estimated from the available data)

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ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology

studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as ‘Not known’.

Adverse Drug Reactions Identified During Post-Marketing Experience with Guaifenesin by Frequency Category

Estimated from Clinical Trials or Epidemiology Studies:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any

suspected adverse reactions 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.

4.9 Overdose

Symptoms and signs

The effects of acute toxicity from guaifenesin may include gastrointestinal discomfort, nausea and drowsiness. When

taken in excess, guaifenesin may cause renal calculi.

Treatment

Treatment should be symptomatic and supportive.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Guaifenesin is thought to exert its pharmacological action by stimulating receptors in the gastric mucosa.

This increases the output from secretory glands of the gastrointestinal system and reflexly increases the flow of fluids

from glands lining the respiratory tract. The result is an increase in volume and decrease in viscosity of bronchial

secretions.

Other actions may include stimulating vagal nerve endings in bronchial secretory glands and stimulating certain centres in

the brain, which in turn enhance respiratory fluid flow. Guaifenesin produces its expectorant action within 24 hours.

5.2 Pharmacokinetic properties

Absorption

Guaifenesin is well absorbed from the gastro-intestinal tract following oral administration, although limited information

regarding its pharmacokinetics is available. After the administration of 600 mg guaifenesin to healthy adult volunteers, the

was approximately 1.4 ug/ml, with t

occurring approximately 15 minutes after drug administration.

Body System (SOC)

Adverse Event preferred term

Frequency Category

Immune System Disorders:

Hypersensitivity reactions

(Hypersensitivity, pruritus, and urticaria)

Not known

Rash

Not known

Gastrointestinal Disorders:

Abdominal pain upper

Not known

Diarrhoea

Not known

Nausea

Not known

Vomiting

Not known

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Distribution

No information is available on the distribution of guaifenesin or menthol in humans.

Metabolism and elimination

Guaifenesin appears to undergo both oxidation and demethylation. Following an oral dose of 600 mg guaifenesin to 3

healthy male volunteers, the t½ was approximately 1 hour and the drug was not detectable in the blood after approximately

8 hours.

Pharmacokinetics in Renal/Hepatic Impairment

There have been no specific studies of Benylin Children's Chesty Cough or guaifenesin in subjects with renal or hepatic

impairment.

Caution is therefore recommended when administering this product to subjects with severe renal or hepatic impairment.

Pharmacokinetics in the Elderly

Not applicable.

5.3 Preclinical safety data

Mutagenicity

There is insufficient information available to determine whether guaifenesin has mutagenic potential.

Carcinogenicity

There is insufficient information available to determine whether guaifenesin or menthol have carcinogenic potential.

Teratogenicity

There is insufficient information available to determine whether guaifenesin has teratogenic potential.

Fertility

There is insufficient information available to determine whether guaifenesin or menthol have the potential to impair

fertility.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glycerol (E422)

Sorbitol, liquid (non-crystallising) (E420)

Sodium citrate (E331)

Citric acid monohydrate

Saccharin sodium

Sodium benzoate (E211)

Carmellose sodium

Strawberry Flavour

Purified water

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6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25

Store in the original container.

Keep the container tightly closed in order to protect from moisture.

6.5 Nature and contents of container

30 ml, 125 ml and 300 ml amber glass bottles with a polyester wadded white aluminium ROPP cap or a 3 piece plastic

child resistant, tamper evident closure fitted with a polyester faced wad or polyethylene/expanded polyethylene

laminated wad, or 2 piece plastic child resistant, tamper evident closure fitted with a PVDC wad.

A spoon with a 5 ml and 2.5 ml measure is supplied with the pack.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Do not used if bottle seal is broken when purchased.

7 MARKETING AUTHORISATION HOLDER

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

8 MARKETING AUTHORISATION NUMBER

PA0823/031/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 27 July 1998

Date of last renewal: 27 July 2008

10 DATE OF REVISION OF THE TEXT

June 2015

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