CALPOL SIX PLUS

Main information

  • Trade name:
  • CALPOL SIX PLUS 250 MG/5ml Oral Suspension
  • Dosage:
  • 250 MG/5ml
  • Pharmaceutical form:
  • Oral Suspension
  • Prescription type:
  • Product not subject to medical prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CALPOL SIX PLUS 250 MG/5ml Oral Suspension
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Analgesics and antipyretics

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Authorised
  • Authorization number:
  • PA0823/010/003
  • Authorization date:
  • 25-01-1995
  • Last update:
  • 20-10-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Calpol Six Plus contains methyl

parahydroxybenzoate,sucrose,

sorbitol and sunset yellow.

Methyl parahydroxybenzoate (E218) may cause

allergic reactions which could possibly be delayed and

exceptionally,bronchospasm.

The sucrose and sorbitol (E420) content of this

product means that this product is unsuitable for

people with inherited intolerance to some sugars.This

medicine contains 2.1 g of sucrose per 5 ml dose.

This should be taken into account in patients with

diabetes mellitus.

SunsetYellow (E110) may cause allergic reactions.

3 How to use Calpol

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.

Check the tables below to see how much

medicine to use.

For oral use only

It is important to shake the bottle

for at least 10 seconds before use

Never give more medicine that shown in the table

Do not overfill the spoon.

Always use the spoon supplied with the pack.

Do not give with any other paracetamol-containing

products

There is a double-ended

spoon in the pack.

i Childrenunder 6 years

Not recommended for children under 6 years old.

Read all of this leaflet carefully before you start using

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 your child gets 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 your child does not feel

better or feels worse after 3 days.

What is in this leaflet

1.What Calpol is and what it is used for

2.What you need to know before you use Calpol

3.How to take Calpol

4.Possible side-effects

5.How to store Calpol

6.Contents of the pack and other information

1 What Calpol is and what it

is used for

The paracetamol in Calpol SixPlus Suspension is used

to relieve pain such as teething pain and toothache,

headache,migraine,neuralgia,sore throat and aches and

pains that come with colds and flu.It also brings down

2 What you need to know

before you use Calpol

Do not give your child this medicine…

If s/he has ever had a bad reactionto any of

the ingredients.

If s/he is taking anything else with

paracetamol in it.

If any of these apply, get advice from a doctor or

pharmacist without using Calpol.

Warnings and precautions

Talk to your doctor or pharmacist…

If your child has serious kidney or liver problems.

If your child has an inherited intolerance

to fructoseor been diagnosed with an

intolerance to some other sugars.

Other medicines and Calpol

Tell your doctor or pharmacist if your child is

taking any other medicinesincluding:

metoclopramideordomperidone(used to treat

nausea and vomiting)

cholestyramine(used to treathigh cholesterol)

anticoagulants(drugs thatthin the blood,such

as warfarin)

anticonvulsants(drugs to treatepilepsy)

barbiturates or tricyclic antidepressants.

If you are not sure about the medicine your child is

taking,show the bottle or pack to your pharmacist.

If any of these bullet points apply,talk to a doctor

or pharmacist.

If adultstake this medicine:

The following additional warnings are included in case an

adult takes this product:

You can use this medicine while you are taking oral

contraceptives (‘the pill’),but it may not work so well on

your pain or fever.

If you drink large amounts of alcohol,you may be more

open to the side-effects of paracetamol.

Ask your doctor or pharmacist for advice before taking this

medicine if you might be pregnant or breast-feeding.

250mg/5mlOralSuspension

Package leaflet: Information for the user

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F310246

i Childrenfrom6 years

Child's ageHow much How often

(in 24 hours)

6 – 8 years One 5 ml spoonful (large end)4 times

8 – 10 years One 5 ml spoonful (large

end) and one 2.5 ml spoonful

(small end) 4 times

10 – 12 yearsTwo 5 ml spoonfuls (large end)4 times

Do not give more than 4 doses in any 24 hour period.

Leave at least 4 hours between doses.

Do not give this medicine to your child for more than 3

days without speaking to your doctor or pharmacist.

Do not give to children under the age of 6 years.

Children aged 12 – 16 years:

Two – three 5 ml spoonfuls (large end) up to 4 times a day.

Adults and children over 16 years:

Two – four 5 ml spoonfuls (large end) up to 4 times a day.

Speak to your doctor:

If your child needs more than the doses shown in

the table,or if fever doesn’t go away,speak to

your doctor as soon as possible.

If you are not sure of the cause of your child’s

illness or it is accompanied by a rash,breathing

difficulties,diarrhoea or excessive tiredness or

lethargy,speak to your doctor straight away.Do

not give Calpol until you get medical advice.

If anyone has too much

Immediate medical advice should be sought in the

event of an overdose,even if the child seems well,

because of the risk of delayed,serious liver damage.

If you forget to give Calpol

Give the next dose when needed,provided that the

last dose was given at least 4 hours ago. Do not

4 Possible side-effects

Like all medicines,this medicine can cause side-effects

although not everybody gets them.

Stop using this medicine and contact your

doctor immediately if you experience:

Severe skin reactions.Symptoms may include,

skin reddening,blisters,rash.

Tell your doctor as soon as possible if

you notice any of these:

skin rashes or other signs of allergy.

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.

If your child shows any of these signs, stop giving

paracetamol and talk to a doctor.

Long term use:People who use medicines containing

paracetamol every day for a long time (several months or

more) could get certain side-effects,including liver and

kidney damage.People taking paracetamol in the usual

way for shorter periods have not had these problems.

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,EarlsfortTerrace,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 Calpol

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

Do not store above 25°C.

Store in original package to protect from light.

Do not use after the end of the month stated as the

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 Calpol contains

The active substance is:Paracetamol 250 mg per 5 ml.

Other ingredients are:Sucrose,sorbitol solution (E420),

glycerol,dispersible cellulose,polysorbate 80,methyl

parahydroxybenzoate (E218),sunset yellow (E110) and

purified water.The flavouring is orange and imitation

white sugar.

What Calpol looks like and contents of

the pack

Calpol Six Plus Suspension is an orange coloured and

flavoured liquid,available in 60 ml bottle.

It contains 250 mg of the active ingredient Paracetamol

in every 5 ml of medicine.

Marketing Authorisation Holder and

Manufacturer.

The Product Authorisation holderis McNeil Healthcare

(Ireland) Ltd,Airton Road,Tallaght,Dublin 24,Ireland.

The manufactureris Famar Orleans,5 avenue de

Concyr,45071 Orléans,Cedex 2,France.

This leaflet was last revised October 2014.

3 How to use Calpol

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