Calpol Six Plus 250mg/5ml Sugar/Colour Free Oral Suspension

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Paracetamol
Available from:
McNeil Healthcare (Ireland) Ltd
ATC code:
N02BE; N02BE01
INN (International Name):
Paracetamol
Dosage:
250 mg/5ml
Pharmaceutical form:
Oral suspension
Prescription type:
Medicinal product not subject to medical prescription
Therapeutic area:
Anilides; paracetamol
Authorization status:
Marketed
Authorization number:
PA0823/010/004
Authorization date:
1994-10-14

Package leaflet: Information for the user

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 use 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

Sugar/Colour Free

Suspension is used to relieve pain such as tooth pain,

headache, sore throat and aches and pains that come with

colds and flu. It also brings down fever (high temperature).

2

What you need to know

before you use Calpol

Do not give your child this medicine…

If s/he is allergic to paracetamol or any of the

other ingredients of this medicine (listed in section 6).

If s/he has ever had a bad reaction to any of

the ingredients.

If s/he is taking anything else with paracetamol in it.

If any of these applies, 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 fructose or 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 medicines including:

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 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 adults take 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

Calpol

®

contains methyl and propyl

parahydroxybenzoate, sorbitol, maltitol

liquid and sodium

Methyl (E218) and propyl (E216) parahydroxybenzoate

may cause allergic reactions which could possibly be

delayed.

This medicine contains 1345.5 mg sorbitol in each 5 ml

which is equivalent to 270.9 mg/ml. Sorbitol is a source

of fructose. If your doctor has told you that you (or your

child) have an intolerance to some sugars or if you (or

your child) have been diagnosed with hereditary fructose

intolerance (HFI), a rare genetic disorder in which a

person cannot break down fructose, talk to your doctor

before you (or your child) take or receive this medicine.

Sorbitol may cause gastrointestinal discomfort and mild

laxative effect.

This product contains maltitol liquid (E965). If you

have been told by your doctor that you have an

intolerance to some sugars, contact your doctor before

taking this medicinal product.

Maltitol has a calorific value of 2.3 kcal/g. Maltitol

may have a mild laxative effect.

This medicine contains less than 1 mmol sodium

(23 mg) per 5 ml dose, that is to say essentially

‘sodium free’.

3 How to use Calpol

Check the tables below to see how much

medicine to use.

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.

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.

Children under 6 years

Not recommended for children under 6 years old.

Ask your pharmacist to recommend a suitable product.

turn over

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3 How to use Calpol

(continued)

Children from 6 years

Child's age

How 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 years

Two 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 give a

double dose.

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, 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 Calpol

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

Do not store above 25°C.

Store in the original package to protect from light. Keep the

bottle tightly closed.

Do not use this medicine after the expiry date which is stated

on the carton and bottle label after EXP.

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

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. Each 5 ml of oral

suspension contains 250 mg paracetamol.

The other ingredients are: Maltitol liquid (E965), sorbitol

liquid (E420), glycerol, dispersible cellulose, xanthan gum,

polysorbate 80, methyl parahydroxybenzoate (E218), propyl

parahydroxybenzoate (E216), acesulfame potassium (E950),

sodium saccharin and purified water. The flavouring is

imitation strawberry.

What Calpol

®

looks like and contents of

the pack

CALPOL SIXPLUS

Sugar/Colour Free is an off-white liquid,

available in 60 ml, 70 ml, 100 ml, 140 ml, 500 ml or 1000

ml bottles. Not all pack sizes may be marketed. A spoon with

a 2.5 ml and 5 ml measure is supplied with all packs of the

product.

Marketing Authorisation Holder and

Manufacturer

The Marketing Authorisation holder is McNeil Healthcare

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

The manufacturer is Famar Orleans, 5 avenue de Concyr,

45071 Orléans, Cedex 2, France.

This leaflet was last revised in May 2018.

CALPOL

and CALPOL SIXPLUS

are registered trade marks.

LN513701 - 17-0253

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Calpol Six Plus 250mg/5ml Sugar/Colour Free Oral Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

CALPOL SIX PLUS SUGAR/COLOUR FREE SUSPENSION contains Paracetamol 250 mg per 5 ml.

Excipients with known effect:

Maltitol 2040mg per 5ml

Sorbitol 1400mg per 5ml

Methyl parahydroxybenzoate 5.0mg per 5ml

Propyl parahydroxybenzoate 1.0mg per 5ml

For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Oral Suspension

An off-white oral suspension with an odour of strawberries.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Calpol products are indicated for the treatment of mild to moderate pain and as antipyretics.

Calpol

is indicated for the symptomatic relief of headache,

migraine,

neuralgia,

toothache and teething pains,

sore

throat, influenza, feverishness and feverish colds.

4.2 Posology and method of administration

For oral administration

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Children aged 6 years – 12 years:

Children aged 12 – 16 years:

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

Adults and children over 16 years:

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

Children under 6 years:

Not suitable for administration to children under 6years of age. [See Section 4.3]

Hepatic/renal dysfunction:

Caution should be exercised when administering the product to patients with severe hepatic or renal impairment.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Contraindicated in children under 6 years.

4.4 Special warnings and precautions for use

Calpol should be used with caution in patients with severe hepatic or renal dysfunction.

Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens - Johnson syndrome (SJS),

and toxic epidermal necrolysis (TEN), have been reported very rarely in patients receiving paracetamol. Patients should

be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance

of skin rash or any other sign of hypersensitivity.

There is no evidence of paracetamol dependence.

Contains 2.04g Maltitol and 1.4g Sorbitol per 5ml

Patients with rare hereditary problems of fructose intolerance should not take this medicine. May have mild laxative

effect. Calorific value 2.3kcal/g maltitol and 2.6 kcal/g sorbitol.

Methyl and propyl parahydroxybenzoates may cause allergic reactions (possibly delayed).

The following precautions should be followed when taking this medicine:

Do not give with any other paracetamol-containing products

Never give more medicine than shown in the table

Do not overfill the spoon

Child’s Age

How Much

How often (in 24 hours)

6 – 8 years

One 5 ml spoonful (large end)

4 times

8 – 10 years

One 5.0 ml spoonful (large end) and

one 2.5ml spoonful (small end)

4 times

10 – 12 years

Two 5 ml spoonfuls (large end)

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.

It is important to shake the bottle for at least 10 seconds before use.

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Always use the spoon supplied with the pack.

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

As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this

product

Keep out of sight and reach of children

4.5 Interaction with other medicinal products and other forms of interaction

Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise

large doses of paracetamol, the plasma half-life of which can be prolonged.

Alcohol can increase the hepatotoxicity of paracetamol overdosage and may have contributed to the acute pancreatitis

reported in one patient who had taken an overdose of paracetamol.

Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of

therapeutic paracetamol levels by increasing first pass metabolism or clearance.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced

by cholestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol

with increased risk of bleeding; occasional doses have no significant effect.

4.6 Fertility, pregnancy and lactation

There are no adequate and well-controlled clinical studies in pregnant or breastfeeding women. Epidemiological studies

indicate that paracetamol, when taken as directed, does not adversely affect the pregnant mother or fetus.

Pregnancy

When given to the mother in labeled doses, paracetamol crosses the placenta into fetal circulation as early as 30

minutes after ingestion and is effectively metabolized by fetal sulfate conjugation. When taken as directed, paracetamol

does not adversely affect the pregnant mother or fetus

Breastfeeding

Paracetamol is excreted in breast milk in low concentrations (0.1% to 1.85% of the ingested maternal dose). Maternal

ingestion of paracetamol in labeled doses does not present a risk to the nursing infant.

4.7 Effects on ability to drive and use machines

CALPOL has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Post marketing Data

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

The frequencies are provided according to the following convention:

Very common (

1/10); common (

1/100, <1/10); uncommon (

1/1 000, <1/100); rare (

1/10 000, <1/1 000); very rare

(<1/10 000); not known (cannot be estimated from the available data).

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

epidemiology studies, if available or 2) when incidence is unavailable, frequency category is listed as Not known.

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*Low level transaminase elevations may occur in some patients taking labelled doses of paracetamol; these are not

accompanied with liver failure and usually resolve with continued therapy or discontinuation of paracetamol.

4.8.1

Description of selected adverse events

Paracetamol is well tolerated when taken at the usual recommended dosages, with most reports of adverse reactions to

paracetamol relating to overdosage with the drug.

At normal therapeutic doses, side effects are mild and infrequent

with reports of adverse reactions rare.

Skin rashes have been documented occasionally, as have case reports of

hypersensitivity and idiosyncratic reactions (e.g.

thrombocytopenic purpura, haemolytic anaemia and agranulocytosis).

Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a

year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods.

A review of a

group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those

who were long-term users of paracetamol nor was the control of their disease improved after paracetamol withdrawal.

Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but papillary necrosis has been reported after

prolonged administration.

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

Signs & Symptoms

Hepatic necrosis is a dose-related complication of paracetamol overdosage.

In adults and adolescents (> 12 years of age), hepatic toxicity may occur following ingestion of greater than 7.5 to 10

grams over a period of 8 hours or less. Fatalities are infrequent (less than 3-4% of untreated cases) and have rarely been

reported with overdoses of less than 15 grams. In children (<12 years of age), an acute overdosage of less than 150

mg/kg has not been associated with hepatic toxicity.

System Organ

Classification (SOC)

Frequency

category

Adverse Event Preferred

Term

Blood and lymphatic

system disorders

Not known

Thrombocytopenic purpura

Not known

Haemolytic anaemia

Not known

Agranulocytosis

Immune system

disorders

Not known

Anaphylactic reaction

Rare

Hypersensitivity

Hepatobilary

disorders

Not known

Hepatic necrosis

Skin and

subcutaneous tissue

disorders

Rare

Rash

Not known

Urticaria

Not known

Pruritic rash

Renal and urinary

disorders

Uncommon

Nephropathy toxic

Not known

Renal papillary necrosis

Investigations

Not known

Transaminases increased*

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Early symptoms following a potentially hepatotoxic overdose may include: anorexia, nausea, vomiting, diaphoresis,

pallor and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72

hours post-ingestion.

If a paracetamol extended release product is involved, it may be appropriate to obtain an additional plasma paracetamol

level 4-6 hours following the initial paracetamol level.

Serious toxicity or fatalities have been extremely infrequent following an acute paracetamol overdose in young

children, possibly because of differences in the way they metabolize paracetamol.

The following are clinical events associated with paracetamol overdose that if seen with overdose are considered

expected, including fatal events due to fulminant hepatic failure or its sequelae.

Adverse Drug Reactions Identified with Overdose of Paracetamol

The following clinical events are sequelae to acute hepatic failure and may be fatal. If these events occur in the setting

of acute hepatic failure associated with paracetamol overdose (adults and adolescents:

12 years of age: >7.5 g within 8

hours; children <12 years of age: >150 mg/kg within 8 hours), they are considered expected.

Expected Sequelae to Acute Hepatic Failure Associated with Paracetamol Overdose

Metabolism and Nutrition Disorders:

Anorexia

Gastrointestinal Disorders:

Vomiting, Nausea, Abdominal discomfort

Hepatobiliary Disorders:

Hepatic necrosis, Acute (fulminant) hepatic failure, Jaundice,

Hepatomegaly, Liver tenderness

General Disorders and Administration Site Conditions:

Pallor, Hyperhidrosis, Malaise

Investigations:

Blood bilirubin increased, Hepatic enzymes increased, International

normalised ratio increased, Prothrombin time prolonged, Blood

phosphate increased, Blood lactate increased

Infections and Infestations:

Sepsis, Fungal infection, Bacterial infection

Blood and Lymphatic System Disorders:

Disseminated intravascular coagulation, Coagulopathy, Thrombocytopenia

Metabolism and Nutrition Disorders:

Abnormalities of glucose metabolism, Hypoglycaemia, Hypophosphatemia,

Metabolic Acidosis, Lactic Acidosis

Nervous System Disorders:

Coma (with massive paracetamol overdose or multiple drug overdose),

Encephalopathy, Brain oedema

Cardiac Disorders:

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Treatment

To protect the patient against delayed hepatotoxicity, paracetamol overdosage should be treated promptly by gastric

lavage followed by intravenous N-acetylcysteine or oral methionine.

Peak plasma paracetamol concentrations may be

delayed by up to 4 hours following overdose.

Additional therapy (further methionine or intravenous N-acetylcysteine)

is normally considered in the light of blood paracetamol content and time elapsed since ingestion.

Fulminant hepatic

failure which may follow paracetamol overdosage requires specialised management.

In paracetamol overdosage with liver cell damage paracetamol half-life is often prolonged from around 2 hours in

normal adults to 4 hours or longer.

However, liver cell damage has been found in patients with a paracetamol half-life

less than 4 hours.

Diminution in

excretion after oral

C-aminopyrine has been reported to correlate better with

liver cell damage in paracetamol overdosage than do either plasma paracetamol concentration or half-life or

conventional liver function test measurements.

It has been proposed that the threshold for treatment with N-acetylcysteine should be reduced by 30-50% in patients

taking drugs which reduce hepatic enzymes, who abuse alcohol long term, or who are chronically malnourished, as

these patients may be more susceptible to the toxic effects of paracetamol.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Code: N02BE01 – other analgesics and antipyretics

Paracetamol is a centrally acting, non-opiate, non-salicylate analgesic. Paracetamol is a clinically proven

analgesic/antipyretic, and it is thought to produce analgesia by elevation of the pain threshold and antipyresis through

action on the hypothalamic heat-regulating center.

Single-dose studies (12.5 mg/kg) of paracetamol in febrile children

showed an onset of fever reduction within 15 to 30 minutes.

5.2 Pharmacokinetic properties

Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract.

Peak plasma concentrations are

reached 30-90 minutes post dose and the plasma half-life is in the range of 1 to 3 hours after therapeutic doses.

Drug is

widely distributed throughout most body fluids following therapeutic doses. 90-100% of the drug is recovered in the

urine within 24 hours almost entirely following hepatic conjugation with glucuronic acid (about 60%), sulphuric acid

(about 35%) or cysteine (about 3%).

Small amounts of hydroxylated and deacetylated metabolites have also been

detected.

Children have less capacity for glucuronidation of the drug than do adults.

In overdosage there is increased

N-hydroxylation followed by glutathione conjugation.

When the latter is exhausted, reaction with hepatic proteins is

Cardiomyopathy

Vascular Disorders:

Hypotension

Respiratory, Thoracic and Mediastinal Disorders:

Respiratory failure

Gastrointestinal Disorders:

Pancreatitis, Gastrointestinal haemorrhage

Renal and Urinary Disorders:

Acute renal failure with acute tubular necrosis

General Disorders and Administration Site Conditions:

Multi-organ failure

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increased leading to necrosis.

5.3 Preclinical safety data

The active ingredients of Calpol are well known constituents of medicinal products and their safety profile is well

documented.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Maltitol Liquid (E965)

Sorbitol Liquid (non – cystallising) (E420)

Glycerol

Dispersible Cellulose

Xanthan Gum

Methyl Parahydroxybenzoate (E218)

Propyl Parahydroxybenzoate (E216)

Acesulfame Potassium

Polysorbate 80

Sodium Saccharin

Flavour, Strawberry 500286E

Flavour, Strawberry Cream 11407-33

Purified Water

6.2 Incompatibilities

None known

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25

Store in the original package in order to protect from light. Keep the bottle tightly closed.

6.5 Nature and contents of container

Amber

glass

bottle closed with a two-piece plastic screw child resistant,

tamper

evident

closure fitted with a

polyethylene or polyvinylidene chloride (PVDC) laminate faced wad

Amber glass bottle closed with a three-piece screw child resistant, tamper evident closure fitted with a polyethylene or

polyvinylidene chloride (PVDC) laminate faced wad.

Amber glass bottle closed with a two-piece screw child resistant,

tamper evident

closure fitted with a polyethylene

laminate faced wad

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Amber glass bottle closed with a plastic screw closure or a metal Roll-on-pilfer-proof closure fitted with a polyethylene

or polyvinylidene chloride (PVDC) faced wad.

A spoon with a 2.5ml and 5ml measure is supplied with all packs of this product.

Package sizes: 60ml, 70ml, 100ml, 140ml, 500ml or 1000ml.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Shake well before use.

7 MARKETING AUTHORISATION HOLDER

McNeil Healthcare (Ireland) Ltd.

Airton Road

Tallaght

Dublin 24

8 MARKETING AUTHORISATION NUMBER

PA0823/010/004

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 14

October 1994

Date of last renewal: 14

October 2009

10 DATE OF REVISION OF THE TEXT

January 2015

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