Paracetamol Elixir Paediatric Bp 120mg/5ml

RECOMMENDED FOR

Pain /Feverishness /

HOW TO TAKE IT

AGE

CHILDREN 1 TO 6 YEARS CHILDREN 3 MONTHS TO 1 YEAR

CHILDREN UNDER 3 MONTHS

DOSAGE

One to two 5 ml teaspoons every 4-6 hours. Half to one 5ml teaspoon every 4-6 hours.

On doctor's advice only.

NOT MORE THAN 4 DOSES IN ANY 24-HOUR PERIOD. DO NOT EXCEED THE STATED DOSE.

IF SYMPTOMS PERSIST CONSULT YOUR DOCTOR.

Each 5ml of the elixir contains:

Paracetamol BP 120mg. Paracetamol is an analgesic (reduces pain) and an anti-pyretic (reduces temperature). Also contains:

Ethanol (10% v/v), Propylene Glycol,

Invert Syrup,

Amaranth (E123), Glycerol (E422).

BN:

EXP:

Do not use this product after its 'EXP' date.

100 ml

e \E

BP 120mg/5ml

For the relief of pain and feverish conditions in children

CONTAINS PARACETAMOL -

Do not give with any other Paracetamol-containing products. 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.

PLEASE READ THE REVERSE OF THIS LABEL WHICH PROVIDES

IMPORTANT INFORMATION ABOUT THIS PRODUCT

KEEP THE CONTAINER TIGHTLY CLOSED

MA Holder: Cox Pharmaceutical Ltd

788-790 Finchley Road, London NW117TJ, United Kingdom PL 42671/0002

Date of last revision: Oct 2014

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

( ; ^

YOUR MEDICINE: Each 5ml of the elixir contains: Active Ingredient: I20mg Paracetamol. Inactive Ingredients: Ethanol (10% v/v), Propylene Glycol,

Chloroform Spirit, Concentrated Raspberry Juice, Invert Syrup, Amaranth Solution (E123) and Glycerol (E422).

WARNINGS: Do not give this medicine if the child is hypersensitive to Paracetamol or any other ingredients. Do not give with any other Paracetamol-containing products.

Please tell your doctor or pharmacist before taking this medicine; if you suiter from severe liver or kidney problems or if you are pregnant or breast-feeding.

This medicinal product contains a small amount of Ethanol (Alcohol), less than 100mg per 5ml spoonful which may cause drowsiness.

This product contains Invert Syrup (glucose & fructose). It may be harmful to the teeth. If you have been told by a doctor, that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Caution! This medicine must not be taken by people suffering from liver disease, epilepsy, brain injury or brain disease. Reactions may be slow.

It may modify or increase the effect of other medicines.

This product contains Glycerol, which is harmful in high doses and may cause headaches, stomach upset and diarrhoea.

This product contains Amaranth and Propylene Glycol, which may cause allergic-type reactions. These reactions are more common in people who are allergic to Aspirin.

The product should not be diluted.

INTERACTIONS: Advise your doctor or pharmacist of any other medicines you are taking, as there could be an interaction between them and this product.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone (a gastric sedative) and reduced by colestyramine

(lowers cholesterol levels). The anticoagulant effect of warfarin and other coumarins (anti-coagulants) may be enhanced by prolonged regular use of paracetamol

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

IN CASE OF AN OVERDOSE: Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of serious

liver damage. There may be no symptoms during the first 24 hours though pallor, nausea, vomiting and abdominal pain may occur.

WHAT SIDE EFFECTS MAY OCCUR? Side effects are rare. Reactions such as blood disorders and skin rashes may

occasionally occur. If your child experiences these or any other side effects, consult your doctor or pharmacist. Date of last revision: Oct 2014

Height-60mm Height-60mm Height-60mm

Paracetamol. i?omg/5T< Etixir.

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• • • • ••

IPr oral administration.

₉ For the relief of pain and feverish conditions in children.

The Elixir contains:

Paracetamol 120mg per 5mlof Elir. •

Also contains: e han l

(96%, .0%v/v),

Propylene Glycol, Chloroform, Concentrated I Raspberry Juice,

I Invert Syrup,

| Amaranth Solution (E123), , Glycero(/Glycerine(E422).

200 ml

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I MA Holder;

I Cox Pharmaceutical Ltd 788-790 Finchley Road,

London NW1 7f •

¹ United Kingdom

Manufacturen To Be Confirmed

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instructions that have been given. Do not change the dose without discussing it with the doctor first. Symptoms of overdose include pallor (paleness of skin), nausea, vomiting, anorexia and stomach pain. If your child accidentally takes more than the recommended dose, their doctor or nearest hospital casualty immediately. Take any remaining medicine and this leaflet with you if possible.

If you have any further questions on the use of this product, ask the doctor or pharmacist.

4. possible side effects

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell the doctor.

6. further information

IF you FoRget To give Paracetamol ELixir PAEDiAtric

If your child misses a dose, give it as soon as you remember. NEVER give a double dose to make up for the dose that has been forgotten.

Like all medicines, Paracetamol Elixir Paediatric can cause side effects, although not everybody gets them.

Your child maY suffer an allergic reaction, SYmptoms of which include skin rash. If this happens, stop giving the medicine immediately and seek urgent medical help.

Blood abnormalities have also been reported but these were not necessarily due to the paracetamol treatment.

5. how to store paracetamol elixir

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original container and keep the bottle tightly closed.

Do not use Paracetamol Elixir after the expiry date shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Paracetamol Elixir Paediatric contains The active substance is paracetamol, 120mg per 5ml. The other ingredients are ethanol (96%, 10%v/v), propylene glycol, chloroform, concentrated raspberry juice, invert syrup, amaranth solution (E123), glyoerol/glyoerine (E422). See also end of Section 2 on ‘important information about some of the ingredients of Paracetamol Elixir Paediatric',

What Paracetamol Elixir Paediatric looks like and contents of the pack

This medicine is a clear bright syrupy liquid with odours of raspberry and ethanol. It is supplied in a

yellow 100ml glass bottle with plastic cap as well as 2000ml plastic containers.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Cox Pharmaceutical Ltd 788-790 Finohley Road, London NW11 7TJ, United Kingdom

Manufacturer:

To Be Confirmed

PL 42671/0002 Date of last revision: Oct 2014

immediate medical advice should be sought in the event of an overdose, even if your child feels well, because of the risk of delayed, serious liver damage.

iPlease read the Package Leaflet on the reverse of this label before use.

HOW MUCH TO GIVE

DO NOT EXCEED THE STATED DOSE.

AGE

CHILDREN 1 TO 6 YEARS CHILDREN 3 MONTHS TO 1 YEAR CHILDREN UNDER 3 MONTHS NOT MORE THAN 4 DOSES IN ANY 24 HOUR PERIOD. DO NOT EXCEED THE STATED DOSE.

IF SYMPTOMS PERSIST CONSULT YOUR DOCTOR.

DOSAGE

One to two 5ml spoonfuls every 4 hours. Half to one 5ml spoonful every 4 hours. On doctors advice only.

CONTAINS PARACETAMOL - Do not give with any other Paracetamol-containing products.

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.

DO NOT STORE ABOVE 25*C. KEEP THE CONTAINER TIGHTLY CLOSED. STORE IN THE ORIGINAL CONTAINER.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

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