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PARACETAMOL 120MG/5ML ELIXIR

Active substance(s): PARACETAMOL

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Black

Product: Paracetamol 120mg/5ml Elixir
PL Number:

28444/0068

Artwork Code/Version: A0068/P/100-LL/A0.1

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol 120mg/5ml Elixir

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 Paracetamol Elixir 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 effect not listed in this leaflet, please tell your
doctor or pharmacist.

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3 – 6 months
6 – 24 months

One 2.5 mL spoonful (small end)
One 5 mL spoonful (large end)
One 5.0 mL spoonful (large end) and
one 2.5mL spoonful (small end)
Two 5 mL spoonfuls (large end)
Three 5 mL spoonfuls (large end)
Four 5 mL spoonfuls (large end)

2 – 4 years
4 – 8 years
8 – 10 years
10 – 12 years

Paracetamol Elixir contains the active ingredient
Paracetamol and is used to treat mild to
moderate pain in children, including:
• Aches and pains
• Neuralgia (severe nerve pain), period pain
• Migraine, headache
• Fevers, colds, flu and influenza
• Sore throat, toothache, pain in teething

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Children:
How Much

1. WHAT PARACETAMOL ELIXIR IS
AND WHAT IT IS USED FOR

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Child’s Age

In this leaflet:
1. What Paracetamol Elixir is and what it is used for
2. Before you give Paracetamol Elixir
3. How to give Paracetamol Elixir
4. Possible side effects
5. How to store Paracetamol Elixir
6. Further information

How often
(in 24 hours)
4 times
4 times
4 times
4 times
4 times
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
WARNING: DO NOT EXCEED THE STATED DOSE
Contains Paracetamol. Do not give with other
Paracetamol containing products.

If you give more Paracetamol Elixir than you
should
It is extremely important to follow the dosage
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, contact their doctor or nearest
hospital casualty immediately. Take any remaining
medicine and this leaflet with you if possible.
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.
If you forget to give Paracetamol Elixir
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.
If you have any further questions on the use of this
product, ask the doctor or pharmacist.

2. BEFORE YOU GIVE PARACETAMOL
ELIXIR
DO NOT give your child Paracetamol Elixir
if he/she is:
• Allergic (hypersensitive) to Paracetamol, other
pain relievers or any of the other ingredients in
the product (see Section 6 and end of Section 2).
• Taking any other Paracetamol-containing
medicines, i.e. over-the-counter cold remedies.
Take special care with Paracetamol Elixir
Consult the doctor before giving this medicine to
your child if he/she has impaired kidney or liver
function.

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4. POSSIBLE SIDE EFFECTS
Like all medicines, Paracetamol Elixir can cause
side effects, although not everybody gets them.
Your child may suffer an allergic reaction,
symptoms of which include skin rashes and
itching. If this happens, stop giving the medicine
immediately and seek urgent medical help.
The following have also been reported:
• Blood abnormalities, but these were not
necessarily due to the Paracetamol treatment.
• Kidney disorders
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell the doctor.

5. HOW TO STORE PARACETAMOL ELIXIR
Keep out of the sight and reach of children.

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Taking other medicines
Please tell the doctor if your child is taking, or has
recently taken, any other medicines, including
those obtained without a prescription, particularly:
• Other products containing Paracetamol (see ‘DO
NOT give your child Paracetamol Elixir’ above).
• Medication for the liver
• Metoclopramide and Domperidone (used to treat
nausea, vomiting or other stomach problems).
• Cholestyramine (reduces blood cholesterol
levels)
• Warfarin and other drugs which thin the blood
• Drugs for epilepsy i.e. Phenytoin, Phenobarbital,
Carbamazepine
• Rifampicin (antibiotic most frequently used to
treat tuberculosis)
• St. John’s wort (used to treat depression)
• Alcohol-containing products.

Important information about some of the
ingredients of Paracetamol Elixir
• Alcohol – this medicinal product contains 8.4%
vol of ethanol (alcohol), i.e. up to 421mg per
dose, equivalent to 8.4ml of beer, 3.5ml wine per
dose. Harmful for those suffering from
alcoholism. To be taken into account in children
and high-risk groups such as patients with liver
disease, or epilepsy.
• Propylene Glycol – may cause alcohol like
symptoms
• Sorbitol – when taken according to the dosage
recommendation each dose supplies up to 6.9g
of Sorbitol. If your child has an intolerance to
some sugars like fructose, ask the doctor before
giving this medicine. Sorbitol may have a mild
laxative effect.
• Amaranth – may cause allergic reactions.

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Do not store above 25ºC. 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.

6. FURTHER INFORMATION
What Paracetamol Elixir contains
The active substance is Paracetamol, 120mg per
5ml of Elixir. The other ingredients are Alcohol
96% (Ethanol 8.4% w/v), Propylene Glycol,
Potassium Sorbate (E202), Sorbitol (E420),
Glycerol (E422), Saccharin Sodium, Raspberry
Flavour (IFF 17.40.0478), Citric Acid Hydrated
(E330), Amaranth Ariavit 311801 (E123), Purified
Water (see also end of Section 2 on ‘Important

• Glycerol – may cause headache, stomach upset
and diarrhoea.

3. HOW TO GIVE PARACETAMOL ELIXIR
Always give Paracetamol Elixir exactly as the
doctor has told you. For oral use only.
Check the table below to see how much of the
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 than shown in the
table
• Do not overfill the spoon
• Always use the spoon supplied with the pack
• Do not give this medicine with any other
paracetamol-containing product

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information about some of the ingredients of
Paracetamol Elixir’).
What Paracetamol Elixir looks like and
contents of the pack
This medicine is a clear red oral solution with
raspberry flavouring. It is supplied in an amber
glass bottle in packs of 60ml, 100ml and 200ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Activase Pharmaceuticals Limited,
11 Boumpoulinas Street, 1060 Nicosa, Cyprus
Manufacturer:
DDSA Pharmaceuticals Limited,
310 Old Brompton Road, London, SW5 9JQ
Date of last revision: February 2013

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

HOW MUCH TO GIVE
NEVER GIVE MORE MEDICINE THAN SHOWN IN THE TABLE
As with all medicines, if your child is currently taking any medicine consult your doctor or
pharmacist, before taking this product.
Child’s Age

New Dosage

3 – 6 months
6 – 24 months

One 2.5 mL spoonful (small end)
One 5 mL spoonful (large end)
One 5.0 mL spoonful (large end) and
one 2.5mL spoonful (small end)
Two 5 mL spoonfuls (large end)
Three 5 mL spoonfuls (large end)
Four 5 mL spoonfuls (large end)

2 – 4 years

A0068/P/200-LL/A0.1

MA Holder: Activase

How often
(24 hours)
4 times
4 times
4 times

4 – 8 years
4 times
8 – 10 years
4 times
10 – 12 years
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

CONTAINS PARACETAMOL – Do not give this medicine
with any other Paracetamol-containing products.
IMMEDIATE MEDICAL ADVICE SHOULD BE SOUGHT IN THE EVENT
OF AN OVERDOSE, EVEN IF THE CHILD SEEMS WELL.
DO NOT STORE ABOVE 25°C. KEEP THE BOTTLE TIGHTLY CLOSED.
STORE IN THE ORIGINAL PACKAGE
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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