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PARACETAMOL ELIXIR BP 120MG/5ML

Active substance(s): PARACETAMOL / PARACETAMOL / PARACETAMOL

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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.
-

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 gets serious, or if you notice any side effect not listed in this leaflet, please tell
your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Paracetamol Elixir is and what it is used for
Before you give Paracetamol Elixir
How to give Paracetamol Elixir
Possible side effects
How to store Paracetamol Elixir
Further information

1.

WHAT PARACETAMOL ELIXIR IS AND WHAT IT IS USED FOR
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

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.
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’)
• 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
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Pregnancy and breast-feeding
This medicine is intended for use in children. Caution is advised if taking Paracetamol Elixir during
pregnancy or if breast-feeding.
Important information about some of the ingredients of Paracetamol Elixir






3.

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.
Propylene Glycol - may causes alcohol like symptoms.
Glycerol - may cause headache, stomach upset and diarrhoea.
Alcohol - This medicinal product contains 8.4% vol of ethanol (alcohol), i.e. up to 421mg per
dose, equivalent to 8.4 ml 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.

HOW TO GIVE PARACETAMOL ELIXIR
Always give Paracetamol Elixir exactly as the doctor has told you. For oral use only.
Children:
6 - 12 years: two to four 5ml spoonfuls every 4 hours
1 - 6 years: one to two 5ml spoonfuls every 4 hours
3 - 12 months: half to one 5ml spoonful every 4 hours
Under 3 months: not to be given, except on medical advice.
The dose should not be repeated more frequently than 4 hourly intervals. If symptoms persist, speak to
the doctor.
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.

4.

POSSIBLE SIDE EFFECTS
Like all medicines, Paracetamol Elixir may 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.
4

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 gets serious, or if you notice any side effects not listed in this leaflet,
please tell the doctor.
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.
5.

HOW TO STORE PARACETAMOL ELIXIR
Do not used use Paracetamol Elixir after 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 flavor (IFF 17.40.0478), Citric Acid Hydrated (E330), Amaranth
Ariavit 311801 (E123), Purified Water (see also end of Section 2 on ‘Important 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, 3rd Floor, P.C. 1060, Nicosia, Cyprus.
Manufacturer
Sidefarma, Rua da Guine, 26.2689-514, Prior Velho-Portugal.
Date of last revision
September 2013

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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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