Patient leaflet - PARACETAMOL 120 MG / 5ML ELIXIR
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’ 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.
- Glycerol – may cause headache, stomach upset and diarrhoea.
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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
Children:
| Child’s Age | How Much | How often (in 24 hours) |
| 3 – 6 months | One 2.5 mL spoonful (small end) | 4 times |
| 6 – 24 months | One 5 mL spoonful (large end) | 4 times |
| 2 – 4 years | One 5.0 mL spoonful (large end) and one 2.5mL spoonful (small end) | 4 times |
| 4 – 8 years | Two 5 mL spoonfuls (large end) | 4 times |
| 8 – 10 years | Three 5 mL spoonfuls (large end) | 4 times |
| 10 – 12 years | Four 5 mL spoonfuls (large end) | 4 times |
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| 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 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.
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.
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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 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
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 | How often (24 hours) |
| 3 – 6 months | One 2.5 mL spoonful (small end) | 4 times |
| 6 – 24 months | One 5 mL spoonful (large end) | 4 times |
| 2 – 4 years | One 5.0 mL spoonful (large end) and one 2.5mL spoonful (small end) | 4 times |
| 4 – 8 years | Two 5 mL spoonfuls (large end) | 4 times |
| 8 – 10 years | Three 5 mL spoonfuls (large end) | 4 times |
| 10 – 12 years | Four 5 mL spoonfuls (large end) | 4 times |
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| 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