Paracetamol 120mg/5ml Oral Suspension
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Module 1.3.1
SPC, Labelling and Leaflet
PATIENT INFORMATION LEAFLET Paracetamol 120mg/5ml Oral Suspension
Read all of this leaflet carefully before you start taking this medicine.- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
In this leaflet:
1. What Paracetamol Oral Suspension is and what it is used for
2. Before you take Paracetamol Oral Suspension
3. How to take Paracetamol Oral Suspension
4. Possible side effects
5. Storing Paracetamol Oral Suspension
6. Further information.
Paracetamol 120mg/5ml Oral Suspension
- The active substance is Paracetamol.
- The other ingredients are methyl and propyl parahydroxybenzoate (E218 and E216), propylene glycol (E1520), xanthan gum (E415), sorbitol liquid 70% (E420), sucrose, mango flavour (containing propylene glycol and isopropyl alcohol) and purified water.
Marketing Authorisation Holder and Manufacturer:
Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.
The product is distributed by: Peach Ethical Ltd., 16 Rancliffe Avenue, Keyworth, Nottinghamshire, NG12 5HY, UK.
1. WHAT PARACETAMOL ORAL SUSPENSION IS AND WHAT IT IS USED FOR
It is a white to off-white oral suspension with odour of mango.
It is provided in an amber glass bottle containing 100ml or 500ml of suspension.
A 2.5ml/5ml double ended spoon is provided to measure the dose.
Paracetamol belongs to a group of medicines called pain-killers or analgesics.
It is used for mild to moderate pain including headache, toothache or teething, sore throat and general aches and pains.
It is also used to relieve the symptoms of cold and flu.
It is also used to help reduce a fever (high temperature) including after immunisations.
2. BEFORE YOU TAKE PARACETAMOL ORAL SUSPENSION
Do not take this medicine but speak to your doctor if:
■ you have ever had an unusual reaction to paracetamol or any of the ingredients listed
Take special care with this medicine:
You must speak to the doctor if your child has a serious liver or kidney problem.
If you are adult taking this medicine, you must speak to your doctor if you are dependent on alcohol. If you drink large amounts of alcohol, you may be more susceptible to the side effects of paracetamol.
Pregnancy and Breast-feeding:
You must ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines:
This medicine should not affect your ability to drive or use machines.
Important information about some of the ingredients of this medicine:
This medicine contains parahydroxybenzoates (preservatives) which may cause allergic reactions, possibly delayed. The medicine also contains 3g of sucrose in each 5ml. This should be taken into account if you have diabetes mellitus. It also contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Taking other medicines:
Please inform your doctor or pharmacist if your child or you are taking or have recently taken any other medicines, even those not prescribed.
Inform your doctor if you are taking any of the following:
■ barbiturates (sleeping tablets)
■ tricyclic antidepressants (e.g. amitriptyline)
■ colestyramine (used in the treatment of high cholesterol levels)
■ warfarin (used to thin the blood and prevent clotting)
■ zidovudine (used in HIV infections and AIDS)
■ domperidone and metoclopramide (used in the treatment of nausea and vomiting)
■ medicines used to treat epilepsy or fits such as phenytoin
■ oral contraceptives “the pill”.
3. HOW TO TAKE PARACETAMOL ORAL SUSPENSION
Check the tables below to see how much medicine to use
• This medicine contains 120mg of paracetamol in one 5ml spoonful.
• Take this medicine by mouth only.
• Never give more medicine than shown in table.
• It is important to shake the bottle for at least 10 seconds before use.
• Always use the spoon supplied with the pack. Do not overfill the spoon.
• Do not give this medicine with any other paracetamol-containing product.
Immediate medical advice should be sought in the event of an overdose even if your child seems well because of the risk of delayed, serious liver damage.
TherD may be n 2 symptoms during the first 24 hours although pallor, nausea and vomiting and abdominal pain may occur.
How much to take
|
Age 2 - 3 months |
Dose |
|
Post-vaccination fever |
One 2.5 mL spoonful (small end) If necessary, after 4-6 hours, give a second 2.5 mL spoonful |
|
Other causes of Pain and Fever only if • Weighs over 4 kg • Born after 37 weeks | |
|
• Do not give to babies less than 2 months of age • Do not give more than 2 doses • Leave at least 4 hours between doses • If further doses are needed, talk to your doctor or pharmacist | |
|
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 2.5 mL spoonful (small end) |
4 times |
|
4 - 6 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 | ||
4. POSSIBLE SIDE EFFECTS
Like all medicines, paracetamol can cause side effects, although not everybody gets them. The side effects below may sometimes happen.
If you have an allergic reaction to this medicine see a doctor straight away.
An allergic reaction may include:
• skin rash, flaking skin, boils, sore lips and mouth, swelling of the face, fever.
• sudden wheezing, fluttering or tightness of the chest or collapse.
If you get any of the following side effects, stop taking this medicine and see your doctor as soon as possible:
• bruising more easily, sore throat or other signs of infection (these may be signs of a blood disorder)
• severe pain in the abdomen and back, with fever (high temperature), loss of appetite, nausea and vomiting (these may be signs of pancreas inflammation)
• very rare cases of serious skin reactions have been reported.
Tell your doctor if you get any of these side effects:
■ Skin rash
If paracetamol is taken for a long time, it may lead to liver and kidney problems but if the right amount is taken over a short period of time there should be no problems.
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
5. STORING PARACETAMOL ORAL SUSPENSION
Keep out of the reach and sight of children.
Paracetamol Oral Suspension should be stored below 25°C. Store in the original package.
The label on the bottle shows an expiry date (month, year). Do not use this product after this date. Do not keep outdated medicine or medicine that is no longer wanted. Take it to your pharmacist for safe disposal.
Always keep the medicine in the bottle in which it was originally given to you.
6. FURTHER INFORMATION
For any information about this medicinal product, please contact the Marketing Authorisation Holder.
Rosemont Pharmaceuticals Ltd
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK Tel: + 44 (0) 113 244 1400
This leaflet was last revised in 12/2014 Code: P
Version: December 2014 Page 20