Paracetamol 120mg/5ml Oral Suspension
SPC, Labelling and Leaflet
Paracetamol 120mg/5ml Oral Suspension Module
Package leaflet: Information for the user
Paracetamol 120mg/5ml Oral Suspension
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse.
In this leaflet:
1. What Paracetamol Oral Suspension is and what it is used for
2. What you need to know before you take Paracetamol Oral Suspension
3. How to take Paracetamol Oral Suspension
4. Possible side effects
5. How to store Paracetamol Oral Suspension
6. Contents of the pack and other information.
1. WHAT PARACETAMOL ORAL SUSPENSION IS AND WHAT IT IS USED FOR
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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL ORAL SUSPENSION
Do not take Paracetamol:
■ If you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions:
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.
Paracetamol Suspension contains methyl and propyl parahydroxbenzoate, sucrose and sorbitol.
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.
Other medicines and Paracetamol:
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.
How much to take
For the relief of fever after vaccination at 2, 3 and 4 months
One 2.5 mL spoonful (small end).This dose may be given up to 4 times a day starting at the time of vaccination. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist._
|
Age: 2 - 3 months |
Dose |
|
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/Yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE PARACETAMOL ORAL SUSPENSION
Keep out of the sight and reach of children.
Paracetamol Oral Suspension should be stored below 25°C. Store in the original package.
Do not use after the expiry date (month, year) on the label and carton. The expiry date refers to the last day of that month.
If it is out of date or you no longer want it, take it back to the pharmacy.
Always keep the medicine in the bottle in which it was originally given to you.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Paracetamol 120mg/5ml Oral Suspension contains
- 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.
What Paracetamol 120mg/5ml Oral Suspension looks like and contents of the pack
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.
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.
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 11/2015
Pain and other causes of fever - if your baby weighs over 4 kg and was born after 37 weeks
One 2.5 mL spoonful (small end)
If necessary, after 4-6 hours, give a second 2.5 mL spoonful
• Do not give to babies less than 2 months of age
• Leave at least 4 hours between doses
• Do not give more than 2 doses. This is to ensure that fever that may be due to a serious infection is quickly diagnosed. If your child is still feverish after two doses, talk to your doctor or pharmacist.
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.
There may be no symptoms during the first 24 hours although pallor, nausea and vomiting and abdominal pain may occur.
Version: February 2016 Page 5