Wednesday 5 September 2012

Paracetamol 120mg / 5ml Oral Suspension






Paracetamol 120mg/5ml Oral Suspension


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


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. How to store Paracetamol Oral Suspension

  • 6. Further information




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, migraine, nerve pain, toothache, sore throat, period pains 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).



Before you take Paracetamol Oral Suspension



Do not take this medicine if you have:


  • had an allergic reaction to paracetamol or any of the ingredients listed in section 6.

    An allergic reaction can include a rash, itching or shortness of breath.

  • a liver disorder

Speak to your doctor or pharmacist if any of these apply to you.




Take special care with this medicine if you have:


  • kidney problems

  • liver problems, including those due to drinking too much alcohol.

You may be more at risk of the side effects of paracetamol.


Speak to your doctor or pharmacist if any of these apply to you.




Pregnancy and Breast-feeding:


If you are pregnant, planning to become pregnant or are breast-feeding, talk to your doctor or pharmacist before taking this medicine.




Driving and using machines:


This medicine should not affect your ability to drive or use machines.




Important information about some of the ingredients of Paracetamol Suspension


This medicine contains:


  • Methyl and propyl parahydroxybenzoates – some people are allergic to these (the allergy may happen some time after starting the medicine).

  • Sucrose (3g per 5ml spoonful). This should be taken into account if you have diabetes.

  • Sorbitol. If your doctor has told you that you cannot tolerate some sugars, see your doctor before taking this medicine.



Taking other medicines:


You must not take any other medicines that contain paracetamol while you are taking this medicine.


Tell your doctor if you are taking any of these medicines:


  • barbiturates (sleeping tablets)

  • tricyclic antidepressants (such as amitriptyline)

  • colestyramine (used to treat high cholesterol)

  • warfarin (used to thin the blood and prevent clotting)

  • zidovudine (used in HIV infections and AIDS)

  • domperidone and metoclopramide (used to treat nausea and vomiting)


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.




How to take Paracetamol Oral Suspension


Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or pharmacist if you are not sure.



How to take


  • This medicine contains 120mg of paracetamol in one 5ml spoonful.

  • Take this medicine by mouth only.

  • Shake the bottle well before use.



How much to take – babies with a fever after their immunisations


  • This medicine is not usually given to babies under 3 months old. If your doctor advises you to use this medicine for your baby, please follow these instructions only. They are different to those written below for children and adults.

  • If your baby has a fever (high temperature) after their immunisations at 2 to 3 months old, your doctor may advise you to give them 2.5ml (half a 5ml spoonful)



How often to take – babies with a fever after their immunisations


  • Give them another 2.5ml (half a 5ml spoonful) after 4-6 hours if needed

  • If your baby continues to have a fever after these two doses please talk to your doctor or pharmacist



How much to take – children and adults



  • Children 3 – 12 months: 2.5ml to 5ml (half to one 5ml spoonful)


  • Children 1- 5 years: 5ml to 10ml (one to two 5ml spoonsful)


  • Children 6- 12 years: 10ml to 20ml (two to four 5ml spoonsful)


  • Adults and Children over 12: 20ml to 40ml to a maximum of 4g (160ml) per day



How often to take – children and adults


  • Take a dose of this medicine every 4 to 6 hours when needed.

  • Do not give more than 4 doses in 24 hours.

  • Do not exceed the stated dose.

  • You must see a doctor if your symptoms worsen or do not improve after 3 days.



If you take more paracetamol than you should (overdose):


  • Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Phone your doctor or go to your nearest accident and emergency department straight away.

  • There may be no symptoms during the first 24 hours although paleness, nausea (feeling sick), vomiting (being sick) and abdominal pain may occur.



If you forget to take this medicine:


Take the next dose when needed. Do not take a double dose to make up for a forgotten dose.





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).



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.



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.




How to store Paracetamol Oral Suspension


  • Keep out of the reach and sight of children.

  • Do not store above 25°C. Protect from light.

  • 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.

  • Do not use Paracetamol Suspension if you notice anything wrong with the medicine. Talk to your pharmacist.



Further information



What Paracetamol Suspension contains


The active substance is paracetamol.


The other ingredients are methyl and propyl parahydroxybenzoate (E218 and E216), propylene glycol (E1520), xanthan gum (E415), liquid sorbitol (E420), sucrose, mango flavour and purified water.




What Paracetamol Suspension looks like and contents of the pack


Paracetamol Suspension is a white to off-white liquid which smells of mango. It comes in a brown glass bottle holding 100ml or 500ml of suspension.




The Marketing Authorisation Holder and Manufacturer is:



Rosemont Pharmaceuticals Ltd

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

UK

Tel: + 44 (0) 113 244 1400





This leaflet was last approved in October 2009.


P0442





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