PARACETAMOL ADULT 500MG/5ML ORAL SUSPENSION

Active substance: PARACETAMOL

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Tell your doctor if you get any of these side effects:
n 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.


5. How to store Paracetamol Oral Suspension
n
n

Keep out of the reach and sight of children.
Do not store above 25°C. Do not refrigerate or

freeze. Store in the original package.
Do not use 1 month after you first open it. Take it
back to the pharmacy.
n Do not use after the expiry date (month, year) on the label. The expiry
date refers to the last day of that month.
n If it is out of date or you no longer want it, take it back to the pharmacy.
n Do not use Paracetamol Oral Suspension if you notice anything wrong
with the medicine. Talk to your pharmacist.
n



6. Further information

What Paracetamol Oral Suspension contains
The active substance is paracetamol. Each 5ml contains 500mg paracetamol.
The other ingredients are methyl and propyl parahydroxybenzoate (E218 and E216), propylene
glycol (E1520), liquid maltitol (E965), saccharin sodium, acesulfame potassium (E950), sodium
dihydrogen phosphate dihydrate, disodium hydrogen phosphate dihydrate, magnesium
aluminium silicate, masking flavour, strawberry flavour and purified water.
What Paracetamol Oral Suspension looks like and contents of the pack
Paracetamol Oral Suspension is a pink-brown liquid which smells of strawberry.
It comes in a brown glass bottle holding 150ml of oral suspension with a 5ml purple syringe and
an adaptor.
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 medicinal product is authorised in the Member States of the EEA under the
following names:
UK: Paracetamol Adult 500mg/5ml Oral Suspension
Eire: Paracetamol Adult 500mg/5ml Oral Suspension
This leaflet was last revised in 12/2014
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Patient Information Leaflet
Paracetamol Adult 500mg/5ml Oral Suspension
Read all of this leaflet carefully before you start taking this medicine.
n Keep this leaflet. You may need to read it again
n If you have any further questions, ask your doctor
or pharmacist
n This medicine has been prescribed only for you. Do
not pass it on to others. It may harm them, even if
their symptoms are the same as yours
n 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

245

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1. What Paracetamol Oral Suspension is and what it is used for
Paracetamol belongs to a group of medicines called pain-killers or analgesics. This medicine is a
higher strength Paracetamol Oral Suspension. It is used for mild to moderate pain when you
cannot take other paracetamol formulations such as lower strength liquid paracetamol,
effervescent tablets or tablets.


2. Before you take Paracetamol Oral Suspension

Do not take this medicine if you have:
n 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
n a liver disorder.
This medicine should not be given to children or adolescents under the age of 16 years.
Do not take paracetamol if any of the above apply to you. If you are not sure, talk to your doctor
or pharmacist before taking paracetamol.
Take special care with this medicine if you have:
n kidney problems
n 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.
Taking other medicines
You must not take any other medicines that contain paracetamol while you are taking
this medicine.
Continued overleaf

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval
Product:

Paracetamol Adult 500mg/5ml
Oral Suspension

Date:

Strength:

500mg/5ml

Proof Number:

ONE

New Item Code:

P0765

Page:

2 of: 2

Previous Item Code:

P0593

Design Icon:

-

Sugar-Free

Cutter Ref:

-

Pack Size

Dimensions:

210 x 300mm (folded 150 x 30mm)

Number of 
colours used:

ONE

15.12.14

New Pharmacode:

Black

245

YES
150ml

Barcode:

Keyline

Tick
applicable
box

Tell your doctor if you are taking any of these medicines:
n barbiturates (sleeping tablets)
n tricyclic antidepressants (such as amitriptyline)
n colestyramine (used to treat high cholesterol)
n warfarin (used to thin the blood and prevent clotting)
n zidovudine (used in HIV infections and AIDS)
n 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.
Taking Paracetamol Oral Suspension with food and drink
Do not drink alcohol while taking paracetamol. This is because taking alcohol and paracetamol
together can increase the risk of liver damage.
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 Oral
Suspension
This medicine contains:
n Methyl and propyl parahydroxybenzoates – some people are allergic to these (the allergy may
happen some time after starting the medicine).
n Liquid maltitol (2.05g per 5ml dose). If your doctor has told you that you cannot tolerate some
sugars, talk to your doctor before taking this medicine.

3. 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
n This medicine contains 500mg of paracetamol in one 5ml dose.
n Take this medicine by mouth only.
n Shake the bottle for at least 10 seconds before use.
n Always use the syringe supplied with the pack.
Measuring your dose:
1. Open the bottle: press the cap and turn it
anticlockwise (figure 1).
2. Insert the syringe adaptor into the bottle neck
(figure 2).
3. Take the syringe and put it in the adaptor
opening (figure 2).
4. Turn the bottle upside down (figure 3).

5. Fill the syringe with a small
amount of solution by pulling
the piston down (figure 4 A).
Then push the piston upward
A
B
C
in order to remove any
possible bubbles (figure 4 B).
Finally, pull the piston down
to the graduation mark
corresponding to the quantity
in millilitres (ml) prescribed by your doctor
(figure 4 C).
6. Turn the bottle the right way up.
7. Remove the syringe from the adaptor. Put the end of the syringe into
your mouth and push the piston slowly back in to take the medicine.
8. Wash the syringe with water and let it dry before you use it again.
9. Close the bottle with the plastic screw cap.
How much to take
n Adults and adolescents over 16:
500mg (5ml) to 1000mg (10ml) up to three to four times a day, as required. Maximum daily
intake should not exceed 4g (40ml).
How often to take
n Take a dose of this medicine every 4 to 6 hours when needed.
n Do not take more than 4 doses in 24 hours.
Do not exceed the stated dose.
If you take more paracetamol than you should (overdose):
n 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.
n 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.


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:
n skin rash, flaking skin, boils, sore lips and mouth, swelling of the face, fever
n 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:
n bruising more easily, sore throat or other signs of infection (these may be signs of a blood
disorder)
n severe pain in the abdomen and back, with fever (high temperature), loss of appetite, nausea
and vomiting (these may be signs of pancreas inflammation)
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n very rare cases of serious skin reactions have been reported.
Continued overleaf

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval
Product:

Paracetamol Adult 500mg/5ml
Oral Suspension

Date:

Strength:

500mg/5ml

Proof Number:

ONE

New Item Code:

P0765

Page:

2 of: 2

Previous Item Code:

P0593

New Pharmacode:

Design Icon:

-

Sugar-Free

Cutter Ref:

-

Pack Size

Dimensions:

210 x 300mm (folded 150 x 30mm)

Number of 
colours used:

ONE

Black

15.12.14

245

YES
150ml

Barcode:

Keyline

Tick
applicable
box

Expand view ⇕

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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