Skip to Content

UK Edition. Click here for US version.

PARACETAMOL 10MG/ML SOLUTION FOR INFUSION

Active substance(s): PARACETAMOL

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
Paracetamol 10 mg / ml solution for infusion
Paracetamol
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, nurse or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
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.
The name of your medicine is Paracetamol 10 mg / ml solution for infusion.
In the rest of this leaflet this medicine will be called Paracetamol.
What is in this leaflet
1. What Paracetamol is and what it is used for
2. What you need to know before you use Paracetamol
3. How to use Paracetamol
4. Possible side effects
5. How to store Paracetamol
6. Contents of the pack and other information
1. What Paracetamol is and what it is used for
This medicine is an analgesic (it relieves pain) and an antipyretic (it lowers fever). It is indicated
for the short-term treatment of moderate pain, especially following surgery, and for the short-term
treatment of fever. The 100 ml bottle is restricted to adults, adolescents and children weighing
more than 33 kg. The 50 ml bottle is restricted to term newborn infants, infants, toddlers and
children weighing less than 33 kg
2. What you need to know before you use Paracetamol
Do not use Paracetamol
if you are allergic to paracetamol or to any of the other ingredients of Paracetamol (listed in
section 6);
if you are allergic to propacetamol (another pain reliever for infusion and a precursor of
paracetamol);
if you suffer from a severe liver disease.
Warnings and precautions
Before using Paracetamol it is important you know:
use a suitable oral treatment (pain reliever taken by mouth) as soon as possible.
Talk to your doctor or pharmacist before using Paracetamol:
if you suffer from a liver or kidney disease, or from alcohol abuse.
if you are taking other medicines containing paracetamol.
if you have nutrition problems (malnutrition) or dehydration.
Inform your doctor before treatment if any of the above mentioned conditions apply to you.
Other medicines and Paracetamol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. Especially tell your doctor if you are taking:
- medicines containing paracetamol or propacetamol; Tell your doctor if you are taking other
medicines containing paracetamol or propacetamol. Your doctor will take this into account in
order not to exceed the recommended daily dose (listed in section 3).
- probenecid (used for gout). Your doctor may reduce your Paracetamol dose in case you are
taking both these medicines at the same time.
- salicylamide (anti-inflammatory drug).
- medicines that induce liver enzymes
- medicines used to thin your blood (anticoagulants), which are taken by mouth. Your doctor
may check-up closely the effect of the anticoagulants.
Paracetamol with food and drink
The effect of paracetamol is not influenced by food including dairy products.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine. Inform your doctor if you are
pregnant. Paracetamol may be used during pregnancy. However, in this case your doctor must
evaluate if the treatment is advisable. Paracetamol may be used during breast-feeding. Ask your
doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Paracetamol has no influence on the ability to drive and use machines
Paracetamol contains sodium: This medicinal product contains less than 1 mmol sodium (23
mg) per 100 ml of Paracetamol, it is essentially "sodium free".
3. How to use Paracetamol
Paracetamol will be administered to you by a healthcare professional. It will be given directly into a
vein, by slow intravenous infusion. The 100 ml bottle is restricted to adults, adolescents and
children weighing more than 33 kg. The 50 ml bottle is restricted to term newborn infants, infants,
toddlers and children weighing less than 33 kg. Your doctor will monitor you closely before the end
of your infusion.
Dosage: Dosing based on patient weight (please see the following dosing table)
Patient Weight

Dose per
administra
tion

Volume
per
administra
tion

≤10 kg*
>10kg to ≤33kg

7.5 mg/kg
15 mg/kg

0.75 mL/kg
1.5 mL/kg

Maximum volume of
(10 mg/mL)
per administration based
on upper weight limits of
group (mL)***
7.5 mL
49.5 mL

>33kg to ≤50kg

15 mg/kg

1.5 mL/kg

75 mL

Maximum
daily dose **

30 mg/kg
60 mg/kg not
exceeding 2g
60 mg/kg not
exceeding 3g
3g

> 50kg with
1g
100 mL
100 mL
additional risk
factors for
hepatoxicity
> 50kg and no
1g
100 mL
100 mL
4g
additional risk
factors for
hepatoxicity
* Pre-term newborn infants: No safety and efficacy data are available for pre-term newborn
infants.

** Maximum daily dose: The maximum daily dose as presented in the table above is for patients
that are not receiving any paracetamol containing products and should be adjusted accordingly
taking such products into account.
*** Patients weighing less will require smaller volumes.
The minimum interval between each administration must be at least 4 hours.The minimum interval
between each administration in patients with severe renal insufficiency must be at least 6 hours.
No more than 4 doses to be given in 24 hours.
Method of administration
RISK OF MEDICATION ERRORS
Take care to avoid dosing errors due to confusion between milligram (mg) and milliliter
(mL), which could result in accidental overdose and death.
Paracetamol is administered as an intravenous infusion over 15 minutes. In children, the volume
of solution to be infused is 1.5 ml per kg per administration. It can also be diluted in 9 mg/ml
(0.9%) sodium chloride or 50 mg/ml (5%) glucose up to one tenth. The diluted solution should be
visually inspected and must not be used if the solution is milky (opalescent), or has visible
particulate matter or precipitate. If you have the impression that the effect of Paracetamol 10
mg/ml, solution for infusion is too strong or too weak, talk to your doctor.
If you use more Paracetamol than you should: Talk to your doctor or pharmacist immediately.
In overdose cases, symptoms generally appear within the first 24 hours and consist of: nausea,
vomiting, anorexia, having a pale colour (pallor), abdominal pain and a risk of liver injury. If you
have any further questions on the use of this product ask your doctor or pharmacist.
If you forget to use Paracetamol: If you are concerned that you may have missed a dose of
Paracetamol, contact your doctor immediately.
If you stop using Paracetamol: If you have any further questions on the use of this medicine, ask
your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects include:
Very rare (may affect up to 1 in 10,000 people):
Very rare cases of serious skin reactions have been reported.
allergic reaction. The signs of an allergic reaction include:
rash
sudden wheeziness,
difficulty in breathing,
swelling of the eyelids, face, lips or throat.
If you experience any of the above symptoms, stop treatment immediately and inform your
doctor.
Rare (may affect up to 1 in 1,000 people):
general feeling of being unwell (malaise),
a drop in blood pressure,
changes in laboratory test results: abnormally high levels of hepatic enzymes found during blood
checks.
Should any of the above occur, inform your doctor as regular blood checks may be required later.
In isolated cases, other changes in laboratory test results have been observed which have
necessitated regular blood checks:
abnormally low levels of some types of blood cells (platelets, white cells), possibly leading to
bleeding from the nose or gums. Should this occur, inform your doctor.
Cases of redness of the skin, flushing, itching and abnormally rapid beating of the heart have been
reported. Cases of pain and burning sensation at injection site have been reported.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly Yellow Card Scheme,
Website: 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
Keep this medicine out of the sight and reach of children. Do not use Paracetamol after the expiry
date which is stated on the packaging after EXP. The expiry date refers to the last day of that
month. Do not store above 30°C. Do not refrigerate or freeze. For the 50 ml bottle, after dilution in
9 mg/ml (0.9% w/v) sodium chloride or 50 mg/ml (5% w/v) glucose: do not store for more than 1
hour (infusion time included). Before administration, the product should be inspected visually. Do
not use Paracetamol if you notice any particulate matter and discoloration. For single use only.
The product should be used immediately after opening. Do not throw away any medicines via
household waste. Ask your pharmacist how to throw medicines you no longer use. These
measures will help protect the environment
6. Contents of the pack and other information
What Paracetamol contains
• The active substance is paracetamol. Each bottle contains 1 g paracetamol. 1 ml contains 10
mg paracetamol.
• The other ingredients are mannitol, disodium phosphate anhydrous, hydrochloric acid (for pHadjustment), sodium hydroxide (for pH-adjustment) and water for injections.
What Paracetamol looks like and contents of the pack
Paracetamol is a clear, slightly yellowish solution for infusion. Paracetamol is packaged in carton
boxes containing 50 ml polypropylene bottles. Each bottle is placed in a metalized plastic pouch.
Paracetamol is packaged in carton boxes containing 100 ml polypropylene bottles. Each bottle is
placed in a metalized plastic pouch. The 50 ml and 100 ml bottles are available in packs of 1, 5, 10
and 12 bottles. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building
3, Office 115, 1065 Nicosia, Cyprus.
Manufacturer: DEMO S.A., 21st km National Road Athens-Lamia, 14568 Krioneri, Athens,
Greece.
This medicinal product is authorised in the Member States of the EEA under the following
names:
Portugal
Paracetamol Noridem
United Kingdom Paracetamol 10mg/ml Solution for infusion
Germany
Paracetamol Noridem 10 mg/ml Infusionslösung
Spain
Paracetamol KERN PHARMA 10mg/ml solución para perfusión
EFG
This leaflet was last revised in 06/2014
---------------------------------------------------------------------------------------If this leaflet is difficult to see or read, please contact the following address for help:
Fannin Limited, Fannin House, South County Business Park, Leopardstown, Dublin 18,
Ireland Tel +353-1-2907000.

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.

Hide