Paracetamol 500mg/5ml Oral Solution

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

PARACETAMOL

Διαθέσιμο από:

Wockhardt UK Limited

Φαρμακολογική κατηγορία (ATC):

N02BE; N02BE01

INN (Διεθνής Όνομα):

PARACETAMOL

Δοσολογία:

500 mg/5ml

Φαρμακοτεχνική μορφή:

Oral solution

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Anilides; paracetamol

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2016-07-01

Φύλλο οδηγιών χρήσης

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 any further questions, ask your doctor, 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 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.
CONTAINS PARACETAMOL
DO NOT take any other paracetamol containing products
DO NOT exceed the stated dose.
IMMEDIATE medical advice should be sought in the event of
overdosage, because of the risk of irreversible liver damage.
WHAT IS IN THIS LEAFLET
1. What Paracetamol Oral Solution is and what it is used for
2. Before you take Paracetamol Oral Solution
3. How to take Paracetamol Oral Solution
4. Possible side effects
5. How to store Paracetamol Oral Solution
6. Contents of the pack and other information
1. WHAT PARACETAMOL ORAL SOLUTION 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 Solution. 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 SOLUTION
DO NOT TAKE THIS MEDICINE IF YOU HAVE:
•
had an allergic reaction to paracetamol or any of the other
ingredients listed in section 6. An allergic reaction can
include a rash, itching or shortness of breath
•
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:
•
kidney problems
•
liver problems, including those due to drinking too much
alcohol.
You may be more at risk of th

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
12 November 2019
CRN009FV2
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains 500mg Paracetamol
Excipients with known effect:
Glycerol
1.5 g
/5ml
Propylene glycol
1.66 g
/5ml
Methylparahydroxybenzoate
9 mg
/5ml
Propylparahydroxybenzoate
1 mg
/5ml
Sunset yellow
0.15 mg
/5ml
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution.
A clear, amber solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of mild to moderate pain in patients who are unable
to receive other paracetamol formulations such as lower
strength liquid preparations, effervescent tablets or tablets.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration only.
Posology
Adults and adolescents over 16 years:
500mg (5ml) to 1000mg (10ml) up to three to four times a day, as
required.
Maximum daily dose should not exceed 4g (40ml).
The dose should not be repeated more frequently than every four hours,
and not more than four doses should be taken in any
24 hour period.
Method of administration
A calibrated oral dosing syringe is supplied with this dosage form for
accurate and convenient dose adjustment.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Patients with severe hepatic dysfunction.
Do not use this medicine in children and adolescents under 16 years.
Health Products Regulatory Authority
12 November 2019
CRN009FV2
Page 2 of 5
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Care is advised in the administration of paracetamol to patients with
renal or hepatic impairment. The hazards of overdose are
greater in those with non-cirrhotic alcoholic liver disease.
Do not take with any other paracetamol-containing products.
Immediate medical advice should be sought in the event of an overdose,
even if you feel well, because of the risk of delayed
serious or irreversible l