Paracetamol Krka 500 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol

Available from:

KRKA, d.d., Novo mesto

ATC code:

N02BE01

INN (International Name):

Paracetamol

Dosage:

500 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

paracetamol

Authorization status:

Not marketed

Authorization date:

2020-05-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PARACETAMOL KRKA 500 MG TABLETS
paracetamol
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 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.
WHAT IS IN THIS LEAFLET
1.
What Paracetamol Krka is and what it is used for
2.
What you need to know before you take Paracetamol Krka
3.
How to take Paracetamol Krka
4.
Possible side effects
5.
How to store Paracetamol Krka
6.
Contents of the pack and other information
1.
WHAT PARACETAMOL KRKA IS AND WHAT IT IS USED FOR
Paracetamol Krka relieves mild to moderate pain and reduces fever.
You can use Paracetamol Krka for aches and pains of various kinds,
such as headache, menstrual
pains, toothache, muscle and joint pain and during fever, for example
in cold.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL KRKA
DO NOT TAKE PARACETAMOL KRKA
-
if you are allergic to paracetamol or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Paracetamol Krka.
If the recommended dose is exceeded, life-threatening poisoning may
occur. If there is suspicion of
overdose, you should contact your doctor immediately. If you take
other medicines that also contain
paracetamol, there is a risk of overdose.
Caution is required in weakened and exhausted patients and alcoholics.
Talk to your doctor before taking Paracetamol Krka if:
-
you have impaired liver function.
-
you have impaired kidney function.
-
you have a poor nutritional status, eg. due to alcohol abuse, loss of
appetite (anorexia) or
malnutrition.
-
you may n

Summary of Product characteristics

Health Products Regulatory Authority
04 July 2022
CRN00CX8L
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol Krka 500 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg paracetamol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, caplet-shaped tablet, debossed with "500" on one side and plain
on other side (17.5 mm long x 7.3 mm x 5.7 mm thick).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of mild to moderate pain and fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Paracetamol should be used at the lowest effective dose for the
shortest possible time. The maximum daily dose must not be
exceeded.
_Adults and adolescents aged 16 years and older (≥ 55 kg of body
weight)_
500-1000 mg 3-4 times a day, but not more than 4 g per day. In
individual cases, 500 mg 3-4 times a day may be sufficient.
Minimum dosing interval between doses should be at least 4 hours.
_Paediatric population_
Children between 9-12 years (30-40 kg of body weight) 500 mg up to 3
times a day.
Children between 12-15 years (40-55 kg of body weight) 500 mg up to 4
times a day.
Doses depend on body weight and age. Recommended single dose is 15
mg/kg of body weight. The maximal daily dose for
patients weighing less than 50 kg is 60 mg/kg of body weight/day.
Minimum dosing interval between doses should be at least 4 hours.
Paracetamol Krka is not suitable for children under 9 years of age.
_Patients with renal insufficiency_
The drug should be used with caution in patients with renal
insufficiency.
In case of moderate and severe renal insufficiency the dose should be
adjusted:
Glomerular filtration
Dose
10-50 ml/min
500 mg every 6 hours
<10 ml/min
500 mg every 8 hours
_Patients with hepatic impairment_
The drug should be used with caution in patients with hepatic
dysfunction (see section 4.4). In patients with impaired liver
function, the dose should be reduced or the dosing interval extended.
The daily do