Paracetamol 500 mg Capsules, hard

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Paracetamol

Prieinama:

Azure Pharmaceuticals Ltd

ATC kodas:

N02BE01

INN (Tarptautinis Pavadinimas):

Paracetamol

Vaisto forma:

Capsule, hard

Gydymo sritis:

paracetamol

Autorizacija statusas:

Not marketed

Leidimo data:

2022-06-03

Pakuotės lapelis

Package leaflet: Information for the patient
PARACETAMOL 500 MG CAPSULES, HARD
paracetamol
3. HOW TO TAKE PARACETAMOL CAPSULES
ADULTS (INCLUDING THE ELDERLY) AND
CHILDREN AGED 16 YEARS AND OVER:
Take 1-2 capsules every 4 to 6 hours as
required. Do not take more than eight
capsules in any 24 hours.
Do not take more than four capsules a day
(2 g/day) in the following situations, unless
directed by your doctor:
-
Weight less than 50 kg
-
Use of large quantities of alcohol
regularly (alcoholism)
-
Dehydration
- Malnutrition.
CHILDREN AGED 10-15 YEARS:
Give 1 capsule every 4 to 6 hours as
required. Do not take more than 4 capsules
in any 24 hours.
Do not give to children for more than 3
days without consulting a doctor.
CHILDREN UNDER 10 YEARS:
Do not give to children under 10 years of
age.
Use in kidney or liver impairment:
If you have been diagnosed with kidney or
liver problems, please consult your doctor
or pharmacist. You may need to take a
lower dose or increase the length of time
between doses.
•
CONTAINS PARACETAMOL.
•
DO NOT TAKE MORE THAN THE
RECOMMENDED DOSE.
•
DO NOT TAKE MORE FREQUENTLY THAN
EVERY 4 HOURS.
•
DO NOT TAKE MORE THAN 4 DOSES IN 24
HOURS.
•
IF SYMPTOMS PERSIST CONSULT YOUR
DOCTOR.
•
PROLONGED USE EXCEPT UNDER MEDICAL
SUPERVISION MAY BE HARMFUL.
•
ALWAYS USE THE LOWEST EFFECTIVE DOSE TO
RELIEVE YOUR SYMPTOMS.
IF YOU TAKE TOO MANY CAPSULES
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines Paracetamol capsules
can have side effects, but not everybody
gets them.
Very rare cases of serious skin reactions
have been reported.
STOP TAKING THIS MEDICINE AND TELL YOUR
DOCTOR IMMEDIATELY IF:
•
you experience serious skin reactions,
very rare cases of which have been
reported.
•
you experience allergic reactions such as
skin rash or itching, sometimes with
breathing problems or swelling of the
lips, tongue, throat or face.
•
you experience a seve

Prekės savybės

Health Products Regulatory Authority
03 June 2022
CRN00C3F6
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500 mg Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 500 mg paracetamol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
CAPSULE, HARD (Capsules)
White to off-white crystalline powder filled in size '0' capsules with
ivory colour body
and ivory colour cap, having a nominal lock length of 21.4 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in the short-term management of mild pain and fever and for
symptoms of common colds and flu in adults, the elderly
and children aged over 10 years. Paracetamol may also be used in the
symptomatic relief of mild to moderate pain associated
with osteoarthritis in adults and the elderly, as diagnosed by a
doctor.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS (INCLUDING THE ELDERLY) AND CHILDREN AGED 16 YEARS AND OVER:
One or two capsules up to four times daily as required.
Renal impairment
Paracetamol should be used with caution in patients with renal
impairment as a reduced dose and/or prolonged dosing
interval may be necessary (see section 4.4).
Hepatic impairment
Paracetamol should be used with caution in patients with hepatic
impairment as a reduced dose or prolonged dosing interval
may be necessary (see section 4.4).
The elderly
Experience has indicated that normal adult dosage of paracetamol is
usually appropriate. However, in frail, immobile elderly
subjects or in elderly patients with renal or hepatic impairment, a
reduction in the amount or frequency of dosing may be
appropriate (see section 4.4).
In all patients over 16 years of age, the maximum daily dose of
paracetamol should not exceed 60 mg/kg/day (up to a
maximum of 2 g per day) in the following situations, unless directed
by a physician: (see section 4.4)
• Weight less than 50kg
• Dehydration
• Malnutrition
• Chronic alcoholism
CHILDREN AGED 10-15 YEARS:
One capsule up to four times