Panadol Original 500 mg film-coated Tablets

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Paracetamol

Доступно од:

Haleon Ireland Limited

АТЦ код:

N02BE; N02BE01

INN (Међународно име):

Paracetamol

Дозирање:

500 milligram(s)

Фармацеутски облик:

Film-coated tablet

Тип рецептора:

Product not subject to medical prescription

Терапеутска област:

Anilides; paracetamol

Статус ауторизације:

Not marketed

Датум одобрења:

1978-04-01

Информативни летак

PA 678/39/5
_PATIENT INFORMATION LEAFLET TEXT _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
PANADOL ORIGINAL 500MG FILM-COATED TABLETS PARACETAMOL
PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS
MEDICINE.
This medicine is available without prescription, but you still need to
use Panadol Original tablets
carefully to get the best results from them.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not
included in section 4 of this leaflet.
•
If you have any further questions, ask your pharmacist.
•
Keep this leaflet, you may need to read it again.
WHAT IS IN THIS LEAFLET:
1.
What Panadol Original tablets are and what they are used for
2.
Check before you take Panadol Original tablets
3.
How to take Panadol Original tablets
4.
Possible side effects
5.
How to store and dispose of Panadol Original tablets
6.
Contents of the pack and other information
1.
WHAT PANADOL ORIGINAL TABLETS ARE AND WHAT THEY ARE USED FOR
PANADOL ORIGINAL TABLETS CONTAINS THE ACTIVE SUBSTANCE PARACETAMOL
WHICH IS A PAINKILLER AND ALSO
REDUCES YOUR TEMPERATURE WHEN YOU HAVE A FEVER.
PANADOL ORIGINAL TABLETS ARE USED FOR FAST AND EFFECTIVE RELIEF OF
HEADACHES, TOOTHACHE, BACKACHE,
RHEUMATIC AND MUSCLE PAINS AND PERIOD PAIN. It also relieves sore
throat and the feverishness, aches
and pains of colds and flu. Panadol Original tablets also provide
relief from the pain associated with
osteoarthritis as diagnosed by a doctor.
2.
CHECK BEFORE YOU TAKE PANADOL ORIGINAL TABLETS
CONTAINS PARACETAMOL. DO NOT TAKE WITH ANY OTHER PARACETAMOL
CONTAINING PRODUCTS.
DO NOT TAKE PANADOL ORIGINAL TABLETS:
•
IF YOU HAVE EVER HAD AN ALLERGIC REACTION to paracetamol or to any of
the other ingredients (listed
in Section 6).
•
if you are UNDER 10 YEARS.
CHECK WITH YOUR DOCTOR BEFORE USE IF YOU:
•
have liver or kidney problems, including alcoholic liver disease
•
are underweight or ma

Карактеристике производа

Health Products Regulatory Authority
12 July 2023
CRN00DKWJ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Panadol Original 500 mg film-coated 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
Film-coated tablet
White, film-coated capsule-shaped tablets, 14 mm, with flat edges,
with a triangular logo debossed on one side and a break
line on the other.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Panadol Original is a mild analgesic and antipyretic. The tablets are
recommended for use in the short-term management of
headaches, musculoskeletal disorders, menstrual pain, toothache and
for symptoms of common colds and flu. Panadol Original
may also be used in the symptomatic relief of mild to moderate pain
associated with osteoarthritis as diagnosed by a doctor.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Panadol Original is for oral administration.
ADULTS (INCLUDING THE ELDERLY) AND CHILDREN AGED 16 YEARS AND OVER:
One or two tablets up to four times daily as required.
CHILDREN AGED 10-15 YEARS:
One tablet up to four times daily as required. Children should not be
given Panadol Original Tablets for more than 3 days
without consulting a doctor.
Panadol Original tablets are not recommended for children under 10
years of age.
These doses should not be repeated more frequently than every 4 hours
and not more than 4 doses should be given in any 24
hour period.
The lowest dose necessary to achieve efficacy should be used.
4.3 CONTRAINDICATIONS
Hypersensitivity to paracetamol or any of the other constituents.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Contains paracetamol. Do not use with any other paracetamol-containing
products. The concomitant use with other products
containing paracetamol may lead to an overdose. Paracetamol overdose
may cause liver failure which can lead to liver
transplant or death.
Health Products Regulatory