Paracetamol 500mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Paracetamol

זמין מ:

Accord-UK Ltd

קוד ATC:

N02BE01

INN (שם בינלאומי):

Paracetamol

כמות:

500mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 04070100; GTIN: 5060149310250 05012617001573 5012617009371 5012617010469

עלון מידע

PACKAGE LEAFLET – INFORMATION FOR THE USER
PARACETAMOL 500MG TABLETS
(PARACETAMOL)
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
This medicine is available without prescription. However, you still
need to take Paracetamol
Tablets carefully to get the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
You must contact a doctor if your symptoms worsen or do not improve
after 3 days.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What are Paracetamol Tablets and what are they used for
2.
Before you take Paracetamol Tablets
3.
How to take Paracetamol Tablets
4.
Possible side effects
5.
How to store Paracetamol Tablets
6.
Further information
1.
WHAT ARE PARACETAMOL TABLETS AND WHAT ARE THEY USED FOR
Paracetamol tablets belongs to a group of medicines called Analgesics
and Antipyretics. It works by
relieving pain and reducing high temperature and fever.
Paracetamol tablets are used for the relief of mild to moderate pain
including headache , migraine,
tension headaches, neuralgia (severe pain in nerves), backache,
toothache, sore throat, period pain,
symptomatic relief of sprains, strains, rheumatic pain, sciatica (low
back pain and leg pain), lumbago
(low back pain), fibrositis (muscle and connective tissue pain),
muscular aches and pains, joint
swelling
and
stiffness,
influenza
,
feverishness
and
feverish
colds.
It
may
also
be
used
for
symptomatic relief of pain due to non-serious arthritis.
2.
BEFORE YOU TAKE PARACETAMOL TABLETS
Do not take Paracetamol tablets:
•
If you are allergic to paracetamol or any of the other ingredients of
Paracetamol tablets (see
section 6).
•
If you are taking any other products that contain Paracetamol.
•
If you are under 10 years of age.
TAKE SPECIAL CARE WITH PARACETAMOL TABLETS
BEFORE TAKING PARACETAMOL TABLETS,
Tell your doc

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500 mg.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, uncoated caplet with inscription
B
T
on one side and plain on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paracetamol is a mild analgesic and antipyretic, and is recommended
for the
treatment of most painful and febrile conditions, for example,
headache including
migraine and tension headaches, toothache, neuralgia, backache,
rheumatic and
muscle pains, dysmenorrhoea, sore throat, and for relieving the fever,
aches and pains
of colds and flu. Also recommended for the symptomatic relief of pain
due to non-
serious arthritis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Oral administration only.
_ _
_ADULTS, THE ELDERLY AND CHILDREN OVER 16 YEARS AGE: _
One to two tablets up to four times daily as required, up to a maximum
of 8
tablets in 24 hours.
_ _
CHILDREN 10 – 15 YEARS: 1 tablet every 4 hours as required, to a
maximum of 4
tablets in 24 hours.
NOT RECOMMENDED FOR CHILDREN UNDER 10 YEARS OF AGE.
The dose should not be repeated more frequently than every 4 hours and
not
more than 4 doses should be taken in any 24 hour period.
4.3
CONTRAINDICATIONS
Hypersensitivity to paracetamol or any of the other constituents.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Care is advised in the administration of paracetamol to patients with
severe
renal or hepatic impairment. The hazard of overdosage is greater in
those with
non-cirrhotic alcoholic liver disease.
DO NOT EXCEED THE RECOMMENDED_ _DOSE.
If symptoms persist for more than 3 days or get worse consult your
doctor.
Do not to take with other paracetamol-containing products.
Patients should be advised to consult a doctor if they suffer from
non-serious
arthritis and need to take painkillers every day.
Keep out of the sight and reach of children.
Immediate medical advice should be sought