Paracetamol 500mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Paracetamol

Dostupné z:

Noumed Life Sciences Ltd

ATC kód:

N02BE01

INN (Medzinárodný Name):

Paracetamol

Dávkovanie:

500mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 04070100; GTIN: 5060453460733

Príbalový leták

LPAR02/01
5.
HOW TO STORE PARACETAMOL
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage
conditions.
Do not use this medicine after the expiry date which is stated on the
carton after
EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask
your
pharmacist how to throw away medicines you no longer use. These
measures will
help protect the environment.
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT PARACETAMOL 500 MG TABLETS CONTAINS
-
The active substance is paracetamol. Each tablet contains paracetamol
500 mg
-
The other ingredient(s) are pregelatinised starch, povidone (K 30),
stearic acid.
WHAT PARACETAMOL 500 MG TABLETS LOOKS LIKE AND CONTENTS OF THE PACK
Paracetamol 500 mg tablets are white to off-white, capsule shaped
biconvex tablets
with P 500 embossing on one side and a break-line on other side.
Paracetamol is available in blister packs containing 100 tablets.
MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Noumed Life Sciences Limited, Noumed House,
Shoppenhangers Road, Maidenhead,
Berkshire SL6 2RB, United Kingdom.
This leaflet was last revised in May 2022.
TO LISTEN TO OR REQUEST A COPY OF THIS LEAFLET IN BRAILLE,
LARGE PRINT OR AUDIO PLEASE CALL,
020 33998960 (UK ONLY)
PLEASE BE READY TO GIVE THE FOLLOWING INFORMATION:
PRODUCT NAME
REFERENCE NUMBER
PARACETAMOL 500MG TABLETS
PL 44041/0087
PARACETAMOL 500 MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This
includes any possible side effec

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol 500 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol Ph.Eur. 500 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White to off-white capsule shaped biconvex tablets with P 500
embossing on one side
and a break line on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paracetamol 500 mg Tablets 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, 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
Posology
For all indications:
Adults and adolescents above the age of 16:
One or two tablets up to four times a day, as required.
Maximum daily dose is 4 g in divided doses
CHILDREN AGED 12 TO 15 YEARS:
One to one and a half tablets up to four times a day, as required,
CHILDREN AGES 10 TO 11 YEARS:
One tablet up to four times a day, as required,
CHILDREN 6 TO 9 YEARS:
Half a tablet up to four times a day, as required.
CHILDREN UNDER 6 YEARS:
Do not give to children under 6.
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.
Dosage should not be continued for longer than 3 days without
consulting a doctor.
The maximum daily dose of paracetamol should not exceed 2g in the
following
situations unless directed by physician:
- Adults or adolescents weighing less than 50 kg
- Mild to moderate hepatic insufficiency, Gilbert’s syndrome
(familial non-
haemolytic
jaundice)
- Chronic alcoholism
- Dehydration
- Chronic malnutrition
Method of administration
Oral administration only.
4.3
CONTRAINDICATIONS
Hypersensitivity to paracetamol or any of the o