Paracetamol 500mg tablets

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Paracetamol

Dostupné s:

Aspar Pharmaceuticals Ltd

ATC kód:

N02BE01

INN (Mezinárodní Name):

Paracetamol

Dávkování:

500mg

Léková forma:

Oral tablet

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 04070100; GTIN: 5024071210040 5024071210194 5024071210002

Informace pro uživatele

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WHAT IS IN THIS LEAFLET
1. What Paracetamol is and what it is used for
2. What you need to know before you take Paracetamol 500mg Tablets
3. How to take Paracetamol 500mg Tablets
4. Possible side effects
5. How to store Paracetamol 500mg Tablets
6 Contents of the pack and other information
1. W
HAT
P
ARACETAMOL IS AND WHAT IT IS USED FOR
These tablets contain Paracetamol and are used to treat mild to
moderate pain
including headache, migraine, neuralgia, toothache, sore throat,
period pain, flu, fever,
aches and pains including muscles pains, back ache and rheumatic aches
and pains.
2. W
HAT YOU NEED TO KNOW BEFORE YOU TAKE
P
ARACETAMOL
500
MG
T
ABLETS
DO NOT TAKE THESE TABLETS IF YOU:
•
Are allergic to Paracetamol or any of the other ingredients listed in
section 6
(see section 4 – possible side effects)
• Suffer from liver or kidney problems
• Suffer from alcohol dependency
• Suffer from non-serious arthritis and need to take painkillers
every day
OTHER MEDICINES AND PARACETAMOL
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any
other medicines:
• Blood thinning medicines such as Warfarin
• Metoclopramide and Domperidone (for sickness and digestive
disorders)
• Colestyramine (to help control cholesterol levels)
• Any drugs that affect the liver
• Any other anti-inflammatory drugs e.g. aspirin
• Any other paracetamol containing products
• Flucloxacillin (antibiotic), due to a serious risk of blood and
fluid abnormality (high
anion gap metabolic acidosis) that must have urgent treatment and
which may occur
particularly in case of severe renal impairment, sepsis (when bacteria
and their toxins
circulate in the blood leading to organ damage), malnutrition, chronic
alcoholism, and if
the maximum daily doses of paracetamol are used.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have
a baby, ask your doctor or pharmacist for advice before taking this
medicine.
3. H
OW TO TAKE
P

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: - Paracetamol Ph.Eur. 500mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Uncoated tablet.
A white capsule shaped tablet with break line marked ap/500. The
tablet can be
divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
A mild analgesic and antipyretic, recommended for the treatment of
most
painful and febrile conditions, for example, headache including
migraine and
tension headaches, tooth ache, 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:
_ADULTS, THE ELDERLY AND CHILDREN 16 YEARS AND OVER:_ One or two
tablets to be
taken every four to six hours, when necessary up to four times daily.
Maximum dose of 8 tablets in 24 hours.
_ _
_CHILDREN 10 - 15 YEARS_: One tablet to be taken every four to six
hours, when
necessary to a maximum of four doses in 24 hours.
_ _
_ _
_Not suitable for children under 10 years of age_.
Children should not be given tablets for more than 3 days without
consulting a
doctor.
These doses should not be repeated more frequently than every four to
six
hours nor should more than four doses be administrated in any 24 hour
period.
Method of administration:
Paracetamol tablets to be administered orally only.
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
renal or
hepatic impairment. The hazard of overdose is greater in those with
non-
cirrhotic alcoholic liver disease.
Caution is advised if paracetamol is administered concomitantly with
flucloxacillin due to increased risk of high anion gap metabolic
acidosis
(HAGMA), par