Paracetamol 500mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Paracetamol

Dostopno od:

Flamingo Pharma (UK) Ltd

Koda artikla:

N02BE01

INN (mednarodno ime):

Paracetamol

Odmerek:

500mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 04070100; GTIN: 5060464500862 5060464500039

Navodilo za uporabo

XXXX
PHARMA
CODE
XXXX
PHARMA
CODE
285 mm
285 mm
150 mm
150 mm
FONTS SIZE :
Header's font size : 12 pt.
Generic fonts size : 9 pt.
FONTS : Arial
_(GSL)_
PARACETAMOL 500MG TABLETS (FPL)
LEAFLET SIZE : 285 X 150 MM
MPLLPAR0500CL016FPLXXX240V02
Package leaflet: Information for the patient
PARACETAMOL 500 MG TABLETS
PARACETAMOL
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 or pharmacist.
• 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 or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.
1. WHAT PARACETAMOL TABLETS ARE AND WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL TABLETS
3. HOW TO TAKE PARACETAMOL TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE PARACETAMOL TABLETS
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT IS IN THIS LEAFLET
These tablets contain the active ingredient,
paracetamol.
Paracetamol is an analgesic and an
antipyretic which means it relieves pain and
lowers temperature.
Paracetamol Tablets are used for the relief of
mild to moderate pain including headache,
migraine, neuralgia, toothache, sore throat,
period pains, rheumatic aches and pains.
Also for the relief of symptoms of influenza,
feverishness and feverish colds.
1. WHAT PARACETAMOL TABLETS ARE AND WHAT THEY ARE USED FOR
SOME PEOPLE MUST NOT TAKE THESE TABLETS.
DO NOT TAKE PARACETAMOL TABLETS:
• If you are allergic to paracetamol or to any
other of the other ingredients of this
medicine (listed in section 6).
DO NOT TAKE ANYTHING ELSE CONTAINING
PARACETAMOL WHILE TAKING THIS MEDICINE.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
taking Paracetamol Tablets
• If you suffer from any liver or kidney
prob

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Tablets BP.
PocketPak Paracetamol 500 mg Caplets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol 500mg.
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White, capsule shaped tablet with a break-line on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of mild to moderate pain including headache,
migraine, neuralgia,
toothache, sore throat, period pain, aches and pains.
Symptomatic relief of rheumatic aches and pains.
Symptomatic relief of influenza, feverishness, feverish colds.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
Adults, the elderly and children 16 years and over: One or two tablets
to be taken up to
four times daily. Maximum dose of 8 tablets in 24 hours.
Children 10 to 15 years of age: One tablet to be taken for every 4-6
hours when
necessary to a maximum of 4 doses in 24 hours.
Children under 10 years of age: Not recommended. Alternative
presentations of
paracetamol are recommended for paediatric usage in order to obtain
suitable doses of
less than 500mg.
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.
Dosage should not be continued for more than 3 days without consulting
a doctor.
Method of administration
For oral administration.
4.3
CONTRAINDICATIONS
Hypersensitivity to paracetamol or any of the other ingredients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Where analgesics are used long-term (>3 months) with administration
every two
days or more frequently, headache may develop or worsen. Headache
induced by
overuse of analgesics (MOH medication-overuse headache) should not be
treated
by dose increase. In such cases, the use of analgesics should be
discontinued in
consultation with the doctor.
Care is advised in the administration of paracetamol to patients with
alcohol
dependency (see section 4.9), severe renal or severe hepatic
impairment. The
hazards of overdose are greater