Paracetamol 500mg effervescent tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paracetamol

Available from:

A A H Pharmaceuticals Ltd

ATC code:

N02BE01

INN (International Name):

Paracetamol

Dosage:

500mg

Pharmaceutical form:

Effervescent tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070100; GTIN: 5025903081159 5025903081272 5025903085294

Patient Information leaflet

MAH Generic Paracetamol 500mg (PIL)-word-file
2. BEFORE YOU TAKE PARACETAMOL EFFERVESCENT
a
PATIENT INFORMATION LEAFLET
TAKE SPECIAL CARE WITH PARACETAMOL EFFERVESCENT IF:
PARACETAMOL EFFERVESCENT 500MG TABLETS
The name of this medicine is Paracetamol Effervescent 500mg Tablets,
which will be
referred to as Paracetamol Effervescent throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR
YOU.
• This medicine is available without prescription. However, you
still need to use
Paracetamol Effervescent 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 three
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.
The active ingredient in Paracetamol Effervescent is paracetamol.
Paracetamol Effervescent is used to relieve pain, including muscular
and rheumatic
pains, headache, migraine, neuralgia (severe burning or stabbing pain
following the
line of a nerve), toothache, sore throat, period pains, aches and
pains, discomfort
associated with influenza (flu), feverishness and feverish colds.
DO NOT TAKE PARACETAMOL EFFERVESCENT IF YOU:
• are ALLERGIC (HYPERSENSITIVE) to PARACETAMOL or any of the OTHER
INGREDIENTS in
the tablets (these are listed in Section 6, Further Information)
• are already taking OTHER MEDICINES CONTAINING PARACETAMOL
• you have kidney or liver problems, including alcoholic liver
disease
Taking a painkiller for headaches too often or for too long can make
them worse.
TAKING OTHER MEDICINES
DO NOT take these tablets if you are already taking other medicines
containing
paracetamol.
Please tell your doctor or pharmacist if you are taking or have
recently taken any
other medicines, including medicines obtained without a prescription.
Certain medicines can interfere with

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Effervescent Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500.0 mg
Excipients with known effect
Sodium 316mg / 13.7mmol
Lactose monohydrate 108mg
Sorbitol 80mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Effervescent tablet.
White round, biplane, single scored effervescent tablet. The score
line is not
intended for breaking the tablet.
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, backache, rheumatic and
muscle
pains, dysmenorrhoea, sore throat, and for relieving the fever, aches
and pains of
colds and flu.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, the elderly and children aged 16 years and over: _
1 - 2 tablets in at least half a tumbler of water, up to 4 times daily
as required.
_Paediatric population _
_Children aged 10 - 15 years: _
1 tablet dissolved in water every 4 – 6 hours up to a maximum of 4
doses in
24 hours.
_Children aged under 10 years: _
Not recommended for children under the age of 10 years.
Children should not be given paracetamol for more than 3 days without
consulting a doctor.
Doses of paracetamol should not be given more frequently than every 4
hours,
and no more than 4 doses should be given in any 24 hour period.
Method of administration
Oral administration only.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
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.
Do not exceed the stated dose.
Patients should be advised to consult their doctor if their headaches
become
persistent.