Paracetamol 500mg effervescent tablets

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Paracetamol

Beszerezhető a:

DE Pharmaceuticals

ATC-kód:

N02BE01

INN (nemzetközi neve):

Paracetamol

Adagolás:

500mg

Gyógyszerészeti forma:

Effervescent tablet

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 04070100

Betegtájékoztató

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

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Effervescent Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains 500mg of Paracetamol.
Excipient(s) with known effect
Sodium content approximately 418.5mg/tablet.
Also contains sorbitol (E420) 100mg /tablet.
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Effervescent Tablet
White to off-white round, flat, beveled edged tablets plain on both
sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of mild to moderate pain and/or fever.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults, the elderly and children over 16 years: One or two tablets to
be taken
up to four times daily. Maximum dose of 8 tablets in 24 hours.
Children 12-15 years : One tablet, every 4-6 hours when necessary to a
maximum of 4 doses in 24 hours.
Children under 12 years of age: Not recommended.
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.
The tablets should be placed in a full glass of water and allowed to
dissolve
completely before swallowing.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in
section 6.1
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Prolonged or frequent use is discouraged. Patients should be advised
not to take other
Paracetamol containing products concurrently. Taking multiple daily
doses in one
administration can severely damage the liver; in such case
unconsciousness does not
occur. However, medical assistance should be sought immediately.
Prolonged use
except under medical supervision may be harmful. In adolescents
treated with
60mg/kg daily of Paracetamol, the combination with another antipyretic
is not
justified except in the case of ineffectiveness.
Caution is advised in the administration of Par