Paracetamol 500mg soluble tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Paracetamol

可用日期:

Zentiva Pharma UK Ltd

ATC代码:

N02BE01

INN（国际名称）:

Paracetamol

剂量:

500mg

药物剂型:

Effervescent tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 04070100; GTIN: 5000283601807 5000283509035 5000283598565

资料单张

PACKAGE LEAFLET – INFORMATION FOR THE USER
PARACETAMOL 500MG SOLUBLE TABLETS
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
• Do not pass this medicine 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.
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
3. How to take paracetamol
4. Possible side effects
5. How to store paracetamol
6. Contents of the pack and other information
1. WHAT PARACETAMOL IS AND WHAT IT IS USED FOR
The name of your medicine is Paracetamol 500mg Soluble Tablets (called
paracetamol
throughout this leaflet). This medicine contains paracetamol. It
belongs to a group of
medicines called analgesics (painkillers) and is used to treat pain
(including headache,
toothache and period pain) and cold or flu symptoms.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL
Do not take paracetamol and tell your doctor if:
• You are allergic (hypersensitive) to the active substance or any
of the other ingredients
in your medicine (listed in Section 6) Signs of an allergic reaction
include a rash and
breathing problems. There can also be swelling of the legs, arms,
face, throat or tongue
Children
Paracetamol 500mg Soluble Tablets must not be given to children under
10 years of age
Do not take paracetamol if any of the above apply to you. If you are
not sure, talk to your
doctor or pharmacist before taking paracetamol.
Warnings and precautions
Take special care and check with your doctor before taking paracetamol
if:
• You have severe kidney or liver problems
• You have a liver problem caused by alcohol
If you are not sure if any of the above apply t

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Soluble Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of paracetamol
Excipients with known effect
Each effervescent tablet contains 388 mg of sodium and 50mg of
sorbitol.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Effervescent tablet.
Flat white tablets scored on one side and plain on the reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paracetamol Soluble is a mild analgesic and antipyretic. The tablets
are recommended for the
treatment of most painful conditions for example, headache, including
migraine, toothache, sore throat,
dysmenorrhoea, rheumatic pains and the symptomatic relief of colds and
influenza.
4.2
Posology and method of administration
POSOLOGY
Adults, Elderly and Children over 16 years:
Two tablets in at least half a tumbler full of water, up to 4 times
daily as required. Do not take
for more than 3 days without consulting your doctor.
These doses should not be given more frequently than every 4 hours,
and not more than 4
doses should be given in any 24 hour period.
PAEDIATRIC POPULATION
Not recommended for children under the age of 10 years.
Children aged 10 to 15 years
One tablet every four to six hours when necessary to a maximum of four
doses in 24 hours.
Do not take for more than 3 days without consulting your doctor.
METHOD OF ADMINISTRATION
The tablets should be dissolved in water and are for 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
PAEDIATRIC POPULATION
Not recommended for children under the age of 10 years.
Care is advised in the administration of paracetamol to patients with
severe renal or severe
hepatic impairment. The hazard of overdose is greater in those with
non-cirrhotic alcoholic
liver disease.
Do not exceed the recommended dose.
Caution is advised if paracetamol is administered conc