Paracetamol 500mg effervescent 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:

Cipla EU 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: 8901117079892 8901117238077

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL 500 MG EFFERVESCENT TABLETS
paracetamol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
FOR MEDICINE AVAILABLE WITHOUT A PRESCRIPTION:
Always take this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse has
told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4
•
You must contact a doctor if you do not feel better or if you feel
worse after 3 days.
FOR MEDICINE AVAILABLE ONLY ON PRESCRIPTION:
•
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 or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS THIS LEAFLET:
1.
What Paracetamol Effervescent Tablets is and what it is used for
2.
What you need to know before you take Paracetamol Effervescent Tablets
3.
How to take Paracetamol Effervescent Tablets
4.
Possible side effects
5.
How to store Paracetamol Effervescent Tablets
6.
Contents of the pack and other information
1.
WHAT PARACETAMOL EFFERVESCENT TABLETS IS AND WHAT IT IS USED FOR
This medicine contain paracetamol, which belongs to a group of
medicines called analgesics and
antipyretics that relieve mild to moderate pain and/or fever.
It can be used to relieve headache, migraine, neuralgia, toothache,
period pain, rheumatic aches and
pains, sore throat and the symptoms of colds and flu.
You must talk to a doctor if you do not feel better or if you do not
improve after 3 days
2.
WHAT YOU NEED

产品特点

OBJECT 1
PARACETAMOL 500 MG EFFERVESCENT
TABLETS
Summary of Product Characteristics Updated 03-Oct-2022 | Cipla EU Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
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6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Paracetamol 500 mg effervescent tablets
2. Qualitative and quantitative composition
Each effervescent tablet contains 500 mg of paracetamol.
Excipients with known effects:
Each effervescent tablet contains 439.46 mg of sodium
Each effervescent tablet contains 20 mg of aspartame.
For the full list of excipients see section 6.1.
3. Pharmaceutical form
Effervescent tablet.
White to off-white, circular, flat-faced, bevelled edge tablets
debossed with a ring on one side and plain on
the other. Diameter 25.2 mm.
4. Clinical particulars
4.1 Therapeutic indications
Symptomatic treatment of mild to moderate pain and/or fever in adults
and adolescents aged 12 years and
above.
4.2 Posology and method of administration
Posology
_Paediatric population_
Dose depends on body weight and age. A single dose ranges from 10 to