Paracetamol Accord 500 mg Brustablett

País: Suècia

Idioma: suec

Font: Läkemedelsverket (Medical Products Agency)

ingredients actius:

paracetamol

Disponible des:

Accord Healthcare B.V.

Codi ATC:

N02BE01

Designació comuna internacional (DCI):

paracetamol

Dosis:

500 mg

formulario farmacéutico:

Brustablett

Composición:

sorbitol Hjälpämne; paracetamol 500 mg Aktiv substans

tipo de receta:

Receptbelagt

Resumen del producto:

Förpacknings: Strip, 10 tabletter; Strip, 12 tabletter; Strip, 16 tabletter; Strip, 20 tabletter; Strip, 24 tabletter; Strip, 30 tabletter; Strip, 40 tabletter; Strip, 60 tabletter; Strip, 90 tabletter; Strip, 100 tabletter; Strip, 500 tabletter; Tub, 10 tabletter; Tub, 12 tabletter; Tub, 16 tabletter; Tub, 20 tabletter; Tub, 24 tabletter; Tub, 30 tabletter; Tub, 40 tabletter; Tub, 60 tabletter; Tub, 90 tabletter; Tub, 100 tabletter; Tub, 500 tabletter; Tub, 6 tabletter; Strip, 6 tabletter

Estat d'Autorització:

Godkänd

Data d'autorització:

2019-06-27

Informació per a l'usuari

1
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PARACETAMOL ACCORD 500 MG EFFERVESCENT TABLETS
paracetamol
[For medicines available only on prescription:]
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 pharmacis.
-
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.
[For medicines available without prescription:]
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. Always take this
medicine exactly as described in this
leaflet or as your doctor or pharmacist 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
WHAT IS IN THIS LEAFLET
1.
What is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
[For medicines available only on prescription:]
contains paracetamol which belongs to the group of
medicines called analgesics and
antipyretics. is used to relieve mild to moderate pain
and/or fever.
[For medicines available without prescription:]
contains paracetamol which belongs to th

Fitxa tècnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Paracetamol Accord 500 mg effervescent tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg paracetamol.
Excipients with known effect:
Each 500 mg tablet contains 418.5 mg sodium and 100 mg sorbitol
(E420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Effervescent tablet.
White to off-white, round, flat, beveled edges tablets, plain on both
sides with odour of lemon.
Diameter: 25.4 mm approximately
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of mild to moderate pain and/or fever.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Maximum daily dose should not be exceeded due to risk of serious
hepatic damage (see sections 4.4
and 4.9).
_Adults and adolescents over 50 kg bodyweight (>15 years):_
1 - 2 tablets (500 mg – 1 g) every 4 to 6 hours as required.
It is generally not required to exceed 3 g of paracetamol per day (6
tablets per 24 hours).
The maximum daily dose is 4 g (8 tablets per 24 hours).
_Paediatric population:_
Paediatric dosage should be based on body weight and suitable dosage
form used.
Information on the age of children within the weight group given below
is for guidance only.
The recommended dose for children is 10-15 mg/kg body weight every 4-6
hours, 3 to 4 times per 24
hours. The maximum dose for children is 60 mg/kg/24 hours divided into
4 doses.
_Children over 40 kg bodyweight (>12 years):_
1 tablet (500 mg) every 4-6 hours. The maximum daily dose is 2.5 g (5
tablets per 24 hours).
The dose interval should always be at least 4 hours.
Method of administration
2
For oral administration. The tablets should be placed in a glas of
water and allowed to dissolve
completely before swallowing.
_Special groups of patients:_
Impaired liver function, chronic alcohol consumption:
In patients with impaired hepatic function or Gilbert’s syndrome,
the dose must be reduced or the
dosing interval prolonged (see section 4.4).
Impaired kidney function:
I