Paracetamol Galpharm 1 g Tablett

国: スウェーデン

言語: スウェーデン語

ソース: Läkemedelsverket (Medical Products Agency)

有効成分:

paracetamol

から入手可能:

Galpharm Healthcare Limited

ATCコード:

N02BE01

INN（国際名）:

paracetamol

投薬量:

1 g

医薬品形態:

Tablett

構図:

paracetamol 1 g Aktiv substans

処方タイプ:

Receptbelagt

認証ステータス:

Avregistrerad

承認日:

2016-12-22

情報リーフレット

VERSION 7
PATIENT
LEAFLET:
INFORMATION FOR THE USER
PARACETAMOL GALPHARM 500MG 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 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, pharmacist or nurse.
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.
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 with fever
and 5 days with pain.
WHAT IS IN THIS LEAFLET
1.
What Paracetamol Galpharm is and what it is used for
2.
What you need to know before you take Paracetamol Galpharm
3.
How to take Paracetamol Galpharm
4.
Possible side effects
5.
How to store Paracetamol Galpharm
6.
Contents of the pack and other information
1.
WHAT PARACETAMOL GALPHARM IS AND WHAT IT IS USED FOR
Paracetamol Galpharm contains paracetamol which belongs to the group
of medicines
called analgesics and antipyretics.
Paracetamol Galpharm is used to relieve mild to moderate pain and/or
fever.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL GALPHARM
DO NOT TAKE PARACETAMOL GALPHARM

If you are allergic to paracetamol

製品の特徴

S
UMMARY OF
P
RODUCT
C
HARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Paracetamol Galpharm 500mg tablets
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
1 tablet contains 500 mg of paracetamol.
For the full list of excipients, see section 6.1
3
P
HARMACEUTICAL
F
ORM
Tablet
White, 16.5 x 8.2 mm, oblong tablet with score line on one side.
The tablet can be divided into equal doses.
4
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of mild to moderate pain and/or fever.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including elderly) and children 12 years and older (minimum
40kg):_
Tablets 500 mg: 1-2 tablets every 4-6 hours,,
The maximum daily dose is 4g (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 each weight group given
below is for guidance only.
50 mg /kg/day divided into 3 to 4 doses.
Maximum treatment time without consulting a doctor is 3 days for fever
and 5 days for pain.
Tablets 500 mg:
Weight
Age
Dose
17-25 kg
4 - 7 years
½ tablet every 4-6 hours, max. 4 times per 24 hours.
25-40 kg
7-12 years
½-1 tablet every 4-6 hours, max. 4 times per 24 hours.
>40 kg
>12 years
1-2 tablets every 4-6 hours, max. 8 tablets per 24 hours.
The dose interval should always be at least 4 hours.
Maximum daily dose should not be execeeded due to risk of serious
hepatic damage (see
sections 4.4 and 4.9)
Method of administration
For oral administration.
_Special groups of patients:_
Impaired liver function:
In patients with impaired hepatic function or Gilbert’s syndrome,
the dose must be reduced or
the dosing interval prolonged.
Impaired kidney function:
In patients with renal insufficiency, the dose should be reduced:
Glomerular filtration rate
Dose
10–50 ml/min
500 mg every 6 hours
< 10 ml/min
500 mg every 8 hours
Elderly patients:
Dose adjustment is not required in the elderly.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or any of the ex