Paracetamol & Caffeine Galpharm 500 mg & 65 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Caffeine; Paracetamol

Available from:

Galpharm Healthcare Limited

ATC code:

N02BE; N02BE51

INN (International Name):

Caffeine; Paracetamol

Dosage:

500/65 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol, combinations excl. psycholeptics

Authorization status:

Not marketed

Authorization date:

2013-05-17

Patient Information leaflet

1.3
PRODUCT INFORMATION.
1.3.1
SPC, LABELLING AND PACKAGE LEAFLET.
PARACETAMOL 500MG AND CAFFEINE 65MG TABLETS / MODULE 1.3.1 / APRIL
2013
PACKAGE LEAFLET : INFORMATION FOR THE USER
PARACETAMOL & CAFFEINE GALPHARM 500MG & 65MG TABLETS
PARACETAMOL / CAFFEINE
_ _
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
THIS MEDICINE IS AVAILABLE WITHOUT PRESCRIPTION. HOWEVER, YOU STILL
NEED TO TAKE PARACETAMOL &
CAFFEINE GALPHARM 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
within 3 days for fever
and 5 days for pain.
•
If any of the side effects get serious, or if you notice any side
effect not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
_ _
1.
WHAT PARACETAMOL & CAFFEINE GALPHARM IS AND WHAT IT IS USED FOR.
2.
BEFORE YOU TAKE PARACETAMOL & CAFFEINE GALPHARM.
3.
HOW TO TAKE PARACETAMOL & CAFFEINE GALPHARM.
4.
POSSIBLE SIDE EFFECTS.
5.
HOW TO STORE PARACETAMOL & CAFFEINE GALPHARM.
6.
FURTHER INFORMATION.
1. WHAT PARACETAMOL & CAFFEINE GALPHARM IS AND WHAT IT IS USED FOR.
Paracetamol & Caffeine Galpharm contain PARACETAMOL which is a pain
reliever (analgesic) and helps
reduce your temperature when you have a fever and CAFFEINE which helps
to increase the pain relief
from paracetamol and makes you more alert.
This medicine is for the symptomatic treatment of mild to moderate
pain and fever in conditions such
as headache, toothache and period pains.
2. BEFORE YOU TAKE PARACETAMOL & CAFFEINE GALPHARM
DO NOT TAKE PARACETAMOL & CAFFEINE GALPHARM IF:
•
You are ALLERGIC to paracetamol, caffeine or any of the other
ingredients.
•
If you are under 15 years of age or weigh less than 50kg.
DO
NOT
TAKE
ANYTHING
ELSE
CONTAINING
PARACETAMOL
WHILE
TAKING
THIS
MEDICINE.
TAKE SPECIAL CARE WITH PARACETAMOL & CAFFEINE GALPHARM. CHECK WITH
YOUR DOCTOR BEFORE
TAKING THIS MEDICINE:
�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol & Caffeine Galpharm 500 mg & 65 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500 mg and Caffeine 65 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, capsule-shaped tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of mild to moderate pain and/or fever in adults
and children aged 15 years or over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including elderly) and adolescents aged 15-18 years weighing
more than 50kg:_
1 - 2 tablets according to needs up to 3 times daily.
The single dose of 1 tablet is appropriate for individuals weighing
less than 60 kg while the single dose of 2 tablets is
appropriate only for individuals weighing 60 kg and more. The maximum
single dose is 1 g of paracetamol (2 tablets),
the maximum daily dose is 3 g of paracetamol (6 tablets).
The specific dose interval depends on the symptoms and the maximum
daily dose. Depending on the reoccurrence of
symptoms (fever and/or pain), repeated administration is allowed. It
should, however, preferably never fall below 6
hours and in no case fall below 4 hours.
If the pain persists for more than 5 days or the fever lasts for more
than 3 days, or gets worse or other symptoms
appear, the patient should stop the treatment and consult a doctor.
Paediatric Population
Adolescents of 15 to 18 years and weighing more than 50 kg: as adults.
In children it is imperative to respect the posology defined on the
basis of body weight and thus to use the appropriate
presentation. Approximate ages based on body weight are given for
information.
The product is not suitable for children younger than 15 years.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___