Paracetamol / Caffeine 500mg/65mg Tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

PARACETAMOL; Anhydrous caffeine

Disponibil de la:

Brillpharma (Ireland) Limited

Codul ATC:

N02BE; N02BE51

INN (nume internaţional):

PARACETAMOL; Anhydrous caffeine

Dozare:

500/65 mg/mg

Forma farmaceutică:

Tablet

Zonă Terapeutică:

Anilides; paracetamol, combinations excl. psycholeptics

Statutul autorizaţiei:

Not marketed

Data de autorizare:

2014-12-12

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PARACETAMOL/CAFFEINE 500 MG/65 MG TABLETS
(Paracetamol & Caffeine)
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 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 all the possible
side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if your symptoms worsen or do not
improve within 3 days for
fever and 5 days for pain.
WHAT IS IN THIS LEAFLET
1. What Paracetamol/Caffeine 500 mg/65 mg Tablets are and what they
are used for
2. What do you need to know before you take Paracetamol/Caffeine 500
mg/65 mg Tablets
3. How to take Paracetamol/Caffeine 500 mg/65 mg Tablets
4. Possible side effects
5. How to store Paracetamol/Caffeine 500 mg/65 mg Tablets
6. Contents of the pack and other information
1. WHAT PARACETAMOL/CAFFEINE 500 MG/65 MG TABLETS ARE AND WHAT ARE
THEY USED FOR
The
name
of
your
medicine
is
Paracetamol/Caffeine
500
mg/65
mg
Tablets.
It
is
a
combination of two medicines called caffeine and paracetamol. The
tablets contain two active
ingredients. Paracetamol is a pain reliever (analgesic) and helps to
reduce your temperature
when you have a fever. Caffeine helps to increase the pain relief from
paracetamol and makes
you more alert.
This medicine is for symptomatic treatment of mild to moderate pain
and fever in conditions
such as headache, toothache and period pains.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL/ CAFFEINE 500
MG/65 MG TABLETS
IMPORTANT THINGS YOU SHOULD KNOW ABOUT PARACETAMOL/CAFFEINE 500 MG/65
MG TABLETS
• Do not take this medicine with other paracetamol containing
medicines.
• Excessive intake of caffeine (e.g. coffee, tea and some canned
drinks) should be avoided
while taking this p

Caracteristicilor produsului

Health Products Regulatory Authority
22 July 2022
CRN00CXZD
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol / Caffeine 500mg/65mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500mg and Caffeine 65mg
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsule shaped tablets
White to off white, capsule shaped, biconvex tablets plain on both
sides approximately 17.46mm x 7.14mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of mild to moderate pain and/or fever in adults
and children aged 16 years or over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS (16 YEARS AND OVER):
Two tablets up to four times daily. The dose should not be repeated
more frequently than every 4 hours. Do not exceed 8
tablets in 24 hours.
ELDERLY:
As for adults.
Not recommended for children under 16 years.
_ _
The lowest dose necessary to achieve efficacy should be used.
Should not be used with other paracetamol-containing products.
_ _
Renal Impairment:
Patients who have been diagnosed with renal impairment must seek
medical advice before taking this medication. The
restrictions related to the use of paracetamol and caffeine products
in patients with renal impairment are primarily a
consequence of the paracetamol content of the drug.
_ _
In case of renal insufficiency dose adjustment is necessary:
Hepatic Impairment:
Patients who have been diagnosed with liver impairment must seek
medical advice before taking this medication. The
restrictions related to the use of paracetamol and caffeine products
in patients with hepatic impairment are primarily a
consequence of the paracetamol content of the drug.
In patients with impaired hepatic function or Gilbert's syndrome, the
dose must be reduced or the dosing interval prolonged.
The daily effective dose of paracetamol should not exceed 60 mg/kg/day
(up to maximum 2 g paracetamol /day) in the
following situations:

Adults or adolescents weighing less than 50 kg
