Paracetamol / Caffeine 500mg/65mg Tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

PARACETAMOL; Anhydrous caffeine

थमां उपलब्ध:

Bristol Laboratories Limited

ए.टी.सी कोड:

N02BE; N02BE51

INN (इंटरनेशनल नाम):

PARACETAMOL; Anhydrous caffeine

डोज़:

500/65 mg/mg

फार्मास्यूटिकल फॉर्म:

Tablet

प्रिस्क्रिप्शन प्रकार:

Product not subject to medical prescription

चिकित्सीय क्षेत्र:

Anilides; paracetamol, combinations excl. psycholeptics

प्राधिकरण का दर्जा:

Not marketed

प्राधिकरण की तारीख:

2014-12-12

सूचना पत्रक

SAME SIZE ARTWORK
430 x 120mm
Front
30 mm
430 mm
120 mm
IXXXXXX
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PARACETAMOL / CAFFEINE 500 MG/65 MG TABLETS
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 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 this medicine is and what it is used for
2.
What do you need to know before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1. WHAT THIS MEDICINE IS AND WHAT IT IS 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 THIS MEDICINE
IMPORTANT THINGS YOU SHOULD KNOW ABOUT THIS MEDICINE
•
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 product.
•
Consult your doctor if your headaches or other symptoms persist.
DO NOT TAKE THIS MEDICINE:
•
if you are under 16 years of age.
•
if you are allergic

उत्पाद विशेषताएं

Health Products Regulatory Authority
05 April 2019
CRN008WYV
Page 1 of 7
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
Oral use.
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.
_Impaired Renal Function:_
In case of renal insufficiency dose adjustment is necessary:
_Impaired Hepatic Function:_
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
_ Mild to moderate hepatic insufficiency, Gilbert’s syndrome
(familial non-heamolytic jaundice)
_ Dehydration
_ Chronic malnutrition
_ Chronic alcoholism
Method of administration
Route of administration: Oral
Health Products Regulatory Authority
05 April 2019
CRN008WYV
Page 2 of 7
4.3 CONTRAINDICATIONS
Hypersensitivity to paracetamol, caffeine or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Immediate medical advice should be sought in the event of an overdose,
even if you feel well, because of the risk of delayed,
serious liver damage.
Prolonged or frequent use is discouraged. Patients should be advised
not to take other Paracetamol con