Panadol 500 mg Film Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PARACETAMOL

Available from:

Lexon (UK) Ltd

ATC code:

N02BE; N02BE01

INN (International Name):

PARACETAMOL

Dosage:

500 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol

Authorization status:

Authorised

Authorization date:

2017-05-05

Patient Information leaflet

PANADOL 500 MG FILM COATED TABLETS
(paracetamol)
PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS
MEDICINE.
*
This medicine is available without prescription, but you still need to
use
Panadol tablets carefully to get the best results from them.
*
Keep this leaflet, you may need to read it again.
*
If you have any further questions, ask your pharmacist.
IN THIS LEAFLET:
What Panadol tablets are and what they are used for
Check before you take Panadol tablets
How to take Panadol tablets
Possible side effects
How to store and dispose of Panadol tablets
Contents of the pack and other information
WHAT PANADOL TABLETS ARE AND WHAT THEY ARE USED FOR
PANADOL TABLETS ARE USED FOR FAST AND EFFECTIVE RELIEF OF HEADACHES,
TOOTHACHE, BACKACHE, RHEUMATIC AND MUSCLE PAINS AND PERIOD PAIN. It
also relieves sore throat and the feverishness, aches and pains of
colds and
flu. Panadol tablets also help relieve the pain of osteoarthritis
(which has
been diagnosed by a doctor).
The active ingredient is paracetamol which is a painkiller and also
reduces
your temperature when you have a fever.
CHECK BEFORE YOU TAKE PANADOL TABLETS
DO NOT TAKE PANADOL TABLETS:
*
IF YOU HAVE EVER HAD AN ALLERGIC REACTION to paracetamol or to any of
the
other ingredients (listed in Section 6).
*
if you are taking ANY OTHER MEDICINES CONTAINING PARACETAMOL.
*
if you are UNDER 6 YEARS.
CHECK WITH YOUR DOCTOR BEFORE USE IF YOU:
*
have liver or kidney problems
*
are underweight or malnourished
*
regularly drink alcohol
*
have a SEVERE INFECTION as this may increase the risk of METABOLIC
ACIDOSIS.
Signs of metabolic acidosis include:
- deep rapid, difficult breathing
- feeling sick (nausea), being sick (vomiting)
- loss of appetite
CONTACT A DOCTOR IMMEDIATELY if you get a combination of these
symptoms.
You may need to avoid using this product altogether or limit the
amount of
paracetamol that you take.
IF YOU ARE TAKING OTHER MEDICINES
Talk to your doctor or pharmacist before taking these tablets if you
are taking
any prescribed medicines; p

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Panadol 500 mg Film Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg paracetamol.
Excipients with known effect:
Sodium methyl parahydroxybenzoate (E219)
Sodium ethyl parahydroxybenzoate (E215)
Sodium propyl parahydroxybenzoate (E217)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Czech Republic_
White capsule shaped film coated tablet with convex edges and debossed
with a “p” within a circle on one face and a
break line on the other. The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
As per PA0678/107/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0678/107/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Pregelatinised starch
Calcium carbonate
Alginic acid
Crospovidone type A
Povidone 25
Magnisium stearate
Colloidal anhydrous silica
Parahydroxybenzpates (Sodium ethyl parahydroxybenzoate (E215), Sodium
propyl parahydroxybenzoate (E217) and
Sodium methyl parahydroxybenzoate (E219)
Carnauba wax
Opadry white YS-1-7003 (titanium dioxide, hypromellose, macrogol and
polysorbate 80)
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister