PANADEINE 500/8 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PARACETAMOL, CODEINE PHOSPHATE

Available from:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

ATC code:

N02AJ06

INN (International Name):

PARACETAMOL, CODEINE PHOSPHATE

Dosage:

500/8 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product not subject to medical prescription

Therapeutic area:

codeine and paracetamol

Authorization status:

Authorised

Authorization date:

1993-03-29

Patient Information leaflet

PANADEINE TABLETS 

PARACETAMOL 500MG 
CODEINE PHOSPHATE HEMIHYDRATE 8MG 

WHAT YOU SHOULD KNOW ABOUT THIS MEDICINE. 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 

• Keep this leaflet. You may need to read it again. 
• Ask your pharmacist if you need more information or advice. 
• You must contact your doctor if your symptoms worsen or do not
improve after 3 days. 
• If any of the side effects gets serious or if you notice any
side effect not listed in this leaflet, 
please tell your doctor or pharmacist. 

IN THIS LEAFLET 

1. What are Panadeine Tablets and what are they for? 
2. Before you take Panadeine Tablets. 
3. How to take Panadeine Tablets. 
4. Possible side-effects. 
5. How to store this medicine. 
6. Further information. 

1. WHAT ARE PANADEINE TABLETS AND WHAT ARE THEY FOR? 

Panadeine Tablets contain paracetamol and codeine, which are both
pain-relieving drugs. By 
working on your body in different ways paracetamol and codeine combine
to relieve pain. 
Paracetamol also helps to reduce temperature when you have a fever.
Codeine has some 
cough suppressant action. 

Panadeine Tablets provide effective relief from pain, including: 

• Headache 
• Toothache 
• Period pain 
• Arthritic and rheumatic pain 

Panadeine Tablets can be used in children over 12 years of age for
the short-term relief of 
moderate pain that is not relieved by other painkillers such
as paracetamol or ibuprofen alone. 

This product contains codeine. Codeine belongs to a group of medicines
called opioid 
analgesics which act to relieve pain.  

2. BEFORE YOU TAKE PANADEINE TABLETS 

DO NOT TAKE PANADEINE TABLETS: 
• if you are allergic to paracetamol, codeine or any of the 
other ingredients listed (See Section 6). 
• if you are under 12 years 
• if you suffer from severe asthma (have suffered from recent
asthma attacks). 
• if you are taking any other medicine containing paracetamol

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Panadeine Tablets.
Paracetamol 500mg
Codeine Phosphate Hemihydrate 8mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains paracetamol 500 mg and codeine phosphate
hemihydrate 8 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, flat, circular bevel-edged tablets marked with the word
‘Panadeine’ on one surface and a single scoreline on the
other.
The scoreline allows the tablet to be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Panadeine Tablets is indicated in patients 12 years and older for the
treatment of acute moderate pain (headache,
toothache, dysmenorrhoea and musculosketal pain) that cannot be
considered relieved by other analgesics such as
paracetamol or ibuprofen (alone).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral administration only.
Adults (including the elderly) and children aged 12 years and over:
1-2 tablets to be taken with water three to four times daily as
required.
Panadeine Tablets should be used at the lowest effective dose for the
shortest period of time. Doses should not be
repeated more frequently than every six hours and not more than 4
doses (8 tablets) should be given in any 24 hour
period.
Do not exceed the stated dose.
The duration of treatment
should be limited to 3 days and if no effective pain relief is
achieved the patients/carers
should be advised to seek the views of a physician.
Children aged less than 12 years:
Codeine should not be used in children below the age of 12 years
because of the risk of opioid toxicity due to the
variable and unpredictable metabolism of codeine to morphine (see
sections 4.3 and 4.4).
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