Panadeine Extra Strength Tablets Paracetamol 500 mg Codeine Phosphate hemihydrate 12.8 mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Codeine phosphate hemihydrate

Available from:

Haleon Ireland Limited

ATC code:

N02AJ06

INN (International Name):

Paracetamol; Codeine phosphate hemihydrate

Dosage:

500/12.8 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

codeine and paracetamol

Authorization status:

Not marketed

Authorization date:

2012-06-28

Patient Information leaflet

PANADEINE
EXTRA STRENGTH TABLETS
PARACETAMOL 500MG
CODEINE PHOSPHATE HEMIHYDRATE 12.8MG
PATIENT INFORMATION LEAFLET
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.
•
If you have further questions, ask your doctor or pharmacist.
•
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 are Panadeine Extra Strength Tablets and what are they for?
2.
Before you take Panadeine Extra Strength Tablets
3.
How to take Panadeine Extra Strength Tablets
4.
Possible side-effects
5.
How to store this medicine
6.
Further information
1. WHAT ARE PANADEINE EXTRA STRENGTH TABLETS AND WHAT ARE THEY FOR?
Panadeine Extra Strength Tablets contain paracetamol and codeine,
which are both pain killing 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. Panadeine Extra
Strength Tablets provide effective relief for
mild to moderate pain, including:
•
Joint, muscle and back pain.
•
Headaches, including migraine.
•
Toothache.
•
Sore throat.
•
Period pains.
•
Feverishness.
•
Colds and flu.
Panadeine Extra Strength 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 EXTRA STRENGTH TABLETS
Do NOT take Panadeine Extra Strength Tablets:
•
if you are allergic to paracetamol, codeine, other opioid painkillers
or any other ingredients (listed in section
6).
•
if you are under 12 years.
•
if you suffer from acute asthma (have suffered from recent asthma
attacks).
•
if you suspect or know that you are pregnant.
•

Summary of Product characteristics

Health Products Regulatory Authority
12 July 2023
CRN00DKWJ
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Panadeine Extra Strength Tablets Paracetamol 500 mg Codeine Phosphate
hemihydrate 12.8 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol Ph Eur 500 mg and Codeine Phosphate
Hemihydrate Ph Eur 12.8 mg.
Excipient: Contains 5.9 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
Red, film-coated, capsule-shaped tablets. Embossed on one side with
“Extra”.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Panadeine Extra Strength Tablets is indicated in patients 12 years and
older for the treatment of acute moderate pain
(rheumatic pain, headaches, backache, musculoskeletal pain, migraine,
toothache, sore throat, period pains, feverishness and
the symptoms of colds and influenza) which is not considered to be
relieved by other analgesics such as paracetamol or
ibuprofen alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use only.
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.
Adults and children aged 16 years and over:
One to two tablets to be taken with water three to four times daily as
required.
Paediatric population
Children aged 12-15 years:
One tablet to be taken with water three to four times daily as
required.
Panadeine Extra Strength is not recommended for use in children aged
12 years to 18 years with compromised respiratory
function for the symptomatic treatment of cough or cold (see section
4.4).
Panadeine Extra Strength Tablets should be used at the lowest
effective dose for the shortest period of time. The dose should
not be repeated more frequently than every six hours, and not more
than four doses should be given in any 24-hour period.
Children aged less than 12 years:
Codeine should not be used in children below the age of 12 years
because of t