Panadol Extra 500mg/65mg Soluble Effervescent Tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Paracetamol; Caffeine

Dostupno od:

Haleon Ireland Limited

ATC koda:

N02BE; N02BE51

INN (International ime):

Paracetamol; Caffeine

Doziranje:

500 mg/65 milligram(s)

Farmaceutski oblik:

Effervescent tablet

Tip recepta:

Product not subject to medical prescription

Područje terapije:

Anilides; paracetamol, combinations excl. psycholeptics

Status autorizacije:

Marketed

Datum autorizacije:

2001-11-02

Uputa o lijeku

1
PATIENT INFORMATION LEAFLET
PANADOL
EXTRA 500MG/65MG
SOLUBLE EFFERVESCENT TABLETS
500mg Paracetamol
65mg Caffeine
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 Extra Soluble tablets
carefully to get the best results from them.
• Keep this leaflet, you may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not
improve.
• If any of the side effects get serious, or you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
WHAT IS IN THIS LEAFLET:
1.
What Panadol Extra Soluble tablets do
2.
Check before you take Panadol Extra Soluble tablets
3.
How to take Panadol Extra Soluble tablets
4.
Possible side effects
5.
How to store Panadol Extra Soluble tablets
6.
Further information
1. WHAT PANADOL EXTRA SOLUBLE TABLETS DO
PANADOL EXTRA SOLUBLE TABLETS ARE USED FOR THE RELIEF OF HEADACHE,
BACKACHE, RHEUMATIC PAIN,
MUSCLE PAIN, NEURALGIA, TOOTHACHE AND PERIOD PAIN
. They also relieve discomfort in colds, flu and
sore throat and help reduce temperature. The tablets contain two
active ingredients. Paracetamol is a
painkiller and reduces your temperature when you have a fever.
Caffeine acts to further help the
effectiveness of paracetamol.
2. CHECK BEFORE YOU TAKE PANADOL EXTRA SOLUBLE TABLETS
_ _
DO NOT TAKE PANADOL EXTRA TABLETS:
•
IF YOU HAVE EVER HAD AN ALLERGIC REACTION
to paracetamol, caffeine or to any of the other ingredients
(listed in Section 6).
• If you are taking any
OTHER MEDICINES CONTAINING PARACETAMOL
.
• If you are under
12 YEARS OF AGE
.
CHECK WITH YOUR DOCTOR BEFORE USE IF:
• have
LIVER
or
KIDNEY
problems, including
ALCOHOLIC LIVER DISEASE
• are
UNDERWEIGHT (<50KG)
or malnourished
•
REGULARLY DRINK ALCOHOL
•suffer from severe
DEHYDRATION
• are taking medicines that affect your
LIVER
• have a
SEVERE INFECTION
as this may increase the risk of

Svojstava lijeka

Health Products Regulatory Authority
14 November 2023
CRN00DSJR
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Panadol Extra 500mg/65mg Soluble Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500.0 mg and Caffeine 65 mg.
_Excipients: _Also contains 425mg sodium per tablet.
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Soluble Effervescent tablets.
Flat, white tablets with beveled edges, plain on one side, breakline
on the other.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The tablets are recommended for use as an analgesic in the relief of
mild to moderate pain such as is associated with
rheumatism, neuralgia, musculoskeletal disorders, headache and of
discomfort associated with influenza, feverishness and
feverish colds, toothache and dysmenorrhoea.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Panadol Extra Soluble should be dissolved in at least half a tumbler
full of water.
Adults (including the elderly) and children aged 16 years and over:
2 tablets up to four times daily. Do not exceed 8 tablets in 24 hours.
Children aged 12 – 15 years:
1 tablet up to four times daily. Do not exceed 4 tablets in 24 hours.
Not recommended for children under 12 years of age.
Minimum dosing interval: 4 hours.
The lowest dose necessary to achieve efficacy should be used.
Do not exceed the stated dose.
Should not be used with other paracetamol-containing products.
RENAL IMPAIRMENT
Patients who have been diagnosed with liver or kidney 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.
Health Products Regulatory Authority
14 November 2023
CRN00DSJR
Page 2 of 6
HEPATIC IMPAIRMENT
Patients who have been diagnosed with liver or kidney impairment must
seek medical advi