Panadol Extra Film-coated tablets Paracetamol 500mg Caffeine 65mg

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Paracetamol; Caffeine

Mevcut itibaren:

Haleon Ireland Limited

ATC kodu:

N02BE; N02BE51

INN (International Adı):

Paracetamol; Caffeine

Doz:

500 mg/65 milligram(s)

Farmasötik formu:

Film-coated tablet

Reçete türü:

Product not subject to medical prescription

Terapötik alanı:

Anilides; paracetamol, combinations excl. psycholeptics

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

1994-06-14

Bilgilendirme broşürü

1
PATIENT INFORMATION LEAFLET
PANADOL
EXTRA
Film-coated 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 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 tablets do
2.
Check before you take Panadol Extra tablets
3.
How to take Panadol Extra tablets
4.
Possible side effects
5.
How to store Panadol Extra tablets
6.
Further information
1. WHAT PANADOL EXTRA TABLETS DO
PANADOL EXTRA 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 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 YOU USE IF YOU:
• 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
METABOLIC ACIDOSIS
.
Signs of metabolic acidosis include:
– deep, rapid,

Ürün özellikleri

Health Products Regulatory Authority
23 October 2023
CRN00DQTX
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Panadol Extra Film-coated tablets Paracetamol 500mg Caffeine 65mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500 mg and Caffeine 65 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet (tablet)
White to off white oval shaped coated tablets debossed "xPx" with P
inside a circle on one side, "- -" on the other side.
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.
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.
Should not be used with other paracetamol-containing products.
Renal Impairment
Patients who have been diagnosed with renal 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.
Hepatic Impairment
Patients who have been diagnosed with liver impairment must seek
medical advice before taking this medication. The
restrictions related to the use of paracetamol and caffeine products
in patients with hepatic impairment are primarily a
consequence of the paracetamol content of the drug.
The maximum daily dose of paracetamol should not excee