Panadol Cold and Flu Relief 500mg/65mg Film-Coated Tablets

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Paracetamol; Caffeine

Fáanlegur frá:

Haleon Ireland Limited

ATC númer:

N02BE; N02BE51

INN (Alþjóðlegt nafn):

Paracetamol; Caffeine

Skammtar:

500 mg/65 milligram(s)

Lyfjaform:

Film-coated tablet

Gerð lyfseðils:

Product not subject to medical prescription

Lækningarsvæði:

Anilides; paracetamol, combinations excl. psycholeptics

Leyfisstaða:

Marketed

Leyfisdagur:

2007-05-25

Upplýsingar fylgiseðill

1
PANADOL
COLD&FLU
RELIEF
500mg/65mg
Film coated tablets
Paracetamol & Caffeine
PATIENT INFORMATION LEAFLET
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 Cold & Flu Relief
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.
IN THIS LEAFLET:
1.
What Panadol Cold & Flu Relief tablets do
2.
Check before you take Panadol Cold & Flu Relief tablets
3.
How to take Panadol Cold & Flu Relief tablets
4.
Possible side effects
5.
How to store Panadol Cold & Flu Relief tablets
6.
Further information
1. WHAT PANADOL COLD & FLU RELIEF TABLETS DO
PANADOL COLD & FLU RELIEF TABLETS RELIEVE DISCOMFORT IN COLDS, FLU AND
SORE THROAT AND HELP
REDUCE TEMPERATURE.
They are also used for the relief of headache, backache, rheumatic
pain, muscle
pain, neuralgia, toothache and period pain. 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 COLD & FLU RELIEF TABLETS
_ _
DO NOT TAKE PANADOL COLD & FLU RELIEF 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 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
a

Vara einkenni

Health Products Regulatory Authority
23 October 2023
CRN00DQTX
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Panadol Cold and Flu Relief 500mg/65mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500.0 mg and Caffeine 65 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White, film-coated capsule-shaped tablets with flat edges, with a
triangular logo and a'+' symbol debossed on one side and
blank 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 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 exceed 60mg/kg/