Panadol Sinus Relief Film Coated TabletsParacetamol 500mgCaffeine 25mgPhenylephrine Hydrochloride 5mg

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Paracetamol; Caffeine; Phenylephrine hydrochloride

Tersedia dari:

Haleon Ireland Limited

Kode ATC:

N02BE; N02BE51

INN (Nama Internasional):

Paracetamol; Caffeine; Phenylephrine hydrochloride

Dosis:

500/25/5 milligram(s)

Bentuk farmasi:

Film-coated tablet

Jenis Resep:

Product not subject to medical prescription

Area terapi:

Anilides; paracetamol, combinations excl. psycholeptics

Status otorisasi:

Not marketed

Tanggal Otorisasi:

1992-08-20

Selebaran informasi

PANADOL SINUS RELIEF
FILM COATED TABLETS
Paracetamol 500mg
Caffeine 25mg
Phenylephrine Hydrochloride 5mg
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 Sinus Relief tablets
carefully to get the best results from them.
•
Keep this leaflet. You may need to read it again.
•
If you have any questions, or there is anything you do not understand,
ask your pharmacist.
IN THIS LEAFLET:
1.
What Panadol Sinus Relief is and what it is used for
2.
What you need to know before you take Panadol Sinus Relief
3.
How to take Panadol Sinus Relief
4.
Possible side effects
5.
How to store Panadol Sinus Relief
6.
Contents of the pack and further information
1.
WHAT PANADOL SINUS RELIEF IS AND WHAT IT IS USED FOR
Panadol Sinus Relief provide effective relief from the major cold and
flu symptoms. These symptoms
include headache, shivers, aches and pains, blocked nose and painful
sinuses, catarrh, sore throat,
fatigue and tiredness.
Panadol Sinus Relief tablets contains three active ingredients.
Paracetamol is a pain killer and
reduces your temperature when you have a fever. Phenylephrine
hydrochloride unblocks your nose
and sinuses helping you breathe more easily. Caffeine is present as a
mild stimulant which acts to
further help the effectiveness of paracetamol.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANADOL SINUS RELIEF
DO NOT TAKE PANADOL SINUS RELIEF:
•
If you have ever had an allergic reaction to paracetamol,
phenylephrine hydrochloride, caffeine or
any of the other ingredients (listed in Section 6).
•
if you have severe kidney or severe liver problems, overactive
thyroid, diabetes,
phaeochromocytoma, enlarged prostate, glaucoma or are under the care
of your doctor for high
blood pressure or heart disease
‐if you are taking tricyclic antidepressants (e.g.imipramine or
amitripyline) or have taken monoamine
oxidase inhibitors (MAOIs) prescribed for depressions in the last two
weeks
‐if you are taking beta bl

Karakteristik produk

Health Products Regulatory Authority
20 June 2023
CRN00DKSP
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Panadol Sinus Relief Film Coated TabletsParacetamol 500mgCaffeine
25mgPhenylephrine Hydrochloride 5mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains paracetamol 500 mg, caffeine 25 mg
and phenylephrine hydrochloride 5 mg.
Excipients: also includes sunset yellow (E110), 0.62 mg per tablet.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Orange film-coated tablet embossed with ‘B’ on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The product is recommended for the relief of the symptoms of nasal and
sinus congestion, colds and flus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral administration only.
Do not exceed the stated dose.
The lowest dose necessary to achieve efficacy should be used for the
duration of treatment.
Should not be used with other paracetamol-containing products,
decongestants, or cold and flu medicines.
ADULTS (INCLUDING THE ELDERLY) AND CHILDREN AGED 16 YEARS AND OVER:
One to two tablets every 4-6 hours as required.
Maximum daily dose: Eight tablets in 24 hours.
CHILDREN AGED 12 – 15 YEARS:
One tablet every 4-6 hours as required.
Maximum daily dose: four tablets in 24 hours.
Not recommended for children under 12 years of age
MINIMUM DOSING INTERVAL: 4 hours
MAXIMUM DURATION OF CONTINUED USE WITHOUT MEDICAL ADVICE: 3 DAYS
4.3 CONTRAINDICATIONS
Known hypersensitivity to paracetamol, phenylephrine, caffeine or any
of the other ingredients listed in section 6.1.
Use in children under 12 years of age.
Health Products Regulatory Authority
20 June 2023
CRN00DKSP
Page 2 of 8
Severe hepatic or severe renal impairment, hypertension,
hyperthyroidism, diabetes, closed angle glaucoma,
phaeochomocytoma, prostate hypertrophy and heart disease. Patients
taking tricyclic antidepressants, or beta-blocking drugs
and those who are taking or who have taken within the last two weeks
monoamin