Panadol Extra

Država: Nova Zelandija

Jezik: angleščina

Source: Medsafe (Medicines Safety Authority)

Aktivna sestavina:

Caffeine 65mg;  ; Paracetamol 500mg;  ;  ;  ; Caffeine 65mg; Paracetamol 500mg; Caffeine 65mg; Paracetamol 500mg; Caffeine 65mg; Paracetamol 500mg

Dostopno od:

Haleon New Zealand ULC

INN (mednarodno ime):

Caffeine 65 mg

Odmerek:

500mg/65mg

Farmacevtska oblika:

Film coated tablet

Sestava:

Active: Caffeine 65mg   Paracetamol 500mg       Excipient: Croscarmellose sodium Hypromellose Maize starch Potassium sorbate Povidone Purified talc Starch Stearic acid Triacetin Active: Caffeine 65mg Paracetamol 500mg Excipient: Alginic acid Calcium carbonate Carnauba wax Crospovidone Sodium nipasept Magnesium stearate Opadry white YS-1-7003 Povidone Pregelatinised maize starch Purified water Active: Caffeine 65mg Paracetamol 500mg Excipient: Alginic acid Calcium carbonate Carnauba wax Crospovidone Magnesium stearate Opadry white YS-1-7003 Povidone Pregelatinised maize starch Purified water Sodium ethyl hydroxybenzoate Sodium methyl hydroxybenzoate Sodium propyl hydroxybenzoate Active: Caffeine 65mg Paracetamol 500mg Excipient: Alginic acid Calcium carbonate Carnauba wax Crospovidone Magnesium stearate Microcrystalline cellulose Opadry white YS-1-7003 Povidone Pregelatinised maize starch Purified water

Enote v paketu:

Blister pack, Alu/PVC, Sample pack, 20 tablets

Razred:

General sale

Tip zastaranja:

General sale

Izdeluje:

BASF PharmaChemikalien GmbH & Co KG

Terapevtske indikacije:

The temporary relief of pain and discomfort associated with headache, tension headache, migraine headache, osteoarthritis, arthritis, cold & flu symptoms, toothache, dental procedures, muscular aches, sore throat and period pain. Reduces fever.

Povzetek izdelek:

Package - Contents - Shelf Life: Blister pack, child resistant senior friendly 200 ?m PVC/20 ?m aluminium foil/8 ?m PET - 10 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, child resistant senior friendly 200 ?m PVC/20 ?m aluminium foil/8 ?m PET - 12 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, child resistant senior friendly 200 ?m PVC/20 ?m aluminium foil/8 ?m PET - 16 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, child resistant senior friendly 200 ?m PVC/20 ?m aluminium foil/8 ?m PET Sample pack - 20 tablets - 24 months from date of manufacture stored at or below 30°C

Datum dovoljenje:

1998-12-22

Navodilo za uporabo

PANADOL EXTRA
_500 MG PARACETAMOL & 65 MG CAFFEINE_
CONSUMER MEDICINE INFORMATION
_PLEASE READ THIS INFORMATION BEFORE YOU START USING THIS MEDICINE _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
PANADOL EXTRA. It does not
contain all the available
information.
It does not take the place of talking
to your pharmacist or doctor.
All medicines have risks and
benefits.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
PHARMACIST OR DOCTOR.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read
it again.
WHAT PANADOL
EXTRA IS USED FOR
The active ingredients in this
medicine are paracetamol and
caffeine. Paracetamol is used for
the fast effective temporary relief
of pain and discomfort associated
with
•
Headache
•
Muscular aches
•
Period pain
•
Arthritis/Osteoarthritis
•
Toothache
•
Migraine headache
•
Colds and flu
•
Tension headache
•
Sinus pain/headache
•
Backache
Paracetamol also reduces fever.
Paracetamol works to stop the pain
messages from getting through to
the brain. It also acts in the brain
to reduce fever.
Caffeine acts on paracetamol to
increase its effectiveness.
ASK YOUR PHARMACIST OR DOCTOR
IF YOU HAVE ANY QUESTIONS ABOUT
THIS MEDICINE.
Your pharmacist or doctor may
have given it for another reason.
BEFORE YOU USE
PANADOL EXTRA
Do not take more than the
recommended dose as it may cause
serious harm to your liver.
_ _
_WHEN YOU MUST NOT USE IT _
DO NOT USE PANADOL EXTRA
IF YOU HAVE AN ALLERGY TO:
•
Any of the ingredients listed
at the end of this leaflet
Do not use this medicine if you are
taking any other prescription or
non-prescription medicines
containing paracetamol to treat
pain, fever, symptoms of cold and
flu, or to aid sleep.
ALWAYS READ AND FOLLOW THE
LABEL.
DO NOT USE THIS MEDICINE AFTER
THE EXPIRY DATE PRINTED ON THE
PACK OR IF THE PACKAGING IS TORN
OR SHOWS SIGNS OF TAMPERING.
If it has expired or is damaged,
return it to your pharmacist for
disposal.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START USING THIS MEDICINE,
TALK TO

Lastnosti izdelka

PANADOL EXTRA
– Data Sheet Page 1 of 8
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
PANADOL EXTRA, Paracetamol 500 mg and Caffeine 65 mg, film coated
tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients:
Paracetamol 500mg & Caffeine 65mg caplets
Excipients:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
White to off-white, oval shape, debossed with a logo “P” in a
circle on one side and a deep score line on the
other side.
4.
CLINICAL PARTICULARS
4.1.
Therapeutic Indications
For the temporary relief of pain and discomfort associated with
headache, tension headache, migraine
headache, osteoarthritis, arthritis, cold & flu symptoms, toothache,
dental procedures, muscular aches, sore
throat and period pain. Reduces fever.
4.2.
Dosage and Method of Administration
PANADOL EXTRA is to be administered orally, with or without food. For
Adults and children 12 years and
older: 2 caplets every 4 to 6 hours (as required). Maximum of 8
caplets in 24 hours. Not recommended in
children under the age of 12 years.
Take with water or other fluid.
Can be taken with or without food.
The caplets must not be crushed.
Do not exceed the stated dose.
The lowest dose necessary to achieve efficacy should be used for the
shortest duration of treatment.
Should not be used with other paracetamol-containing products.
Minimum dosing interval: 4 hours.
Maximum daily dose: 4000 mg paracetamol.
PANADOL EXTRA
– Data Sheet Page 2 of 8
4.3.
Contraindications
This product is contraindicated in patients with hypersensitivity to
paracetamol, caffeine or to any of the
excipients.
4.4.
Special Warnings and Precautions for Use
Contains paracetamol. Do not use with any other paracetamol-
containing products. The concomitant use
with other products containing paracetamol may lead to an overdose.
Paracetamol overdose may cause liver failure which may require liver
transplant or lead to death.
Paracetamol should be used with caution in patients with:
•
Impaired liver function: Underlying liver