Paraeze Hard Capsules Paracetamol 500mg Caffeine 32mg

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Caffeine; Paracetamol

Dostępny od:

Pfizer Healthcare Ireland

Kod ATC:

N02BE; N02BE51

INN (International Nazwa):

Caffeine; Paracetamol

Dawkowanie:

500/32 milligram(s)

Forma farmaceutyczna:

Capsule, hard

Typ recepty:

Product not subject to medical prescription

Dziedzina terapeutyczna:

Anilides; paracetamol, combinations excl. psycholeptics

Status autoryzacji:

Marketed

Data autoryzacji:

1982-12-23

Ulotka dla pacjenta

Black
Dieline
Technical
2/5 code
Area reserved
PFIZER -
Product Name:
INS-PARAEZE 500/32MG HFC 12-24X1X10 BLST-T
PLEASE ENSURE ARTWORK IS CHECKED WITH THIS SETTINGS: PRINT PRODUCTION
>> OUTPUT PREVIEW >> OVERPRINT PREVIEW TURNED ON AND COLOR PROFILE
SIMULATION SET TO “COATED FOGRA 39”
Draft No:
04 -
Date:
04/07/2019 -
Operator: BB
Barcode Type(s):
-
X-Hight Rule:
N
Std Spec / Label Text Number:
N/A
Dieline:
117 X 173 MM
2/5 code :
N/A
Standard Color:
0032
Item Code:
MK-PAA112337
PAR:
2019-0006662
Market:
IRELAND
DTP ARTWORK
APRILIA PLANT
PACKAGE LEAFLET: INFORMATION FOR THE USER.
The full name of this medicine as listed above has been abbreviated
throughout the leaflet for ease of reference to ‘Paraeze.’
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in the leaflet or as
your doctor or pharmacist told you. Keep this leaflet. You may need to
read it
again. Ask your pharmacist if you need more information or advice.
IF YOU GET ANY SIDE EFFECTS, TALK TO YOUR DOCTOR, PHARMACIST OR NURSE.
THIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS
LEAFLET. SEE SECTION 4. YOU MUST SEE A DOCTOR IF YOUR SYMPTOMS WORSEN
OR DO NOT IMPROVE AFTER 3 DAYS.
IN THIS LEAFLET:
1. WHAT PARAEZE IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARAEZE
3. HOW TO TAKE PARAEZE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE PARAEZE
6. CONTENT OF THE PACK AND OTHER INFORMATION
1. WHAT PARAEZE IS AND WHAT IT IS USED FOR
Each capsule contains paracetamol 500 mg and caffeine 32 mg.
Paracetamol works by relieving pain and reducing high temperatures.
The capsules are for the treatment of the symptoms of mild to moderate
pain, such as,
SYMPTOMS OF INFLUENZA, FEVERISHNESS AND COLDS, HEADACHE, PERIOD PAINS,
MIGRAINE, RHEUMATIC ACHES, NEURALGIA, TOOTHACHE,
SORE THROAT, BACKACHE, MUSCLE PAIN.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARAEZE
Please read the following information.
DO NOT TAKE IF YOU:
•
are

Charakterystyka produktu

Health Products Regulatory Authority
21 October 2019
CRN00966T
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paraeze Hard Capsules Paracetamol 500mg Caffeine 32mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients:
Paracetamol 500 mg.
Caffeine 32.0 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard (capsule)
Size 0, hard gelatin capsules with an opaque blue cap and an opaque
yellow body, imprinted on both sections with 500/32,
containing a white, free flowing granule mix.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an analgesic and antipyretic agent. The capsules are recommended
for use in the short term management of headaches,
migraine and tension headaches, backache, rheumatic pain, muscle pain,
period pain, neuralgia, toothache and for relieving
fever, aches and pains of colds and influenza including the pain of
sore throat.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults Only: 1 to 2 capsules which may be repeated 4 hourly as
necessary. A maximum of 8 capsules in any 24 hour period.
Adolescents aged 12 to 15 years:
1 capsule which may be repeated every 4 to 6 hours. A maximum of 4
doses in any given 24 hour period.
Not recommended in children under 12 years of age.
Method of Administration: Oral.
4.3 CONTRAINDICATIONS

Use in children under 12 years.

Hypersensitivity to any of the active substances or to any of the
excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Caution should be exercised in patients with impairment of hepatic or
renal function (avoid if severe). The hazards
of overdose are greater in those with non-cirrhotic alcoholic liver
disease.

If symptoms persist, consult your doctor.

Prolonged use without medical advice may be harmful.

Do not exceed the stated dose.

Do not take this medicine with other Paracetamol containing products.

Immediate medical advice should be sought in the event of overdosage
even if you feel well.

Use only when clearly necessary.