Paraeze Hard Capsules Paracetamol 500mg Caffeine 32mg

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Caffeine; Paracetamol

Commercializzato da:

Haleon Ireland Limited

Codice ATC:

N02BE; N02BE51

INN (Nome Internazionale):

Caffeine; Paracetamol

Dosaggio:

500/32 milligram(s)

Forma farmaceutica:

Capsule, hard

Area terapeutica:

Anilides; paracetamol, combinations excl. psycholeptics

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

1982-12-23

Foglio illustrativo

PARAEZE HARD CAPSULES
Paracetamol 500mg
Caffeine 32mg
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.
This medicine contains less than 1 mmol sodium (23 mg) per capsule,
that is to say essentially
"Sodium free".
DO NOT TAKE IF YOU:
• are allergic to paracetamol, caffeine or any of the other
ingredients listed in the leaflet.
• are under 12 years of age.
TAKE SPECIAL CARE AND TALK TO A PHARMACIST OR YOUR DOCTOR BEFORE
TAKING THIS MEDICINE IF YOU:
• suffer from kidney or liver problems particularly if you have
alcoholic liver disease as the hazards of
overdose are greater.
• are underweight (weigh less than 50 kg

Scheda tecnica

Health Products Regulatory Authority
09 January 2024
CRN00DRWY
Page 1 of 6
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.
Children: Not recommended in children under 12 years of age.
Method of Administration: Oral.
The lowest dose necessary to achieve efficacy should be used for the
shortest duration of treatment.
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
Paracetamol should be administered with caution under the following
circumstances:

Hepatic impairment

Chronic alcoholism

Renal impairment (GFR≤50ml/min)

Gilbert's Syndrome (familial non-haemolytic jaundice)

Concomitant treatment with medicinal products affecting hepatic
function

Glucose-6-phosphate dehydrogenase deficiency
Health Products Regulatory Authority
09 January 2024
CRN00DRWY
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