Paravance Extra CapsulesParacetamol 500 mgCaffeine 65 mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Caffeine anhydrous

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

N02BE; N02BE51

INN (International Name):

Paracetamol; Caffeine anhydrous

Dosage:

500 mg/65 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol, combinations excl. psycholeptics

Authorization status:

Authorised

Authorization date:

2017-05-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USE
PARAVANCE EXTRA CAPSULES
Paracetamol 500mg
Caffeine 65mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING PARAVANCE
EXTRA CAPSULES BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told you.

Keep this leaflet. You may need to read it again

Ask your pharmacist if you need more information or advise

If you get any side effects, talk to your doctor, pharmacist or nurse.
This include any possible side effects not
listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET?
1.
What Paravance Extra Capsules are and what they are used for
2.
What you need to know before you take Paravance Extra Capsules
3.
How to take Paravance Extra Capsules
4.
Possible side effects
5.
How to store Paravance Extra Capsules
6.
Contents of the pack and other information
1.
WHAT PARAVANCE EXTRA CAPSULES ARE AND WHAT THEY ARE USED FOR
Each Paravance Extra Capsule contains paracetamol 500mg and caffeine
65mg. Paracetamol has pain killing (analgesic)
and fever reducing (antipyretic) properties. Caffeine is a stimulant
for relief of fatigue and drowsiness. Paravance
Extra Capsules can be used to treat headache, symptoms of common cold
or influenza such as headache, sore throat,
body aches and pains, lowering of high temperatures, fatigue and
drowsiness.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARAVANCE EXTRA CAPSULES
DO NOT TAKE PARAVANCE EXTRA CAPSULES

If you are allergic (hypersensitive) to paracetamol or any of the
other ingredients listed in section 6

If you are taking any other paracetamol containing products

If you have a history of peptic ulcer

If you are less than 12 years of age
TAKE SPECIAL CARE WITH PARAVANCE EXTRA CAPSULES

If you have impaired liver or kidney function

If you are taking other drugs that affect the liver

If you have a poor diet
Prolonged use, except under medical supervision

Summary of Product characteristics

Health Products Regulatory Authority
16 February 2021
CRN009676
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paravance Extra CapsulesParacetamol 500 mgCaffeine 65 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains paracetamol 500 mg and caffeine 65 mg.
Excipients: Contains Tartarazine (E102)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules hard (Capsules).
A red and yellow hard gelatine capsule printed “Extra”.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of symptoms associated with the common cold and
influenza, including relief of aches and pains, fever, sore
throat, headache, fatigue and drowsiness, and lowering of temperature.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Duration of treatment should be limited to a maximum of 3 days. The
patient should consult a doctor if symptoms persist or
worsen, or if the product is required for more than 3 days. POSOLOGY:
Oral administration.
Adults, the elderly and children aged 16 years and over: 2 capsules
every 4 hours as required. Do not take more than 8
capsules (4 doses) in 24 hours.
Children: Ages 12 to 15 years: 1 capsule every 4-6 hours when
necessary to a maximum of 4 capsules in 24 hours
Do not give to children under 12 years of age.
Paracetamol should be used at the lowest effective dose for the
shortest possible time. The maximum daily dose must not be
exceeded.
In all patients over 16 years of age, the maximum daily dose of
paracetamol should not exceed 60 mg/kg/day (up to a
maximum of 2 g per day) in the following situations, unless directed
by a physician: (see section 4.4)

Weight less than 50kg

Dehydration

Malnutrition

Chronic alcoholism
Renal impairment
Paracetamol should be used with caution in patients with renal
impairment as a reduced dose and/or prolonged dosing
interval may be necessary (see section 4.4).
Health Products Regulatory Authority
16 February 2021
CRN009676
Page 2 of 7
Hepatic impairment
Paracetamol should be used wi