Paralief Cold & Flu hard capsules Paracetamol 300 mg Caffeine 25 mg Phenylephrine hydrochloride 5 mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Caffeine; Phenylephrine hydrochloride

Available from:

Clonmel Healthcare Ltd

ATC code:

R05X

INN (International Name):

Paracetamol; Caffeine; Phenylephrine hydrochloride

Dosage:

300/25/5 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product not subject to medical prescription

Therapeutic area:

OTHER COLD PREPARATIONS

Authorization status:

Not marketed

Authorization date:

2016-03-11

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARALIEF COLD & FLU HARD CAPSULES
Paracetamol
300mg
Caffeine
25mg
Phenylephrine hydrochloride 5mg
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 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 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 talk to a doctor if you do not feel better or if you feel
worse after 3 days.
WHAT IS IN THIS LEAFLET
1. What Paralief Cold & Flu is and what it is used for
2. What you need to know before you take Paralief Cold & Flu
3. How to take Paralief Cold & Flu
4. Possible side effects
5. How to store Paralief Cold & Flu
6. Contents of the pack and other information
1. WHAT PARALIEF COLD & FLU IS AND WHAT IT IS USED FOR
Paralief Cold & Flu contains three drugs to help treat your symptoms
(active ingredients):

Paracetamol, which is an analgesic (pain killer) and antipyretic (it
reduces body temperature when
you have a fever)

Phenylephrine, which is a type of drug known as a sympathomimetic.
This works as a decongestant
by unblocking the passages in and around your nose. This helps you to
breathe more easily.

Caffeine, which acts to further help the effectiveness of paracetamol.
Paralief Cold & Flu is used to relieve the symptoms of colds and
influenza (flu) including fever, aches
and pains, sore throat and nasal congestion.
This medicine is for use in adults and children aged 12 years and
over.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARALIEF COLD & FLU
DO NOT TAKE PARALIEF COLD & FLU

If you are ALLERGIC to paracetamol, caffeine, phenylephrine
hydrochloride, or any of the other
ingredients of this medicine (listed in section 6).

If you have a rare

Summary of Product characteristics

Health Products Regulatory Authority
25 July 2022
CRN00CVKR
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paralief Cold & Flu hard capsules Paracetamol 300 mg Caffeine 25 mg
Phenylephrine hydrochloride 5 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 300 mg paracetamol, 25 mg caffeine and 5 mg
phenylephrine hydrochloride.
Excipient(s) with known effect
Each capsule contains 0.2 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Capsule of size 1 with a white body and a yellow cap filled with white
to yellow powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic relief of colds and influenza including fever, aches and
pains, sore throat and nasal congestion in adults and
children aged 12 years and above
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Paracetamol should be used at the lowest effective dose for the
shortest possible time. The maximum daily dose must not be
exceeded.
Posology
_Adults_
2 capsules up to 4 times a day as required. Maximum dose should not
exceed 8 capsules in 24 hours with at least 4 hours
between doses.
_Special populations_
_Elderly_
Experience has indicated that normal adult dosage of paracetamol is
usually appropriate. However, in frail, immobile elderly
subjects or in elderly patients with renal or hepatic impairment, a
reduction in the amount or frequency of dosing may be
appropriate (see section 4.4).
_Renal impairment_
This medicinal product is contraindicated in severe renal impairment
(see section 4.3). Paracetamol should be used with caution
in patients with renal impairment. Consequently, a reduced dose and/or
prolonged dosing interval of this medicinal product
may be necessary (see section 4.4).
_Hepatic impairment_
Paracetamol should be used with caution in patients with hepatic
impairment. Consequently, a reduced dose or prolonged
dosing interval may be necessary (see section 4.4).
_Adults and elderly with special conditions_
Health Products Regulatory Authority
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