Paralief Night Film-coated Tablets Paracetamol 500 mg Diphenhydramine hydrochloride 25 mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Diphenhydramine hydrochloride

Available from:

Clonmel Healthcare Ltd

ATC code:

N02BE; N02BE01; R06AA; R06AA02

INN (International Name):

Paracetamol; Diphenhydramine hydrochloride

Dosage:

500 mg/25 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Anilides; paracetamol; Aminoalkyl ethers; diphenhydramine

Authorization status:

Marketed

Authorization date:

2017-01-06

Patient Information leaflet

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARALIEF NIGHT FILM-COATED TABLETS
PARACETAMOL 500 MG / DIPHENHYDRAMINE HYDROCHLORIDE 25 MG
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, pharmacist or nurse
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 7 days.
THE NAME OF THIS MEDICINE IS PARALIEF NIGHT FILM-COATED TABLETS.
_In the rest of this leaflet Paralief Night Film-coated Tablets is
called Paralief Night._
WHAT IS IN THIS LEAFLET:
1. What Paralief Night is and what it is used for
2. What you need to know before you take Paralief Night
3. How to take Paralief Night
4. Possible side effects
5. How to store Paralief Night
6. Contents of the pack and other information
1.
WHAT PARALIEF NIGHT IS AND WHAT IT IS USED FOR
Paralief Night contains paracetamol which is an analgesic (a pain
killer which relieves aches and
shivers) and antipyretic (it reduces body temperature when you have a
fever) and diphenhydramine
hydrochloride, an antihistamine that causes sleepiness or drowsiness
making it useful when pain is
keeping you awake.
Paralief Night is used for fast and effective relief of, aches and
pains associated with colds and flu,
headaches, backache, rheumatic and muscle pains, period pains and
toothache which is causing
difficulty in getting to sleep.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARALIEF NIGHT
DO NOT TAKE PARALIEF NIGHT:

If you are allergic to paracetamol or diphenhydramine hydrochloride or
to any of the other
ingredients of this medicine (listed in Section 6).

If you have taken another medicine containing pa

Summary of Product characteristics

Health Products Regulatory Authority
24 May 2022
CRN00CXTK
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paralief Night Film-coated Tablets Paracetamol 500 mg Diphenhydramine
hydrochloride 25 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains paracetamol 500.0mg and diphenhydramine
hydrochloride 25.0mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet
Blue/light blue film coated capsule shaped tablets
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the short term treatment of bedtime symptoms of pain, for example
arising from colds and flu, rheumatic and muscle pain,
backache, toothache, headache and period pain which is causing
difficulty in getting to sleep.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral administration only.
ADULTS (INCLUDING THE ELDERLY) AND ADOLESCENTS 16 YEARS AND OVER:
2 tablets to be taken 20 minutes before bedtime. Other products
containing paracetamol may be taken during the day but the
total daily dose of paracetamol must not exceed 4000 mg (including
this product) in any 24 hour period. Allow at least four
hours between taking any paracetamol-containing product and this
product.
MAXIMUM DAILY DOSE OF PARALIEF NIGHT FILM-COATED TABLETS:
Two tablets (1000mg paracetamol, 50mg diphenhydramine) in 24 hours.
ADOLESCENTS 12 TO 15 YEARS:
1 tablet to be taken 20 minutes before bedtime. Other products
containing paracetamol may be taken during the day but the
total daily dose of paracetamol must not exceed 3000 mg (including
this product) in any 24 hour period. Allow at least four to
six hours between taking any paracetamol-containing product and this
product.
MAXIMUM DAILY DOSE OF PARALIEF NIGHT FILM-COATED TABLETS:
ONE TABLET (500MG PARACETAMOL, 25MG DIPHENHYDRAMINE) IN 24 HOURS.
The maximum daily dose of paracetamol should not exceed 2000 mg in the
following situations, unless directed by a physician:
• Adults or adolescents weighing less than 50 Kg
• Hepatic impairment
• Chronic alcoholism
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