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

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

PARACETAMOL; DIPHENHYDRAMINE HYDROCHLORIDE

Предлага се от:

Chanelle Medical

АТС код:

N02BE; N02BE01; R06AA; R06AA02

INN (Международно Name):

PARACETAMOL; DIPHENHYDRAMINE HYDROCHLORIDE

дозиране:

500 mg/25 milligram(s)

Лекарствена форма:

Film-coated tablet

Вид предписание :

Product not subject to medical prescription

Терапевтична област:

Anilides; paracetamol; Aminoalkyl ethers; diphenhydramine

Статус Оторизация:

Marketed

Дата Оторизация:

2017-01-06

Листовка

ID: PL186M (DCP) IE (OLS Clonmel - IE)
Version: 03
Revision Date: 04/02/2018
IE/H/0463/001/DC
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 me

Данни за продукта

Health Products Regulatory Authority
26 March 2021
CRN00C3YT
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