Paracetamol/Diphenhydramine Hydrochloride 500 mg/25 mg Film-coated Tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

PARACETAMOL; DIPHENHYDRAMINE HYDROCHLORIDE

可用日期:

Chanelle Medical

ATC代码:

N02BE; N02BE01; R06AA; R06AA02

INN（国际名称）:

PARACETAMOL; DIPHENHYDRAMINE HYDROCHLORIDE

剂量:

500mg/25 milligram(s)

药物剂型:

Film-coated tablet

处方类型:

Product not subject to medical prescription

治疗领域:

Anilides; paracetamol; Aminoalkyl ethers; diphenhydramine

授权状态:

Not marketed

授权日期:

2017-01-06

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL/DIPHENHYDRAMINE HYDROCHLORIDE 500MG/25MG FILM-COATED
TABLETS
PARACETAMOL/DIPHENHYDRAMINE HYDROCHLORIDE
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 PARACETAMOL/DIPHENHYDRAMINE HYDROCHLORIDE
500MG/25MG FILM-COATED TABLETS.
_In the rest of this leaflet Paracetamol/Diphenhydramine Hydrochloride
500mg/25mg Film-_
_coated Tablets is called Paracetamol/Diphenhydramine Hydrochloride._
WHAT IS IN THIS LEAFLET:
1. What Paracetamol/Diphenhydramine Hydrochloride is and what it is
used for
2. What you need to know before you take Paracetamol/Diphenhydramine
Hydrochloride
3. How to take Paracetamol/Diphenhydramine Hydrochloride
4. Possible side effects
5. How to store Paracetamol/Diphenhydramine Hydrochloride
6. Contents of the pack and other information
1.
WHAT PARACETAMOL/DIPHENHYDRAMINE HYDROCHLORIDE IS AND WHAT IT IS USED
FOR
Paracetamol/Diphenhydramine Hydrochloride 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.
Paracetamol/Diphenhydramine Hydrochloride 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 difficult

产品特点

Health Products Regulatory Authority
24 May 2022
CRN00CXS2
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol/Diphenhydramine Hydrochloride 500 mg/25 mg Film-coated
Tablets
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 PARACETAMOL/DIPHENHYDRAMINE HYDROCHLORIDE 500
MG/25MG 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 PARACETAMOL/DIPHENHYDRAMINE HYDROCHLORIDE 500
MG/25MG 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