Easofen 200mg Film-Coated Tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Ibuprofen

可用日期:

Clonmel Healthcare Ltd

ATC代码:

M01AE; M01AE01

INN（国际名称）:

Ibuprofen

剂量:

200 milligram(s)

药物剂型:

Film-coated tablet

处方类型:

Product not subject to medical prescription

治疗领域:

Propionic acid derivatives; ibuprofen

授权状态:

Marketed

授权日期:

1986-07-02

资料单张

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
EASOFEN 200 MG FILM-COATED TABLETS
IBUPROFEN
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 Easofen 200 mg film-coated tablets are and what they are used for
2.
What you need to know before you take Easofen 200 mg film-coated
tablets
3.
How to take Easofen 200 mg film-coated tablets
4.
Possible side effects
5.
How to store Easofen 200 mg film-coated tablets
6.
Contents of the pack and other information
1. WHAT EASOFEN 200 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE
USED FOR
Easofen 200 mg contains the active substance ibuprofen, which belongs
to a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs). These medicines reduce
pain and inflammation,
and bring down a high temperature.
Easofen is used for the relief of headaches, dental pain, period pain,
muscle strain and cold and flu
symptoms.
You must talk to a doctor if you do not feel better or if you feel
worse.
_ _
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EASOFEN 200 MG FILM-COATED
TABLETS
DO NOT TAKE EASOFEN
•
if you are allergic to ibuprofen or any of the other ingredients of
this medicine (listed in section 6)
•
if you previously suffered an allergic reaction (e.g. skin rash, runny
nose or
wheezing/breathlessness, swelling of the lips, face, tongue or throat)
after taking aspirin or any
other NSAIDs
•
if you have or have ever had a stomach or duodenal ulcer, perforation
or bleeding, or other
stomach or bowel prob

产品特点

Health Products Regulatory Authority
17 November 2022
CRN00D8GC
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Easofen 200mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg ibuprofen.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Round, white, biconvex film-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the short term management of mild to moderate pain such as is
associated with headache, dental pain, period pain, muscle
strain and for the management of head cold and influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see section 4.4).
Adults and adolescents (over the age of 12 years)
The usual initial dose is 400 mg and subsequently if necessary 200 to
400 mg every four hours with a maximum of 1200 mg in
a twenty-four hour period.
If in adolescents this medicinal product is required for more than 3
days, or if symptoms worsen a doctor should be consulted.
Not recommended in children under the age of twelve years.
Elderly
NSAIDs should be used with particular caution in elderly patients who
are more prone to adverse events. The lowest dose
compatible with adequate safe clinical control should be employed.
_See also Section 4.4._
Compromised renal or hepatic function and especially cardiac
dysfunction are more likely in the elderly and therefore medically
appropriate supervision should be maintained.
Treatment should be reviewed at regular intervals and discontinued if
no benefit is seen or intolerance occurs.
Method of administration
Oral.
Health Products Regulatory Authority
17 November 2022
CRN00D8GC
Page 2 of 9
4.3 CONTRAINDICATIONS
(i) History of gastrointestinal bleeding or perforation, related to
previous NSAIDs therapy. Active or history of recurrent peptic
ulcer/haemorrhage (two or more distinct episodes of proven ulceration
or bleeding).
(ii) Hypersensitiv