Easofen Max Strength 400 mg Film-coated Tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Ibuprofen

Disponible des:

Clonmel Healthcare Ltd

Codi ATC:

M01AE; M01AE01

Designació comuna internacional (DCI):

Ibuprofen

Dosis:

400 milligram(s)

formulario farmacéutico:

Film-coated tablet

tipo de receta:

Product not subject to medical prescription

Área terapéutica:

Propionic acid derivatives; ibuprofen

Estat d'Autorització:

Marketed

Data d'autorització:

2011-09-09

Informació per a l'usuari

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
EASOFEN MAX STRENGTH 400MG 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 Max Strength is and what it is used for
2. What you need to know before you take Easofen Max Strength
3. How to take Easofen Max Strength
4. Possible side effects
5. How to store Easofen Max Strength
6. Contents of the pack and other information
1. WHAT EASOFEN MAX STRENGTH IS AND WHAT IT IS USED FOR
Easofen Max Strength Tablets contain the active substance ibuprofen,
which belongs to a group of medicines
called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines
reduce pain and inflammation.
Easofen Max Strength is used for the relief of muscular pain,
backache, dental pain and period pain.
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 MAX STRENGTH
DO NOT TAKE EASOFEN MAX STRENGTH TABLETS
•
if you are allergic to ibuprofen or any of the other ingredients in
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 had two or more episodes of) a stomach ulcer,
perforation or bleeding
•
if you have ever had stomach bleeding or perforation after taking
ibuprofen, aspirin, or any other
NSAIDs
•
suff

Fitxa tècnica

Health Products Regulatory Authority
16 November 2022
CRN00D6G5
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Easofen Max Strength 400 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg ibuprofen.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round, white, biconvex film-coated tablets, 12 mm in diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the short term management of muscular pain, backache, dental pain
and dysmenorrhoea.
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 dose is 400 mg and subsequently if necessary 400 mg every
four to six 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 12 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).
Treatment should be reviewed at regular intervals and discontinued if
no benefit is seen or intolerance occurs.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
Method of administration
_ _
Oral.
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 or other gastrointestinal disorder).
(ii) Hypersensitivity to the active substance or to any of the
excipients listed in section 6.1.
Health Products Regulatory Authority
16 Novemb