Melfen 400mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen ph. eur.

Available from:

Clonmel Healthcare Ltd

ATC code:

M01AE; M01AE01

INN (International Name):

Ibuprofen ph. eur.

Dosage:

400 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Propionic acid derivatives; ibuprofen

Authorization status:

Marketed

Authorization date:

1980-07-11

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
MELFEN 200MG FILM-COATED TABLETS
MELFEN 400MG FILM-COATED TABLETS
IBUPROFEN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
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.
WHAT IS IN THIS LEAFLET
1. What Melfen is and what it is used for
2. What you need to know before you take Melfen
3. How to take Melfen
4. Possible side effects
5. How to store Melfen
6. Contents of the pack and other information
1. WHAT MELFEN IS AND WHAT IT IS USED FOR
Melfen 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.
MELFEN TABLETS ARE USED:
For the treatment of arthritis (an inflammation of a joint that may
cause swelling, redness and pain) and other
conditions affecting the joints and muscles.
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 MELFEN
DO NOT TAKE MELFEN TABLETS
•
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 an active peptic ulcer, which is an ulcer in your stomach
or intestines, or bleeding in your
stomach, or have had two or more episodes of peptic ulcers, stomach
bleeding or perforation in the past
•
if you have ever had stomach bleeding or perfora

Summary of Product characteristics

Health Products Regulatory Authority
16 November 2022
CRN00D6G7
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Melfen 400mg 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, 12mm in diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an adjunct in the treatment of rheumatoid arthritis,
osteoarthritis, ankylosing spondylitis, acute articular and
periarticular
disorders, fibrositis, cervical spondylitis, low back pain, painful
musculo-skeletal conditions.
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 only
The usual daily dosage is 600 - 1200 mg in divided doses. The maximum
daily dosage is 2,400 mg in divided doses.
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) Hypersensitivity to the active substance or to any of the
excipients listed in section 6.1.
(ii) Use in patients with asthma, bronchospasm, rhinitis or urticaria
associated with hypersensitivity to acetylsalicylic acid or
other non-steroidal anti-inflammatory drugs.
(iii) 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 chronic dyspepsia.
(iv) Severe he