Irfen-200 Quiktabs

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IBUPROFEN

Available from:

Mepha LDA. Lagoas Park, Edificio 5A, Piso 2, 2740-298 Porto Salvo, Portugal

ATC code:

M01AE01

INN (International Name):

IBUPROFEN 200 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

IBUPROFEN 200 mg

Prescription type:

OTC

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2006-11-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
IRFEN QUIKTABS
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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Irfen is and what it is used for
2.
What you need to know before you take Irfen
3.
How to take Irfen
4.
Possible side effects
5.
How to store Irfen
6.
Contents of the pack and other information
1. WHAT IRFEN IS AND WHAT IT IS USED FOR
Irfen belongs to a group of medicines called NSAIDs (non-steroidal
anti-inflammatory drugs)
which work by reducing pain, inflammation and fever.
Irfen is used to treat the following conditions in adults and children
aged 12 years and older:

provide relief from mild to moderate pain such as headache, toothache,
period pain, post-
traumatic pain (sprains, contusions, dislocations, fractures),
post-surgical pain (general
surgery, episiotomy, dental extraction)

treat fever

treatment of rheumatoid arthritis, osteoarthritis, juvenile rheumatoid
arthritis,
ankylosing spondylitis, extra-articular rheumatism or other
inflammatory or painful
joint conditions, as well as for inflammatory and painful conditions
of soft tissues.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IRFEN
DO NOT TAKE IRFEN:
-
if you are allergic to ibuprofen or any of the other ingredients of
this medicine
-
if you have had allergic reactions such as asthma, bronchospasm, runny
nose, itchy skin
rash or swelling of the lips, face, tongue, or throat after you have
taken medicines
containing acetylsalicylic acid (aspirin) or other drugs for pain and
inflammation
(NSAIDs)
-
if you have s

Summary of Product characteristics

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Irfen-200 Quiktabs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Quiktab contains 200 mg ibuprofen.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Inflammatory and degenerative rheumatic diseases of the joints and
soft tissue.
Non-rheumatic pain such as primary dysmenorrhea, headache and
toothache, postoperative pain.
Fever.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
_ _
_Usual dosage_
Irfen Quiktabs are taken without chewing during or after a meal with
little fluid.
For oral administration and short-term use only.
During short-term use, if symptoms persist or worsen the patient
should be advised to consult a
doctor.
Adults and children over 12 years:
The minimum effective dose should be used for the shortest time
necessary to relieve symptoms. If
the product is required for more than 10 days, or if the symptoms
worsen the patient should consult a
doctor.
Take 1 or 2 tablets with water, up to three times a day as required.
Leave at least four hours between doses.
Do not take more than 6 tablets in any 24 hour period.
Not for use by children under 12 years of age.
_Maximum dose: _
The respective dosing interval should be chosen in line with the
observed symptoms and the
Page 2 of 6
maximum recommended daily dose. It should not be below 6 hours dose. A
total dose of 1200 mg
ibuprofen should not be exceeded in any 24-hour period.
_Elderly patients _
No special dose adjustment is required. Because of the possible
undesirable-effect profile (see
section 4.4), the elderly should be monitored particularly carefully.
_ _
_Patients with renal impairment _
No dose reduction is required in patients with mild to moderate
impairment to renal function (for
patients with severe renal insufficiency, see section