Irfen 400 mg film-coated tablet

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

IBUPROFEN

Dostupné z:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC kód:

M01AE01

INN (Medzinárodný Name):

IBUPROFEN 400 mg

Forma lieku:

FILM-COATED TABLET

Zloženie:

IBUPROFEN 400 mg

Typ predpisu:

OTC

Terapeutické oblasti:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2009-04-14

Príbalový leták

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IRFEN 400 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 has 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 or pharmacist. 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 in adolescents
- after 7 days in adults.
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 NSAID (non-steroidal
anti-inflammatory drugs) which
work by reducing pain, inflammation and fever.
Irfen 400 mg is used to provide relief from mild to moderate pain such
as headache, including
migraine headache, dental pain, period pain and fever.
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 (listed in section
6).
-
if you have had allergic reactions such as asthma, runny nose, itchy
skin rash or swelling of the
lips, face, tongue, or throat after you have taken medicines
containing acetylsalicylic acid or
other drugs for pain and inflammation (NSAIDs).
-
if you have suffered from an ulcer or bleeding in the stomach or small
intestine (duodenum)
related to previous use of drugs for pain and inflammation (NSAIDs)
-
if you are suffering from an ulcer or bleeding in the stomach or small
intestine (duodenum) or
if you have had two or more of these episodes in the past
-
if you suffer from sev

Súhrn charakteristických

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Irfen 200 mg film-coated tablet
Irfen 400 mg film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg ibuprofen.
Each film-coated tablet contains 400 mg ibuprofen.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, oval, biconvex film-coated tablets with a score on one face.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mild to moderate pain, such as headache including migraine headache,
dental pain.
Primary dysmenorrhoea.
Fever.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see
section 4.4). This product is for short-term use only, not longer than
7 days in adults. If symptoms
persist or worsen a doctor should be consulted.
<200 mg:> If a child or adolescent requires this medicinal product for
more than 3 days, or if
symptoms worsen, a doctor should be consulted.
<400 mg:> If an adolescent requires this medicinal product for more
than 3 days, or if symptoms
worsen, a doctor should be consulted.
The ibuprofen dose depends on the patient’s age and body weight.
The tablet should be swallowed with a glass of water during or after a
meal.
_ _
_ _
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_MILD TO MODERATE PAIN AND FEVER _
_Adults and adolescents older than 12 years (≥40 kg): _
200-400 mg given as a single dose or 3-4 times a day with an interval
of 4 to 6 hours. The dosage in
migraine headache should be: 400 mg given as a single dose, if
necessary 400 mg with intervals of 4
to 6 hours.
The maximum daily dose should not exceed 1200 mg.
200 mg only:
_Children 6-12 years (>20 kg): _
Children 6-9 years (20-29 kg): 200 mg 1-3 times a day with intervals
of 4 to 6 hours as required.
The maximum daily dose should not exceed 600 mg.
Children 10-12 years (30-40 kg): 200 mg 1-4 times a day with intervals
of 4 to 6 hours as required.
The m