APAP intense 200 mg/500 mg film-coated tablets

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

IBUPROFEN, PARACETAMOL

זמין מ:

PharOS – Pharmaceutical Oriented Services Limited Lesvou str. (end), Thesi Loggos, Industrial Zone, 144 52 Metamorfossi Attikis,, Greece

קוד ATC:

M01AE51

INN (שם בינלאומי):

IBUPROFEN 200 mg PARACETAMOL 500 mg

טופס פרצבטיות:

FILM-COATED TABLET

הרכב:

IBUPROFEN 200 mg PARACETAMOL 500 mg

סוג מרשם:

OTC

איזור תרפויטי:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

leaflet_short:

Licence number in the source country: NOT APPLICAPABLE

מצב אישור:

Withdrawn

תאריך אישור:

2020-05-06

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
APAP INTENSE
200 MG/500 MG FILM-COATED TABLETS
ibuprofen/paracetamol
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 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.
WHAT IS IN THIS LEAFLET
1.
What APAP intense is and what it is used for
2.
What you need to know before you take APAP intense
3.
How to take APAP intense
4.
Possible side effects
5.
How to store APAP intense
6.
Contents of the pack and other information
1.
WHAT APAP INTENSE IS AND WHAT IT IS USED FOR
APAP intense contains two active ingredients (which make the medicine
work). These are
ibuprofen and paracetamol.
Ibuprofen belongs to a group of medicines known as non-steroidal
anti-inflammatory drugs
(NSAIDs).
NSAIDs
work
by
reducing
pain,
reducing
swelling
and
lowering
high
temperatures.
Paracetamol is an analgesic which works in a different way from
ibuprofen to relieve pain
and fever. This product is especially suitable for pain which requires
stronger analgesia than
ibuprofen or paracetamol alone.
APAP intense is used for the temporary relief of mild to moderate pain
associated with
migraine, headache, backache, period pain, dental pain, rheumatic and
muscular pain, pain
of non-serious arthritis, cold and flu symptoms, sore throat and
fever.
APAP intense
is used in adults aged 18 years and older.
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE APAP INTENSE
DO NOT TAKE APAP INTENSE IF YOU
-
are already taking
ANY OTHER PARACETAMOL-CONTAINING MEDICI

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
APAP intense 200 mg/500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg ibuprofen and 500 mg
paracetamol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
White to off-white, oval shaped, film-coated tablets, with dimensions
19.7 mm x 9.2 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the temporary relief of mild to moderate pain associated with
migraine, headache,
backache, period pain, dental pain, rheumatic and muscular pain, pain
of non-serious
arthritis, cold and flu symptoms, sore throat and fever. This
medicinal product is especially
suitable for pain which requires stronger analgesia than ibuprofen or
paracetamol alone.
APAP intense
is indicated in adults aged 18 years and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For short term-use only.
The patient should consult a doctor if the symptoms persist or worsen
or if the medicinal
product is required for more than 3 days.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest
duration necessary to control symptoms (see section 4.4).
ADULTS:
One tablet to be taken up to three times per day with water. The
interval between
single doses should be at least six hours.
If single doses of one tablet do not control symptoms, a maximum of
two tablets may be
taken up to three times a day. The interval between single doses
should be at least six hours.
The maximum dose is six tablets (1200 mg ibuprofen, 3000 mg
paracetamol) in any 24
hours period.
ELDERLY:
No special dosage modifications are required (see section 4.4).
The elderly are at increased risk of the serious consequences of
adverse reactions. If an
NSAID is considered necessary, the lowest effective dose should be
used for the shortest
possible duration. The patient should be monitored regularly for
gastrointestinal bleeding
during NSAID therapy.
_ _
_Paediatric population