Ibuprofen/Paracetamol Alkaloid-INT 200 mg/500 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IBUPROFEN, PARACETAMOL

Available from:

Alkaloid-INT d.o.o. Šlandrova ulica 4, 1231 Ljubljana-Crnuce, Slovenia

ATC code:

M01AE51

INN (International Name):

PARACETAMOL 500 mg IBUPROFEN 200 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

PARACETAMOL 500 mg IBUPROFEN 200 mg

Prescription type:

OTC

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-06-22

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN/PARACETAMOL ALKALOID-INT 200 MG/500 MG FILM-COATED TABLETS
Ibuprofen and 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 Ibuprofen/Paracetamol Alkaloid-INT is and what it is used for
2.
What you need to know before you take Ibuprofen/Paracetamol
Alkaloid-INT
3.
How to take Ibuprofen/Paracetamol Alkaloid-INT
4.
Possible side effects
5.
How to store Ibuprofen/Paracetamol Alkaloid-INT
6.
Contents of the pack and other information
1.
WHAT IBUPROFEN/PARACETAMOL ALKALOID-INT IS AND WHAT IT IS USED FOR
Your medicine is called Ibuprofen/Paracetamol Alkaloid-INT 200 mg/500
mg tablets (called
Ibuprofen/Paracetamol Alkaloid-INT throughout the rest of this
leaflet). Ibuprofen/Paracetamol
Alkaloid-INT 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 body temperature.
Paracetamol is an analgesic which works in a different way from
ibuprofen to relieve pain and fever.
Ibuprofen/Paracetamol Alkaloid-INT is used for short term treatment of
mild to moderate pain
associated with migraine, headache, backache, menstrual pain, dental
pain, muscular pain, cold and
flu, sore throat and fever.
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
2.
WHAT YOU

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ibuprofen/Paracetamol Alkaloid-INT 200 mg/500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg ibuprofen and 500 mg paracetamol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
White to off white, oblong, biconvex film-coated tablets with
dimensions of (21 mm x 10.5 mm) ±
0.5 mm and marked with double circle mark on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The medicinal product is used for temporary treatment of mild to
moderate pain associated with
migraine, headache, backache, menstrual pain, dental pain, muscular
pain, cold and flu symptoms,
sore throat and fever. This product is especially suitable for pain
which requires stronger analgesia
than ibuprofen or paracetamol alone.
Ibuprofen/Paracetamol Alkaloid-INT is intended for adults from 18
years of age
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For short term-use only.
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see
section 4.4).
The patient should consult a doctor if the symptoms persist or worsen
or if it is necessary to use this
medicine for more than 3 days.
ADULTS:
One tablet to be taken up to three times per day with water. Leave at
least six hours between
doses.
If the one tablet dose does not control symptoms, a maximum of two
tablets may be taken up to three
times a day. Leave at least six hours between doses.
Do not take more than six tablets (3000 mg Paracetamol, 1200 mg
Ibuprofen) within 24 hours period.
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Adverse reactions can be reduced by using the lowest effective dose
for the shortest period necessary
to relieve symptoms (see section 4.4).
To minimise side effects, it is recommended that patients take
Ibuprofen/Paracetamol Alkaloid-INT
with food.
ELDERLY:
No special dosage modifications are required (see section 4.4).
The elderly are at increased risk of the serious consequenc