Paracetamol/Ibuprofen Rontis 500mg/200mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IBUPROFEN, PARACETAMOL

Available from:

Rontis Hellas Medical and Pharmaceutical Products S.A. 38, Sorou Str., Athens, Maroussi, 15125, Greece

ATC code:

M01AE51

INN (International Name):

IBUPROFEN 200 mg PARACETAMOL 500 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

IBUPROFEN 200 mg PARACETAMOL 500 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:

2020-05-08

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL/IBUPROFEN RONTIS 500 MG/200 MG FILM-COATED TABLETS
paracetamol/ibuprofen
[For OTC:]
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 Paracetamol/Ibuprofen Rontis is and what it is used for
2. What you need to know before you take Paracetamo/Ibuprofen Rontis
3. How to take Paracetamol/Ibuprofen Rontis
4. Possible side effects
5. How to store Paracetamol/Ibuprofen Rontis
6. Contents of the pack and other information
1. WHAT PARACETAMOL/IBUPROFEN RONTIS IS AND WHAT IT IS USED FOR
Paracetamol/Ibuprofen Rontis contains two active ingredients (which
make the medicine
work). These are paracetamol and ibuprofen.
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 has not been
relieved by paracetamol
or ibuprofen alone.
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/Ibuprofen Rontis 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 in mild forms of arthritis, cold and flu symptoms,
sore throat and fever.
[
_For _
_OTC:_
]
_ _
_For _
_relief _
_of _
_rheumatic _
_pain _
_and _
_pain _
_of _
_mild _
_forms _
_of _
_arthritis, _
_Paracetamol/Ibuprofen Rontisshoul

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Paracetamol/Ibuprofen Rontis 500 mg/200 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg paracetamol and 200 mg
ibuprofen.
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
in mild forms of
arthritis, cold and flu symptoms, sore throat and fever. This
medicinal product is especially
suitable for pain which has not been relieved by paracetamol or
ibuprofen alone.
Paracetamol/Ibuprofen Rontis is indicated in adults aged 18 years and
older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The patient should consult a doctor if the symptoms persist or worsen
or if the medicinal
product is required for more than 3 days.
This medicine is for short-term use and is not recommended for use
beyond 3 days.
The lowest effective dose should be used for the shortest duration
necessary to relieve
symptoms (see section 4.4).
_Adults _
One tablet to be taken up to three times per day. 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 daily dose is six tablets (3000 mg paracetamol, 1200 mg
ibuprofen) and
should not be exceeded 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