Oki Mouth Wash

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

KETOPROFEN LYSINE

Available from:

Dompe Farmaceutici SpA Via San Martino 12, 20122, Milan, Italy

ATC code:

A01AD11

INN (International Name):

KETOPROFEN LYSINE 1.6 % (W/V)

Pharmaceutical form:

OROMUCOSAL SOLUTION

Composition:

KETOPROFEN LYSINE 1.6 % (W/V)

Prescription type:

OTC

Therapeutic area:

STOMATOLOGICAL PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2007-01-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
OKI 1,6% MOUTHWASH
ketoprofen lysine salt
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
Always use 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.
WHAT IS IN THIS LEAFLET
1.
What OKi 1,6% mouthwash is and what it is used for
2.
What you need to know before you use OKi 1,6% mouthwash
3.
How to use OKi 1,6% mouthwash
4.
Possible side effects
5.
How to store OKi 1,6% mouthwash
6.
Contents of the pack and other information
1. WHAT OKI 1,6% MOUTHWASH IS AND WHAT IT IS USED FOR
OKi 1,6% mouthwash contains the active substance ketoprofen lysine
salt that belongs to a group of medicines called
“Nonsteroidal anti-inflammatory drugs” (NSAIDs) and it is used as
stomatological preparations for local oral treatment.
OKi 1,6% mouthwash is used for symptomatic treatment of
irritative-inflammatory conditions even associated with
pharyngo-oral cavity (for example gingivitis, stomatitis, pharyngitis)
also in consequence to conservative or extractive
dental therapy.
You must talk to a doctor if you do not feel better or if you feel
worse after a brief period of treatment.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OKI 1,6% MOUTHWASH
DO NOT TAKE OKI 1,6% MOUTHWASH
-
if you are allergic to ketoprofen or to any other ingredients of this
medicine (listed in section 6 " Contents of the
pack and other information”);
-
if you are a patients in whom the use of other non-steroidal
anti-inflammatory drugs has caused allergic reactions
such as asthma, urticaria or rhinitis
-
if
you
are
pregnant,
or
think
you
are
pregnant
or
breastfeedin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
OKi 1,6% mouthwash
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml of mouthwash contain the active ingredient: ketoprofen lysine
salt 1.6 g
Excipient with known effect: methyl p-hydroxybenzoate
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Mouthwash 4.
CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Symptomatic treatment of irritative-inflammatory conditions even
associated with pharyngo-oral
cavity (for example gingivitis, stomatitis, pharyngitis), also in
consequence to conservative or
extractive dental therapy.
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
In the packaging is included a measuring cap with a notch
corresponding to 10 ml. To open, press
on the cap and, at the same time, turn anticlockwise until it opens.
_ _
Two rinses or gargles daily with Oki 1,6% mouthwash (up to 5 times per
10 ml dose) diluted in
about 100 ml water
.
The involuntary swallowing of the solution used for rinsing and
gargling does not harm the patient
in any particular way, as the amount corresponds to the dose foreseen
for treatment by systemic
route (160 mg of ketoprofen lysine salt)
_4.3 _
_CONTRAINDICATIONS _
Hypersensitivity to the active substance or any of the excipients
listed in section 6.1, or in patients
in whom the use of other non-steroidal anti-inflammatory drugs has
caused allergic reactions such
as, asthma, urticaria or rhinitis.
_4.4 _
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE _
Topical agents may cause hypersensitivity, especially after prolonged
use. Should hypersensitivity
develop, treatment must be discontinued and suitable therapeutic
measures must be instituted.
During prolonged treatment or treatment with high doses, the
possibility of competition between the
ketoprofen
absorbed
and
other
drugs
which
bind
to
plasma
proteins
must
be
taken
into
consideration.
Oki
1,6%
mouthwash
contains
methyl
p-hydroxybenzoate
that
may
cause
allergic
reactions
(possibly delayed)
_ _
_4.5 _
_INTERACTIONS WITH OTHER MEDICINAL