Flurbiprofen Sandoz sinaasappel suikervrij 8,75 mg, zuigtabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

FLURBIPROFEN

Beschikbaar vanaf:

Sandoz B.V.

ATC-code:

R02AX01

INN (Algemene Internationale Benaming):

FLURBIPROFEN

farmaceutische vorm:

Tablet

Samenstelling:

BETACAROTEEN (E 160a (II)) ; BLOEDSINAASAPPELSMAAKSTOF ; BUTYLHYDROXYANISOL (E 320) ; ISOMALT (E 953) ; KALIUMHYDROXIDE (E 525) ; LEVOMENTHOL (L- Vorm) ; MACROGOL 300 ; MALTITOL, VLOEIBAAR (E 965) ; SINAASAPPELSMAAKSTOF ; SUCRALOSE (E 955),

Toedieningsweg:

Oromucosaal gebruik

Therapeutisch gebied:

Flurbiprofen

Product samenvatting:

Hulpstoffen: BETACAROTEEN (E 160a (II)); BLOEDSINAASAPPELSMAAKSTOF; BUTYLHYDROXYANISOL (E 320); ISOMALT (E 953); KALIUMHYDROXIDE (E 525); LEVOMENTHOL (L- Vorm); MACROGOL 300; MALTITOL, VLOEIBAAR (E 965); SINAASAPPELSMAAKSTOF; SUCRALOSE (E 955);

Autorisatie datum:

2016-10-05

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Flurbiprofen Sandoz sinaasappel suikervrij 8,75 mg, zuigtabletten
Flurbiprofen_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
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.
WHAT IS IN THIS LEAFLET
1. What [Nationally completed name] is and what it is used for
2. What you need to know before you take [Nationally completed name]
3. How to take [Nationally completed name]
4. Possible side effects
5. How to store [Nationally completed name]
6. Contents of the pack and other information
1. WHAT {[NATIONALLY COMPLETED NAME]} IS AND WHAT IT IS USED FOR
{[Nationally completed name]}contains flurbiprofen. It belongs to a
group of medicines known
as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide
relief by changing the body’s
response to pain, swelling, and high temperature. {[Nationally
completed name]} lozenges are used
for the short-term relieve of symptoms of sore throat such as throat
pain and soreness in adults and
children over the age of 12 years.
You must talk to

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Flurbiprofen Sandoz sinaasappel suikervrij 8,75 mg, zuigtabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 8.75 mg Flurbiprofen.
Excipient(s) with known effect
Isomalt 2160 mg/lozenge
Maltitol 383 mg/lozenge
Butylated hydroxyanisole (E320) 0.013 mg/lozenge
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lozenge
Round, orange lozenge with typical line marking and without
debossment, orange flavour.
Diameter: Approximately 19 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
{[Nationally completed name] 8.75 mg lozenges} are indicated for the
short term symptomatic relief
of sore throat in adults and children over the age of 12 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults, the elderly and children over the age of 12 years _
One lozenge sucked/dissolved slowly in the mouth every 3-6 hours as
required. Maximum 5 lozenges
in a 24 hour period.
It is recommended that this product should be used for a maximum of
three days.
_Pediatric population _
Not indicated for children under 12 years.
_Elderly _
A general dose recommendation cannot be given, since to date clinical
experience is limited. The
elderly are at increased risk of the serious consequences of adverse
reactions.
_Hepatic impairment _
In patients with mild to moderate impairment of hepatic function no
dose reduction is required. In
patients with severe hepatic insufficiency flurbiprofen is
contraindicated (see section 4.3).
_Renal impairment _
In patients with mild to moderate impairment of renal function no dose
reduction is required. In
patients with severe renal insufficiency flurbiprofen is
contraindicated (see section 4.3).
Method of administration
_ _
For oromucosal administration and short-term use only.
As with all lozenges, to avoid local irritation, {[nationally
completed name]} should be moved around
the mouth whilst sucking.
The lowest effective dose should be administered for the shortest
duration nece