Ryze Mint 2 mg Munhålepulver i portionspåse

Χώρα: Σουηδία

Γλώσσα: Σουηδικά

Πηγή: Läkemedelsverket (Medical Products Agency)

Δραστική ουσία:

nikotin

Διαθέσιμο από:

Fertin Pharma A/S

Φαρμακολογική κατηγορία (ATC):

N07BA01

INN (Διεθνής Όνομα):

nicotine

Δοσολογία:

2 mg

Φαρμακοτεχνική μορφή:

Munhålepulver i portionspåse

Σύνθεση:

nikotin 2 mg Aktiv substans

Τρόπος διάθεσης:

Receptfritt

Περίληψη προϊόντος:

Förpacknings: Burk, 20 portionspåsar (i aluminiumpåse)

Καθεστώς αδειοδότησης:

Godkänd

Ημερομηνία της άδειας:

2017-09-06

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ryze Mint 2 mg oromucosal powder in pouch
Ryze Mint 4 mg oromucosal powder in pouch
nicotine
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, pharmacist or nurse has told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask you pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
-
You must talk to a doctor or pharmacist if you have used for more than 6 months.
WHAT IS IN THIS LEAFLET
1.
What is and what it is used for
2.
What you need to know before you use
3.
How to use
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1. WHAT IS AND WHAT IS IT USED FOR
contains the active substance nicotine. It relieves
craving for nicotine and withdrawal
symptoms when you stop smoking and thereby counteracts relapse to
smoking in smokers who are motivated
to stop.
facilitates smoking reduction in smokers who cannot or
are unwilling to stop smoking
completely.
It is indicated for adults aged 18 years and above.
When you suddenly stop providing nicotine in the form of tobacco to
your body, you experience different
kinds of discomfort, called withdrawal symptoms. When using you can prevent or reduce
this discomfort, by continuing to provide a small amount of nicotine
to your body during a transitional
period.
Advice and support may help you to improve the success rate.
You must talk to a doctor or pharmacist if you have used for more than 6 months.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
DO NOT USE :
-
if you are
ALLERGIC
to nicotine or any of the o

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ryze Mint 2 mg oromucosal powder in pouch.
Ryze Mint 4 mg oromucosal powder in pouch.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2 mg: One pouch contains 2 mg nicotine.
4 mg: One pouch contains 4 mg nicotine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oromucosal powder in pouch
Rectangular pouch filled with powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
oromucosal powder in pouch is indicated in adults for
the treatment of tobacco
dependence by relieving nicotine craving and withdrawal symptoms.
facilitates smoking cessation in smokers who are
motivated to quit and facilitates
smoking reduction in smokers who are not able or willing to quit
smoking.
oromucosal powder in pouch should preferably be used in conjunction
with a behavioural support
program.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly_
Initially, one pouch may be administered every 1-2 hours. The usual
dosage is 8-12 pouches a day.
The maximum daily dose is 24 pouches.
_Smoking cessation_
The duration of treatment is individual. Normally, the treatment
should continue for at least 3 months.
The nicotine dose should then be gradually reduced. Treatment should
be discontinued when the dose
has been reduced to 1-2 pouches per day. Regular use of for more than one year is
generally not recommended. In some cases a longer treatment period
might be necessary in order to
avoid relapse. Any spare pouches should be retained, as craving may
suddenly occur.
Counselling and support may increase the probability to succeed in
quitting smoking.
_Smoking reduction_
is used between periods of smoking in order to extend
the non-smoking intervals
and with the objective to reduce smoking as much as possible.
Professional help should be sought if a
decrease in number of cigarettes per day has not been achieved after 6
weeks of