Novynta, 1.5 mg, tablets

Land: Malta

Taal: Engels

Bron: Malta Medicines Authority

Werkstoffen:

CYTISINE

Beschikbaar vanaf:

Aflofarm Farmacja Polska SP. zo.o. ul. Partyzancka 133/151 95-200 Pabianice, Poland

ATC-code:

N07BA04

INN (Algemene Internationale Benaming):

CYTISINE 1.5 mg

farmaceutische vorm:

TABLET

Samenstelling:

CYTISINE 1.5 mg

Prescription-type:

POM

Therapeutisch gebied:

OTHER NERVOUS SYSTEM DRUGS

Product samenvatting:

Licence number in the source country: NOT APPLICAPABLE

Autorisatie-status:

Authorised

Autorisatie datum:

2022-02-17

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NOVYNTA, 1.5 MG, TABLETS
Cytisine
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.
-
If you have any further questions, ask your doctor or pharmacist.
-
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 or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Novynta is and what it is used for
2.
What you need to know before you use Novynta
3.
How to use Novynta
4.
Possible side effects
5.
How to store Novynta
6.
Contents of the pack and other information
1.
WHAT NOVYNTA IS AND WHAT IT IS USED FOR
Smoking cessation and reduction of nicotine cravings in smokers who
are willing to stop smoking. The
treatment goal of Novynta is the permanent cessation of the
nicotine-containing products use.
The use of Novynta allows for a gradual reduction of nicotine
dependence by relieving withdrawal
symptoms.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NOVYNTA
DO NOT USE NOVYNTA:
-
if you are allergic to cytisine or any of the other ingredients of
this medicine (listed in section 6),
-
if you have unstable angina,
-
if you have a history of recent myocardial infarction,
-
if you have clinically significant cardiac arrhythmias,
-
if you had stroke recently,
-
if you are pregnant or breast-feeding.
WARNINGS AND PRECAUTIONS
Novynta should be used with caution in case of ischemic heart disease,
heart failure, hypertension,
pheochromocytoma (a tumour of the adrenal gland), atherosclerosis
(hardening of the arteries) and other
peripheral vascular diseases, gastric and duodenal ulcer,
gastroesophageal reflux disease, hyperthyroidism
(overactive thy

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Novynta, 1.5 mg, tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.5 mg of cytisine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Round, biconvex, white tablet with diameter 6 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Smoking cessation and reduction of nicotine cravings in smokers who
are willing to stop smoking. The
treatment goal of Novynta is the permanent cessation of the
nicotine-containing products use.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One package of Novynta (100 tablets) is sufficient for a complete
treatment course.
The duration of therapy is 25 days.
Novynta should be taken according to the following schedule:
_ _
DAYS OF TREATMENT
RECOMMENDED DOSING
MAXIMUM DAILY DOSE
From the 1st to the 3rd day
1 tablet every 2 hours
6 tablets
From the 4th to the 12th day
1 tablet every 2.5 hours
5 tablets
From the 13th to the 16th day
1 tablet every 3 hours
4 tablets
From the 17th to the 20th day
1 tablet every 5 hours
3 tablets
From the 21st to the 25th day
1-2 tablets a day
to 2 tablets
Smoking should be stopped no later than on the 5th day of treatment.
Smoking should not be continued
during treatment as this may aggravate adverse reactions (see section
4.4). In case of treatment failure, the
treatment should be discontinued and may be resumed after 2 to 3
months.
_Special population (renal impairment, hepatic impairment) _
There is no clinical experience of Novynta in patients with renal or
hepatic impairment, therefore the drug
product is not recommended for use in this patient population.
_Elderly population _
Due to limited clinical experience, Novynta is not recommended for use
in elderly patients over 65 years of
age.
2
_Paediatric population _
The safety and efficacy of Novynta in persons under 18 years of age
have not been established. Novynta is
not recommended for use in persons under 18 years of age.
Method of administration
Novynta should be ta