Nicorama Mint 2 mg Medicinskt tuggummi

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

nikotinresinat

Tillgänglig från:

Enorama Pharma AB

ATC-kod:

N07BA01

INN (International namn):

nicotine resinate

Dos:

2 mg

Läkemedelsform:

Medicinskt tuggummi

Sammansättning:

nikotinresinat 10 mg Aktiv substans; xylitol Hjälpämne; butylhydroxitoluen Hjälpämne; glycerol Hjälpämne

Receptbelagda typ:

Receptfritt

Produktsammanfattning:

Förpacknings: Blister, 105 tuggummin; Blister, 30 tuggummin; Blister, 96 tuggummin; Blister, 204 tuggummin

Bemyndigande status:

Godkänd

Tillstånd datum:

2019-08-02

Bipacksedel

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
NICORAMA MINT 2 MG MEDICATED CHEWING-GUM
NICORAMA MINT 4 MG MEDICATED CHEWING-GUM
nicotine
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, pharmacist or nurse
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
-
Contact healthcare professionals if you are still using Nicorama Mint
after 6 months.
WHAT IS IN THIS LEAFLET
1.
What Nicorama Mint is and what it is used for
2.
What you need to know before you take Nicorama Mint
3.
How to take Nicorama Mint
4.
Possible side effects
5.
How to store Nicorama Mint
6.
Contents of the pack and other information
1.
WHAT NICORAMA MINT IS AND WHAT IT IS USED FOR
Nicorama Mint belongs to a group of medicines that is used to help you
stop smoking.
The nicotine in Nicorama Mint relieves nicotine cravings and
withdrawal problems when you stop
smoking, thereby preventing relapse to smoking in smokers who are
motivated to stop. Permanent
cessation of tobacco use is the aim of the treatment.
When the body is suddenly no longer supplied with nicotine from
tobacco, you can experience various
discomforts which are known as withdrawal problems. Using Nicorama
Mint chewing-gum can
prevent or relieve such discomfort and smoke cravings by continuing to
supply a small amount of
nicotine to your body during a transitional period. When you chew
Nicorama Mint, nicotine is
released slowly and absorbed into the oral cavity. Unlike cigarettes,
Nicorama Mint does not contain
harmful tar and carbon monoxide.
Nicorama Mint should preferably be used togehter with a smoking
cessation program. Counselling and
support usually increase the chances of success to

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Nicorama Mint 2 mg medicated chewing-gum
Nicorama Mint 4 mg medicated chewing-gum
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_2_
_mg: _
Nicotine resinate 10 mg, corresponding to nicotine 2 mg.
_4_
_mg: _
Nicotine resinate 20 mg, corresponding to nicotine 4 mg.
Excipients with known effect
Xylitol and butylated hydroxytoluene.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Medicated chewing-gum
_2 mg:_
White to off-white, round, biconvex, coated chewing-gums, which are
smooth on both sides.
Diameter: 15 mm and thickness: 8 mm.
_4 mg:_
Light yellow, round, biconvex, coated chewing-gums, which are smooth
on both sides.
Diameter: 15 mm and thickness: 8 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For treatment of tobacco dependence by providing relief of nicotine
craving and withdrawal
symptoms, and thereby facilitating smoking cessation in smokers
motivated to stop smoking.
Permanent cessation of tobacco use is the aim of the treatment.
Nicorama Mint should preferably be used in conjugation with a
behavioral support program.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly:_
The strength of the chewing-gum should be selected based on the
patient’s nicotine dependency. For
low nicotine dependency, the 2 mg chewing-gum is recommended. For high
nicotine dependency
(FTND ≥ 6 or if the patient smokes > 20 cigarettes/day) or after
previous failure with 2 mg chewing-
gums, the 4 mg chewing-gum is recommended.
Nicorama Mint chewing-gum should be used when cigarettes normally
would have been smoked or if
smoke craving arise.
At the beginning of treatment, 1 chewing-gum can be taken every 1 to 2
hours. Sufficient number of
gums should be used daily. The dosage is individual and should be
based on the smoker’s nicotine
dependency. In most cases, 8-12 chewing-gums per day are sufficient,
irrespective of strength. In
order to maximize the chances to succeed, it is important to avoid
underdosin