Nicorette icy mint 2 mg gum

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Buy It Now

Active ingredient:
NICOTINE RESINATE
Available from:
JOHNSON & JOHNSON SDN BHD
INN (International Name):
NICOTINE RESINATE
Units in package:
15 gums/blisterpieces Pieces; 105 pieces/box, 15 pieces/ blisterpieces Pieces; 105pieces Pieces
Manufactured by:
McNeil AB
Authorization number:
MAL15045076ARZ

Documents in other languages

Patient Information leaflet Patient Information leaflet - Malay

05-09-2016

Consumer Medication Information Leaflet (RiMUP)

nicorette

®

icy mint gum

Nicotine (as resinate) (2mg and 4mg)

What is in this leaflet

What nicorette

icy mint

gum is used for

How nicorette

icy mint

Gum works

Before you use nicorette

icy mint gum

How to use nicorette

mint gum

While you are using it

Side effects of nicorette

icy mint gum

Storage and disposal of

nicorette

icy mint gum

Product description

Manufacturer and Product

Registration

Holders

10. Date of revision

What nicorette

®

icy mint gum

is used for

nicorette

icy mint gum is used

to relieve withdrawal symptoms

and reduce the cravings for

nicotine that you get when you

try to stop smoking.

How nicorette

®

icy mint gum

works

When you stop smoking, your

body misses the nicotine that you

have been absorbing. You may

experience unpleasant feelings

and a strong desire to smoke

(craving). This indicates you

were dependent on nicotine.

When you chew nicorette

mint gum, nicotine is released

and passes into your body

through the lining of your mouth.

The nicotine released from the

gum is sufficient to relieve the

unpleasant withdrawal

symptoms. It will also help to

stop the craving to smoke, but

nicorette® icy mint gum will

not give you the “buzz” you get

from smoking a cigarette.

Before you use nicorette

®

icy

mint gum

When you must not use it

Do not use

If you have an allergy to

nicotine or any of the other

ingredients.

If you are pregnant, trying

to get pregnant or think you

may be pregnant.

If you are breast-feeding.

Ask your doctor or

pharmacist for advice.

Before you start to use it

Talk to your doctor or

pharmacist

If you have experienced a

serious cardiovascular event

(heart disease), or

hospitalization for a

cardiovascular complaint, in

the previous 4 weeks (e.g.

stroke, myocardial

infarction, unstable angina,

cardiac arrhythmia,

coronary artery bypass graft

and angioplasty) or if you

suffer from uncontrolled

hypertension (high blood

pressure).

If you have stomach ulcer,

duodenal ulcer,

inflammation of the

stomach or inflammation of

the oesophagus.

If you have liver or kidney

disease.

If you have an overactive

thyroid gland or have a

phaeochromocytoma (a

tumour of the adrenal gland

that can affect blood

pressure).

If you have diabetes,

monitor your blood sugar

levels more often when

starting to use nicorette

icy mint gum as you may

find your insulin or

medication dose require

adjustments.

If you have persistent

indigestion or pains in the

chest.

Taking other medicines

Talk to your doctor or

pharmacist if you are taking

other medicines such as

theophylline, clozapine,

ropinirole, tacrine, insulin,

imipramine, olanzapine,

clonipramine, or fluvoxamine.

Tell your doctor or pharmacist if

you are taking or have recently

taken other medicines,

even

those

not prescribed. Stopping

smoking may require the dose of

these medicines to be adjusted.

How to use nicorette

®

icy

mint gum

How much to use

Adults:

Most people use between 8 to 12

gums per day. You must not

exceed 24 gums per day.

Chew a piece of chewing gum

when feeling the need to smoke.

The chewing gum is chewed to

release nicotine, then rested so

Consumer Medication Information Leaflet (RiMUP)

that nicotine can be taken in

through the lining of the mouth.

Nicotine swallowed in the saliva

is not beneficial and in excess

may irritate your throat or upset

your stomach causing e.g.

hiccups. To avoid this, refer to

the nicorette

chewing Gum

technique below.

The nicorette

chewing gum

technique

When the chewing gum has lost

its strength, dispose of it

carefully, such as back in the

hole of the blister.

Children & adolescents: Not to

be administered to persons

under 18 years of age without

recommendation from health

care professional.

When to use it

The nicorette

icy mint gum

should be used when

cigarettes normally would

have been smoked or if

cravings emerge. Sufficient

nicorette

icy mint gum should

be used each day.

How long to use it

We suggest that you use nicorette

icy mint gum for at least 3 months,

8 to 12 chewing gum per day.

Stop smoking completely at the

same time in order to increase your

chances of success.

Regular use beyond 12 months is

generally not recommended.

If you forget to use it

Do not take double dose if you

forget to use.

If you use too much (overdose)

If you have used more than the

recommended dosage, you may

experience nausea, increased

salivation, pain in your abdomen,

diarrhea, sweating, headache,

dizziness, hearing disturbance or

weakness. If you do get any of

these effects, seek medical

treatment immediately.

While you are using it

Things you must do

Use the nicorette

chewing

gum technique. Chew only one

piece of gum at a time.

Things you must not do

Give this product to children.

Things to be careful of

Avoid swallowing the gum. If a

child has used or swallowed the

gum, seek medical treatment

immediately. Nicotine ingestion

by a child may result in severe

poisoning.

Side effects

Like all medicines, nicorette

icy mint gum can cause side

effects.

As many of the effects are due

to nicotine, they can also occur

when nicotine is obtained by

smoking.

Effects related to smoking

(nicotine withdrawal)

You may experience unwanted

effects because you have

stopped smoking or you have

reduced the amount of nicotine

you are taking. These effects

include:

Dizziness

Headache

Irritability or aggression

Feeling low

Anxiety Restlessness

Poor concentration

Increased appetite or weight

gain

Urge to smoke (craving)

Sleeplessness or sleep

disturbance

Lowering of heart rate

Side effects of nicorette

®

icy

mint gum

Most of the undesirable effects

reported by the subjects occur

during the early phase of

treatment and are mainly dose

dependent. Irritation in the

mouth and throat may be

experienced, however most

subjects adapt to this with

ongoing use.

Allergic reactions (including

symptoms of anaphylaxis) occur

rarely during use of nicorette

icy mint gum. The chewing

gum may stick to and in rare

cases, damage dentures.

Side effects observed in post-

marketing experience

(frequency category estimated

from clinical trial):

Co mmo n (≥ 1 /1 0 0 an d <1

/10 )

Diarrhoea

Un co mmo n (≥ 1 /1 ,000 and

<1/100)

Palpitations

Tachycardia

Burping

Soreness of the tongue

Consumer Medication Information Leaflet (RiMUP)

Oral mucosal blistering and

exfoliation

Prickling/ tingling sensation of the

mouth

Body weakness

Chest discomfort and pain

Malaise

Pain in jaw

Abnormal dream

Wheezing

Voice disorder Shortness

of breath

Nasal congestion

Oropharyngeal pain

Sneezing

Throat tightness

Increase sweating

Itching

Rash

Hives

Flushing

High blood pressure

R a re ≥ 1 /1 0 ,0 0 0 a nd

<1/1,000

Difficulty in swallowing

Mouth numbness

Retching

Tightness of jaw and pain in jaw

with nicotine gum formulation

Systemic effects

Reported as similar or less

frequently compare to without

nicotine gum

If you notice these or any other

unwanted effects not listed in this

leaflet, tell your doctor or

pharmacist.

When you stop smoking, you may

also develop mouth ulcers. The

reason why this happens is unclear.

Malaysia:

You may report any side effects or

adverse drug reactions directly to the

National Centre for Adverse Drug

Reaction Monitoring by calling Tel:

03-78835550, or visiting the website

portal.bpfk.gov.my

(Consumers Reporting).

Storage and disposal of

nicorette

®

icy mint

gum

Storage

Keep out of reach and sight

of children.

Store below 30

Protect from light.

Do not use the chewing gum

after the ‘EXP’ date on the

box and blister.

Disposal

Dispose of nicorette

gum sensibly.

Product description

What it looks like

nicorette

®

icy mint 2mg

gum

Chewing

Gum:

square

coated white coloured piece

with a size of about 15 x 15 x

6 mm.

nicorette

®

icy mint 4mg

gum

Chewing Gum: A square

coated crème coloured piece

with a size of about 15 x 15 x

6 mm.

Ingredients

Active Ingredient:

Nicotine

Inactive Ingredients:

- nicorette

®

icy mint 2mg

gum

Chewing Gum: Chewing

gum base, levomenthol,

acesulfame potassium, talc,

magnesium oxide (light),

xylitol, peppermint oil,

sodium carbonate anhydrous,

and sodium hydrogen

carbonate.

nicorette

®

icy mint 4mg

gum

Chewing Gum: Chewing

gum base, xylitol,

levomenthol, Quinoline

yellow E104 Al-lake,

acesulfame potassium,

magnesium oxide (light),

peppermint oil, sodium

carbonate anhydrous and talc.

The other ingredients are the ingredients

used in the coating

nicorette

mint gums are: Pregelatinized starch,

titanium dioxide, hypromellose, water,

xylitol, carnauba wax, polysorbate 80,

winterfresh, sucralose and quinoline

yellow E104 Al-lake (4mg only).

MAL Numbers:

2mg (MAL

4mg (MAL

SIN Numbers:

2mg (SIN14326P)

4mg (SIN14327P)

Manufacturer

McNeil AB, Norrbroplatsen 2,

SE-251 09, Helsingborg,

Sweden.

Product Registration Holders

Johnson & Johnson Sdn Bhd

Lot 3 & 5, Jalan Tandang,

46050 Petaling Jaya,

Selangor, Malaysia

Johnson & Johnson Pte. Ltd. No. 2

International Business Park, #07-

01, Tower One,

The Strategy, Singapore 609930

Date of revision

Feb 2015

Similar products

Search alerts related to this product

View documents history

Share this information