Nicorette

Nicorette

nicotine

Manufacturer:

Johnson & Johnson

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Nicotine.
Description
Each strength of Nicorette Invisi Transdermal Patch has a different size: 10 mg: 9.0 cm2, 15 mg: 13.5 cm2, 25 mg: 22.5 cm2, respectively.
Each Nicorrette Icy Mint Medicated Chewing Gum contains nicotine 2 mg or 4 mg, respectively.
Excipients/Inactive Ingredients: Nicorette Invisi Transdermal Patch: Medium chain triglycerides, basic butylated methacrylate copolymer, polyethylenterephthalate film (PET), acrylic adhesive solution, potassium hydroxide, croscarmellose sodium, aluminium acetylacetonate, siliconized PET release liner with aluminized single side, printing inks.
Nicorrette Icy Mint Medicated Chewing Gum: 2-mg: Chewing gum base, levomenthol, acesulfame potassium, talc, magnesium oxide (light), xylitol, peppermint oil, sodium carbonate anhydrous, and sodium hydrogen carbonate.
4-mg: Chewing gum base, xylitol, levomenthol, Quinoline yellow E 104 Al-lake, acesulfame potassium, magnesium oxide (light), peppermint oil, sodium carbonate anhydrous and talc.
Coating: Pregelatinized starch, titanium dioxide, hypromellose, water, xylitol, carnauba wax, polysorbate 80, winterfresh, and sucralose and quinoline yellow E 104Al-lake (4 mg only).
Action
When the patient stops smoking, the body misses the nicotine that the patient has been absorbing. The patient may experience unpleasant feelings and a strong desire to smoke (craving). This indicates that the patient is dependent on nicotine.
When the patient apply Nicorette Invisi Transdermal Patch to the skin and chew Nicorette Icy Mint Gum, nicotine is released and passes into the body and through the lining of the mouth.
The nicotine released from the patch and gum are sufficient to relieve the unpleasant withdrawal symptoms. It will also help to stop the craving to smoke, but Nicorette Invinsi Transdermal Patch and Nicorette Icy Mint Gum will not give the buzz the patient got from smoking a cigarette.
Indications/Uses
Used to relieve withdrawal symptoms and reduce the cravings for nicotine during smoking cessation.
Dosage/Direction for Use
Nicorette Invisi Transdermal Patch: Apply when the patient wakes up (usually in the morning) and remove 16 hours later (usually at bedtime). On the day of starting the treatment, patient should stop smoking completely, so the last cigarette is the day before using the patch. Do not smoke during treatment.
Heavy smokers (those smoking 15 or more cigarettes in a 24-hour period): Recommended to start at Step 1 with the 25 mg/16 hours patch and use one patch daily for 8 weeks.
Gradual weaning from the patch should then be initiated. One 15 mg/16 hours patch should be used daily for 2 weeks followed by one 10 mg/16 hours patch daily for 2 weeks.
Light smokers (those smoking less than 15 cigarettes in a 24-hour period): Recommended to start at Step 2 (15 mg/16 hours) for 8 weeks and decrease the dose to Step 3 (10 mg/16 hours) for the final 4 weeks. (See Tables 1 and 2.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Nicorette Invisi Transdermal Patch is usually not recommended for use over a period in excess of 6 months but some people may need longer treatment in order to avoid getting into a smoking habit again.
Nicorrette Icy Mint Medicated Chewing Gum:Adults: See Table 3.

Click on icon to see table/diagram/image

Most people use between 8 to 12 gums per day. The patient 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 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 the throat or upset the stomach causing e.g. hiccups. To avoid this, Nicorette Chewing Gum Technique: Chew gum slowly until taste becomes strong (approx-1 min). Rest the gum between the gum and cheek (wait for 1 min). Chew the gum again when taste has faded then repeat for 10-30 mins.
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.
The full course for using Nicorette Icy Mint Gum lasts around 16 weeks, from quitting cigarettes to no longer requiring Nicorette Icy Mint Gum. During that time the patient should gradually reduce the intake of nicotine, until patient can do without it. Use Nicorette Icy Mint Gum for 12 weeks, reducing the number of piece used in the next 4 weeks. (See Table 4.)

Click on icon to see table/diagram/image
Overdosage
Nicorette Invisi Transdermal Patch: If the patient have used more than the recommended dosage, left the patch on for too long or have smoked while using Nicorette Invisi Transdermal Patch, the patient may experience nausea, salivation, pain in abdomen, diarrhea, sweating, headache, dizziness, hearing disturbance or weakness. In case of high doses, the symptoms can be followed by hypotension (decreased blood pressure), weak and irregular pulse, breathing difficulties, sudden weakness, fainting and generalized seizures. If patient do get any of these effects, seek medical treatment immediately. Dosage of nicotine that is normally tolerated by adult smokers during their treatment can cause severe poisoning in young children and can even result in their death. Used patches still contain residual levels of nicotine, which can be harmful to children.
Nicorrette Icy Mint Medicated Chewing Gum: If the patient have used more than the recommended dosage, he/she may experience nausea, salivation, pain in abdomen, diarrhea, sweating, headache, dizziness, hearing disturbance or weakness.
Contraindications
Hypersensitivity to nicotine or any of the other ingredients.
Do not use if the patient is pregnant, trying to get pregnant or may be pregnant.
Do not use if the patient is breast-feeding.
Special Precautions
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 patient suffers from uncontrolled hypertension (high bloodpressure).
Stomach ulcer, duodenal ulcer, inflammation of the stomach or inflammation of the oesophagus.
Liver or kidney disease.
Overactive thyroid gland or have a pheochromocytoma (a tumour of the adrenal glands that can affect blood pressure).
If the patient has diabetes, monitor blood sugar levels more often when starting to use Nicorette. Insulin or medication dose requires adjustment.
Nicorette Invisi Transdermal Patch: Nicorette Invisi Transdermal Patch should not be used by non-smokers.
If the patient has skin disorder such as psoriasis, eczema or hives (urticaria) covering large area of the skin.
Nicorrette Icy Mint Medicated Chewing Gum: Persistent indigestion or pains in the chest.
Use In Pregnancy & Lactation
Do not use if the patient is pregnant, trying to get pregnant or may be pregnant.
Do not use if the patient is breast-feeding.
Side Effects
Like all medicines, Nicorette 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): May experience unwanted effects because the patient have stopped smoking or have reduced the amount of nicotine the patient is 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.
Effects of too much nicotine: Patient may also get these effects if not used to inhaling tobacco smoke. These effects include: Feeling faint, feeling sick (nausea), headache. Transdermal patch: Hiccupping (due to excessive swallowing of nicotine).
Nicorette Invisi Transdermal Patch: Most of the undesirable effects reported by the subjects occur during the early phase of treatment and are mainly dose dependent.
Allergic reactions (including symptoms of anaphylaxis) occur rarely during use of Nicorette Invisi Transdermal Patch.
About 20% of users experienced mild local skin reactions during the first weeks of treatment.
Side effects observed in post-marketing experience (frequency category estimated from clinical trial): Common (≥1/100 and <1/10): Rash**, hives**.
Uncommon (≥1/1,000 and <1/100): Palpitations**, tachycardia**, application site reactions, body weakness**, chest discomfort and pain**, malaise**, muscle pain*, abnormal dream**, shortness of breath**, increase sweating**, flushing**, high blood pressure**.
*In vicinity/region of patch
**Systemic effects
Nicorrette Icy Mint Medicated Chewing 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): Common (≥1/100 and <1/10): Diarrhoea#.
Uncommon (≥1/1,000 and <1/100): Palpitations**, tachycardia**, burping, soreness of the tongue, 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**.
Rare ≥1/10,000 and <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 than placebo
Drug Interactions
Inform the physician or pharmacist if the patient is taking other medicines such as theophylline, clozapine, ropinirole, tacrine, insulin, imipramine, olanzapine, clonipramine, or fluvoxamine.
Flecainide or pentazocine (for transdermal patch). Stopping smoking may require the dose of these medicines to be adjusted.
Caution For Usage
Instructions for Use/Handling: Nicorette Invisi Transdermal Patch: Use one new patch per day.
Wash hands before applying the patch.
Each Nicorette Invisi Transdermal Patch comes with a child-resistant sachet which can be opened by cutting along the edge with a pair of scissors.
Remove the patch from its sachet and then peel one part of the silvery aluminium backing away.
Avoid touching the sticky surface of the patch with fingers.
Carefully apply the sticky part of the patch to the chosen area of skin and then peel off the remaining half of the silvery backing foil.
Press the patch firmly onto the skin with palm or fingertips.
Run fingers around the edge to ensure it sticks firmly.
Things patient must do: Before applying Nicorette Invisi Transdermal Patch, choose a completely clean, dry area of hairless skin on thefront or side of the chest, upper arm or hip.
Things not to do: Do not use more than one patch at a time. If patient lose a patch while swimming, bathing or showering, patient can replace it with another patch.
Do not apply oil, lotion or talcum powder to the skin before putting on the patch as this may prevent it from sticking properly.
The patch should not be kept on at night while sleeping as it may cause nicotine-induced sleep disturbance. If patient forget to remove the patch the night before, continue treatment the following morning by removing the old patch and applying the new one.
Things to be careful of: Avoid placing the patch onto any area of skin that is red, cut or irritated.
Nicorrette Icy Mint Medicated Chewing Gum: Things patient must do: Use the Nicorette Chewing Gum technique. Chew only one piece of gum at a time.
Things patient must not do: Give 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.
Storage
Nicorette Invisi Transdermal Patch: Store below 30°C.
Nicorrette Icy Mint Medicated Chewing Gum: Store at or below 30°C. Protect from light.
ATC Classification
N07BA01 - nicotine ; Belongs to the class of drugs used in the management of nicotine dependence.
Presentation/Packing
Nicorette Invisi Transdermal Patch (semi-transparent, beige, imprinted, rectangular with rounded corners) 10 mg/16 hr x 7's. 15 mg/16 hr x 7's. 25 mg/16 hr x 7's. Nicorrette Icy Mint Medicated Chewing Gum 2 mg (square coated white coloured piece with a size of about 15 x 15 x 6 mm) x 30's, 105's. 4 mg (square coated crème coloured piece with a size of about 15 x 15 x 6 mm) x 30's, 105's.
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