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Natural Product Number (NPN):

80126099

Market status:

Not Marketed

Licence Status:

Active

Brand name(s):

Nicotine Mist 2 mg ;
Nicotine Spray 2 mg

Licence holder:

CellChem Pharmaceuticals Inc.

Dosage Form:

Spray

Recommended route of administration:

Buccal

Recommended use or purpose:

Nicotine Mist 2 mg is the Nicotine replacement therapy to help quit smoking.

Risk Information:

Cautions and Warnings 

Ask your doctor before use if you have/had: a heart attack or stroke, chest pain (unstable angina) or resting angina, a heart condition that affects yourheart rate or rhythm, Ask your doctor before use if you have/had high blood pressure that is not being controlled by medicines, severe liver or kidney disease. Consult your doctor before using this product if you have or have had diabetes, thyroid, circulation, stomach, or throat or mouth problems Consult your doctor before using this product if you have or have had a tumour or the adrenal gland (phaeochromocytoma), esophagitis, or if you aretaking insulin. Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including g medicines obtained without a prescription. Discontinue using Nicotine Mist and consult your doctor if irregular heartbeat or chest pain occurs or if severe persistent stomach upset (indigestion,heartburn) develops. Consult your doctor if you have difficulty in reducing the number of sprays. In case of overdose or if a child swallows/uses this product, contact your doctor or local poison control centre at once. Young children are especially sensitive to the effects of even small doses of nicotine. Do not smoke, use nicotine patches or any other form of nicotine while using this product. Avoid becoming pregnant while using this product. If you think you are pregnant, stop using this product at once and see your doctor. Keep out of reach of children and pets.

Contra-Indications 

Do not use Nicotine Mist if you are under 18 years of age, are pregnant or breastfeeding, are an occasional or non-smoker or are allergic(hypersensitive) to any of the ingredients in the mouth spray.

Known Adverse Reactions 

Nicotine Mist can cause the same side effects as other ways of taking nicotine. The side effects generally depend on the dose you take. Some common side effects include: hiccups, headache, nausea; local effects of the spray such as tingling, burning sensation, inflammation or pain inthe mouth, lips or throat. Nicotine Mist may cause changes in taste perception; dryness of the mouth or throat, or increase amounts of saliva; feelings of indigestion; cough Nicotine Mist may cause pain or discomfort in the tummy (abdomen) or chest; vomiting, flatulence or diarrhea; tightness or numbness of the throat;feeling tired Symptoms of an overdose include nausea, abdominal pain, vomiting, diarrhea and cold sweat Symptoms of an overdose also include dizziness, disturbed hearing and vision, mental confusion, rapid heartbeat, difficulty breathing and markedweak At high doses, these symptoms may be followed by low blood pressure, weak and irregular pulse, breathing difficulties, extreme exhaustion, circulatorycollapse and general convulsions.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
1-Methyl-2-(3-pyridyl)pyrrolidine	2.0 mg

List of non-medicinal ingredients:

• Glycerol
• Mint flavour
• Propylene glycol
• Purified water
• Xylitol

Date of licensing:

2023-08-10

Revised date of licence: