Nicorette Transdermal Therapy System 10 mg / 16 h, translucent patch in sachet, # 7

Nicorette Transdermal Therapeutic System 10mg / 16h translucent patch in sachet # 7

Name ENG

NICORETTE

Clinical and pharmacological group

Drug for the treatment of nicotine addiction

ATX code

Nicotine

Dosage

10mg / 16h

Structure

The composition of 1 transdermal patch includes:

Active substance: nicotine - 23.62 mg (dose released in 16 hours - 15 mg)

Auxiliary components (15 mg at 16 h): triglycerides (average chain length) - 27.41 mg, copolymer of basic butyl methacrylate - 21.87 mg, polyethylene terephthalate film 19 m (on one side can be varnished) - carrier of the layer containing the active substance

Acrylate base (15 mg at 16 h): acrylic adhesive solution - 185.76 mg, potassium hydroxide - 1.05 mg, croscarmellose sodium - 7.49 mg, aluminum acetylacetonate - 0.09 mg, polyethylene terephthalate film 100? M, siliconized on both sides and aluminized on one side - the removable backing (the carrier is the protection of the adhesive layer), discarded before use.

Indications

For the treatment of tobacco dependence by reducing the need for nicotine, relieving withdrawal symptoms that occur when smoking cessation in patients with appropriate motivation

Contraindications

Hypersensitivity to nicotine or other components of the drug. With caution Patients with recent myocardial infarction, unstable angina pectoris or worsening of its course, including Prinzmetal's angina, with severe arrhythmia, recent cerebrovascular disease and / or patients with uncontrolled hypertension should be advised to stop smoking without the help of pharmacological intervention. If such attempts are unsuccessful, the use of the Nicorette® patch can be considered, however, since the safety data in this category of patients is limited, such treatment should be started only under strict medical supervision.Patients with diabetes mellitus after smoking cessation and since the beginning of nicotine replacement therapy are recommended to more closely monitor the blood glucose concentration, since a decrease in the content of catecholamines, the release of which is induced by nicotine, can affect the metabolism of carbohydrates. Patients with diabetes may need to lower their insulin dose after smoking cessation. The drug should be used with caution in patients with severe or moderate hepatic impairment and / or severe renal impairment, since the clearance of nicotine and its metabolites may be reduced, which may increase the risk of adverse events. Nicotine, both released from substitution therapy and absorbed during smoking, stimulates the release of catecholamines from the adrenal medulla.Therefore, the drug should be used with caution in patients with uncontrolled hyperthyroidism and pheochromocytoma. Nicotine can exacerbate the symptoms of esophagitis, gastritis or peptic ulcers, therefore, nicotine replacement therapy should be used with caution in this pathology.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 3 years

INN / Active ingredient

Nicotine

Specifications

Category

Smoking

Scope of the medicinal product

Metabolism

Release form

Patch

Manufacturer country

Sweden

Package quantity, pcs

7

Way of introduction

Outwardly

Vacation conditions

Without recipe

Brand name

Nicorette

The amount of the dosage form in the primary package

1 PC.

Primary packaging type

Sachet (sachet)

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Nicotine addiction treatment

Anatomical and therapeutic characteristics

N07BA01 Nicotine

Dosage form

Transdermal Therapeutic System

Packaging

Box

Expiration date in days

1095

The target audience

Adult

Package weight, g

twenty

Mode of application

:

Heavy smokers (from 20 cigarettes per day) are recommended to start therapy with the daily use of 1 patch 25 mg / 16 h for 2 months.

After that, the dose is reduced - 1 patch at 15 mg / 16 h for 2 weeks, then at 10 mg / 16 h during the same period.

For non-smokers (10 to 20 cigarettes per day), therapy is recommended to start with a 15 mg / 16 h patch for 2 months, then treatment is continued with a 10 mg / 16 h patch for 2 months.