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NICORETTE Inhalation cartridge (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Nicorette 15mg Inhalator / Boots NicAssist 15 mg Inhalator.

2. Qualitative and quantitative composition

Nicotine 15mg per cartridge. For a full list of excipients see section 6.1.

3. Pharmaceutical form

Inhalation cartridge for oromucosal use. A white to slightly coloured porous plug in a sealed, transparent plastic tube.

4.1. Therapeutic indications

Nicorette Inhalator relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to ...

4.2. Posology and method of administration

Adults and Children over 12 years of age Nicorette Inhalator should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur. Smokers willing or able ...

4.3. Contraindications

Hypersensitivity to any component of the inhalator. Nicorette Inhalator is contraindicated in children under the age of 12 years.

4.4. Special warnings and precautions for use

Any risks that may be associated with NRT are substantially outweighed by the well established dangers of continued smoking. A risk-benefit assessment should be made by an appropriate healthcare professional ...

4.5. Interaction with other medicinal products and other forms of interaction

No clinically relevant interactions between nicotine replacement therapy and other drugs have definitely been established. However nicotine may possibly enhance the haemodynamic effects of adenosine i.e. ...

4.6. Fertility, pregnancy and lactation

Pregnancy Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. Ideally smoking ...

4.7. Effects on ability to drive and use machines

This medicinal product has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Effects of smoking Cessation Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include; irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, ...

4.9. Overdose

Symptoms Symptoms of overdose with nicotine from this product may occur in smokers who have previously had a low nicotine intake from cigarettes or if other sources of nicotine are used concomitantly with ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic Group: Drug for treatment of addiction. ATC Code: N07BA01 Nicorette Inhalator facilitates uptake of nicotine through the buccal mucosa into the venous circulation. The amount taken ...

5.2. Pharmacokinetic properties

The following information is based on data derived from Nicorette 10mg Inhalator: Nicotine given i.v. has a volume of the distribution of 2 or 3 l/kg with a half life of 1-2 hours. Average plasma clearance ...

5.3. Preclinical safety data

None stated.

6.1. List of excipients

Levomenthol Porous plug of polyethylene

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

Shelf life: 36 months. Once inserted into the mouthpiece the cartridge should be disposed of within 48 hours even if it has not been used.

6.4. Special precautions for storage

Store below 25°C. This product works best at room temperature. In cold conditions (below 15°C) the nicotine evaporates less readily and it will be necessary to inhale more frequently, whilst in warm conditions ...

6.5. Nature and contents of container

Polypropylene mouthpiece with acrylonitrile/methacrylate copolymer cartridges containing polyethylene porous plugs with polyester/aluminium foil seals. The cartridges are provided in a PVC tray which is ...

6.6. Special precautions for disposal and other handling

Potential choking hazard: This product contains some small parts. Any unused cartridges should remain in the cartridge tray to minimise the risk of swallowing. Because of residual nicotine, used cartridges ...

7. Marketing authorization holder

McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire, SL6 3UG, UK

8. Marketing authorization number(s)

PL 15513/0358

9. Date of first authorization / renewal of the authorization

03 June 2011

10. Date of revision of the text

30 December 2019

Πηγαίο έγγραφο

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