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 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

NICORETTE INVISI Transdermal patch (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Nicorette invisi 10 mg patch / NicAssist Translucent 10 mg Patch.

2. Qualitative and quantitative composition

Each patch is 9 sq.cm, containing nicotine 1.75 mg/sq.cm, releasing a nominal 10 mg of nicotine per 16 hours. For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Transdermal patch. Semi-transparent, beige, imprinted 9 cm² rectangular TTS with rounded corners. Centrally located on a rectangular, aluminized and siliconised release liner.

4.1. Therapeutic indications

Nicorette Invisi Patch 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, ...

4.2. Posology and method of administration

When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. It is intended that the patch is worn through the waking hours (approximately 16 hours) being ...

4.3. Contraindications

Nicorette Invisi Patches should not be administered to patients with known hypersensitivity to nicotine or any component of the patch.

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

4.8. Undesirable effects

Effect 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 used in nicotine dependence ATC code: N07BA01 Nicotine has no therapeutic uses except as replacement therapy for the relief of abstinence symptoms in nicotine-dependent ...

5.2. Pharmacokinetic properties

The patches are labelled by the average amount of nicotine released over 16 hours. A linear relationship exists between released amount of nicotine (dose) and plasma levels of nicotine over the therapeutic ...

5.3. Preclinical safety data

Preclinical data indicate that nicotine is neither mutagenic nor genotoxic. There are no other findings derived from preclinical testing of relevance to the prescriber in determining the safety of the ...

6.1. List of excipients

Triglycerides, medium-chain basic butylated methacrylate copolymer Polyethylenterephthalate film (PET) Acrylate Matrix: Acrylic adhesive solution Potassium hydroxide Croscarmellose sodium Aluminium acetylacetonate ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

Shelf life: 36 months.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Package sizes: 10 mg/16 h 7 and 14 patches. All pack sizes may not be marketed. Each patch is packed in a heat-sealed laminate pouch consisting of paper, PET film, aluminium acrylnitrilcopolymer or cyclo ...

6.6. Special precautions for disposal and other handling

Nicotine residues in the used patches may present a hazard to children and pets, thus used patches should be folded, sticky sides together, put back in an empty pouch and placed in household rubbish. ...

7. Marketing authorization holder

McNeil Products Limited, 50–100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

8. Marketing authorization number(s)

PL 15513/0159

9. Date of first authorization / renewal of the authorization

02 December 2008

10. Date of revision of the text

29 June 2020

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