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Nicorette 15mg Inhaler

*
General Sale: Non-prescription

  • Company:

    Kenvue

  • Status:

    No Recent Update

  • Legal Category:

    Supply through general sale

  • Active Ingredient(s):

    Nicotine

    *Additional information is available within the SPC or upon request to the company

  • (84047) NICORETTE INHALER 15MG 20.jpeg
  • (84147) NICORETTE INHALER 15MG 4.jpeg

Updated on 03 January 2024

File name

ie-leaflet-nicorette-inhaler-2506.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 03 January 2024

File name

ie-spc-v11-nic-inhaler-clean-2506.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Updated on 14 August 2023

File name

ie-pl-nic-inhaler-2266.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 14 August 2023

File name

ie-spc-v10-nic-inhaler-2266.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Updated on 01 September 2020

File name

ie-mockup-pl-clean-bv1920.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 01 September 2020

File name

NCG02 BV 1920 SPC v9.1.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Updated on 03 August 2018

File name

NCG02 1695 SPC V8.pdf

Reasons for updating

  • Improved presentation of SPC

Legal category:Supply through general sale

Updated on 14 May 2018

File name

spc.docx

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

Legal category:Supply through general sale

Updated on 08 January 2018

File name

PIL_15072_839.pdf

Reasons for updating

  • New PIL for new product

Updated on 08 January 2018

Reasons for updating

  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 12 April 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Updated on 12 April 2017

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

*Please note that the approval date was on the 13th March, however the notification was received on the 29th March*

Text highlighted and struck through have been deleted, text highlighted and underlined has been added:

5.3   Preclinical Safety Data

6.5   Nature and Contents of Container

[...]

Packs containing 1plastic mouthpiece

[...]

6.6 Special Precautions for Disposal and Other HandlingSpecial precautions for disposal

[...]

This product works best at room temperature.

[...]

10.   Date of (Partial) Revision of the text

27 July 2016 March 2017

Updated on 29 July 2016

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Text that has been highlighted and underlined has been added, text that has been struck through has been removed:

4.8              Undesirable Effects

                [...]

Body System

Incidence

Reported adverse event

(Preferred Term)

 

 

Immune system

disorders

Common

Hypersensitivitya

 

Not known

Anaphylactic reaction

 

Psychiatric disorders

Uncommon

Abnormal dreams*

 

Nervous system

disorders

Very common

Headache a#

 

Common

Burning sensation c

 

Common

Dysgeusia

 

Common

Paraesthesia a

 

 

 

Eye disorders

Not known

Blurred vision

 

Not known

Lacrimation increased

 

 

 

 

Cardiac disorders

Uncommon

Palpitations a

 

Uncommon

Tachycardia a

 

Vascular disorders

Uncommon

Flushing a

 

Uncommon

Hypertension a

 

Respiratory, thoracic

and mediastinal disorders

Very common

Cough**

 

Very common

Throat irritation

 

Uncommon

Bronchospasm

 

Uncommon

Dysphonia

 

Uncommon

Dyspnoea a

 

Uncommon

Nasal congestion

 

Uncommon

Sneezing

 

Uncommon

Throat tightness

 

Gastrointestinal

disorders

Very common

Hiccups

 

Very common

Nausea a

 

Common

Abdominal pain

 

Common

Diarrhoea***

 

Common

Dry mouth

 

Common

Dyspepsia

 

Common

Flatulence

 

Common

Salivary hypersecretion

 

Common

Stomatitis

 

Common

Vomiting a

 

Uncommon

Eructation

 

Uncommon

Glossitis

 

Uncommon

Oral mucosal blistering and exfoliation

 

Uncommon

Paraesthesia oral***

 

Rare

Dysphagia

 

Rare

Hypoaesthesia oral***

 

Rare

Retching

 

Not known

Dry throat

 

Not known

Gastrointestinal discomfort a

 

Not known

Lip pain

 

Skin and subcutaneous disorder

Uncommon

Hyperhidrosis a

 

Uncommon

Pruritus a

 

Uncommon

Rash a

 

Uncommon

Urticaria a

 

Not known

Angioedema a

 

Not known

Erythema a

 

Muscoskeletal and connective tissue disorders

Uncommon

Pain in jaw b

 

Not known

Muscle tightness b

 

General disorders and administration site conditions

Common

Fatigue a

 

Uncommon

Asthenia a

 

Uncommon

Chest discomfort and pain

 

Uncommon

Malaise

 

 

 

a Systemic effects;

b Tightness of jaw and pain in jaw with nicotine gum

formulation

c At the application site

*

 

 

Identified only for formulations applied during the night

 

** Higher frequency observed in clinical studies with inhaler formulation.

***Reported the same or less frequently than placebo

# Although the frequency in the active group is less than that of the placebo

group, the frequency in the specific formulation in which the PT was identified

as a systemic ADR was greater in the active group than the placebo group.

 

4.9 Overdose

 

 

 

Excessive use of nicotine from either NRT and/or smoking might cause symptoms of an overdose. Symptoms of overdosage are those of acute nicotine poisoning and include nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases these symptoms may be followed by hypotension, rapid irregular pulse, breathing difficulties, prostration, circulation collapse and terminal convulsions. Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in small children and may prove fatal.

 

Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately.

 

 

 

 

 

Management of overdose

 

 

 

All nicotine intake should cease immediately and the patient should be treated symptomatically.

 

If excessive amount of nicotine is swallowed, activated charcoal reduces the gastrointestinal absorption of nicotine. Tachycardia causing circulatory impairment may require treatment with a b blocker. Excitation and convulsions may be treated with diazepam. Artificial respiration with oxygen should be instituted if necessary.

 

10. Date of (Partial) Revision of the text.

 

 

March 201627 July 2016

 

 

 

Updated on 28 July 2016

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 05 April 2016

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 4.1 added text “In certain circumstances, Nicorette Inhaler may be used in combination with Nicorette Invisi 10mg and 15mg Transdermal Patch for the treatment of tobacco dependence as part of a stop smoking programme.”

 

Section 4.2 added text “Combination Therapy

It may sometimes be beneficial to utilize more than one form of NRT concurrently. For example, combination therapy could be used by heavy smokers (more than 20 cigarettes a day) or smokers who have relapsed with NRT monotherapy in the past, who experience breakthrough acute cravings or have difficulty controlling cravings for cigarettes using monotherapy. Hence, if required, the Nicorette Invisi Patch may be combined with the Nicorette Inhaler.

Step 1: The Nicorette Invisi 15mg Patch would be applied daily on waking for 16 hoursand removed just before bedtime for a total of 8 weeks. The Nicorette Inhaler 15mg would be used ad libitum when the smoker feels an urge to smoke or in situations where he/she feels that breakthrough cravings may occur, up to a maximum of 6 cartridges per day.

Step 2: After the initial 8 weeks the lower dose Nicorette Invisi 10mg Patch should be used. The Nicorette Invisi 10mg Patch would be applied daily on waking for 16 hours and removed just before bedtime for a total of 4 weeks. The Nicorette Inhaler would be used ad libitum when the smoker feels an urge to smoke or in situations where he/she feels that breakthrough cravings may occur, up to a maximum of 6 cartridges per day.

Step 3: Use of the Nicorette Invisi Patch should be stopped after the 12 week treatment program. The Nicorette Inhaler can continue to be used for a further 3 months during which time the habits associated with smoking will be lost.

Recommended dosage

 

Dose regimen

 

Duration

 

Step 1

 

Nicorette Invisi Patch

15 mg

 

Nicorette Inhaler

 

First 8 weeks

 

Step 2

 

Nicorette Invisi Patch

10 mg

 

Nicorette Inhaler

 

Next 4 weeks

 

Step 3

 

No patch applied

 

Nicorette Inhaler

 

Next 3 months


Section 10 replaced date with "March 2016"

Updated on 04 April 2016

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 28 July 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 09 July 2015

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

4.2 – the following information was added

Administration of nicotine should be stopped temporarily if any symptoms of nicotine excess occur. Nicotine intake should be decreased by lowering dosing frequency if nicotine excess symptoms persist (see Section 4.9).

 

Section 4.3 – QRD updates

 

 

Section 4.4 – additional warnings added

 

Section 4.5 – information on possible interaction with adenosine added

 

Section 4.6 – information updated

 

Section 4.7 – QRD updates

 

Section 4.8 – additional AEs added

 

Section 5.1 – ATC code added

 

SNAS 1353

 

Updated on 04 July 2014

Reasons for updating

  • Change to dosage and administration

Updated on 25 September 2013

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Extension of shelf-life to 3 years.

Updated on 11 January 2013

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Replace stomach discomfort with stomach discomfort and/or pain.

Updated on 10 January 2013

Reasons for updating

  • Change to side-effects

Updated on 22 July 2011

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

None provided

Updated on 20 July 2011

Reasons for updating

  • New PIL for new product