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Introducing
CITIDARON
The burden
of smoking
The need for
effective cessation
Prescribing
information
Back to
main site
Link to: Introducing Citidaron

Introducing CITIDARON®

Link to: How Citidaron works

How CITIDARON® works

Link to: When to use CITIDARON

When to use CITIDARON®?

Link to: Why use CITIDARON

Why use CITIDARON®?

Link to: How to use CITIDARON

How to use CITIDARON®?

Link to: CITIDARON prescribing considerations

CITIDARON® prescribing considerations

CITIDARON® PRESCRIBING CONSIDERATIONS

CITIDARON® INDICATION1

  • CITIDARON® is indicated for smoking cessation and reduction of nicotine cravings in smokers who are willing to stop smoking
  • The treatment goal of CITIDARON® is the permanent cessation of the nicotine-containing products use
  • Please refer to the full Summary of Product Characteristics before prescribing CITIDARON®

CONTRAINDICATIONS 1

CITIDARON® is contraindicated in patients with:

  • Hypersensitivity to the active substance of any of excipients
  • Unstable angina
  • A history of recent myocardial infarction
  • Clinically significant arrhythmia
  • A history of recent stroke
  • Pregnancy or breastfeeding

CITIDARON® should be used with caution in patients with:

  • Ischaemic heart disease
  • Heart failure
  • Hypertension
  • Pheochromocytoma
  • Atherosclerosis and other peripheral vascular disease
  • Gastric and duodenal ulcer
  • Gastroesophageal reflux disease
  • Hyperthyroidism
  • Diabetes
  • Schizophrenia
  • Depressed mood may be a symptom of nicotine withdrawal. Clinicians should be aware of the possible emergence of serious neuropsychiatric symptoms in patients attempting to quit smoking with and without treatment
  • Patients should be aware that the simultaneous administration of CITIDARON® and smoking or use of products containing nicotine could lead to aggravated adverse reactions of nicotine
  • Women of childbearing potential must use highly effective contraception while taking CITIDARON®. It is currently unknown whether CITIDARON® may reduce the effectiveness of systemically acting hormonal contraceptives, and therefore women using systemically acting hormonal contraceptives should add a second barrier method
  • There is no clinical experience of CITIDARON® in patients with renal or hepatic impairment, therefore CITIDARON® is not recommended for use in this patient population
  • CITIDARON® is not recommended for use in patients <18 years and patients >65 years

CITIDARON® TOLERABILITY1

  • Mild to moderate adverse reactions have been observed with the use of CITIDARON®, most frequently concerning the gastrointestinal tract.
  • Clinical trials and prior experience indicate that the majority of adverse reactions occurred at the beginning of CITIDARON® therapy and resolved during treatment.

The following more frequently noted adverse events were observed in clinical trials.

References

  1. CITIDARON® Summary of Product Characteristics, Consilient Health 2023.

Adverse Events / Product Complaints or for
Pharmacovigilance or Medical enquiries please contact:
E: drugsafety@consilienthealth.com
T: (01) 205 7766
All other queries: (01) 205 7760

Healthcare professionals are asked to report any suspected adverse reactions. To report an adverse event or a product complaint about a Consilient Health medicine, please contact Consilient Health at drugsafety@consilienthealth.com or 012057766. Adverse events and product complaints may also be reported to the Health Products Regulatory Authority. Reporting form and information can be found at http://www.hpra.ie then click on “report an issue”.

IE-CH-1564 Date of Preparation April 2024

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