Package leaflet: Information for the patient

Denicit, 1.5 mg, coated tablets
( Cytisinicum )
Please read all of this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the
doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, contact your doctor.

Contents of the leaflet

What Denicit is and what it is used for
Important information before taking Denicit
How to take Denicit
Possible side effects
How to store Denicit
Contents of the pack and other information

1. What Denicit is and what it is used for

Denicit is indicated for smoking cessation and reduction of nicotine craving in individuals who wish to stop smoking. The aim of Denicit treatment is permanent discontinuation of nicotine-containing products.

2. Important information before using Denicit

When not to use Denicit:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
in the case of unstable angina pectoris,
following a recent myocardial infarction,
in the case of clinically significant cardiac arrhythmias,
following a recent stroke,
during pregnancy and breastfeeding.

Warnings and precautions
Denicit should be used with caution in patients with ischaemic heart disease, heart failure,
arterial hypertension, phaeochromocytoma, atherosclerosis and other peripheral vascular
diseases, peptic ulcer of the stomach and duodenum, gastroesophageal reflux disease,
hyperthyroidism, diabetes, schizophrenia, renal or hepatic impairment.
Denicit should be taken only by individuals with a serious intention to quit smoking.
Taking Denicit while continuing to smoke may lead to an intensification of nicotine-related
adverse effects.

Children and adolescents
Due to limited experience, the use of Denicit is not recommended in children and adolescents under 18 years of age.

Elderly patients
Due to limited clinical experience, the use of Denicit is not recommended in elderly patients (over 65 years of age).

Use in patients with hepatic or renal impairment
There is no clinical experience with Denicit in patients with hepatic or renal impairment; therefore, its use is not recommended in these patient groups.

Denicit with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. Denicit must not be taken together with antituberculosis medicines.
In some cases, cessation of smoking, with or without the use of Denicit, may require adjustment of the dosage of other medicines. This is particularly important for medicines containing theophylline (used in asthma), tacrine (used in Alzheimer's disease), clozapine (used in schizophrenia), and ropinirole (used in Parkinson's disease). If in doubt, consult your doctor or pharmacist.
It is currently unknown whether Denicit may reduce the efficacy of systemic hormonal contraceptives. Women using systemic hormonal contraceptives should use an additional barrier method (e.g. condoms).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Women of childbearing potential must use an effective method of contraception during treatment with Denicit. Please seek advice from a doctor.
Denicit is contraindicated during pregnancy and while breastfeeding.

Driving and operating machinery
Denicit has no effect or has a negligible effect on the ability to drive and operate machinery.

Smoking cessation
Changes in the body associated with smoking cessation, whether using Denicit or not, may alter the way other medicines work. Therefore, in some cases, dosage adjustments of other medicines may be necessary. More detailed information can be found above under "Denicit with other medicines".
In some individuals, smoking cessation—whether with or without medication—has been associated with an increased risk of changes in thinking or behaviour, feelings of depression and anxiety (including, rarely, suicidal thoughts and suicide attempts), and may be associated with worsening of pre-existing psychiatric disorders. If the patient has current or past psychiatric disorders, these should be discussed with a doctor.

3. How to use Denicit

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
One pack of Denicit (100 coated tablets) is sufficient for a complete course of treatment. The treatment duration is 25 days. Denicit tablets should be taken orally with an adequate amount of water according to the following schedule:

Days of therapy | Recommended dosage | Maximum daily dose
--- | --- | ---
Days 1 to 3 | 1 coated tablet every 2 hours | 6 coated tablets
Days 4 to 12 | 1 coated tablet every 2.5 hours | 5 coated tablets
Days 13 to 16 | 1 coated tablet every 3 hours | 4 coated tablets
Days 17 to 20 | 1 coated tablet every 5 hours | 3 coated tablets
Days 21 to 25 | 1-2 coated tablets per day | up to 2 coated tablets

Smoking should be discontinued no later than the 5th day after starting treatment. Smoking should not be continued during treatment, as it may worsen adverse effects. If the treatment outcome is unsatisfactory, treatment should be discontinued and may be restarted after 2 to 3 months.

Taking more Denicit than recommended
Symptoms occurring after an overdose of Denicit are characteristic of nicotine poisoning. Symptoms of overdose include: malaise, nausea, vomiting, increased heart rate, blood pressure fluctuations, breathing difficulties, visual disturbances, and seizures.
If even one of the described symptoms or any unlisted symptom occurs, stop taking Denicit and contact a doctor or pharmacist immediately.

Missed dose of Denicit
Do not take a double dose to make up for a missed dose.

Stopping Denicit treatment
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur with the frequency specified below:
Very common – affecting more than 1 in 10 people: change in appetite (mainly increased), weight gain, irritability, mood changes, anxiety, increased blood pressure (hypertension), dry mouth, sleep disturbances (insomnia, drowsiness, somnolence, strange dreams, nightmares), headache, rapid heartbeat, nausea, abdominal pain (especially in the epigastric region), muscle pain.
Common – affecting 1 to 10 in 100 people: dizziness, difficulty concentrating, slowed heart rate, bloating, altered taste, heartburn, constipation, vomiting, burning sensation of the tongue, diarrhoea, rash, increased fatigue, malaise.
Uncommon – affecting 1 to 10 in 1,000 people: feeling of heaviness in the head, reduced libido, watery eyes, shortness of breath, increased expectoration, excessive salivation, increased sweating, decreased skin elasticity, fatigue, increased liver enzyme activity.
Most of the adverse reactions listed above occur mainly during the initial period of treatment and subside as treatment continues. They may also result from cessation of smoking (withdrawal symptoms), rather than from taking Denicit.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Denicit

Keep this medicine out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Denicit contains

The active substance is cytisine hydrochloride. Each coated tablet contains 1.5 mg of cytisine hydrochloride.
Other ingredients are: calcium hydrogen phosphate anhydrous, potato starch, maize starch gelatinised, talc, calcium phosphate, Opadry AMB II 88A265001 brown.

What Denicit looks like and contents of the pack
Denicit is a round, biconvex, brown coated tablet with a diameter of 6.1 mm.
PVC/PVDC/Aluminium blisters packed in a cardboard box containing 100 coated tablets.

Marketing Authorisation Holder:

Solinea Sp. z o.o.
Elizówka, Szafranowa 6 Street
21-003 Ciecierzyn
Poland

Manufacturer:
Mako Pharma Sp. z o.o.
Kolejowa 231 A Street
05-092 Dziekanów Polski
Poland

Medicofarma S.A.
Tarnobrzeska 13 Street
26-613 Radom
Poland