Denicit

Package Leaflet: Information for the Patient

Denicit, 1.5 mg, Coated Tablets

(Cytisinum)

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in the Patient Leaflet or as Advised by a Doctor or Pharmacist.

• Keep this Leaflet, so you can Read it Again if you Need to.
• If you Need Advice or More Information, Consult a Pharmacist.
• If you Experience any Side Effects, including those not Listed in the Leaflet, Tell your Doctor or Pharmacist. See Section 4.
• If there is no Improvement or you Feel Worse, Contact your Doctor.

Table of Contents of the Leaflet

• 1. What is Denicit and what is it Used for
• 2. Important Information Before Taking Denicit
• 3. How to Take Denicit
• 4. Possible Side Effects
• 5. How to Store Denicit
• 6. Package Contents and Other Information

1. What is Denicit and what is it Used for

Denicit is Indicated for Smoking Cessation and Reduction of Nicotine Cravings in Individuals who Want to Quit Smoking. The Goal of Denicit Treatment is Permanent Cessation of Nicotine-Containing Product Use.

2. Important Information Before Taking Denicit

When Not to Take Denicit:

• If you are Allergic to the Active Substance or any of the other Ingredients of this Medication (Listed in Section 6),
• In Case of Unstable Angina Pectoris,
• After a Recent Myocardial Infarction,
• In Case of Clinically Significant Heart Rhythm Disorders,
• After a Recent Stroke,
• During Pregnancy and Breastfeeding.

Warnings and Precautions

Denicit Should be Used with Caution in Patients with Coronary Artery Disease, Heart Failure, Hypertension, Pheochromocytoma, Atherosclerosis, and other Peripheral Vascular Diseases, Peptic Ulcer Disease, Gastroesophageal Reflux Disease, Hyperthyroidism, Diabetes, Schizophrenia, Renal and Hepatic Impairment. Denicit Should only be Taken by Individuals with a Strong Intention to Quit Smoking. Taking the Medication and Continuing to Smoke may Lead to Increased Nicotine-Related Side Effects.

Children and Adolescents

Due to Limited Experience, the Use of Denicit is not Recommended in Children and Adolescents Below 18 Years of Age.

Elderly Patients

Due to Limited Clinical Experience, the Use of Denicit is not Recommended in Elderly Patients (Above 65 Years of Age).

Use in Patients with Hepatic and Renal Impairment

There is no Clinical Experience with Denicit in Patients with Hepatic and Renal Impairment, therefore its Use is not Recommended in this Patient Group.

Denicit and Other Medications

Tell your Doctor or Pharmacist about all Medications you are Currently Taking or have Recently Taken, as well as any Medications you Plan to Take. Do not Take Denicit with Anti-Tuberculosis Medications. In some Cases, due to Smoking Cessation, with or without Denicit, it may be Necessary to Adjust the Dose of other Medications. This is especially Important if you are Taking Medications Containing Theophylline (Used in Asthma), Tacrine (Used in Alzheimer's Disease), Clozapine (Used in Schizophrenia), and Ropinirole (Used in Parkinson's Disease). If you have any Doubts, Consult your Doctor or Pharmacist. It is not Known whether Denicit may Reduce the Effectiveness of Systemic Hormonal Contraceptives. Women Using Systemic Hormonal Contraceptives should Use an Additional Barrier Method (e.g., Condom).

Pregnancy and Breastfeeding

If you are Pregnant or Breastfeeding, Think you may be Pregnant, or are Planning to have a Child, Consult your Doctor or Pharmacist before Taking this Medication. Women of Childbearing Age must Use Effective Contraception during Denicit Treatment. Consult your Doctor. Denicit is Contraindicated during Pregnancy and Breastfeeding.

Driving and Operating Machinery

Denicit has no Influence or a Negligible Influence on the Ability to Drive and Operate Machinery.

Smoking Cessation

Changes in the Body due to Smoking Cessation, with or without Denicit, may Alter the Effect of other Medications. Therefore, in some Cases, it may be Necessary to Adjust the Dose of other Medications. More Detailed Information can be Found above in the Section "Denicit and other Medications". In some Individuals, Smoking Cessation, with or without Medications, has been Associated with an Increased Risk of Changes in Thinking or Behavior, Depression, and Anxiety (including Rare Suicidal Thoughts and Attempts) and may be Associated with Worsening of Existing Psychiatric Disorders. If you have a History of Psychiatric Disorders, Discuss this with your Doctor.

3. How to Take Denicit

This Medication should Always be Taken Exactly as Described in the Patient Leaflet or as Advised by a Doctor or Pharmacist. If you have any Doubts, Consult your Doctor or Pharmacist. One Package of Denicit (100 Coated Tablets) is Enough for a Full Course of Treatment. The Treatment Duration is 25 Days. Denicit should be Taken Orally with a Sufficient Amount of Water according to the Following Schedule.

Treatment Days Recommended Dosage Maximum Daily Dose

From Day 1 to 3: 1 Coated Tablet every 2 Hours, 6 Coated Tablets. From Day 4 to 12: 1 Coated Tablet every 2.5 Hours, 5 Coated Tablets. From Day 13 to 16: 1 Coated Tablet every 3 Hours, 4 Coated Tablets. From Day 17 to 20: 1 Coated Tablet every 5 Hours, 3 Coated Tablets. From Day 21 to 25: 1-2 Coated Tablets per Day, up to 2 Coated Tablets. You should Stop Smoking no Later than the 5th Day after Starting Treatment. Do not Smoke during Treatment, as this may Increase Side Effects. If the Treatment Result is Unsatisfactory, Discontinue Treatment and you can Restart it after 2 to 3 Months.

Overdose of Denicit

Symptoms that Occur after Overdosing on Denicit are Characteristic of Nicotine Poisoning Symptoms. Overdose Symptoms include: Malaise, Nausea, Vomiting, Increased Heart Rate, Blood Pressure Fluctuations, Breathing Difficulties, Vision Disturbances, Seizures. If any of these Symptoms Occur or if a Symptom not Listed in the Leaflet Occurs, Discontinue Denicit and Contact your Doctor or Pharmacist.

Missed Dose of Denicit

Do not Take a Double Dose to Make up for a Missed Dose.

Discontinuation of Denicit

If you have any Further Doubts about Taking this Medication, Consult your Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Denicit can Cause Side Effects, although not Everybody gets them. The Following Side Effects may Occur with the Specified Frequency: Very Common – Occurring in 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, Lethargy, Vivid Dreams, Nightmares), Headaches, Increased Heart Rate, Nausea, Abdominal Pain (especially in the Epigastric Region), Muscle Pain. Common – Occurring in 1 to 10 People in 100:Dizziness, Difficulty Concentrating, Decreased Heart Rate, Bloating, Taste Changes, Heartburn, Constipation, Vomiting, Tongue Burning, Diarrhea, Rash, Increased Fatigue, Malaise. Uncommon – Occurring in 1 to 10 People in 1000:Feeling of Heaviness in the Head, Decreased Libido, Lacrimation, Dyspnea, Increased Coughing, Excessive Salivation, Increased Sweating, Decreased Skin Elasticity, Fatigue, Increased Liver Enzyme Activity. Most of the Above Side Effects Occur Mainly in the Initial Treatment Period and Disappear with its Duration. They may also be a Result of Smoking Cessation (Withdrawal Symptoms) rather than Denicit Use.

Reporting Side Effects

If you Experience any Side Effects, including those not Listed in the Leaflet, Tell your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. By Reporting Side Effects, you can Help Gather more Information on the Safety of this Medication. Side Effects can also be Reported to the Marketing Authorization Holder.

5. How to Store Denicit

Keep the Medication out of Sight and Reach of Children. There are no Special Precautions for Storage. Do not Use this Medication after the Expiration Date Stated on the Package. The Expiration Date refers to the Last Day of the Specified Month. Medications should not be Disposed of via Wastewater or Household Waste. Ask your Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Denicit Contains

• The Active Substance of Denicit is Cytisine. One Coated Tablet contains 1.5 mg of Cytisine.
• The other Ingredients are: Calcium Hydrogen Phosphate Anhydrous, Potato Starch, Corn Starch, Talc, Calcium Phosphate, Opadry AMB II 88A265001 Brown

What Denicit Looks like and what the Package Contains

Denicit is a Round, Biconvex, Brown Coated Tablet with a Diameter of 6.1 mm. PVC/PVDC/Aluminum Blister Packs in a Carton Containing 100 Coated Tablets.

Marketing Authorization Holder:

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

Manufacturer:

Mako Pharma Sp. z o.o.
ul. Kolejowa 231 A
05-092 Dziekanów Polski
Medicofarma S.A.
ul. Tarnobrzeska 13
26-613 Radom

Date of the Last Update of the Leaflet: 07.2023