Nikozipix

Package Leaflet: Information for the User

Nikozipix, 1.5 mg, Coated Tablets

Cytisine

Read the Package Leaflet Carefully Before Taking the Medicinal Product

This medicinal product must be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

• 1. What is Nikozipix and What is it Used For
• 2. Important Information Before Taking Nikozipix
• 3. How to Take Nikozipix
• 4. Possible Side Effects
• 5. How to Store Nikozipix
• 6. Contents of the Pack and Other Information

1. What is Nikozipix and What is it Used For

Nikozipix is used for the treatment of nicotine addiction. The use of Nikozipix is indicated for smoking cessation and reduction of nicotine craving in individuals who wish to quit smoking. The ultimate goal of Nikozipix treatment is permanent cessation of nicotine-containing product use.

2. Important Information Before Taking Nikozipix

When Not to Take Nikozipix:

• if you are allergic to cytisine or any of the other ingredients of this medicinal product (listed in section 6),
• in case of unstable angina pectoris,
• in case of recent myocardial infarction,
• in case of clinically significant cardiac arrhythmias,
• in case of recent stroke,
• during pregnancy and breastfeeding.

Warnings and Precautions:

Before taking Nikozipix, you should discuss it with your doctor or pharmacist if:

• you have coronary artery disease, heart failure, hypertension, pheochromocytoma, atherosclerosis, and other peripheral vascular diseases, peptic ulcer disease, gastroesophageal reflux disease, hyperthyroidism, diabetes, schizophrenia.

Nikozipix should only be taken by individuals with a serious intention to quit smoking. Taking the medicinal product and continuing to smoke may lead to increased nicotine side effects.

Children and Adolescents

Due to limited experience, Nikozipix is not recommended for use in children and adolescents under 18 years of age.

Elderly Patients

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

Patients with Liver or Kidney Impairment

There is no clinical experience with Nikozipix in patients with liver or kidney impairment, therefore, Nikozipix is not recommended for use in this patient group.

Nikozipix and Other Medicinal Products

Inform your doctor or pharmacist about all medicinal products you are taking or have recently taken, as well as any medicinal products you plan to take. Do not take Nikozipix with anti-tuberculosis medicinal products. In some cases, due to smoking cessation, with or without Nikozipix, it may be necessary to adjust the dose of other medicinal products. This is especially important if you are taking medicinal products 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 Nikozipix 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 baby, ask your doctor or pharmacist for advice before taking this medicinal product. Women of childbearing potential must use effective contraception during treatment with Nikozipix. Consult your doctor. Nikozipix is contraindicated during pregnancy and breastfeeding.

Driving and Using Machines

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

Smoking Cessation

Changes in the body associated with smoking cessation, due to Nikozipix or not, may alter the effect of other medicinal products. Therefore, in some cases, it may be necessary to adjust the dose of other medicinal products. More detailed information can be found above in the section "Nikozipix and Other Medicinal Products". In some individuals, smoking cessation, with or without medicinal products, 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, you should discuss this with your doctor.

Aspartame

The medicinal product contains 0.12 mg of aspartame in each Nikozipix 1.5 mg coated tablet. Aspartame (E951) is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its impaired elimination.

3. How to Take Nikozipix

This medicinal product should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist. One pack of Nikozipix (100 tablets) is sufficient for a full course of treatment. The treatment duration is 25 days. Recommended dose: Nikozipix should be taken orally with a sufficient amount of water according to the following schedule.

Treatment days: - From day 1 to 3: 1 tablet every 2 hours, - From day 4 to 12: 1 tablet every 2.5 hours, - From day 13 to 16: 1 tablet every 3 hours, - From day 17 to 20: 1 tablet every 5 hours, - From day 21 to 25: 1-2 tablets per day.

The blister pack is marked with the consecutive days of taking Nikozipix. A smoker should completely quit smoking no later than the 5th day after starting treatment. A person who has quit smoking should never light a cigarette again. This is crucial for the sustainability of the treatment outcome. If the treatment result is unsatisfactory, the treatment should be discontinued and restarted after 2 to 3 months.

Overdose of Nikozipix

Symptoms that occur after an overdose of Nikozipix are characteristic of nicotine poisoning symptoms. Overdose symptoms include: malaise, nausea, vomiting, increased heart rate, blood pressure fluctuations, respiratory disorders, vision disorders, seizures. If any of these symptoms occur or if a symptom not listed in the package leaflet occurs, you should stop taking Nikozipix and contact your doctor or pharmacist.

Missed Dose of Nikozipix

Do not take a double dose to make up for a missed dose. Discontinuation of NikozipixIn case of any further doubts regarding the use of this medicinal product, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicinal products, Nikozipix can cause side effects, although not everybody gets them. Very common (affects more than 1 in 10 people): change in appetite (mainly increased), weight gain, headache, irritability, sleep disorders (insomnia, somnolence, drowsiness, unusual dreams, nightmares), mood changes, anxiety, increased heart rate, dry mouth, abdominal pain (mainly in the upper abdomen), nausea, muscle pain. Common (affects no more than 1 in 10 people): dizziness, difficulty concentrating, decreased heart rate, increased blood pressure, vomiting, taste changes, constipation, diarrhea, bloating, burning sensation in the tongue, heartburn, rash, fatigue, malaise. Uncommon (affects no more than 1 in 100 people): feeling of heaviness in the head, decreased libido, lacrimation, dyspnea, increased coughing, hypersalivation, increased sweating, decreased skin elasticity, fatigue, increased activity of liver enzymes (aminotransferases). The listed side effects occur mainly in the initial treatment period and subside with its duration. They may also be the result of smoking cessation (withdrawal symptoms) rather than taking Nikozipix. If you experience any side effects, including those not listed in the package leaflet, please inform your doctor or pharmacist.

Reporting of Side Effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to Store Nikozipix

Keep this medicinal product out of the sight and reach of children. Do not use this medicinal product after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month. There are no special precautions for storage temperature. Store in the original package to protect from light. Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Nikozipix Contains

• The active substance is cytisine. Each tablet contains 1.5 mg of cytisine.
• The other ingredients are: Tablet core: hypromellose type 2208 and type 2910, mannitol, maize starch, magnesium aluminometasilicate, colloidal anhydrous silica, magnesium stearate. Coating: AquaPolish P green Project 16712 [hypromellose (E464), microcrystalline cellulose (E460), talc (E553b), glycerol, titanium dioxide (E171), quinoline yellow (E 104) aluminum lake, indigo carmine (E132) aluminum lake], peppermint flavor powder (SC552873), aspartame (E951).

What Nikozipix Looks Like and Contents of the Pack

The tablets are round, biconvex, light green or greenish in color. The carton contains 100 coated tablets in PVC/PVDC/Aluminum blisters.

Marketing Authorization Holder

Promedo Pharma Products GmbH Anklamer Strasse 28 10115 Berlin biuro@promedopharma.de

Manufacturer

Adamed Pharma S.A. ul. Marszałka Józefa Piłsudskiego 5 95-200 Pabianice Poland Date of Last Revision of the Package Leaflet:January 2025