Package leaflet: Information for the user

Nikozipix, 1.5 mg, coated tablets
Cytisinum
Please read all of this leaflet carefully before taking this medicine, because 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 so that you can read it again if necessary.
If advice or additional information is needed, consult your pharmacist.
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If symptoms do not improve or worsen, contact your doctor.

Table of contents

What Nikozipix is and what it is used for
What you need to know before taking Nikozipix
How to take Nikozipix
Possible side effects
How to store Nikozipix
Contents of the pack and other information

1. What Nikozipix is and what it is used for

Nikozipix is used in the treatment of nicotine dependence. Nikozipix is indicated for smoking cessation and for reducing nicotine craving in individuals who wish to stop smoking. The ultimate goal of using Nikozipix is the permanent discontinuation of nicotine-containing products.

2. Important information before using Nikozipix

When not to use Nikozipix:

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

Warnings and precautions:
Before starting treatment with Nikozipix, consult a doctor or pharmacist if:

the patient has ischaemic heart disease, heart failure, hypertension, pheochromocytoma, atherosclerosis and other peripheral vascular diseases, peptic ulcer disease of the stomach and duodenum, gastroesophageal reflux disease, hyperthyroidism, diabetes, schizophrenia.

Nikozipix should only be used by individuals with a serious intention to stop smoking tobacco. Taking the medicine while continuing to smoke may increase the adverse effects of nicotine.

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

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

Patients with impaired liver or kidney function
There is no clinical experience with Nikozipix in patients with impaired liver or kidney function; therefore, the use of Nikozipix is not recommended in these patient groups.

Nikozipix with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use.
Do not take Nikozipix together with antituberculosis medicines.
In some cases, cessation of smoking, with or without the use of Nikozipix, may require dose adjustments 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 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, 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 Nikozipix. Seek advice from a doctor.
Nikozipix is contraindicated during pregnancy and breastfeeding.

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

Stopping smoking
Changes in the body associated with stopping smoking, whether using Nikozipix or not, may alter the way other medicines work. Therefore, in some cases, dose adjustments of other medicines may be necessary. More detailed information can be found above under the section "Nikozipix with other medicines".
In some individuals, stopping smoking, 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 existing psychiatric disorders. If the patient has or has had psychiatric disorders in the past, this should be discussed with a doctor.

Aspartame
The medicine 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 for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

3. How to use Nikozipix

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

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

The blister pack is marked with the consecutive days of taking Nikozipix.
The patient should completely stop smoking no later than the 5th day of treatment.
Once smoking has been stopped, under no circumstances should even a single cigarette be smoked. This is crucial for the long-term success of treatment. If the treatment outcome is unsatisfactory, discontinue therapy and wait 2 to 3 months before starting treatment again.

Taking more Nikozipix than recommended
Symptoms following an overdose of Nikozipix are characteristic of nicotine poisoning. Symptoms of overdose include: malaise, nausea, vomiting, increased heart rate, fluctuations in blood pressure, breathing difficulties, visual disturbances, and seizures. If even one of the described symptoms occurs, or any symptom not listed in this leaflet appears, discontinue taking Nikozipix immediately and contact a physician or pharmacist.

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

Stopping Nikozipix
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Very common (occur in more than 1 out of 10 people): change in appetite (mainly increased), weight gain, headache, irritability, sleep disorders (insomnia, drowsiness, somnolence, unusual dreams, nightmares), mood changes, anxiety, increased heart rate, dry mouth, abdominal pain (mainly in the epigastric region), nausea, muscle pain.
Common (occur in up to 1 out of 10 people): dizziness, difficulty concentrating, slowed heart rate, increased blood pressure, vomiting, taste disturbances, constipation, diarrhoea, flatulence, burning sensation of the tongue, heartburn, rash, fatigue, malaise.
Uncommon (occur in up to 1 out of 100 people): feeling of heaviness in the head, decreased libido, tearing, shortness of breath, increased expectoration, excessive salivation, increased sweating, decreased skin elasticity, fatigue, increased aminotransferase activity (liver enzymes).
The adverse reactions listed above occur mainly during the initial period of treatment and subside as treatment continues. They may also result from smoking cessation (withdrawal symptoms), rather than from taking Nikozipix.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Nikozipix

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer carton after EXP. The expiry date refers to the last day of the specified month.
No special storage temperature requirements apply.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the packaging and other information

What the medicine contains Nikozipix

The active substance is cytisine. Each tablet contains 1.5 mg of cytisine.
Other components are: Tablet core: hypromellose type 2208 and type 2910, mannitol, corn starch, magnesium aluminum metasilicate, anhydrous colloidal silicon dioxide type A, magnesium stearate. Coating composition: AquaPolish P green Project 16712 [hypromellose (E464), microcrystalline cellulose (E460), talc (E553b), glycerol, titanium dioxide (E171), quinoline yellow aluminium lake (E104), indigo carmine aluminium lake (E132)], menthol flavour powder (SC552873), aspartame (E951).

What Nikozipix looks like and contents of the pack
Film-coated tablets are round, biconvex, light green or greenish in colour.
The cardboard box contains 100 film-coated tablets in PVC/PVDC/Aluminium blisters.
Marketing Authorisation Holder
Promedo Pharma Products GmbH
Anklamer Strasse 28
10115 Berlin
[email protected]
Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland