EXICYT

Package leaflet: Information for the user

Exicyt, 1.5 mg, coated tablets
Cytisiniclinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

• Keep this leaflet. You may need to read it again.
• If you need advice or additional information, please contact your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
• If you are unable to stop smoking within 5 days of starting treatment, or if there is no improvement or you feel worse, you should contact your doctor.

Table of contents

1. What Exicyt is and what it is used for
2. Important information before taking Exicyt
3. How to take Exicyt
4. Possible side effects
5. How to store Exicyt
6. Contents of the pack and other information

1. What Exicyt is and what it is used for

Exicyt is used to help adult smokers stop smoking and reduce nicotine cravings. Treatment with Exicyt helps gradually reduce nicotine dependence and enables smoking cessation without withdrawal symptoms (e.g., low mood, irritability, anxiety, difficulty concentrating, insomnia, increased appetite). The goal of using Exicyt is permanent abstinence from nicotine-containing products.

2. Important information before taking Exicyt

When not to take Exicyt:

• if you are allergic to cytisinicline or any of the other ingredients of this medicine (listed in section 6),
• if you have unstable angina,
• if you have recently had a heart attack,
• if you have clinically significant cardiac arrhythmias,
• if you have recently had a stroke,
• during pregnancy and breastfeeding.

Warnings and precautions

Exicyt should be used with caution in patients with ischemic heart disease, heart failure, hypertension, pheochromocytoma, atherosclerosis (arterial hardening), and other peripheral vascular diseases, peptic ulcer disease of the stomach or duodenum, gastroesophageal reflux disease, hyperthyroidism, diabetes, schizophrenia, or renal or hepatic impairment.

Exicyt should only be taken by individuals who are seriously committed to quitting smoking. Taking Exicyt while continuing to smoke or using nicotine-containing products may increase the risk of nicotine-related adverse effects.

Children and adolescents

Due to limited experience, Exicyt is not recommended for use in individuals under 18 years of age.

Elderly patients

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

Use in patients with impaired liver or kidney function

There is no clinical experience with Exicyt in patients with impaired liver or kidney function; therefore, its use is not recommended in these patient groups.

Exicyt and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Do not take Exicyt together with antituberculosis medicines.

In some cases, stopping smoking, with or without using Exicyt, 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 you have any doubts, consult your doctor or pharmacist.

It is currently unknown whether Exicyt may reduce the effectiveness of systemic hormonal contraceptives. Women using systemic hormonal contraceptives should use an additional barrier method (e.g., condoms).

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Women of childbearing age must use an effective method of contraception during treatment with Exicyt. Please seek advice from your doctor.

Exicyt is contraindicated during pregnancy and breastfeeding.

Driving and operating machinery

Exicyt has no influence on the ability to drive or operate machinery.

Stopping smoking

Changes in the body associated with stopping smoking, whether using Exicyt or not, may alter the way other medicines work. Therefore, in some cases, dose adjustments of other medicines may be necessary. More information is provided above in the section "Exicyt and other medicines."

In some individuals, stopping smoking—whether with or without medication—has been associated with an increased risk of changes in thinking or behavior, feelings of depression and anxiety (including, rarely, suicidal thoughts and attempts), and may be associated with worsening of psychiatric disorders. If you have or have had psychiatric disorders in the past, discuss this with your doctor.

Aspartame

This medicine contains 0.12 mg of aspartame (E 951) per coated tablet. Aspartame 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 improper excretion.

3. How to take Exicyt

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

If you have any doubts, consult your doctor or pharmacist.

One pack of Exicyt (100 tablets) is sufficient for a complete course of treatment. The duration of treatment is 25 days. Exicyt is intended for oral use and should be taken with sufficient water according to the following dosing schedule.

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

The blister pack is labeled with the consecutive days of Exicyt treatment.

Smoking should be discontinued no later than on day 5 of treatment. Smoking should not be continued during treatment, as this may worsen adverse effects. If you are unable to stop smoking within 5 days of starting Exicyt treatment, you should contact your doctor. If the treatment outcome is unsatisfactory, treatment should be discontinued and restarted after 2 to 3 months.

Use in children and adolescents

Exicyt is not recommended for use in individuals under 18 years of age.

Taking more Exicyt than recommended

Symptoms of Exicyt overdose are characteristic of nicotine poisoning. Symptoms include malaise, nausea, vomiting, tachycardia, blood pressure fluctuations, respiratory disturbances, visual disturbances, and seizures.

If any of the described symptoms occur—even a single symptom not listed in this leaflet—discontinue taking Exicyt and contact your doctor or pharmacist.

Missing a dose of Exicyt

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

Stopping treatment with Exicyt

If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions may occur with the frequency specified below:
Very common – may occur in more than 1 in 10 people: change in appetite (mainly increased),
weight gain, dizziness, irritability, mood changes, anxiety, elevated blood pressure
(hypertension), dry mouth, diarrhoea, rash, fatigue, sleep disturbances
(insomnia, somnolence, drowsiness, unusual dreams, nightmares), headache, increased heart rate,
nausea, taste disturbances, heartburn, constipation, vomiting, abdominal pain (especially in the epigastrium), muscle pain.
Common – may occur in 1 to 10 in 100 people: difficulty concentrating, slowed heart rate,
bloating, burning sensation of the tongue, malaise.
Uncommon – may occur in 1 to 10 in 1000 people: feeling of heaviness in the head, decreased libido,
lacrimation, shortness of breath, increased sputum production, excessive salivation, increased sweating, reduced skin elasticity, fatigue, increased liver enzyme activity.
Most of the adverse reactions listed above occur mainly during the initial period of treatment and diminish as treatment continues. These symptoms may also result from stopping smoking (withdrawal symptoms), rather than from taking Exicyt.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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.: + 48 22 49 21 301,
fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables more information about the safety of the medicine to be collected.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Exicyt

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the blister and carton after EXP.
The expiry date refers to the last day of that month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What the medicine Exicyt contains

• The active substance is cytisine hydrochloride (previously used name: cytisine). One coated tablet contains 1.5 mg of cytisine hydrochloride.
• Other ingredients are:
  Tablet core: hypromellose, mannitol, corn starch, magnesium aluminometasilicate type A, colloidal anhydrous silica, magnesium stearate.
  Coating: Aqua Polish P green 079.79 [hypromellose (E 464), microcrystalline cellulose (E 460), talc (E 553b), glycerol (E 422), titanium dioxide (E 171), quinoline yellow, lake (E 104), indigo carmine, lake (E132)], powdered mint flavour SC552873, aspartame.

What Exicyt looks like and contents of the pack

Exicyt is a round, biconvex coated tablet, light green to greenish in colour, 5 mm in diameter.

Packs containing 100 coated tablets in PVC/PVDC/Aluminium blisters, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice
Poland

This medicinal product is authorised in the European Economic Area member states under the following names:
Poland: Exicyt
Czech Republic: Heavis