Exicit

Package Leaflet: Information for the Patient

Exicyt, 1.5 mg, Coated Tablets

Cytisiniclinum

Read the package 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 package leaflet for the patient or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• Ask your pharmacist if you need advice or more information.
• 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, contact your doctor.

Table of Contents of the Leaflet

• 1. What is Exicyt and what is it 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 is Exicyt and what is it used for

Smoking cessation and reduction of nicotine craving in adult smokers who want to stop smoking. The use of the medicinal product Exicyt allows for gradual reduction of nicotine dependence and weaning from smoking tobacco without nicotine withdrawal symptoms (e.g. decreased mood, irritability, anxiety, concentration difficulties, insomnia, increased appetite). The goal of using Exicyt is permanent cessation of using nicotine-containing products.

2. Important information before taking Exicyt

When not to take Exicyt:

• if you are allergic to cytisiniclinum or any of the other ingredients of this medicine (listed in section 6),
• in case of unstable angina pectoris,
• if you have recently had a heart attack,
• if you have clinically significant heart rhythm disorders,
• 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 (arteriosclerosis) and other peripheral vascular diseases, gastric and duodenal ulcer disease, gastroesophageal reflux disease, hyperthyroidism, diabetes, schizophrenia, renal and hepatic impairment. Exicyt should only be taken by individuals with a serious intention to quit smoking tobacco. Taking Exicyt and continuing to smoke tobacco or using nicotine-containing products may lead to increased nicotine side effects.

Children and adolescents

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

Elderly

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

Use in patients with liver and kidney function disorders

There is no clinical experience with Exicyt in patients with liver and kidney function disorders, therefore its use is not recommended in this group of patients.

Exicyt and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Do not take Exicyt with anti-tuberculosis medicines. In some cases, as a result of quitting smoking, with or without the use of Exicyt, it may be necessary to adjust the doses of other medicines. This is especially important if you are taking 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 Exicyt can 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 or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine. Women of childbearing potential must use effective contraception during treatment with Exicyt. Consult your doctor. Exicyt is contraindicated during pregnancy and breastfeeding.

Driving and using machines

Exicyt has no influence on the ability to drive and use machines.

Quitting smoking

Changes in the body associated with quitting smoking, as a result of using Exicyt or not, may change the way other medicines work. Therefore, in some cases, it may be necessary to adjust the doses of other medicines. More information can be found above in the "Exicyt and other medicines" section. In some people, quitting smoking, with or without the use of medicines, has been associated with an increased risk of changes in thinking or behavior, feelings of depression and anxiety (including rare suicidal thoughts and attempts) and may be associated with worsening of psychiatric disorders. If you have or have had psychiatric disorders, you should 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 its improper excretion.

3. How to take Exicyt

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist. One package of Exicyt (100 tablets) is sufficient for a full course of treatment. The treatment duration is 25 days. Exicyt is intended for oral use, it should be taken with a sufficient amount of water according to the scheme below.

Days of therapy Recommended dosage Maximum daily dose

From day 1 to 3 1 tablet every 2 hours 6 tablets From day 4 to 12 1 tablet every 2.5 hours 5 tablets From day 13 to 16 1 tablet every 3 hours 4 tablets From day 17 to 20 1 tablet every 5 hours 3 tablets From day 21 to 25 1-2 tablets per day up to 2 tablets The blister is marked with consecutive days of taking Exicyt. You should stop smoking no later than on the 5th day of treatment. During treatment, do not continue smoking, as this may increase side effects. If you are unable to stop smoking within 5 days of starting treatment with Exicyt, you should contact your doctor. If the treatment result is unsatisfactory, you should stop treatment and restart it after 2 to 3 months.

Use in children and adolescents

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

Overdose of Exicyt

Symptoms of Exicyt overdose are characteristic of nicotine poisoning symptoms. Overdose symptoms are malaise, nausea, vomiting, increased heart rate, blood pressure fluctuations, respiratory disorders, vision disorders, seizures. If any of the described symptoms occur or a symptom that has not been listed in this leaflet, you should stop taking Exicyt and contact your doctor or pharmacist.

Missed dose of Exicyt

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

Stopping Exicyt treatment

If you have further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Exicyt can cause side effects, although not everybody gets them. The following side effects may occur with the frequency shown below: Very common - may affect more than 1 in 10 people:change in appetite (mainly increased), weight gain, dizziness, irritability, mood changes, anxiety, increased blood pressure (hypertension), dry mouth, diarrhea, rash, fatigue, sleep disorders (insomnia, drowsiness, lethargy, strange dreams, nightmares), headaches, increased heart rate, nausea, taste changes, heartburn, constipation, vomiting, abdominal pain (especially in the upper abdomen), muscle pain. Common - may affect up to 1 in 10 people:concentration difficulties, slowed heart rate, bloating, tongue burning, malaise. Uncommon - may affect up to 1 in 100 people:feeling of heaviness in the head, decreased sex drive, tearing, shortness of breath, increased coughing, excessive salivation, increased sweating, decreased skin elasticity, fatigue, increased liver enzyme activity. Most of the side effects listed above occur mainly in the initial period of treatment and subside with its duration. These symptoms may also be the result of quitting smoking tobacco (withdrawal symptoms), not taking Exicyt.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 By reporting side effects, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Exicyt

Keep this medicine out of the sight and reach of children. Store in the original package 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Exicyt contains

• The active substance is cytisiniclinum (previously used name: cytisine). One coated tablet contains 1.5 mg of cytisiniclinum.
• The other ingredients are: Tablet core: hypromellose, mannitol, maize 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)], peppermint powder SC552873, aspartame.

What Exicyt looks like and contents of the pack

Exicyt is a round, biconvex, coated tablet, light green to greenish, with a diameter of 5 mm. PVC/PVDC/Aluminum blisters placed in a cardboard box containing 100 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów

Manufacturer

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland: Exicyt Czech Republic: Heavis Date of last revision of the leaflet:October 2023