Desmoxan

Package Leaflet: Information for the Patient

Desmoxan, 1.5 mg, Tablets

(Cytisinum)

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

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

• Keep this Leaflet, You May Need to Read it Again.
• If You Need Advice or Further 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 if You Feel Worse, Contact Your Doctor.

Table of Contents of the Leaflet

• 1. What is Desmoxan and What is it Used for
• 2. Important Information Before Using Desmoxan
• 3. How to Use Desmoxan
• 4. Possible Side Effects
• 5. How to Store Desmoxan
• 6. Contents of the Pack and Other Information

1. What is Desmoxan and What is it Used for

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

Using Desmoxan Allows for Gradual Reduction of the Body's Dependence on Nicotine by Relieving Withdrawal Symptoms.

2. Important Information Before Using Desmoxan

When Not to Use Desmoxan:

• If the Patient is 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

Desmoxan Should be Used with Caution in Patients with Ischemic Heart Disease, Heart Failure, Hypertension, Pheochromocytoma, Atherosclerosis, and other Peripheral Vascular Diseases, Peptic Ulcer Disease, Gastroesophageal Reflux Disease, Hyperthyroidism, Diabetes, Schizophrenia, Renal and Hepatic Impairment.

Desmoxan 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 Desmoxan is not Recommended in Children and Adolescents Under 18 Years of Age.

Elderly Patients

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

Use in Patients with Hepatic and Renal Impairment

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

Desmoxan 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 Desmoxan with Anti-Tuberculosis Medications.

In Some Cases, Quitting Smoking, with or Without Desmoxan, may Require Adjustment of the Dose of Other Medications. This is Especially Important if You are Taking Medications Containing Theophylline (Used for Asthma), Tacrine (Used for Alzheimer's Disease), Clozapine (Used for Schizophrenia), and Ropinirole (Used for Parkinson's Disease). If in Doubt, Consult Your Doctor or Pharmacist.

It is not Known Whether Desmoxan 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 Using this Medication.

Women of Childbearing Age Must Use Effective Contraception During Treatment with Desmoxan. Consult Your Doctor.

Desmoxan is Contraindicated in Pregnancy and During Breastfeeding.

Driving and Operating Machinery

Desmoxan Does not Affect the Ability to Drive and Operate Machinery.

Quitting Smoking

Changes in the Body Associated with Quitting Smoking, with or Without Desmoxan, may Change the Way Other Medications Work. 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 "Desmoxan and Other Medications".

In Some Individuals, Quitting Smoking, 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 Use Desmoxan

This Medication Should Always be Used Exactly as Described in the Patient Leaflet or as Advised by a Doctor or Pharmacist. If in Doubt, Consult Your Doctor or Pharmacist.

One Package of Desmoxan (100 Tablets) is Enough for a Full Course of Treatment. The Treatment Duration is 25 Days. Desmoxan Should be Taken Orally with a Sufficient Amount of Water According to the Following Schedule.

Treatment Days Recommended Dosage Maximum Daily Dose

From 1 to 3 Days: 1 Tablet Every 2 Hours, 6 Tablets.

From 4 to 12 Days: 1 Tablet Every 2.5 Hours, 5 Tablets.

From 13 to 16 Days: 1 Tablet Every 3 Hours, 4 Tablets.

From 17 to 20 Days: 1 Tablet Every 5 Hours, 3 Tablets.

From 21 to 25 Days: 1-2 Tablets per Day, up to 2 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, Stop the Treatment and You can Restart it After 2 to 3 Months.

Using a Higher than Recommended Dose of Desmoxan

Symptoms of Overdose of Desmoxan are Characteristic of Nicotine Poisoning. Overdose Symptoms Include: Malaise, Nausea, Vomiting, Increased Heart Rate, Blood Pressure Fluctuations, Breathing Difficulties, Vision Disturbances, Seizures.

If any of the Above Symptoms Occur, or if a Symptom not Listed in the Leaflet Occurs, Stop Taking Desmoxan and Consult Your Doctor or Pharmacist.

Missing a Dose of Desmoxan

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

Stopping Desmoxan Treatment

If You have any Further Questions About the Use of this Medication, Consult Your Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Desmoxan can Cause Side Effects, although not Everybody gets them.

The Following Side Effects may Occur with the Following Frequencies:

Very Common – Occurring in 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, Increased Fatigue, Sleep Disturbances (Insomnia, Somnolence, Lethargy, Vivid Dreams, Nightmares), Headaches, Increased Heart Rate, Nausea, Taste Changes, Heartburn, Constipation, Vomiting, Abdominal Pain (Especially in the Epigastric Region), Muscle Pain.

Common – Occurring in 1 to 10 People in 100:Difficulty Concentrating, Decreased Heart Rate, Bloating, Burning Sensation of the Tongue, 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, Reduced 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 Quitting Smoking (Withdrawal Symptoms) rather than Taking Desmoxan.

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, 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 Side Effects can Help Gather more Information on the Safety of the Medication.

Side Effects can also be Reported to the Marketing Authorization Holder.

5. How to Store Desmoxan

Keep the Medication out of Sight and Reach of Children.

Store in a Temperature Below 25°C. Store in the Original Package to Protect from Moisture and Light. Do not Use this Medication After the Expiry Date Stated on the Package. The Expiry Date Refers to the Last Day of the 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. Contents of the Pack and Other Information

What Desmoxan Contains

• The Active Substance of Desmoxan is Cytisine. One Coated Tablet Contains 1.5 mg of Cytisine.
• The Other Ingredients are: Mannitol, Microcrystalline Cellulose, Magnesium Stearate, Glycerol Dibehenate, Hypromellose.

What Desmoxan Looks Like and What the Pack Contains

Desmoxan is a Round, Convex, White Tablet with a Diameter of 6 mm.

PVC/PCTFE/Aluminum or PVC/PE/PVDC/Aluminum Blisters in a Carton Containing 100 Tablets.

Marketing Authorization Holder:

Aflofarm Farmacja Polska Sp. z o.o., Partyzancka 133/151, 95-200 Pabianice, Poland, tel. (42) 22-53-100

Manufacturer:

Aflofarm Farmacja Polska Sp. z o.o., Szkolna 31, 95-054 Ksawerów, Poland

Date of the Last Update of the Leaflet: 07/2023