Desmoxan

Leaflet attached to the packaging: information for the user

Desmoxan

1.5 mg, hard capsules

Cytisiniclinum

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

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

• Please keep this leaflet, you may need to read it again.
• If you need advice or additional information, please contact a pharmacist. If you experience any side effects, including any possible side effects not listed in the leaflet, please tell your doctor or pharmacist. See section 4.
• If after 4 weeks there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Desmoxan and what is it used for
• 2. Important information before taking Desmoxan
• 3. How to take 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 contains the active substance cytyzyniklina, which has an action similar to nicotine.
Cytyzyniklina gradually replaces nicotine in the body. This reduces nicotine dependence and makes it possible to quit smoking without withdrawal symptoms (nicotine craving).

Indications for use

The medicine is used to treat nicotine dependence. Taking Desmoxan allows for a gradual reduction in the body's dependence on nicotine and quitting smoking without nicotine withdrawal symptoms.
The ultimate goal of taking Desmoxan is to permanently stop using nicotine-containing products.

2. Important information before taking Desmoxan

When not to take Desmoxan

• if you are allergic to the active substance (cytyzyniklina) or to 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 or stroke,
• in case of clinically significant heart rhythm disorders,
• if you are pregnant or breastfeeding.

Warnings and precautions

Desmoxan should only be taken by patients who have a serious intention to quit smoking. Taking Desmoxan and smoking can lead to increased adverse effects of nicotine.
Before starting to take Desmoxan, you should discuss it with your doctor or pharmacist if:

• you have coronary heart disease, heart failure, cerebrovascular disorders, impaired blood vessel patency, high blood pressure, pheochromocytoma, gastric and duodenal ulcers, gastroesophageal reflux disease, hyperthyroidism, diabetes, certain types of schizophrenia, kidney and liver failure;
• you are an elderly person (over 65 years old).

Children and adolescents

Children and adolescents under 18 years of age should consult a doctor before taking this medicine.

Desmoxan and other medicines

Please tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Taking Desmoxan with anti-tuberculosis medicines (PASA, streptomycin) reduces the stimulating effect of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor or pharmacist before taking this medicine.
This medicine should not be taken during pregnancy and breastfeeding.

Driving and using machines

Desmoxan has no effect on the ability to drive and use machines.

3. How to take Desmoxan

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If you are unsure, please contact your doctor or pharmacist.

Recommended dosage

Desmoxan should be taken orally, with a sufficient amount of water, according to the following schedule.

from day 21 to 25
1 to 2 capsules per day
From the first day of treatment, you should gradually reduce the number of cigarettes smoked. A smoker should completely quit smoking no later than 5 days after starting treatment. A person who has quit smoking should never allow themselves to light even one cigarette. This depends on the sustainability of the treatment result.
If the treatment result is unsatisfactory, treatment should be discontinued. Treatment can be started again after 2 to 3 months.

Children and adolescents

Do not use in children and adolescents under 18 years of age without consulting a doctor.

Taking a higher dose of Desmoxan than recommended

In case of taking a higher dose of the medicine than recommended, please contact your doctor immediately.
Overdose symptoms may occur, such as:

• nausea, vomiting,
• increased heart rate,
• increased blood pressure,
• breathing difficulties,
• pupil constriction,
• decreased blood pressure,
• slowed heart rate,
• shortness of breath,
• respiratory failure,
• coma.

Missing a dose of Desmoxan

You should take the medicine as soon as possible and take the next dose at the usual time.
You should not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, please contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects most often occur at the beginning of treatment. These are:

• fatigue, malaise, tiredness,
• tearfulness,
• appetite change (mainly increased), weight gain,
• pains, dizziness, irritability, feeling of heaviness in the head,
• sleep disorders (insomnia, drowsiness, strange dreams, nightmares, drowsiness),
• mood changes, anxiety, difficulty concentrating,
• decreased sex drive,
• increased or decreased heart rate,
• increased blood pressure,
• shortness of breath, increased coughing,
• dry mouth, excessive salivation,
• gastrointestinal disorders (abdominal pain, nausea, vomiting, constipation, diarrhea, bloating, heartburn),
• tongue burning, taste changes,
• muscle pain,
• rash, increased sweating, decreased skin elasticity,
• increased activity of aminotransferases (a type of liver enzyme).

Most side effects disappear during treatment.
If you experience any of the above symptoms, you should stop taking the medicine and contact your doctor.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department of 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.: + 48 22 49 21 301
fax: + 48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Desmoxan

The medicine should be stored out of sight and reach of children.
Store in the original packaging, at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month.
Batch: Batch number.
EXP: Expiry date.
Medicines should not be disposed of via wastewater or household waste. Please 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 Desmoxan contains

• The active substance of the medicine is cytyzyniklina. One hard capsule contains 1.5 mg of cytyzyniklina (Cytisiniclinum).
• The other ingredients are: microcrystalline cellulose, corn starch, colloidal silica anhydrous, magnesium stearate. The composition of the hard capsule is: titanium dioxide, indigo carmine, gelatin.

What Desmoxan looks like and contents of the pack

Desmoxan is a hard gelatin capsule, white-blue in color, filled with a light yellow powder.
The pack contains 100 hard capsules. The blisters are packaged in a cardboard box with a leaflet.

Marketing authorization holder

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

Manufacturer

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

Date of last revision of the leaflet: