Package leaflet: Information for the user

Desmoxan
1.5 mg, hard capsules
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 or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse after 4 weeks, you should contact your doctor.

Contents of the leaflet

What Desmoxan is and what it is used for
Important information before taking Desmoxan
How to take Desmoxan
Possible side effects
How to store Desmoxan
Contents of the pack and other information

1. What Desmoxan is and what it is used for

Desmoxan contains the active substance cytisiniclinum, which acts similarly to nicotine.
Cytisiniclinum gradually displaces nicotine from the body. This reduces nicotine dependence and enables smoking cessation without withdrawal symptoms (nicotine craving).
Indications
Desmoxan is used in the treatment of nicotine dependence. Treatment with Desmoxan helps achieve a gradual reduction in the body's dependence on nicotine and enables smoking cessation without nicotine withdrawal symptoms.
The ultimate goal of using Desmoxan is permanent cessation of using nicotine-containing products.

2. Important information before using Desmoxan

When not to take Desmoxan

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

Warnings and precautions
Desmoxan should be used only by patients who have a serious intention to stop smoking.
Using Desmoxan and smoking tobacco simultaneously may intensify adverse effects of nicotine.
Before starting Desmoxan, consult a doctor or pharmacist if:

the patient has ischaemic heart disease, heart failure, cerebrovascular disorders, arterial stenosis, arterial hypertension, phaeochromocytoma, peptic ulcer of the stomach or duodenum, gastro-oesophageal reflux disease, hyperthyroidism, diabetes, certain forms of schizophrenia, or renal or hepatic impairment;
if the patient is elderly (over 65 years of age).

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

Desmoxan and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Concomitant use of Desmoxan with antituberculosis drugs (PAS, streptomycin) reduces the stimulating effect of the medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
This medicine must not be used during pregnancy or while breastfeeding.

Driving and operating machinery
Desmoxan has no influence on the ability to drive vehicles or operate machinery.

3. How to take Desmoxan

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dosage
Desmoxan should be taken orally, with an adequate amount of water, according to the following scheme.

Days 1 to 3	1 capsule	every 2 hours (maximum 6 capsules per day)
Days 4 to 12	1 capsule	every 2.5 hours (maximum 5 capsules per day)
Days 13 to 16	1 capsule	every 3 hours (maximum 4 capsules per day)
Days 17 to 20	1 capsule	every 5 hours (maximum 3 capsules per day)

from day 21 to day 25, 1 to 2 capsules per day
From the first day of treatment, the number of cigarettes smoked should be gradually reduced.
The smoker must completely stop smoking no later than the 5th day after starting 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 the treatment.
If the treatment outcome is unsatisfactory, therapy should be discontinued. Treatment may be
restarted after an interval of 2 to 3 months.
Children and adolescents
Do not use in children and adolescents under 18 years of age without consulting a doctor.
Taking more than the recommended dose of Desmoxan
In case of ingestion of more than the recommended dose, contact a doctor immediately.
Symptoms of overdose may include:

nausea, vomiting,
increased heart rate,
elevated arterial blood pressure,
breathing disturbances,
pupil constriction,
decreased arterial blood pressure,
slowed heart function,
shortness of breath,
respiratory failure,
coma.

Missed dose of Desmoxan
The missed dose should be taken as soon as possible, and the next dose should be taken at the
usual time.
Do not take a double dose to make up for a missed dose.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody experiences them.
Adverse reactions most commonly occur at the beginning of treatment. These include:

fatigue, malaise, tiredness,
lacrimation,
appetite changes (mainly increased appetite), weight gain,
pain, dizziness, irritability, feeling of heaviness in the head,
sleep disturbances (insomnia, drowsiness, unusual dreams, nightmares, lethargy),
mood changes, anxiety, difficulty concentrating,
decreased libido,
accelerated or slowed heart rate,
increased blood pressure,
shortness of breath, increased expectoration,
dry mouth, excessive salivation,
gastrointestinal disturbances (abdominal pain, nausea, vomiting, constipation, diarrhoea, bloating, heartburn),
burning sensation of the tongue, taste alterations,
muscle pain,
rash, increased sweating, reduced skin elasticity,
increased aminotransferase activity (a certain type of liver enzyme).

Most adverse reactions disappear during treatment.
If any of the above symptoms occur, the medicine should be discontinued
and a doctor should be contacted.
Reporting adverse reactions
If any adverse symptoms occur, including any adverse effects not listed
in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of 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
e-mail: [email protected]
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Desmoxan

Keep this medicine 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 stated month.
LOT: Batch number.
EXP: Expiry date.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This practice helps protect the environment.

6. Contents of the packaging and other information

What Desmoxan contains

The active substance is cytisine chloride. Each hard capsule contains 1.5 mg of cytisine chloride (Cytisiniclinum).
Other ingredients are: microcrystalline cellulose, corn starch, colloidal anhydrous silica, magnesium stearate. Capsule shell composition: titanium dioxide, indigo carmine, gelatin.

What Desmoxan looks like and contents of the pack
Desmoxan is a hard gelatin capsule, white-blue in colour, filled with a light yellow powder.
The pack contains 100 hard capsules. Blister packs are packed in a cardboard box together with the leaflet.

Marketing Authorisation 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