Patient Information Leaflet

Defucitan, 1.5 mg, tablets

Cytisine
Generic Medicine
Please read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Defucitan is and what it is used for
What you need to know before using Defucitan
How to use Defucitan
Possible side effects
How to store Defucitan
Contents of the pack and other information

1. What Defucitan is and what it is used for

Stopping smoking and reducing nicotine craving in smokers who intend to quit smoking.
The goal of treatment with Defucitan is the permanent cessation of using nicotine-containing products.
The use of Defucitan enables a gradual reduction of nicotine dependence, relieving withdrawal symptoms.

2. What you need to know before using Defucitan

Do not use Defucitan:

if you are allergic to cytisine or to any of the other ingredients of this medicine (listed in section 6),
if you have unstable angina,
if you have a history of recent myocardial infarction,
if you have clinically significant cardiac arrhythmias,
if you have recently had a stroke,
if you are pregnant or breastfeeding.

Warnings and precautions
Defucitan should be used with caution in patients with ischemic heart disease, heart failure, hypertension,
pheochromocytoma (a tumor of the adrenal gland), atherosclerosis (hardening of the arteries), and other
peripheral vascular diseases, gastric and duodenal ulcers, gastroesophageal reflux disease, hyperthyroidism
(overactive thyroid), diabetes, schizophrenia, and renal or hepatic impairment.
Defucitan should only be used by individuals who are seriously committed to quitting nicotine dependence.
Using Defucitan without stopping smoking may lead to aggravated nicotine-related side effects.

Children and adolescents
Due to limited clinical experience, the use of this medicine is not recommended in individuals under 18 years of age.

Elderly population
Due to limited clinical experience, the use of Defucitan is not recommended in elderly patients over 65 years of age.

Patients with renal or hepatic impairment
There is no clinical experience with Defucitan in patients with renal or hepatic impairment; therefore, the use of this medicine is not recommended in such patients.

Other medicines and Defucitan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Defucitan with anti-tuberculosis medications.
In some cases, after stopping smoking—whether or not using Defucitan—it may be necessary to adjust the dosage of other medicines. This is particularly important if you are taking other medicines containing theophylline (for the treatment of asthma), tacrine (for Alzheimer's disease), clozapine (for schizophrenia), or ropinirole (for the treatment of Parkinson's disease). If you have any doubts, consult your doctor or pharmacist.
It is currently unknown whether Defucitan may reduce the effectiveness of systemic hormonal contraceptives. If you are using systemic hormonal contraceptives, you should add a second barrier method (e.g., condoms).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Effective contraceptive methods must be used if you are a woman of childbearing potential. Consult your doctor.
Defucitan is contraindicated during pregnancy and breastfeeding.

Driving and using machines
Defucitan does not impair the ability to drive or operate machinery.

Stopping smoking
The effects of changes in your body resulting from stopping smoking, with or without treatment with Defucitan, may alter how other medicines work. Therefore, in some cases, a dosage adjustment may be necessary. See section “Other medicines and Defucitan” for more information.
In some individuals, quitting smoking—with or without treatment—has been associated with an increased risk of experiencing changes in thinking or behavior, feelings of depression and anxiety (including, rarely, suicidal thoughts and suicide attempts), and may be associated with worsening of psychiatric disorders. If you have a history of psychiatric disorder, you should discuss this with your doctor.

3. How to use Defucitan

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
One pack of Defucitan (100 tablets) is sufficient for a complete course of treatment. The duration of treatment is 25 days. Defucitan is for oral use and must be taken with an adequate amount of water according to the following schedule:

Days of treatment | Recommended dose | Maximum daily dose
--- | --- | ---
Days 1 to 3 | 1 tablet every 2 hours | 6 tablets
Days 4 to 12 | 1 tablet every 2.5 hours | 5 tablets
Days 13 to 16 | 1 tablet every 3 hours | 4 tablets
Days 17 to 20 | 1 tablet every 5 hours | 3 tablets
Days 21 to 25 | 1-2 tablets per day, up to a maximum of 2 tablets

You must stop smoking no later than the 5th day of treatment. Smoking must not continue during treatment, as it may worsen adverse reactions. If the treatment fails, it should be discontinued and may be resumed after 2-3 months.

If you take more Defucitan than you should
In case of overdose with Defucitan, symptoms of nicotine poisoning may occur. Symptoms of overdose include malaise, nausea, vomiting, increased heart rate, fluctuations in blood pressure, breathing difficulties, blurred vision, and seizures.
If you experience even one of the symptoms described, or any symptom not mentioned in this leaflet, stop taking Defucitan and contact your doctor or pharmacist.

If you forget to take Defucitan
Do not take a double dose to make up for the forgotten dose.

If you stop treatment with Defucitan
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
These side effects may occur with certain frequencies, defined as follows:
Very common – may affect more than 1 in 10 users: altered appetite (mainly increased appetite), weight gain, dizziness, irritability, mood changes, anxiety, increased blood pressure (hypertension), dry mouth, diarrhoea, rash, fatigue, sleep disorders (insomnia, drowsiness, lethargy, abnormal dreams, nightmares), headache, increased heart rate, nausea, taste disturbances, heartburn, constipation, vomiting, abdominal pain (especially in the upper abdomen), muscle pain.
Common – may affect from 1 to 10 in 100 users: difficulty concentrating, slow heartbeat, abdominal distension, inflamed tongue, malaise.
Uncommon – may affect from 1 to 10 in 1000 users: feeling of heaviness in the head, decreased libido, tearing, dyspnoea, increased sputum production, excessive salivation, sweating, reduced skin elasticity, tiredness, increased serum transaminase levels.
Most of the above side effects occur at the beginning of treatment and resolve as treatment continues. These symptoms may also result from stopping smoking (withdrawal symptoms), rather than from treatment with Defucitan.
Reporting of side effects
If you experience any side effect, talk to your doctor or pharmacist. This includes any side effect not listed in this leaflet.
You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Defucitan

Keep this medicine out of the sight and reach of children.
Store in the original container at a temperature not exceeding 25°C, protected from moisture and light. Do not use
this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Defucitan contains

The active substance is cytisine. One tablet contains 1.5 mg of cytisine.
The other excipients are: mannitol, microcrystalline cellulose, magnesium stearate, glycerol dibehenate, hypromellose.

Description of the appearance of Defucitan and pack contents
Defucitan is a white, round, biconvex tablet with a diameter of 6 mm.
The blisters are made of PVC/PCTFE/aluminium and are placed in a cardboard box containing 100 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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