Package leaflet: Information for the patient

Cytisinum Aflofarm
1.5 mg, hard capsules
Cytisiniclinum
Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Cytisinum Aflofarm is and what it is used for

Cytisinum Aflofarm contains the active substance – cytisinicline, which acts similarly to
nicotine.
Cytisinicline gradually displaces nicotine from the body. This reduces nicotine dependence and makes it possible to stop smoking without experiencing withdrawal symptoms (nicotine craving).
Indications
The medicine is used in the treatment of nicotine dependence. Treatment with Cytisinum Aflofarm helps gradually reduce the body's dependence on nicotine and enables smoking cessation without nicotine withdrawal symptoms.
The ultimate goal of using Cytisinum Aflofarm is the permanent discontinuation of using nicotine-containing products.

2. Important information before taking Cytisinum Aflofarm

When not to take Cytisinum Aflofarm

if the patient is allergic to cytisine or 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
Cytisinum Aflofarm should only be used by patients who have a serious intention to stop smoking. Taking Cytisinum Aflofarm while continuing to smoke may increase the adverse effects of nicotine.
Before starting Cytisinum Aflofarm, consult a doctor in the following cases:

ischemic heart disease,
heart failure,
cerebrovascular disorders,
arterial stenosis,
arterial hypertension,
pheochromocytoma,
gastric or duodenal ulcer,
gastroesophageal reflux disease,
hyperthyroidism,
diabetes,
certain forms of schizophrenia,
renal or hepatic impairment,
elderly patients (over 65 years of age).

Children and adolescents
Due to limited experience, the use of Cytisinum Aflofarm is not recommended in individuals under 18 years of age.
Cytisinum Aflofarm and other medicines
Inform your doctor or pharmacist about any other medicines you are currently taking, have recently taken, or plan to take.
Concomitant use of Cytisinum Aflofarm with antituberculosis drugs (PAS, streptomycin) reduces the stimulant effect of the medicine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
This medicine must not be used during pregnancy and breastfeeding.
Driving and using machines
Cytisinum Aflofarm has no influence on the ability to drive or operate machinery.

3. How to take Cytisinum Aflofarm

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dosage
Cytisinum Aflofarm should be taken orally, with a sufficient amount of water, according to the following schedule.

from day 1 to day 3	1 capsule	every 2 hours (maximum 6 capsules per day)
from day 4 to day 12	1 capsule	every 2.5 hours (maximum 5 capsules per day)
from day 13 to day 16	1 capsule	every 3 hours (maximum 4 capsules per day)
from day 17 to day 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 should completely stop smoking no later than the 5th day after starting treatment.
A person who has stopped smoking must under no circumstances allow themselves to smoke even a single cigarette. This is crucial for the long-term success of the treatment.
If the treatment outcome is unsatisfactory, consult a doctor. The doctor may decide to discontinue treatment and restart therapy after 2 to 3 months have elapsed.

Use in children and adolescents
Cytisinum Aflofarm is not recommended for use in children and adolescents under 18 years of age.

Taking more than the recommended dose of Cytisinum Aflofarm
If more than the recommended dose is taken, contact a doctor immediately.
Symptoms of overdose may include:

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

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions most commonly occur at the beginning of treatment.
Very common (may occur in more than 1 in 10 people):

change in appetite (mainly increased), weight gain,
headache,
irritability, mood changes,
anxiety,
sleep disturbances (insomnia, drowsiness, somnolence, unusual dreams, nightmares),
increased heart rate,
dry mouth,
nausea, abdominal pain (mainly in the epigastric region),
muscle pain.

Common (may occur in up to 1 in 10 people):

dizziness,
difficulty concentrating,
slowed heart rate,
increased blood pressure,
vomiting, constipation, diarrhoea, flatulence, heartburn,
burning sensation of the tongue, taste disturbances,
rash,
fatigue, malaise.

Uncommon (may occur in up to 1 in 100 people):

feeling of heaviness in the head,
decreased libido,
lacrimation,
dyspnoea, increased sputum production,
excessive salivation,
increased sweating, reduced skin elasticity,
tiredness,
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 of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store Cytisinum Aflofarm

Keep the medicine out of sight and reach of children.
Store below 25°C in the original packaging.
Do not use this medicine after the expiry date stated on the blister and carton (EXP).
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Cytisinum Aflofarm contains

The active substance is cytisine hydrochloride. Each hard capsule contains 1.5 mg of cytisine hydrochloride (Cytisiniclinum).
The other ingredients are: microcrystalline cellulose, maize starch, colloidal anhydrous silica, magnesium stearate. Composition of the hard capsule shell: titanium dioxide (E 171), indigo carmine (E 132), gelatin.

What Cytisinum Aflofarm looks like and contents of the pack
Cytisinum Aflofarm is a hard gelatin capsule, white-blue in colour, filled with a light yellow powder.
The pack contains 100 hard capsules. The blisters 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