Citisinum Aflofarm

Package Leaflet: Information for the Patient

Cytisinum Aflofarm

1.5 mg, hard capsules

Cytisiniclinum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Cytisinum Aflofarm and what is it used for
• 2. Important information before taking Cytisinum Aflofarm
• 3. How to take Cytisinum Aflofarm
• 4. Possible side effects
• 5. How to store Cytisinum Aflofarm
• 6. Contents of the pack and other information

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

Cytisinum Aflofarm 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 hunger).

Indications for Use

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

2. Important information before taking Cytisinum Aflofarm

When not to take Cytisinum Aflofarm

• if you are allergic to cytyzyniklina or any of the other ingredients of this medicine (listed in section 6),
• in case of unstable angina pectoris,
• if you have recently had a myocardial infarction or stroke,
• in case of clinically significant heart rhythm disorders,
• if you are pregnant or breastfeeding.

Warnings and precautions

Cytisinum Aflofarm should only be taken by patients who have a serious intention to quit smoking. Taking Cytisinum Aflofarm and smoking at the same time may lead to an increase in unwanted nicotine effects.
Before starting to take Cytisinum Aflofarm, you should discuss it with your doctor if you have:

• ischemic heart disease,
• heart failure,
• cerebrovascular disorders,
• arterial obstruction,
• hypertension,
• chromaffin tumor of the adrenal gland,
• peptic ulcer disease and duodenal ulcer,
• gastroesophageal reflux disease,
• hyperthyroidism,
• diabetes,
• certain types of schizophrenia,
• renal and hepatic insufficiency,
• elderly people (over 65 years old).

Children and adolescents

Due to limited experience, it is not recommended to use Cytisinum Aflofarm in people under 18 years old.

Cytisinum Aflofarm and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Taking Cytisinum Aflofarm 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 plan to have a child, consult your doctor or pharmacist before taking this medicine.
This medicine should not be taken during pregnancy and breastfeeding.

Driving and using machines

Cytisinum Aflofarm has no effect on the ability to drive vehicles and operate machines.

3. How to take Cytisinum Aflofarm

Take this medicine always exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dosage

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

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 durability of the treatment result.
If the treatment result is unsatisfactory, you should consult your doctor. The doctor may decide to stop the treatment and restart it after 2 to 3 months.

Use in children and adolescents

Cytisinum Aflofarm is not recommended for use in children and adolescents under 18 years old.

Taking a higher dose of Cytisinum Aflofarm than recommended

If you take more of the medicine than you should, 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 Cytisinum Aflofarm

Take the medicine 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 you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cytisinum Aflofarm can cause side effects, although not everybody gets them.
Side effects most often occur at the beginning of treatment.
Very common(may affect more than 1 in 10 people):

• change in appetite (mainly increased), weight gain,
• headache,
• irritability, mood changes,
• anxiety,
• sleep disorders (insomnia, drowsiness, lethargy, strange dreams, nightmares),
• increased heart rate,
• dry mouth,
• nausea, abdominal pain (mainly in the upper abdomen),
• muscle pain.

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

• dizziness,
• difficulty concentrating,
• slowed heart rate,
• increased blood pressure,
• vomiting, constipation, diarrhea, bloating, heartburn,
• tongue burning, taste changes,
• rash,
• fatigue, malaise. Uncommon(may affect up to 1 in 100 people):
• feeling of heaviness in the head,
• decreased libido,
• tearfulness,
• shortness of breath, increased coughing,
• excessive salivation,
• increased sweating, decreased skin elasticity,
• fatigue,
• increased activity of aminotransferases (a type of liver enzyme).

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.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 Cytisinum Aflofarm

Keep the medicine out of the sight and reach of children.
Store in a temperature 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 stated is the last day of the month.
Medicines should not be disposed of via wastewater or household waste. 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 Cytisinum Aflofarm contains

• The active substance of the medicine is cytyzyniklina. Each hard capsule contains 1.5 mg of cytyzyniklina (Cytisiniclinum).
• The other ingredients are: microcrystalline cellulose, cornstarch, anhydrous colloidal silica, magnesium stearate. The composition of the hard capsule: 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 color, filled with a light yellow powder.
The pack contains 100 hard capsules. The blisters are packed in a cardboard box with a leaflet.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
phone: (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: