Patient Information Leaflet

TABEX 1.5 mg film-coated tablets
(Cytisinum)
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as directed by your doctor
or pharmacist.

Keep this leaflet so that you can read it again if necessary.
Consult your pharmacist if you need advice or further information.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist immediately.
If your condition does not improve or worsens, contact your doctor.

Contents of the leaflet

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

1. What TABEX is and what it is used for

Treatment of nicotine dependence. TABEX helps gradually reduce the body's dependence on nicotine and enables smoking cessation without experiencing nicotine withdrawal symptoms. The ultimate goal of using TABEX is permanent discontinuation of all nicotine-containing products.

2. Important information before taking TABEX

Do not take TABEX:

if you are allergic to cytisine or any of the other ingredients of this medicine (listed in section 6),
in case of unstable angina pectoris,
following a recent myocardial infarction,
in the presence of clinically significant cardiac arrhythmias,
following a recent stroke,
during pregnancy and breastfeeding.

Warnings and precautions:

TABEX should be used with caution in patients with ischemic heart disease, heart failure,
arterial hypertension, pheochromocytoma, atherosclerosis, gastric or duodenal ulcer,
gastroesophageal reflux disease, hyperthyroidism, diabetes, certain forms of schizophrenia,
and in patients with renal or hepatic impairment.
Due to limited experience, the use of this medicine is not recommended in elderly patients (over 65 years of age).
TABEX should only be taken by individuals who are seriously committed to quitting smoking.
Taking the medicine while continuing to smoke may increase the adverse effects of nicotine.

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

TABEX and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not take TABEX together with antituberculosis medications.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
TABEX is contraindicated during pregnancy and breastfeeding.

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

3. How to use the medicine TABEX

This medicine should always be taken according to the instructions provided in the patient leaflet or as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
One pack of TABEX (100 tablets) is sufficient for a complete course of treatment.
The duration of treatment is 25 days.
TABEX tablets should be taken orally with an adequate amount of water according to the following schedule:

| Days of therapy | Dosage | 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 2 tablets |

The smoker must completely stop smoking no later than on day 5 of 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, treatment should be discontinued and restarted after 2 to 3 months.

Taking a higher than recommended dose of TABEX
Symptoms occurring after an overdose of TABEX are characteristic of nicotine poisoning. Symptoms of overdose include: malaise, nausea, vomiting, increased heart rate, fluctuations in blood pressure, breathing difficulties, visual disturbances, and seizures.
If even one of the described symptoms occurs, or any symptom not listed in the leaflet appears, administration of TABEX must be stopped immediately and medical advice should be sought from a doctor or pharmacist.

Missed dose of TABEX
Do not take a double dose to make up for a missed dose.

Discontinuation of TABEX treatment
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.
Mild to moderate adverse reactions are usually observed, such as gastrointestinal disorders (dry mouth, abdominal pain, nausea, vomiting, taste disturbances, constipation, diarrhoea, flatulence, burning sensation of the tongue, heartburn, excessive salivation), increased appetite and weight gain, and irritability. In addition, increased fatigue, malaise, tiredness, lacrimation, increased or decreased heart rate, elevated blood pressure, headaches and dizziness, sleep disorders (insomnia, somnolence, drowsiness, unusual dreams, nightmares), mood changes, anxiety, difficulty concentrating, reduced libido, dyspnoea, increased sputum production, muscle pain, skin rash, increased sweating, decreased skin elasticity, and increased liver enzyme activity may occur.
The aforementioned adverse reactions occur mainly during the initial period of treatment and diminish as treatment continues. They may also result from smoking cessation (withdrawal symptoms) rather than from taking TABEX.

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. 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, phone: +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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine TABEX

Store below 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.

6. Contents of the package and other information

What Tabex contains

The active substance is cytisine. One coated tablet contains 1.5 mg of cytisine.
Other ingredients are: cellulose powder, calcium sulfate dihydrate, colloidal anhydrous silica, magnesium stearate, coating Opadry II brown 85G 265001 containing: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, lecithin, talc, yellow iron oxide (E172), red iron oxide (E172), iron oxide/iron oxide black (E172).

What Tabex looks like and contents of the pack
Round, beige, biconvex coated tablets, 5.5 mm in diameter, with the letter "S" embossed on one side of the tablet.
20 (twenty) coated tablets are packed in PVC/PE/PVdC/PE/PVC/Aluminium blisters.
The carton contains 5 (five) blisters and one patient leaflet.

Marketing Authorisation Holder
Sopharma Warszawa Sp. z o.o.
Al. Jerozolimskie 136, 02-305 Warsaw, Poland

Manufacturer
SOPHARMA AD
16, Iliensko Shosse str., 1220 Sofia, Bulgaria

Availability category: OTC - Medicinal product available without a doctor's prescription.