Tabex

Leaflet attached to the packaging: information for the user

TABEX 1.5 mg coated tablets

(Cytisinum)

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used in accordance with the description in the patient leaflet or as directed by a doctor or pharmacist.
The patient should always follow the instructions for use and consult a doctor or pharmacist if necessary.

• The patient should keep this leaflet to be able to read it again if necessary.
• The patient should consult a pharmacist if advice or additional information is needed.
• If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor or pharmacist.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is TABEX and what is it used for
• 2. Important information before using TABEX
• 3. How to use TABEX
• 4. Possible side effects
• 5. How to store TABEX
• 6. Contents of the packaging and other information

1. What is TABEX and what is it used for

Treatment of nicotine addiction. Using TABEX allows for gradual reduction of the body's dependence on nicotine and quitting smoking without nicotine withdrawal symptoms. The ultimate goal of using TABEX is permanent cessation of using nicotine-containing products.

2. Important information before using TABEX

When not to use TABEX:

• if the patient is allergic to cytisin or any other component of this medicine (listed in point 6),
• in case of unstable angina pectoris,
• after a recent myocardial infarction,
• in case of clinically significant cardiac arrhythmias,
• after a recent stroke,
• during pregnancy and breastfeeding.

Warnings and precautions:

TABEX should be used with caution in patients with coronary artery disease, heart failure, hypertension, pheochromocytoma, atherosclerosis, gastric or duodenal ulcer, gastroesophageal reflux disease, hyperthyroidism, diabetes, certain types of schizophrenia, renal or hepatic impairment.
Due to limited experience, it is not recommended to use the medicine in patients over 65 years of age.
TABEX should only be taken by individuals with a serious intention to quit smoking. Taking the medicine and continuing to smoke may lead to increased nicotine side effects.

Children

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

TABEX and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should not take TABEX with anti-tuberculosis medicines.

Pregnancy and breastfeeding

In case of pregnancy, suspected pregnancy, or planning a pregnancy, the patient should consult their doctor or pharmacist before using this medicine.
TABEX is contraindicated during pregnancy and breastfeeding.

Driving and using machines

TABEX does not affect the ability to drive or operate machines.

3. How to use TABEX

This medicine should always be used in accordance with the description in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
One package of TABEX (100 tablets) is sufficient for a full course of treatment.
The treatment duration is 25 days.
TABEX should be taken orally with a sufficient amount of water according to the following schedule.
Days of therapy
Dosage
Maximum daily dose
From 1 to 3 days
1 tablet every 2 hours
6 tablets
From 4 to 12 days
1 tablet every 2.5 hours
5 tablets
From 13 to 16 days
1 tablet every 3 hours
4 tablets
From 17 to 20 days
1 tablet every 5 hours
3 tablets
From 21 to 25 days
1-2 tablets per day
up to 2 tablets
The 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, the treatment should be discontinued and restarted after 2 to 3 months.

Using a higher dose of TABEX than recommended

Symptoms that occur after overdosing on TABEX are characteristic of nicotine poisoning symptoms. Overdose symptoms include: malaise, nausea, vomiting, accelerated heart rate, blood pressure fluctuations, respiratory disorders, vision disorders, seizures.
In case of occurrence of even one of the described symptoms or a symptom that has not been listed in the leaflet, the patient should stop taking TABEX and contact their doctor or pharmacist.

Missing a dose of TABEX

The patient should not take a double dose to make up for a missed dose.

Stopping the use of TABEX

In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, TABEX can cause side effects, although not everybody gets them.
Usually, mild to moderate side effects are observed, such as gastrointestinal disorders (dry mouth, abdominal pain, nausea, vomiting, changes in taste, constipation, diarrhea, bloating, burning of the tongue, heartburn, excessive salivation), increased appetite and weight gain, and irritability. Additionally, increased fatigue, malaise, drowsiness, tearing of the eyes, accelerated or slowed heart rate, increased blood pressure, headaches, dizziness, sleep disorders (insomnia, drowsiness, lethargy, strange dreams, nightmares), mood changes, anxiety, difficulty concentrating, decreased libido, shortness of breath, increased coughing, muscle pain, rash, increased sweating, decreased skin elasticity, increased liver enzyme activity.
These side effects occur mainly in the initial treatment period and subside with its duration. They may also be a result of quitting smoking (withdrawal symptoms) rather than taking TABEX.
If any side effects occur, including any possible side effects not listed in the leaflet, the patient should consult their doctor or pharmacist.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor or pharmacist, or nurse. 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, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects allows for the collection of more information on the safety of the medicine.

5. How to store TABEX

Store in a temperature 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 given month.

6. Contents of the packaging and other information

What TABEX contains

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

What TABEX looks like and what the packaging contains

Round, beige, biconvex coated tablets with a diameter of 5.5 mm, with the letter "S" embossed on one side of the tablet.
20 (twenty) coated tablets are packaged in PVC/PE/PVdC/PE/PVC/Aluminum blisters.
The carton contains 5 (five) blisters along with the patient leaflet.

Marketing authorization holder

Sopharma Warszawa Sp. z o.o.
Al. Jerozolimskie 136, 02-305 Warsaw
Manufacturer
SOPHARMA AD
16, Iliensko Shosse str., 1220 Sofia, Bulgaria
Category of availability: OTC - Medicinal product available without a prescription.
Date of last update of the leaflet: