Tabex Original & Official

TABEX Leaflet

Information for the Patient

This leaflet provides essential information regarding the use of TABEX, including its intended benefits, dosage instructions, possible side effects, and storage guidelines.

It is crucial for users and healthcare providers to thoroughly understand how TABEX works and the precautions to take before commencing treatment.

The information contained herein is aimed at ensuring the safe and effective use of TABEX for individuals seeking to overcome nicotine addiction and embark on a healthier, smoke-free lifestyle.

For your convenience and to cater to our diverse audience, the complete leaflet is available for download in PDF format in various languages at the bottom of this page. Please scroll down to access the downloadable files, ensuring you can read the information in your preferred language. This feature aims to provide comprehensive access to TABEX information worldwide, supporting users in making informed decisions about their health journey.

Tabex 1,5 mg Cytisine (100 tablets) - Official Tabex Sopharma

Leaflet: Information for the Patient

 

TABEX® 15 mg film-coated tablets

Cytisine

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
  • Keep this leaflet. You may need to read it again.
  • If you need more information or advice, ask your pharmacist.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What this leaflet contains:

  1. What TABEX is and what it is used for
  2. What you need to know before you take TABEX
  3. How to take TABEX
  4. Possible side effects
  5. How to store TABEX
  6. Contents of the pack and other information

1. What TABEX is and what it is used for

TABEX contains the active substance cytisine, which acts on the smoker’s body similarly to nicotine. Taking TABEX leads to the gradual cessation of smoking without unpleasant sensations and discomfort associated with quitting cigarettes. TABEX is used in people addicted to smoking (chronic nicotine addiction) who want to quit.

2. What you need to know before you take TABEX

Do not take TABEX if you have:

  • an allergy (hypersensitivity) to the active substance or any of the other ingredients of this medicine (listed in section 6);
  • recently had a myocardial infarction or stroke, unstable angina, arrhythmia, severe arterial hypertension, atherosclerosis;
  • are pregnant or breastfeeding.

If you are not sure about anything, ask your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking TABEX if you suffer from:

  • ischemic heart disease;
  • heart failure;
  • arterial hypertension;
  • cerebrovascular diseases;
  • blood vessel blockage;
  • kidney or liver diseases;
  • hyperthyroidism;
  • peptic ulcer disease;
  • diabetes;
  • pheochromocytoma;
  • gastroesophageal reflux disease;
  • mental illness (some forms of schizophrenia).

Children, adolescents, and adults over 65 years

There is insufficient clinical experience for the safe use of TABEX in children under 18 years and adults over 65 years.

Other medicines and TABEX

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Notify your treating doctor if you use medicines such as physostigmine, galantamine, statins, blood pressure lowering drugs, theophylline, ropinirole, clozapine, olanzapine, due to the possible enhancement of their side effects when used concurrently with TABEX.

TABEX with food and drinks

Food and drinks do not affect the action of TABEX.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or planning to have a baby, ask your doctor for advice before using this medicine. If you are pregnant or breastfeeding, you should not undergo treatment with TABEX.

Driving and using machines

There is no data on the adverse effects of TABEX when performing activities requiring increased attention and quick reactions.

3. How to take TABEX

Always take this medicine exactly as described in this leaflet. If you are unsure about anything, ask your doctor or pharmacist.

The treatment is carried out according to the following scheme:

  • 1st-3rd day: 1 tablet 6 times a day (every 2 hours). During these days, a gradual reduction in the number of cigarettes smoked is expected. If the result is unsatisfactory, the treatment is discontinued and may be repeated after 2-3 months. If the effect is satisfactory (significant reduction in the number of cigarettes), the treatment continues according to the scheme;
  • 4th-12th day: 1 tablet every 2.5 hours (5 tablets daily);
  • 13th-16th day: 1 tablet every 3 hours (4 tablets daily);
  • 17th-20th day: 1 tablet every 5 hours (3 tablets daily);
  • 21st-25th day: 1-2 tablets daily.

The final cessation of smoking should occur on the 5th day after starting the treatment. After the end of the treatment course, the patient must exert willpower and not allow themselves to smoke even a single cigarette.

Method of administration: The tablets are taken orally with a sufficient amount of water.

If you take more TABEX than you should

If you have taken a dose higher than prescribed, you may experience nausea, sweating, trembling, vision impairment, general weakness, accelerated heart rate, convulsions, difficulty breathing. In such a case, stop taking TABEX and consult a doctor or seek help at the nearest health facility.

If you forget to take TABEX

If you miss a dose, take it as soon as possible. If it is almost time for your next dose, take it as usual, skipping the missed dose. Do not take a double dose to make up for a forgotten one. Continue to take the medicine as described in this leaflet.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Especially at the beginning of treatment with TABEX, the following side effects are possible:

Common (affects up to 1 in 10 patients):

  • headache;
  • dizziness;
  • dry mouth;
  • nausea;
  • dyspepsia;
  • upper abdominal pain.

Uncommon (affects up to 1 in 100 patients):

  • drowsiness;
  • insomnia;
  • constipation;
  • diarrhea;
  • vomiting.

With unknown frequency (cannot be estimated from the available data):

  • palpitations;
  • accelerated heart rate;
  • slight increase in blood pressure;
  • increased irritability;
  • difficulty breathing;
  • changes in taste and appetite;
  • abdominal pain;
  • muscle pain;
  • chest pain;
  • weight loss;
  • sweating

5. How to store TABEX

Store in the original package to protect from moisture.

  • Store below 25°C.
  • Keep out of the reach of children.
  • Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What TABEX contains

  • The active ingredient is cytisine 15 mg.
  • The other ingredients are calcium sulfate dihydrate, powdered cellulose, colloidal anhydrous silica, magnesium stearate.
  • Coating composition: Opadry II brown (partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 4000, lecithin, talc (E553b), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172)).

What TABEX looks like and contents of the pack

The tablets are beige, round, biconvex, engraved with the letter “S” on one side. Each pack contains 20 tablets in a PVC/PE/PVdC/Al foil blister, with 5 blisters in a cardboard box along with a leaflet.

Marketing Authorization Holder and Manufacturer

SOPHARMA AD

Tabex Leaflet: Information for the Patient

English

Leaflet: TABEX® 15 mg film-coated tablets

Tabex Leaflet: Information for the Patient

Deutsch

Packungsbeilage: TABEX® 15 mg Filmtabletten

Tabex Leaflet: Information for the Patient

Español

Prospecto: TABEX® 15 mg comprimidos recubiertos con película

Tabex Leaflet: Information for the Patient

Français

Dépliant : TABEX® 15 mg, comprimés pelliculés

Tabex Leaflet: Information for the Patient

Italiano

Opuscolo: TABEX® 15 mg compresse rivestite con film

Tabex Leaflet: Information for the Patient

Nederlands

Bijsluiter: TABEX® 15 mg filmomhulde tabletten

Tabex Leaflet: Information for the Patient

Português

Folheto: TABEX® 15 mg comprimidos revestidos por película