Sopharma Tabex 1,5 mg (100 tablets) – LIMITED STOCK

DOSAGE AND ADMINISTRATION

• 1-3 days – 1 tablet 6 times a day (every 2 hours). These days, a gradual reduction in the number of cigarettes smoked is expected. If the result is unsatisfactory, the treatment is stopped and can be repeated after 2-3 months. In case of satisfactory effect (significantly reduced number of cigarettes) after the 3rd day the treatment continues according to the scheme;
• 4-12 days – 1 tablet every 2.5 hours (5 tablets daily);
• 13-16 days – 1 tablet every 3 hours (4 tablets daily);
• 17-20 days – 1 tablet every 5 hours (3 tablets daily);
• 21-25 days – 1-2 tablets daily.

The final cessation of smoking should take place on the 5th day after starting treatment. At the end of the course of treatment, the patient must show will and not afford a single cigarette.

INTERACTION

Tabex should not be used simultaneously with anti-tuberculosis drugs.

OVERDOSE

Symptoms:  nausea, vomiting, dilated pupils, general weakness, tachycardia, convulsions, respiratory paralysis.

Treatment:  gastric lavage, control of heart rate, blood pressure, respiratory function; if necessary, the introduction of infusion solutions, anticonvulsants, cardiotonic, analeptic and other symptomatic drugs.

CONTRAINDICATIONS

Contraindication to the use of Tabex is:

• acute myocardial infarction;
• unstable angina;
• arrhythmias;
• recent cerebrovascular accident;
• severe atherosclerosis;
• bleeding from large vessels;
• arterial hypertension;
• pulmonary edema;
• peptic ulcer of the stomach and duodenum (exacerbation phase);
• bronchial asthma;
• pregnancy;
• lactation (breastfeeding);
• hypersensitivity to cytisine.

With caution:  Tabex is prescribed for schizophrenia, chromaffin tumors of the adrenal glands, gastroesophageal reflux, for ischemic heart disease (including chronic heart failure), cerebrovascular diseases, hyperthyroidism, peptic ulcer of the stomach, diabetes mellitus, with renal and hepatic insufficiency. In children under 18 years of age and patients over 65 years of age, Tabex should be used after a careful assessment of the ratio of expected benefits and potential risks.

PRECAUTIONS WHILE TAKING TABEX

Tabex should be used only if the patient has a serious and conscious intention to stop smoking.

The patient should be warned that the use of Tabex against the background of continued smoking can lead to nicotine intoxication.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

Taking Tabex does not cause changes in the psychophysical state of the patient, does not impair the ability to drive vehicles and work with mechanisms.

STORAGE CONDITIONS

Tabex should be stored in a dry, dark place, out of the reach of children, at a temperature not exceeding 25°C.

TABEX tablets 1.5 mg * 100 SOPHARMA

Package leaflet: patient information

TABEX® 1.5 mg film-coated tablets TABEX® 1.5 mg film-coated tablets

cytisine

Read all of 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 have to read it again.
If you need further 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 is in this leaflet:

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 cytisin, which acts on the smoker’s body like nicotine. Taking Tabex leads to gradual cessation of smoking without unpleasant sensations and discomfort associated with quitting smoking.

Tabex is used in people dependent on smoking (chronic nicotinism) who want to quit.

2. What you need to know before you take Tabex

Do not take Tabex at:

• the presence of 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,
• heart rhythm disorder (cardiac arrhythmia), severe arterial hypertension, atherosclerosis;
• pregnancy or breast-feeding.

Check with your doctor or pharmacist if you are not sure about anything before taking this medicine.

Warnings and precautions

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

• ischemic heart disease (impaired blood supply to the heart muscle); heart failure (weakness of the heart muscle);
• arterial hypertension (high blood pressure);
• cerebrovascular diseases;
• blockage of blood vessels;
• kidney or liver diseases;
• hyperthyroidism (increased thyroid function);
• peptic ulcer disease;
• diabetes;
• chromaphine tumors of the adrenal;
• gastro-esophageal reflux disease (return of gastric juice to the lower part of the esophagus, which is manifested by a burning sensation);
• 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 of age.

Other medicines and Tabex

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are using medicines such as physostigmine, galantamine, statins, medicines to lower blood pressure, theophylline, ropinirole, clozapine, olanzapine, due to a possible increase in their side effects when used with Tabex at the same time.

Tabex with food and drink

Food and drink do not affect the action of Tabex.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

If you are pregnant or breast-feeding, you should not be treated with Tabex.

Driving and using machines

There is no evidence of adverse influence of Tabex in activities that require increased attention and speed of reactions.

3. How to take Tabex

Always take this medicine exactly as described in this leaflet. Check with your doctor or pharmacist if you are not sure.

Treatment is carried out according to the following scheme:

1 – 3 day – 1 tablet 6 times a day (every 2 hours). In these days, a gradual decrease in the number of cigarettes smoked is expected. If the result is unsatisfactory, treatment is discontinued and can be repeated after 2-3 months. With a satisfactory effect (significantly reduced number of cigarettes) after the 3rd day, treatment continues according to the scheme;
4-12 days – 1 tablet every 2.5 hours (5 tablets daily);
13-16 day – 1 tablet every 3 hours (4 tablets daily);
17 – 20 day – 1 tablet every 5 hours (3 tablets daily);
21-25 day – 1-2 tablets daily.

The final cessation of smoking should take place on the 5th day after starting treatment. After the end of the treatment course, the patient must show will and not allow himself a single cigarette.

Method of administration:

Tablets are taken orally with a sufficient amount of liquid.

If you take more Tabex than you should

If you take a dose greater than prescribed, you may experience nausea, vomiting, sweating, shaking, visual impairment, general weakness, an acceleration of the heart rhythm;
seizures, difficulty breathing.

In this case, stop taking Tabex and consult a doctor or ask for help at the nearest health facility.

If you forget to take Tabex

If you forget to take a dose, take it as soon as possible. If it’s almost time for your next dose, take it as usual, skipping the dose you forgot. Do not take a double dose to make up for the 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.

When treated with Tabex, especially at the beginning, the following side effects are possible:

Common (affects up to 1 in 10 patients)

• headache;
• vertigo;
• dry mouth;
• nausea;
• Dyspepsia;
• pain in the upper abdomen.

Uncommon (affects up to 1 in 100 patients)

• drowsiness;
• insomnia;
• constipation;
• Diarrhea;
• Vomiting.

Not known (cannot be estimated from the available data)

• Palpitations;
• acceleration of the heart rhythm;
• a slight increase in blood pressure;
• increased irritability;
• dyspnea;
• changes in taste and appetite;
• abdominal pain;
• muscle pain;
• chest pain;
• weight loss;
• perspiration.

Reporting of adverse reactions

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Tabex

Store in the original package in order to protect from moisture.
Store below 25°C.Keep
out of the reach of children!
The medicine should not be used after the expiry date which is stated on the package. The expiry date includes the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unnecessary medicines. These measures will help to protect the environment.

6. Contents of the pack and other information

What Tabex contains

The active ingredient is cytisine (cytisine) 1.5 mg.

The other ingredients are: calcium sulfate dihydrate, cellulose powder, colloidal anhydrous silica, magnesium stearate.

Film coating composition: Opadaray P brown (polyvinyl alcohol – partially hydrolyzed, titanium dioxide (E171), macrogol 4000, lecithin, talc (E55Hb), yellow iron oxide (E172), red iron oxide (E 172), black iron oxide (E 172).

What Tabex looks like and contents of the pack

The tablets are beige, round, biconvex, engraved with an “S” sign on one side of the tablet.

20 tablets in PVC/PE/PVdC/Al foil blister, 5 blisters per carton, together with a leaflet.

Marketing Authorisation Holder and Manufacturer

SOPHARMA AD, Bulgaria