What Sopharma Tabex is and what it is used for

Sopharma Tabex contains the active substance cytisine, which acts on the smoker's body similar to nicotine. Taking Sopharma Tabex leads to a gradual cessation of smoking without unpleasant sensations and discomfort associated with quitting cigarettes.

Sopharma Tabex is used in people addicted to smoking (chronic nicotinism) who want to quit.

What you need to know before you take Sopharma Tabex

Do not take Sopharma Tabex if:

• presence of allergy (hypersensitivity) to the active substance or any of the other ingredients (listed below);
• recent myocardial infarction or stroke, unstable angina pectoris,
• heart rhythm disorder (cardiac arrhythmia), severe arterial hypertension, atherosclerosis;
• pregnancy or breastfeeding.

If you are not sure, ask your doctor or pharmacist before taking Sopharma Tabex.

Warnings and precautions

Talk to your doctor or pharmacist before taking Sopharma 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 function of the thyroid gland);
• ulcer;
• diabetes;
• chromaffin tumors of the adrenal gland;
• gastroesophageal reflux disease (return of stomach 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 of age

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

Other medicines and Sopharma Tabex

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

Inform your doctor if you are using drugs such as: physostigmine, galantamine, statins, blood pressure lowering drugs, theophylline, ropinirole, clozapine, olanzapine, due to possible enhancement of their side effects when used simultaneously with Sopharma Tabex.

Sopharma Tabex with food and drinks

Food and drink do not affect the effect of Sopharma Tabex.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using Sopharma Tabex.

If you are pregnant or breastfeeding, you should not be treated with Sopharma Tabex.

Driving and using machines

There are no data on adverse effects of Sopharma Tabex when performing activities that require increased attention and speed of reactions.

How to take Sopharma Tabex

Always take Sopharma Tabex exactly as described in this leaflet. If you are not sure, ask your doctor or pharmacist.

The treatment is carried out according to the following scheme:

• 1 - 3 days: 1 tablet 6 times a day (in 2 hours).
  During these days, a gradual decrease 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. With a 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 the start of treatment. After the end of the treatment course, the patient must show willpower and not allow himself a single cigarette.

Application method: tablets are taken orally with a sufficient amount of liquid.

If you have taken more than the required dose of Sopharma Tabex

If you have taken a dose greater than prescribed, you may feel nausea, vomiting, sweating, tremors, impaired vision, general weakness, increased heart rate; convulsions, difficulty breathing.

In such a case, stop taking Sopharma Tabex and consult a doctor or seek help at the nearest health facility.

If you forget to take Sopharma Tabex

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

If you have any further questions related to the use of Sopharma Tabex, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Sopharma Tabex can cause side effects, although not everybody gets them.

During treatment with Sopharma 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;

Not known (frequency cannot be estimated from the available data)

• palpitations;
• acceleration of heart rate;
• slight increase in blood pressure;
• increased irritability;
• difficulty breathing;
• changes in taste and appetite;
• stomach ache;
• muscle aches;
• chest pains;
• weight loss;

Adverse reactions

If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet.

How to store Sopharma Tabex

Store in original packaging to protect from moisture.

To be stored below 25°C.

Keep out of the reach of children!

Sopharma Tabex should not be used after the expiry date marked on the package. The expiration date includes the last day of the specified month.

Medicines should not be disposed of down the drain or in the household waste container. Ask your pharmacist how to dispose of your unwanted medicines. These measures will help protect the environment.

Contents of the package and additional information

What Sopharma 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.

Composition of the film coating: Opadray P brown (polyvinyl alcohol - partially hydrolyzed, titanium dioxide (E171), macrogol 4000, lecithin, talc (E553b), yellow iron oxide (E172), red iron oxide (E 172), black iron oxide ( E 172).

What Sopharma Tabex looks like and contents of the pack

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

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