What Sopharma Tabex is and what it is used for

Sopharma Tabex is a treatment for nicotine addiction. The use of Sopharma Tabex allows you to gradually reduce the body's dependence on nicotine and stop smoking without symptoms of nicotine withdrawal. The ultimate goal of using Sopharma Tabex is to permanently stop using nicotine-containing products.

What you need to know before taking Sopharma Tabex

Do not take Sopharma Tabex:

• if you are allergic to cytisine or any of the other ingredients (listed below)
• if you have unstable angina
• if you have recently had a heart attack
• if you have clinically significant heart rhythm problems
• if you have recently had a stroke
• during pregnancy and breastfeeding.

Warnings and precautions:

Sopharma Tabex should be used with caution in ischemic heart disease, heart failure, arterial hypertension, pheochromocytoma, atherosclerosis, gastric and duodenal ulcer, gastroesophageal reflux disease, hyperthyroidism, diabetes mellitus, some forms of schizophrenia, renal failure and liver.

Due to limited experience, it is not recommended to use Sopharma Tabex in elderly patients (over 65 years of age).

Sopharma Tabex should only be used by people with the serious intention of quitting smoking tobacco. Taking Sopharma Tabex and continuing to smoke can make your effects worse unwanted nicotine.

Kids

Due to limited experience, Sopharma Tabex is not recommended for use in children under the age of 18 years.

Other medicines and Sopharma Tabex

Please tell your doctor or pharmacist if you are taking or are taking any other medicines recently, as well as about medications that the patient is planning to take.

Do not take Sopharma Tabex together with medicines for tuberculosis.

Pregnancy and breastfeeding

Pregnant and breastfeeding, or when it is suspected or when the woman is pregnant are planning to become pregnant, consult your doctor or pharmacist for advice before taking Sopharma Tabex.

Sopharma Tabex is contraindicated during pregnancy and breastfeeding.

Driving vehicles and operating machinery

Sopharma Tabex has no influence on the ability to drive and use machines.

Sopharma Tabex contains lactose

One tablet of Sopharma Tabex contains 28 mg of lactose. If previously stated in the patient have an intolerance to some sugars, contact your doctor before taking Sopharma Tabex.

How to use Sopharma Tabex

Always use Sopharma Tabex exactly as described in the package leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

One package of Sopharma Tabex (100 tablets) is sufficient for a complete therapy.

The treatment time is 25 days.

Sopharma Tabex should be taken orally with a sufficient amount of water according the following scheme:

• From day 1 to day 3: 1 tablet every 2 hours (6 tablets)
• From day 4 to day 12: 1 tablet every 2.5 hours (5 tablets)
• From day 13 to day 16: 1 tablet every 3 hours (4 tablets)
• From day 17 to day 20: 1 tablet every 5 hours (3 tablets)
• From day 21 to day 25: 1-2 tablets a day (up to 2 tablets)

A smoker should give up smoking completely, at the latest 5 days after starting treatment.

A person who quit smoking can never afford to smoke even one cigarette. The durability of the obtained treatment result depends on it.

If the treatment effect is unsatisfactory, treatment should be discontinued and treatment restarted after 2 to 3 months.

If you take more Sopharma Tabex than you should

Symptoms of an overdose of Sopharma Tabex are characteristic of symptoms of nicotine poisoning.

Symptoms of overdose are: malaise, nausea, vomiting, increased heart rate, fluctuating blood pressure, breathing disorders, visual disturbances, convulsions.

If you experience even only one of these symptoms or a symptom not listed in this leaflet, stop taking Sopharma Tabex and contact your doctor or pharmacist.

If you forget to take Sopharma Tabex

Do not take a double dose to make up for a forgotten dose.

If you stop taking Sopharma Tabex

If you have any further questions on 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. Usually mild to moderate side effects such as gastrointestinal symptoms (dry mouth, abdominal pain, nausea, vomiting, taste changes, constipation, diarrhea, flatulence, burning of the tongue, heartburn, excessive salivation), increased appetite with weight gain, and irritability. In addition, there may be increased fatigue, malaise, tiredness, watery eyes, rapid or slow heart rate, high blood pressure, headache and dizziness, sleep disturbances (insomnia, sleepiness, drowsiness, strange dreams, nightmares), mood changes, anxiety, difficulty in concentration, decreased libido, shortness of breath, increased expectoration, muscle pain, rash, increased sweating, decreased skin elasticity, increased activity of liver enzymes.

These side effects occur mainly at the start of treatment and disappear as treatment continues. They can also be caused by stopping smoking (withdrawal symptoms) and not taking Sopharma Tabex.

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

How to store Sopharma Tabex

Store below 25 ° C. Store in the original package for the purpose protection against moisture. Keep out of the sight and reach of children.

Do not use after the expiry date which is stated on the package. Deadline validity refers to the last day of that month.

Package contents and other Information

What Sopharma Tabex contains

• The active substance is cytisine. One film-coated tablet contains 1,5 mg of cytisine.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, talc, magnesium stearate. The composition of the shell (Opadry II): polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide, red iron oxide, black iron oxide.