TACTIZEN 1.5 MG TABLETS - patient leaflet, side effects, dosage

Package leaflet: Information for the user

Cytisine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – 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 Tactizen is and what it is used for

• 2. What you need to know before you use Tactizen

• 3. How to use Tactizen

• 4. Possible side effects

• 5. How to store Tactizen

• 6. Contents of the pack and other information

1. what tactizen is and what it is used for

Smoking cessation and reduction of nicotine cravings in smokers who are willing to stop smoking. The treatment goal of Tactizen is the permanent cessation of the nicotine-containing products use.

The use of Tactizen allows for a gradual reduction of nicotine dependence by relieving withdrawal symptoms.

2. what you need to know before you use tactizen- if you are allergic to cytisine or any of the other ingredients of this medicine (listed in section 6).

• – if you have unstable angina,

• – if you have a history of recent myocardial infarction,

• – if you have clinically significant cardiac arrhythmias,

• – if you had stroke recently,

• – if you are pregnant or breast-feeding.

Warnings and precautions

Tactizen should be used with caution in case of ischemic heart disease, heart failure, hypertension, pheochromocytoma (a tumour of the adrenal gland), atherosclerosis (hardening of the arteries) and other peripheral vascular diseases, gastric and duodenal ulcer, gastroesophageal reflux disease, hyperthyroidism (overactive thyroid), diabetes, schizophrenia, kidney and liver failure.

Tactizen should be taken only by those with a serious intention of weaning off nicotine. The use of Tactizen and continuation of smoking could lead to aggravated side effects of nicotine.

Children and adolescents

Due to limited experience, the drug is not recommended for use in persons under 18 years of age.

Elderly population

Due to limited clinical experience, Tactizen is not recommended for use in elderly patients over 65 years of age.

Patients with kidney and liver impairment

There is no clinical experience of Tactizen in patients with kidney or liver impairment, therefore the medicine is not recommended for use in these patients.

Other medicines and Tactizen

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Do not take Tactizen with anti-tuberculosis drugs.

In some cases as a result of stopping smoking, with or without Tactizen an adjustment of the dose of other medicines may be necessary. This is especially important if you use other medicines which contain theophylline (to treat asthma), tacrine (for Alzheimer’s di­sease), clozapine (for schizophrenia) and ropinirole (to treat Parkinson’s di­sease). If you are not sure, talk to your doctor or pharmacist.

It is currently unknown whether Tactizen may reduce the effectiveness of systemically acting hormonal contraceptives. If you are using systemically acting hormonal contraceptives, you should add a second barrier method (e.g. condoms).

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 or pharmacist for advice before taking this medicine.

You must use effective methods of contraception if you are a woman of childbearing potential. Ask your doctor for advice.

Tactizen is contraindicated during pregnancy and breastfeeding.

Driving and using machines

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

Stopping smoking

The effects of changes in your body resulting from stopping smoking, with or without treatment with Tactizen, may alter the way other medicines act. Therefore, in some cases an adjustment of the dose may be necessary. See above under ‘Other medicines and Tactizen for further details.

For some people, stopping smoking with or without treatment has been associated with an increased risk of experiencing changes in thinking or behaviour, feelings of depression and anxiety (rarely including suicidal ideation and suicide attempt) and can be associated with a worsening of psychiatric disorder. If you have a history of psychiatric disorder you should discuss this with your doctor.

3. how to use tactizen

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

One package of Tactizen (100 tablets) is sufficient for a complete therapy. The duration of treatment is 25 days. Tactizen is for oral use and it should be taken with a suitable amount of water according to the following schedule.

Smoking should be stopped no later than on the 5th day of treatment. Smoking should not be continued during treatment as this may aggravate adverse reactions. In case of treatment failure, the treatment should be discontinued and may be resumed after 2 to 3 months.

If you use more Tactizen than you should

Symptoms of nicotine intoxication are observed in Tactizen overdose. Symptoms of overdose include malaise, nausea, vomiting, increased heart rate, fluctuations in blood pressure, breathing problems, blurred vision, convulsions.

If you have only one of described symptoms or the symptom, which is not mentioned in this leaflet, stop taking Tactizen and contact your doctor or pharmacist.

If you forget to use Tactizen

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

If you stop using Tactizen

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.

These side effects may occur with certain frequencies, which are defined as follows:

Very common may affect more than 1 user in 10: change in appetite (mainly increase), weight gain, dizziness, irritability, mood changes, anxiety, increased blood pressure (hypertension), dry mouth, diarrhea, rash, fatigue, sleep disorders (insomnia, drowsiness, lethargy, abnormal dreams, nightmares), headaches, increased heart rate, nausea, changes flavour, heartburn, constipation, vomiting, abdominal pain (especially in the upper abdomen), muscle pain.

Common may affect 1 to 10 users in 100: difficulty in concentration, slow heart rate, abdominal distension, burning tongue, malaise.

Uncommon affects 1 to 10 users in 1,000: feeling of heaviness in the head, decreased libido, tearing, dyspnea, increased sputum, excessive salivation, sweating, decreased elasticity of the skin, tiredness, increase in serum transaminase levels.

Most of above side effects occur at the beginning of the therapy and resolve along with its duration. These symptoms could also be the result of smoking cessation (withdrawal symptoms), not treatment with Tactizen.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: Yellow Card Scheme

Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store tactizen

Keep this medicine out of the sight and reach of children.

Store below 25°C in the original package in order to protect from moisture and light.

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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information- the active substance is cytisine. one tablet contains 1.5 mg of cytisine.

• – The other ingredients are: mannitol, microcrystalline cellulose, magnesium stearate, glycerol dibehenate, hypromellose.

What Tactizen looks like and contents of the pack

Tactizen is round, biconvex, white tablet with diameter 6 mm.

PVC/PCTFE/Aluminium blisters placed into cardboard box containing 100 tablets.

Marketing Authorisation Holder

Bonteque Consulting Ltd

29 Westcott Crescent, Hanwell

W7 1PL London, United Kingdom

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.

Szkolna 31

95–054 Ksawerow

Poland

This leaflet was last revised in 07/2021

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