Cytisine 1.5mg Smoking Cessation Tablets

How to use Cytisine

Always use this medicine exactly as your doctor or pharmacist has told you.

One complete treatment of Cytisine is 25 days. Cytisine is for oral use and it should be taken with a water in accordance with the schedule below.

Smoking should be stopped no later than on the 5th day of treatment. Do not continue smoking during the treatment as that can lead to negative side effects. If the treatment does not work for you, then the treatment should be stopped and you can start again after 2 to 3 months.

If you use more Cytisine than you should

Cytisine overdose can result in nicotine intoxication. 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 Cytisine and contact your doctor or pharmacist. If you forget to use Cytisine Do not take a double dose to make up for a forgotten dose. If you stop using Cytisine If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What's in Cytisine Tablets?

The active substance of Cytisine is cytisine.

One tablet contains 1.5 mg of cytisine.

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

Cytisine side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some common side effects include: 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.

See the full patient leaflet for the full list of side effects, or speak to a pharmacist.

Warnings

Do not use Cytisine:

• if you are allergic to cytisine or any of the other ingredients of this medicine

• 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

Warnings and precautions

Cytisine 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.

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

Elderly population

Due to limited clinical experience, Cytisine 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 Cytisine in patients with kidney or liver impairment, therefore the medicine is not recommended for use in these patients.

Other medicines and Cytisine

• Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines
• Do not take Cytisine with anti-tuberculosis drugs.
• In some cases as a result of stopping smoking, with or without Cytisine 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).
• It is currently unknown whether Cytisine 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. Cytisine is contraindicated during pregnancy and breastfeeding.

Driving and using machines

Cytisine 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 Cytisine, may alter the way other medicines act. Therefore, in some cases an adjustment of the dose may be necessary.

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.