Todacitan 1.5 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Todacitan 1.5 mg tablets EFG
cytisine
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Todacitan is and what it is used for
- What you need to know before taking Todacitan
- How to take Todacitan
- Possible side effects
- How to store Todacitan
- Contents of the pack and other information
1. What Todacitan is and what it is used for
Aid in quitting smoking and in relieving the anxiety that occurs when stopping smoking. The goal of Todacitan treatment is permanent cessation of smoking.
The use of Todacitan enables a gradual reduction of nicotine dependence by alleviating withdrawal symptoms.
2. What you need to know before starting to use Todacitan.
Do not use Todacitan:
- if you are allergic to cytisine (formerly known as: corydaline), or to any of the other components of this medicine (listed in section 6),
- if you have unstable angina,
- if you have a history of recent myocardial infarction,
- if you suffer from clinically significant cardiac arrhythmias,
- if you have recently had a stroke,
- if you are pregnant or breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Todacitan.
Todacitan should be used with caution in cases of ischemic heart disease, heart failure, hypertension, pheochromocytoma (a tumor of the adrenal gland), atherosclerosis (hardening of the arteries), and other peripheral vascular diseases, gastric and duodenal ulcers, gastroesophageal reflux disease, hyperthyroidism (overactive thyroid), diabetes, schizophrenia, and renal or hepatic impairment.
Todacitan should only be taken by individuals who are firmly committed to quitting smoking. Using Todacitan without quitting smoking could lead to worsening of nicotine-related adverse effects.
Children and adolescents
Due to limited experience, the medicine is not recommended for use in individuals under 18 years of age.
Elderly population
Due to limited clinical experience, Todacitan is not recommended for use in patients over 65 years of age.
Patients with hepatic or renal impairment
There is no clinical experience with Todacitan in patients with renal or hepatic impairment; therefore, the medicine is not recommended for use in such patients.
Use of Todacitan with other medicines
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.
Do not take Todacitan together with antituberculosis medicines.
In some cases, as a result of quitting smoking (with or without Todacitan), dosage adjustments of other medicines may be necessary. This adjustment is particularly important if you are taking other medicines containing theophylline (for asthma treatment), tacrine (for Alzheimer's disease), clozapine (for schizophrenia), or ropinirole (for the treatment of Parkinson's disease). If you are unsure, consult your doctor or pharmacist.
It is currently unknown whether Todacitan may reduce the effectiveness of systemic hormonal contraceptives. If you use systemic hormonal contraceptives, you should add a second barrier method (e.g., condoms).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Women of childbearing potential must use effective contraceptive methods. Ask your doctor for advice.
Todacitan is contraindicated during pregnancy and breastfeeding.
Driving and using machines
Todacitan has no influence on the ability to drive or operate machinery.
Effects of quitting smoking
The effects of changes occurring in the body as a result of quitting smoking (with or without treatment with Todacitan) may alter the mechanism of action of other medicines. Therefore, in some cases, a dose adjustment may be necessary. For further details, see the section "Use of Todacitan with other medicines."
In some individuals, quitting smoking, with or without treatment, has been associated with an increased risk of experiencing changes in thinking or behavior, feelings of depression and anxiety (including, rarely, suicidal ideation and suicide attempts), and may be linked to worsening of psychiatric disorders. If you have a history of psychiatric disorders, you should discuss this with your doctor.
3. How to use Todacitan.
Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
One package of Todacitan (100 tablets) is sufficient for a complete treatment. The duration of treatment is 25 days. Todacitan is for oral use and must be taken with an adequate amount of water according to the schedule outlined below.
Treatment days | Posological schedule | Maximum daily dose |
Days 1 to 3 | 1 tablet every 2 hours | 6 tablets |
Days 4 to 12 | 1 tablet every 2.5 hours | 5 tablets |
Days 13 to 16 | 1 tablet every 3 hours | 4 tablets |
Days 17 to 20 | 1 tablet every 5 hours | 3 tablets |
Days 21 to 25 | 1-2 tablets per day | Up to 2 tablets |
You must stop smoking no later than the 5th day of treatment. You must not continue smoking during treatment, as this could worsen adverse reactions. If treatment fails, it should be discontinued and may be restarted after 2 or 3 months.
If you take more Todacitan than you should
Symptoms of nicotine poisoning may occur in case of Todacitan overdose. Overdose symptoms include, among others, general malaise, nausea, vomiting, increased heart rate, fluctuations in blood pressure, breathing difficulties, blurred vision, and seizures.
If you experience even just one of the described symptoms or any other symptom not mentioned in this leaflet, stop taking Todacitan and consult your doctor or pharmacist.
If you forget to take Todacitan
Do not take a double dose to make up for forgotten doses.
If you stop treatment with Todacitan
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
These adverse effects may occur with certain frequencies defined as follows:
Very common (may affect more than 1 in 10 users): changes in appetite (mainly increased appetite), weight gain, dizziness, irritability, mood changes, anxiety, increased blood pressure (hypertension), dry mouth, diarrhoea, skin rash, exhaustion, sleep disorders (insomnia, drowsiness, lethargy, abnormal dreams, nightmares), headache, increased heart rate, nausea, taste disturbance, heartburn, constipation, vomiting, abdominal pain (especially in the upper abdomen), muscle pain.
Common (may affect between 1 and 10 in 100 users): difficulty concentrating, slow heart rate, abdominal distension, burning sensation in the tongue, malaise.
Uncommon (may affect between 1 and 10 in 1,000 users): feeling of heaviness in the head, decreased libido, tearing, dyspnoea, increased sputum, excessive salivation, sweating, decreased skin elasticity, fatigue, increased serum transaminase levels.
Most of the adverse effects mentioned occur at the beginning of treatment and disappear over time. These symptoms may also be due to quitting smoking (withdrawal symptoms) rather than the treatment with Todacitan.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Todacitan.
Keep this medicine out of the sight and reach of children.
Store below 25 °C. Keep in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Todacitan
- The active substance is cytisinicline (previously known as cytisine). One tablet contains 1.5 mg of cytisinicline.
- The other components are: mannitol, microcrystalline cellulose, magnesium stearate, glycerol dibehenate, hypromellose.
Appearance of the medicinal product and contents of the pack
Todacitan is a white, round, biconvex tablet, 6 mm in diameter.
PVC/PCTFE/aluminum or PVC/PE/PVDC/aluminum blisters placed in a cardboard box containing 100 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Aflofarm Farmacja Polska Sp. z o.o.
Partyzancka 133/151
95-200 Pabianice
Poland
Tel. +48 42 22-53-100
Local Representative:
Aflofarm Spain S.L.U.,
Avd. Diagonal, 327, 4º2ª B2,
08009 Barcelona, Spain
Telephone: 931 205 432,
Manufacturer:
Aflofarm Farmacja Polska Sp. z o.o.
Szkolna 31
95-054 Ksawerów
Poland
Date of the most recent review of this leaflet: 10/2025
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) http://www.aemps.gob.es/