Leaflet: information for the user

Todacitan1,5 mg EFG tablets

Citisina

Read this leaflet carefully before you start taking 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Todacitan and what it is used for

2.What you need to know before starting to take Todacitan

3.How to useTodacitan

4.Possible side effects

5.Storage ofTodacitan

6.Contents of the pack and additional information

Helps to quit smoking and to relieve the anxiety that occurs when quitting smoking. The goal of Todacitan treatment is permanent cessation of the smoking habit.

The use of Todacitan allows for a gradual reduction in nicotine dependence through relief of withdrawal symptoms.

Do not useTodacitan:

• if you are allergicto citisinaor to any of the other components of this medication (listed in section 6),
• if you have unstable angina,
• if you have a recent history of myocardial infarction,
• if you have clinically relevant cardiac arrhythmias,
• if you have recently had a cerebral hemorrhage,
• if you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Todacitan.

Todacitan should be used with caution in cases of ischemic cardiopathy, heart failure, hypertension, phaeochromocytoma (adrenal gland tumor), atherosclerosis (artery hardening) and other peripheral vascular diseases, gastric and duodenal ulcers, gastroesophageal reflux disease, hyperthyroidism (overactive thyroid), diabetes, schizophrenia, renal and hepatic insufficiency.

Only people who intend to quit smoking should take Todacitan. Using Todacitan without quitting smoking could worsen the adverse effects of nicotine.

Children and adolescents

Due to limited experience, the medication is not recommended for use in individuals under 18 years old.

Older population

Due to limited clinical experience, Todacitan is not recommended for use in patients over 65 years old.

Patients with hepatic and renal insufficiency

There is no clinical experience with Todacitan in patients with renal or hepatic insufficiency; therefore, the medication is not recommended for use in these patients.

Use of Todacitan with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not take Todacitan with antituberculous medications.

In some cases, as a result of quitting smoking (with or without Todacitan), it may be necessary to adjust the dose of other medications. This adjustment is particularly important if you are using other medications that contain theophylline (for asthma treatment), tacrine (for Alzheimer's disease), clozapine (for schizophrenia) or ropinirole (for Parkinson's disease). If unsure, consult your doctor or pharmacist.

It is currently unknown whether Todacitan can 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 lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

If you are a woman who may become pregnant, you should use effective contraceptive methods. Ask your doctor for advice.

Todacitan is contraindicated during pregnancy and lactation.

Driving and operating machinery

Todacitan has no influence on the ability to drive and operate machinery.

Quitting smoking

The effects of the changes that occur in the body as a result of quitting smoking (with or without Todacitan treatment) can alter the mechanism of action of other medications. Therefore, in some cases, it may be necessary to adjust the dose. For more details, see the section "Use of Todacitan with other medications".

Quitting smoking, with or without treatment, has been associated with an increased risk of experiencing changes in thought or behavior, with feelings of depression and anxiety (including rarely suicidal ideation and attempt) and may be related to the worsening of psychiatric disorders. If you have a history of psychiatric disorders, you should discuss this with your doctor.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

One package of Todacitan (100 tablets) is sufficient for a complete treatment. The treatment duration is 25 days. Todacitan is for oral use and should be taken with an adequate amount of water according to the schedule indicated below.

You must stop smoking no later than the 5th day of treatment. Do not continue smoking during treatment as this could worsen adverse reactions. In case of treatment failure, treatment should be interrupted and may be resumed after 2 or 3 months.

If you take more Todacitan than you should

The symptoms of nicotine overdose are observed in case of overdose of Todacitan. Symptoms of overdose include, among others, general discomfort, nausea, vomiting, increased heart rate, fluctuations in blood pressure, respiratory problems, blurred vision, seizures.

If you experience any of the symptoms described or another symptom not mentioned in this leaflet, stop taking Todacitan and consult your doctor or pharmacist.

If you forget to useTodacitan

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Todacitan

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

Very frequent (may affect more than 1 in 10 users):Changes in appetite (mainly increase), weight gain, dizziness, irritability, mood changes, anxiety, increased blood pressure (hypertension), dry mouth, diarrhea, skin rash, fatigue, sleep disturbances (insomnia, somnolence, lethargy, abnormal dreams, nightmares), headaches, increased heart rate, nausea, altered taste, stomach burning, constipation, vomiting, abdominal pain (especially in the upper abdomen), muscle pain.

Frequent (may affect between 1 and 10 in 100 users):Difficulty concentrating, slow heart rate, abdominal distension, tongue burning, general discomfort.

Infrequent (affect between 1 and 10 in 1,000 users):Headache heaviness, decreased libido, tearing, shortness of breath, 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 its duration. These symptoms may also be a consequence of quitting smoking (withdrawal symptoms) and not the treatment withTodacitan.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Store below25 °C.Store in the original packaging to protect it from light and moisture.

Do not use this medication after the expiration date indicated on the packaging. The expiration date is the last day of the month indicated.

Do not dispose of any medication through household waste or sewage. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition ofTodacitan

• The active principle is citisina. A tablet contains 1.5 mg of citisina.
• The other components are: mannitol, microcrystalline cellulose, magnesium stearate, glycerol dibehenate, hypromellose.

Appearance of the product and contents of the packaging

Todacitan is a white, round, biconvex tablet of 6 mm in diameter.

PVC/PCTFE/aluminum or PVC/PE/PVDC/aluminum blisters placed in a cardboard box containing100 tablets..

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aflofarm Farmacja Polska Sp. z o.o.

Partyzancka 133/151

95-200 Pabianice

Poland

tel. (42) 22-53-100

Local Representative

Aflofarm Spain S.L.U.,

Avd. Diagonal, 327, 4º2ª B2,

08009 Barcelona, Spain

Telephone: 931 205 432,

[email protected]

Responsible for manufacturing:

Aflofarm Farmacja Polska Sp. z o.o.

Szkolna 31

95-054 Ksawerów

Poland

Last review date of this leaflet: 07/2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices(AEMPS) http://www.aemps.gob.es/