TODACITAN 1.5 mg Tablets

2. What you need to know before taking Todacitan

Do not useTodacitan:

• if you are allergic to cytisine or any of the other components of this medication (listed in section 6),
• if you have unstable angina,
• if you have had a 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

Consult 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 (adrenal gland tumor), atherosclerosis (hardening of the arteries), and other peripheral vascular diseases, gastric and duodenal ulcers, gastroesophageal reflux disease, hyperthyroidism (overactive thyroid), diabetes, schizophrenia, renal and hepatic insufficiency.

Only people who have a firm intention 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 of age.

Elderly Population

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

Patients with Renal and Hepatic Insufficiency

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

Using Todacitan with Other Medications

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

Do not take Todacitan with anti-tuberculosis 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. Such 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 treatment). If you are 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 Breastfeeding

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

If you are a woman of childbearing potential, you should 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 and use machines.

Quitting Smoking

The effects of the changes that occur in the body as a result of quitting smoking (with or without Todacitan treatment) may 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 "Using Todacitan with Other Medications".

In some individuals, quitting smoking, with or without treatment, has been associated with an increased risk of experiencing changes in thinking or behavior, with feelings of depression and anxiety (including, rarely, suicidal ideation and attempted suicide), 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.

3. How to Take Todacitan

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

A pack of Todacitan (100 tablets) is sufficient for a complete treatment course. 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 should quit smoking no later than the 5th day of treatment. Do not continue smoking during treatment, as this could worsen adverse reactions. If treatment fails, it should be interrupted and may be resumed after 2 or 3 months.

If you take more Todacitan than you should

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

If you experience any of the symptoms described or any other symptom not mentioned in this package 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 interrupt treatment with Todacitan

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

Very Common (may affect more than 1 in 10 users):changes in appetite (mainly increased), weight gain, dizziness, irritability, mood changes, anxiety, increased blood pressure (hypertension), dry mouth, diarrhea, skin rash, fatigue, sleep disorders (insomnia, somnolence, lethargy, abnormal dreams, nightmares), headaches, increased heart rate, nausea, altered taste, 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, tongue burning, general malaise.

Uncommon (affect between 1 and 10 in 1000 users):feeling of heaviness in the head, decreased libido, tearing, dyspnea, increased sputum, excessive salivation, sweating, decreased skin elasticity, fatigue, increased serum transaminase levels.

Most of the side effects mentioned occur at the beginning of treatment and disappear during its duration. These symptoms can also be a consequence of quitting smoking (withdrawal symptoms) and not due to treatment with Todacitan.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es

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

5. Storage of Todacitan

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

Store below 25°C. Store in the original packaging to protect 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 wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofTodacitan

• The active ingredient is cytisine. One tablet contains 1.5 mg of cytisine.
• The other ingredients are: mannitol, microcrystalline cellulose, magnesium stearate, glycerol dibehenate, hypromellose.

Appearance of the Product and Package Contents

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

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. (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]

Manufacturer:

Aflofarm Farmacja Polska Sp. z o.o.

Szkolna 31

95-054 Ksawerów

Poland

Date of the Last Revision of this Package Leaflet: 07/2023

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/