Package Insert: Information for the Patient

Zandraqet1.5 mg Film-Coated Tablets

citisiniclina

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.

• Ifyou experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6.Contents of the pack and additional information

Citisiniclina is indicated in adults for the treatment of tobacco dehabituation.

The use of the medication allows for a gradual reduction in nicotine addiction and nicotine abstinence without nicotine abstinence symptoms or signs. The final goal of administering this medication is the definitive interruption of the consumption of products containing nicotine.

Do not take Zandraqet:

• if you are allergic to cilostazol or any of the other ingredients 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 stroke,
• if you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

This medication should be used with caution in cases of ischemic heart disease, heart failure, hypertension, phaeochromocytoma (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.

This medication should only be taken by people who intend to quit smoking. The use of this medication without quitting smoking could lead to the worsening of nicotine's adverse effects.

Children and adolescents

Due to limited experience, this medication is not recommended for use in individuals under 18 years of age.

Older population

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

Patients with hepatic and renal insufficiency

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

Other medications and Zandraqet

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take this medication with antituberculous medications.

In some cases, as a result of quitting smoking (with or without this medication), it may be necessary to adjust the dose of other medications. This adjustment is particularly important if you use other medications containing 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 this medication 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 or intend to become 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.

This medication is contraindicated during pregnancy and lactation.

Driving and operating machinery

This medication 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 treatment with this medication) 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 "Other medications and Zandraqet".

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.

Zandraqet contains aspartame

This medication contains 0.12 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

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

Treatment DaysRECOMMENDED DOSEDAILY MAXIMUM DOSE

You should 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 Zandraqet than you should

The symptoms of nicotine overdose are observed in case of overdose of this medication. Symptoms of overdose include, among others, general discomfort, nausea, vomiting, increased heart rate, blood pressure fluctuations, respiratory problems, blurred vision, seizures. If you experience any of the symptoms described or another symptom not mentioned in this leaflet, stop taking this medication and consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount used.

If you forgot to take Zandraqet

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

If you interrupt treatment with Zandraqet

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 will experience them.

These adverse effects may occur at 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, burning sensation in the tongue, general discomfort.

Infrequent (affect between 1 and 10 in 1,000 users):Heavy-headed sensation, 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 can also be a consequence of quitting smoking (withdrawal symptoms) and not the treatment with this medication.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is 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.esBy reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Store in the original packaging to protect it from light.

This medication does not require any special storage temperature.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Zandraqet

-The active principle is citisinicline, also known as citisina. Each tablet contains 1.5mg of citisinicline.

-The other components (excipients) are:

Tablet core:hypromellose, mannitol (E421), cornstarch, magnesium aluminometasilicate type A (silicon dioxide, aluminium oxide and magnesium oxide), anhydrous colloidal silica and magnesium stearate.

Coating material:hypromellose, microcrystalline cellulose, talc, glycerol (E422), titanium dioxide (E171), quinoline yellow (E104), carmine lake (E132), peppermint aroma and aspartame (E951).

Appearance of the product and contents of the packaging

Coated tablets, round, biconvex, light green to greenish in color, 5 mm in diameter.

PVC/PVDC/Aluminium blisters with 100 coated tablets in a cardboard box.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Adamed Laboratorios, S.L.U.

C/ de las Rosas de Aravaca, 31 - 2nd floor

28023 Madrid

Spain

Responsible manufacturer

Adamed Pharma S.A.

ul. Marszalka Jozefa Pilsudskiego 5

95-200 Pabianice

Poland

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Laboratorios Gebro Pharma, S.A.

Av. Tibidabo, 29

08022 Barcelona

Spain

Last review date of this leaflet: March 2024

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