ZANDRAQET 1.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Zandraqet1.5 mg film-coated tablets EFG

citisincline

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

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

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

Package Leaflet Contents

1. What is Zandraqet and what is it used for
2. What you need to know before taking Zandraqet
3. How to take Zandraqet
4. Possible side effects
5. Storage of Zandraqet

1. Package Contents and Additional Information

1. What is Zandraqet and what is it used for

Citisincline is indicated in adults for the treatment of smoking cessation.

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

2. What you need to know before taking Zandraqet

Do not take Zandraqet:

• if you are allergic to citisincline 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 this medication.

This medication should be used with caution in cases of ischemic heart disease, heart failure, hypertension, pheochromocytoma (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, renal and hepatic insufficiency.

This medication should only be taken by people who have a firm intention to quit smoking. Taking this medication 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, this medication is not recommended for use in patients over 65 years of age.

Patients with Renal and Hepatic 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 such patients.

Other Medications and Zandraqet

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

Do not take this medication with antitubercular 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. Such adjustment is particularly important if you are using other medications that contain theophylline (for the treatment of asthma), 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 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 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.

This medication is contraindicated during pregnancy and breastfeeding.

Driving and Using Machines

This medication has no influence on the ability to drive and use machines.

Smoking Cessation

The effects of the changes that occur in the body as a result of quitting smoking (with or without treatment with this medication) 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 "Other Medications and Zandraqet".

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.

Zandraqet contains aspartame

This medication contains 0.12 mg of aspartame in each tablet.

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

3. How to take Zandraqet

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

Treatment DaysRECOMMENDED DOSEMaximum Daily 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. If treatment fails, it should be discontinued and may be resumed after 2 or 3 months.

If you take more Zandraqet than you should

Symptoms of nicotine poisoning are observed in case of overdose of this medication. The symptoms of overdose include, among others, general malaise, nausea, vomiting, increased heart rate, fluctuations in blood pressure, 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 this medication and consult your doctor or pharmacist.

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

If you forget to take Zandraqet

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Zandraqet

If you have any further questions about 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 1,000 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 may also be a consequence of quitting smoking (withdrawal symptoms) and not of treatment with this medication.

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 Medicines Monitoring System: www.notificaram.es By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Zandraqet

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 stated on the package after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If you are unsure, 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

Zandraqet Composition

• The active ingredient is citisincline, also known as cytisine. Each tablet contains 1.5 mg of citisincline.
• The other components (excipients) are:

Tablet core: hypromellose, mannitol (E421), cornstarch, magnesium aluminometasilicate type A (silicon dioxide, aluminum 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 indigo (E132), menthol flavor, and aspartame (E951).

Product Appearance and Package Contents

Greenish to light green, round, biconvex film-coated tablets, 5 mm in diameter.

PVC/PVDC/Aluminum blisters with 100 film-coated tablets in a cardboard box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

C/ de las Rosas de Aravaca, 31 - 2ª planta

28023 Madrid

Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Jozefa Pilsudskiego 5

95-200 Pabianice

Poland

You can request more information about this medication from the local representative of the marketing authorization holder:

Laboratorios Gebro Pharma, S.A.

Av. Tibidabo, 29

08022 Barcelona

Spain

Date of the last revision of this package leaflet: March 2024

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