Zandraqet 1.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Zandraqet 1.5 mg film-coated tablets EFG

cytisine

Read the entire 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, and you should not give it to other people, 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

1. What Zandraqet is and what it is used for
2. What you need to know before taking Zandraqet
3. How to take Zandraqet
4. Possible adverse effects
5. How to store Zandraqet
6. Contents of the pack and other information

1. What Zandraqet is and what it is used for

Cytisine is indicated in adults for smoking cessation treatment.

The use of this medicinal product allows for a gradual reduction in nicotine addiction and nicotine withdrawal, without symptoms or signs of nicotine withdrawal. The ultimate goal of administering this medicine is the permanent discontinuation of using products containing nicotine.

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

Do not take Zandraqet:

• if you are allergic to cytisinicline or to any of the other ingredients 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 this medicine.

This medicine should be used with caution in patients with 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.

This medicine should only be taken by individuals who are firmly committed to quitting smoking. Using this medicine without quitting smoking may worsen the adverse effects of nicotine.

Children and adolescents

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

Elderly population

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

Patients with hepatic or renal impairment

There is no clinical experience with this medicine in patients with renal or hepatic impairment; therefore, the medicine is not recommended for use in such patients.

Other medicines and Zandraqet

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

Do not take this medicine together with antituberculosis medications.

In some cases, as a result of quitting smoking (with or without this medicine), a dose adjustment of other medicines may be required. 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 Parkinson's disease). If you are unsure, consult your doctor or pharmacist.

It is currently unknown whether this medicine 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 may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Women who could become pregnant should use effective contraceptive methods. Ask your doctor for advice.

This medicine is contraindicated during pregnancy and breastfeeding.

Driving and using machines

This medicine has no effect on the ability to drive or operate machinery.

Smoking cessation

The effects of changes in the body resulting from quitting smoking (with or without treatment with this medicine) may alter the mechanism of action of other medicines. Therefore, in some cases, a dose adjustment may be necessary. For more details, see the section "Other medicines and Zandraqet."

In some individuals, quitting smoking—whether treated or not—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 associated with worsening of psychiatric disorders. If you have a history of psychiatric disorders, you should discuss this with your doctor.

Zandraqet contains aspartame

This medicine contains 0.12 mg of aspartame per tablet.

Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take Zandraqet

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

Days of treatmentRECOMMENDED DOSEMaximum daily dose

You must stop smoking no later than the 5th day of treatment. You should 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 may occur in case of overdose with this medicine. Overdose symptoms include, among others, general discomfort, nausea, vomiting, increased heart rate, fluctuations in blood pressure, breathing difficulties, blurred vision, and seizures. If you experience even one of the described symptoms or any other symptom not mentioned in this leaflet, stop taking this medicine and consult your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Zandraqet

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

If you stop treatment with Zandraqet

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 can 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), weight gain, dizziness, irritability, mood changes, anxiety, increased blood pressure (hypertension), dry mouth, diarrhoea, skin rash, exhaustion, sleep disorders (insomnia, somnolence, lethargy, abnormal dreams, nightmares), headaches, 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, general malaise.

Uncommon (affects between 1 and 10 in 1,000 users): sensation 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 stopping smoking (withdrawal symptoms) rather than the treatment with this medicine.

Reporting of adverse effects

If you experience any type of 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 Medicines: www.notificaram.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zandraqet

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

Store in the original packaging to protect from light.

This medicine does not require any special storage temperature.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zandraqet

• The active substance is cytisine. Each tablet contains 1.5 mg of cytisine.
• The other components (excipients) are:

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

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

Appearance of the product and contents of the pack

Film-coated tablets, round, biconvex, light green to green in colour, 5 mm in diameter.

PVC/PVDC/Aluminium blisters containing 100 film-coated tablets in a cardboard box.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Adamed Laboratorios, S.L.U.

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

28023 Madrid

Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Jozefa Pilsudskiego 5

95-200 Pabianice

Poland

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Laboratorios Gebro Pharma, S.A.

Av. Tibidabo, 29

08022 Barcelona

Spain

Date of the most recent review of this leaflet: March 2024

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