JABLERDIZ 1.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Jablerdiz 1.5 mg film-coated tablets EFG

citisiniclina

Read this package leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Jablerdiz and what is it used for
2. What you need to know before you start using Jablerdiz
3. How to use Jablerdiz
4. Possible side effects
5. Storage of Jablerdiz

1. Contents of the pack and further information

1. What is Jablerdiz and what is it used for

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

The use of this medicine allows for a gradual reduction of nicotine addiction and nicotine withdrawal without symptoms or signs of nicotine withdrawal. The final goal of the administration of this medicine is the definitive interruption of the consumption of products containing nicotine.

2. What you need to know before you start using Jablerdiz

Do not useJablerdizif:

• you are allergic to citisiniclina or any of the other ingredients of this medicine (listed in section 6),
• you have unstable angina,
• you have had a recent myocardial infarction,
• you suffer from clinically significant cardiac arrhythmias,
• you have recently had a stroke,
• you are pregnant or breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking citisiniclina.

Citisiniclina should be used with caution in case 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.

Citisiniclina should only be taken by people who have a firm intention to quit smoking. Using citisiniclina without quitting smoking could worsen the adverse effects of nicotine.

Children and adolescents

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

Elderly population

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

Patients with renal and hepatic insufficiency

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

Other medicines and Jablerdiz

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Do not take this medicine with antitubercular medicines.

In some cases, as a result of quitting smoking (with or without citisiniclina), it may be necessary to adjust the dose of other medicines. Such adjustment is particularly important if you are using other medicines that contain theophylline (for the treatment of asthma), tacrine (for Alzheimer's disease), clozapine (for schizophrenia), or ropinirol (for the treatment of Parkinson's disease). If you are not sure, talk to your doctor or pharmacist.

It is currently unknown whether citisiniclina 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 medicine.

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

Citisiniclina is contraindicated during pregnancy and breastfeeding.

Driving and using machines

This medicine 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 treatment with citisiniclina) may alter the mechanism of action of other medicines. Therefore, in some cases, it may be necessary to adjust the dose. For more details, see the section "Other medicines and Jablerdiz".

In some people, 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.

Jablerdiz contains aspartame

This medicine contains 0.12 mg of aspartame in each film-coated tablet. Aspartame is a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to use Jablerdiz

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

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

Treatment daysRecommended doseMaximum daily dose

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

If you use moreJablerdizthan you should

Symptoms of nicotine poisoning are observed in case of overdose of citisiniclina. The symptoms of overdose are, 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 citisiniclina 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 medicine and the amount used.

If you forget to useJablerdiz

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

If you stop usingJablerdiz

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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, burning sensation in the tongue, 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 the treatment and disappear during its duration. These symptoms may also be a consequence of quitting smoking (withdrawal symptoms) and not of the treatment with citisiniclina.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet. You can also report side effects 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 medicine.

5. Storage of Jablerdiz

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

This medicine does not require any special storage temperature.

Keep in the original packaging to protect from light.

Do not use this medicine after the expiry date which is 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. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Jablerdiz

• The active substance is citisiniclina, also known as cytisine. One tablet contains 1.5 mg of citisiniclina.
• The other ingredients (excipients) are:
• • Core of the tablet: hypromellose, mannitol (E421), corn starch, magnesium aluminometasilicate type A (silicon dioxide, aluminum oxide, and magnesium oxide), colloidal anhydrous silica, and magnesium stearate.
  • Coating material: hypromellose, microcrystalline cellulose, talc, glycerol (E422), titanium dioxide (E171), quinoline yellow (E104), carmine indigo (E132), peppermint flavor, and aspartame (E951).

Appearance of the product and packaging contents

Round, biconvex, film-coated tablets, light green to greenish in color, 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 Pharma S.A.

Pienków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Poland

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

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

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