RECIGARUM 1.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Recigarum 1.5 mg film-coated tablets EFG

citisiniclina

Read the entire package leaflet carefully before starting to use 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.

Contents of the Package Leaflet

1. What is Recigarum and what is it used for
2. What you need to know before taking Recigarum
3. How to take Recigarum
4. Possible side effects
5. Storage of Recigarum
6. Package contents and additional information

1. What is Recigarum and what is it used for

Recigarum contains the active substance citisiniclina.

This medication is used to help stop smoking and reduce the desire for nicotine in adult smokers who want to quit smoking. The goal of citisiniclina treatment is permanent cessation of nicotine-containing product consumption.

The use of citisiniclina allows for a gradual reduction in nicotine dependence without nicotine withdrawal symptoms (such as depressed mood, irritability, anxiety, difficulty concentrating, insomnia, increased appetite).

2. What you need to know before taking Recigarum

Do not use Recigarum

• if you are allergic to citisiniclina 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.

Citisiniclina 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 impairment.

Only people who have a firm intention to quit nicotine should take citisiniclina. Using citisiniclina without quitting smoking or using nicotine-containing products could worsen the adverse effects of nicotine.

You should use effective contraceptive methods if you are a woman of childbearing age. Also, see the section "Pregnancy and breastfeeding".

Children and adolescents

Due to limited experience, this medication is not recommended for use in patients 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 impairment

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

Other medications and Recigarum

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

Do not take citisiniclina with anti-tuberculosis medications.

In some cases, as a result of quitting smoking, with or without citisiniclina, it may be necessary to adjust the dose of other medications. This 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 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 medication.

Contraception in women

You should use effective contraceptive methods if you are a woman of childbearing age.

It is currently unknown whether citisiniclina can reduce the effectiveness of systemic hormonal contraceptives. If you are using systemic hormonal contraceptives, you should add a second barrier method (e.g., condoms).

Ask your doctor for advice.

Pregnancy and breastfeeding

Citisiniclina is contraindicated during pregnancy and breastfeeding.

Driving and using machines

Citisiniclina 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 citisiniclina 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 "Other medications and Recigarum".

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.

Recigarum contains aspartame

This medication contains 0.12 mg of aspartame in each film-coated tablet. Aspartame is a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it properly.

3. How to take Recigarum

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

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

The blister pack is calendarized with the consecutive days of Recigarum intake.

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

Use in children and adolescents

The use of citisiniclina is not recommended in patients under 18 years of age.

If you take more Recigarum than you should

Nicotine intoxication symptoms are observed in case of citisiniclina 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, even if only one, or any other symptom not mentioned in this package leaflet, stop taking citisiniclina and consult your doctor.

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 ingested.

If you forget to use Recigarum

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

If you have any other 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 patients):

• changes in appetite (mainly increased),
• weight gain,
• dizziness,
• irritability,
• mood changes,
• anxiety,
• increased blood pressure (hypertension),
• dry mouth,
• diarrhea,
• 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 patients):

• difficulty concentrating,
• slow heart rate,
• abdominal distension,
• burning mouth,
• general malaise.

Uncommon (affect between 1 and 10 in 1,000 patients):

• feeling of heaviness in the head,
• decreased libido,
• tearfulness,
• 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 of treatment with citisiniclina.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are 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 Recigarum

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

Store in the original package to protect it from light. This medication does not require any special storage temperature.

Do not use this medication after the expiration date indicated on the package and blister pack after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Recigarum

The active substance is citisiniclina (previously called: cytisine). Each film-coated tablet contains 1.5 mg of citisiniclina.

The other components are:

Core: hypromellose, mannitol, cornstarch, magnesium aluminosilicate, anhydrous colloidal silica, and magnesium stearate.

Coating: hypromellose (E464), microcrystalline cellulose (E460), talc (E553b), glycerol (E422), titanium dioxide (E171), aluminum lake of quinoline yellow (E104), aluminum lake of carmine indigo (blue 2) (E132), menthol flavor powder, and aspartame (E951).

See section 2 "Recigarum contains aspartame".

Appearance of the product and package contents

Film-coated tablet, round, biconvex, light green to greenish in color, with a diameter of 5 mm.

This medication is available in packages with blister packs of 100 film-coated tablets.

Marketing authorization holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31

2nd floor

28023 – Madrid

Manufacturer

Adamed Pharma S.A.

ul. Marszalka J. Pilsudskiego 5

95-200 Pabianice

Poland

This medication is authorized inthe Member States of the European Economic Area under the following names:

Date of the last revision of this package leaflet: January 2023

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/