Package Insert: Information for the User

Recigarum 1.5 mg Film-Coated Tablets

Citizensinacin

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

• Keep this package insert, as you may need to read 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, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Recigarum contains the active ingredient citisinicline.

This medication is used to stop smoking and reduce the desire for nicotine in adult smokers who wish to stop smoking. The goal of citisinicline treatment is permanent cessation of nicotine consumption.

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

No use Recigarum

• if you are allergic to citsiniclina or any of the other components 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 cerebral hemorrhage,
• if you are pregnant or breastfeeding.

Advertencias and precautions

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

Citisiniclina should be used with caution in cases of:

• ischemic cardiopathy,
• 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 insufficiency.

Citisiniclina should only be taken by people who have a firm intention to quit nicotine. The use of 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 fertile woman. See also the point "Pregnancy and lactation".

Children and adolescents

Due to limited experience, this medication is not recommended for use in minors under 18 years old.

Geriatric population

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

Patients with hepatic and renal insufficiency

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

Other medications and Recigarum

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

Do not take citisiniclina with antitubercular 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 use other medications containing theophylline (for the treatment of asthma), 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 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 lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Contraception in women

You should use effective contraceptive methods if you are a fertile woman.

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).

Consult your doctor.

Pregnancy and lactation

Citisiniclina is contraindicated during pregnancy and lactation.

Driving and operating machinery

Citisiniclina 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 citisiniclina treatment, 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 Recigarum".

In some people, 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.

Recigarum contains aspartame

This medication contains 0.12 mg of aspartame in each film-coated tablet. Aspartame contains a source of phenylalanine that may be harmful in the case 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 as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

One package of Recigarum (100 tablets) is sufficient for a complete treatment. 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 is calendarized with consecutive days of Recigarum intake.

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, treatment should be interrupted and can be resumed after 2 or 3 months.

Use in children and adolescents

Citsiniclina is not recommended for use in patients under 18 years old.

If you take more Recigarum than you should

The symptoms of nicotine intoxication are observed in case of citisiniclina overdose. The symptoms of overdose are, among others, general discomfort, nausea, vomiting, increased heart rate, blood pressure fluctuations, respiratory problems, blurred vision, seizures.

If you experience, even just one of the symptoms described or another symptom not mentioned in this leaflet, stop taking citisiniclina and consult your doctor.

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 ingested.

If you forgot to use Recigarum

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

These side effects can 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,
• Skin rash,
• Fatigue,
• Sleep disturbances (insomnia, somnolence, lethargy, abnormal dreams, nightmares),
• Headaches,
• Increased heart rate,
• Nausea,
• Alteration of taste,
• Acid reflux,
• 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 discomfort.

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

• Heavy-headed sensation,
• Decreased libido,
• Excessive tearing,
• Dyspnea,
• Increased sputum,
• Excessive salivation,
• Sweating,
• Decreased skin elasticity,
• Fatigue,
• Increased serum transaminase levels.

Most of the mentioned side effects occur at the beginning of treatment and disappear over its duration. These symptoms may also be a consequence of quitting smoking (abstinence symptoms) and not the treatment with citisiniclina.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side 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.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 indicated on the packaging and blister 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 the packaging and medications you no longer need 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 Recigarum

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

The other components are:

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

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

See section 2 “Recigarum contains aspartame”.

Appearance of the product and contents of the packaging

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

This medicine is available in blister packs of 100 film-coated tablets.

Marketing authorization holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31

2nd floor floor

28023 – Madrid

Responsible for manufacturing

Adamed Pharma S.A.

ul. Marszalka J. Pilsudskiego 5

95-200 Pabianice

Poland

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: January 2023

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