CITISINICLINA APC PHARMLOG 1.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Citisiniclina APC Pharmlog 1.5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this 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. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Citisiniclina APC Pharmlog and what is it used for
2. What you need to know before you take Citisiniclina APC Pharmlog
3. How to take Citisiniclina APC Pharmlog
4. Possible side effects
5. Storing Citisiniclina APC Pharmlog
6. Contents of the pack and other information

1. What is Citisiniclina APC Pharmlog and what is it used for

Citisiniclina APC Pharmlog contains the active substance citisiniclina.

It helps to stop smoking and to alleviate the anxiety that occurs when stopping smoking. The goal of citisiniclina treatment is permanent cessation of the smoking habit.

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

2. What you need to know before you take Citisiniclina APC Pharmlog

Do not takeCitisiniclina APC Pharmlog:

• if you are allergic to citisiniclina or any of the other ingredients of this medicine (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 Citisiniclina APC Pharmlog.

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 impairment.

Only people who are strongly motivated to stop smoking should take citisiniclina. Using citisiniclina without stopping smoking or stopping the use of 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 medicine 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 medicine is not recommended for use in these patients.

Other medicines and Citisiniclina APC Pharmlog

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

Do not take citisiniclina with anti-tuberculosis medicines.

In some cases, as a result of stopping 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 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 medicine.

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.

Stopping smoking

The effects of the changes that occur in the body as a result of stopping smoking (with or without citisiniclina treatment) 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 "Using citisiniclina with other medicines".

In some people, stopping 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.

Citisiniclina APC Pharmlogcontains 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 take Citisiniclina APC Pharmlog

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

A pack of Citisiniclina APC Pharmlog (100 tablets) is sufficient for a complete treatment. The duration of treatment is 25 days. Citisiniclina APC Pharmlog 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 the consecutive days of taking Citisiniclina APC Pharmlog.

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.

Use in children and adolescents

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

If you take more Citisiniclina APC Pharmlog than 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 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 medicine and the amount taken.

If you forget to takeCitisiniclina APC Pharmlog

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

If you stop takingCitisiniclina APC Pharmlog

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 people):

• 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),
• headache,
• increased heart rate,
• nausea,
• altered taste,
• heartburn, constipation,
• vomiting,
• abdominal pain (especially in the upper abdomen),
• muscle pain.

Common (may affect up to 1 in 10 people):

• difficulty concentrating,
• slow heart rate,
• abdominal distension,
• tingling of the tongue,
• general malaise.

Uncommon (may affect up to 1 in 100 people):

• feeling of heaviness in the head,
• decreased libido,
• tearfulness,
• shortness of breath,
• 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 stopping smoking (withdrawal symptoms) and not of treatment with Citisiniclina APC Pharmlog.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Citisiniclina APC Pharmlog

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

Store in the original package 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 package. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and other information

C

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

The other ingredients are:

Core:

hypromellose,

mannitol,

corn starch,

magnesium aluminometasilicate,

colloidal anhydrous silica,

magnesium stearate.

Coating:

hypromellose (E464),

microcrystalline cellulose (E460),

talc (E553b),

glycerol (E422),

titanium dioxide (E171),

yellow quinoline aluminum lake (E104),

carmine aluminum lake (blue 2) (E132),

menthol flavor powder,

aspartame (E951).

See section 2 "Citisiniclina APC Pharmlog contains aspartame".

Appearance and packaging

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

PVC/PVDC-Aluminum blisters in packs of 100 film-coated tablets.

Marketing authorization holder

APC Pharmlog Sp. z o.o.

Aleje Jerozolimskie 146 C

02-305 Warszawa

Poland

Manufacturer

Adamed Pharma S.A.

ul. Marszalka J. Pilsudskiego 5

95-200 Pabianice

Poland

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

Date of last revision of this leaflet:January 2023

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/