Cerdablan

1. What is Cerdablan and what is it used for

Cerdablan contains the active substance cytisinicline, also known as cytisine.
This medicine is used to help adults who want to stop smoking and reduce their nicotine cravings.
The goal of taking Cerdablan is to permanently stop using nicotine-containing products.
Taking Cerdablan allows for gradual reduction of nicotine dependence by alleviating withdrawal symptoms (e.g., low mood, irritability, anxiety, concentration difficulties, insomnia, increased appetite).

2. Important information before taking Cerdablan

When not to take Cerdablan:

• if the patient is allergic to cytisinicline or any of the other ingredients of this medicine (listed in section 6),
• in case of unstable angina pectoris,
• after a recent myocardial infarction,
• in case of clinically significant heart rhythm disorders,
• after a recent stroke,
• during pregnancy and breastfeeding.

Warnings and precautions

Before starting to take Cerdablan, the patient should discuss it with their doctor or pharmacist in case of:

• ischemic heart disease,
• heart failure,
• hypertension,
• chromaffin tumor (adrenal gland tumor),
• atherosclerosis (hardening of the arteries) and other peripheral vascular diseases,
• peptic ulcer disease,
• gastroesophageal reflux disease,
• hyperthyroidism,
• diabetes,
• schizophrenia,
• renal and hepatic impairment.

Cerdablan should only be taken by people with a serious intention to quit nicotine. Taking Cerdablan and continuing to smoke or use nicotine-containing products may lead to increased side effects of nicotine.

Children and adolescents

Due to limited experience, Cerdablan is not recommended for use in people under 18 years of age.

Elderly

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

Use in patients with renal and hepatic impairment

There is no clinical experience with Cerdablan in patients with renal or hepatic impairment, so its use is not recommended in this group of patients.

Cerdablan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
Cerdablan should not be taken with anti-tuberculosis medicines.
In some cases, as a result of quitting smoking, with or without Cerdablan, it may be necessary to adjust the doses of other medicines. This is especially important when the patient is taking medicines containing theophylline (used to treat asthma), tacrine (used to treat Alzheimer's disease), clozapine (used to treat schizophrenia), and ropinirole (used to treat Parkinson's disease).
In case of any doubts, the patient should consult their doctor or pharmacist.
It is currently unknown whether Cerdablan may reduce the effectiveness of systemic hormonal contraceptives. Women using systemic hormonal contraceptives should use an additional barrier method (e.g., condoms).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Contraception in women
Women of childbearing age must use effective contraception.
It is currently unknown whether Cerdablan may reduce the effectiveness of systemic hormonal contraceptives. Women using systemic hormonal contraceptives should use an additional barrier method (e.g., condoms).
The patient should consult their doctor.
Pregnancy and breastfeeding
Cerdablan should not be taken during pregnancy and breastfeeding.

Driving and using machines

Cerdablan has no influence or negligible influence on the ability to drive and use machines.

Quitting smoking

Changes in the body associated with quitting smoking, with or without Cerdablan, may change the way other medicines work. Therefore, in some cases, it may be necessary to adjust the doses of other medicines. More information can be found above in the section "Cerdablan and other medicines".
In some people, quitting smoking, with or without medicines, has been associated with an increased risk of changes in thinking or behavior, feelings of depression and anxiety (including rare suicidal thoughts and attempts), and may be associated with worsening of psychiatric disorders. If the patient has or has had psychiatric disorders, they should discuss this with their doctor.

Cerdablan contains ethanol, propylene glycol, sodium, and sodium metabisulfite.

This medicine contains 0.17 mg of alcohol (ethanol) in each dose (0.19 ml), which is equivalent to 90.00 mg/100 ml (0.09% w/v). The amount of alcohol in this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.
This medicine contains 44.87 mg of propylene glycol in each dose (0.19 ml), which corresponds to 237.53 mg/ml.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".
This medicine contains sodium metabisulfite. The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Cerdablan

This medicine should always be taken according to the doctor's or pharmacist's recommendations.
In case of doubts, the patient should consult their doctor or pharmacist.
One package of Cerdablan (100 doses) is sufficient for a full course of treatment. The treatment duration is 25 days.
Recommended dose
Cerdablan should be taken according to the following schedule:

Treatment days Recommended dosing Maximum daily dose

From day 1 to 3
1 dose every 2 hours
6 doses
From day 4 to 12
1 dose every 2.5 hours
5 doses
From day 13 to 16
1 dose every 3 hours
4 doses
From day 17 to 20
1 dose every 5 hours
3 doses
From day 21 to 25
1-2 doses per day
up to 2 doses
The patient should stop smoking no later than on the 5th day of treatment. A person who has quit smoking cannot smoke even one cigarette. This is necessary to achieve therapeutic success.
In case of treatment failure, it should be discontinued. Treatment can be started again after 2 to 3 months.

Use in children and adolescents

Cerdablan is not recommended for use in people under 18 years of age.

Use in the elderly

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

Use in patients with renal and hepatic impairment

There is no clinical experience with Cerdablan in patients with renal or hepatic impairment, so its use is not recommended in this group of patients.

Method of administration

Cerdablan is intended for oral use and can be taken with or without water/liquid.
Recommendations for unblocking the pump and using it

• Remove the protective cap from the applicator.
• Place the container so that the pump is on top of the container.
• Pump the pump by pressing the top part of the container (pump) with your index finger 5 times until a full dose appears. After initial preparation (which is only necessary when using the product for the first time), each pump activation delivers 1.5 mg of cytisinicline.
• After preparation, the patient should direct the nozzle as close as possible to the open mouth.
• Press the top part of the dispenser once and release one portion into the mouth, avoiding contact with the lips and parts of the mouth.
• After use, put the protective cap back on the applicator.

Overdose of Cerdablan

Symptoms of Cerdablan overdose are characteristic of nicotine poisoning symptoms. Overdose symptoms include: malaise, nausea, vomiting, rapid heartbeat, blood pressure fluctuations, respiratory disorders, vision disorders, seizures.
In case of any of the described symptoms or a symptom that has not been listed in this leaflet, the patient should stop taking Cerdablan and contact their doctor or pharmacist.

Missed dose of Cerdablan

A double dose should not be taken to make up for a missed dose.
In case of further questions about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Cerdablan can cause side effects, although not everybody gets them.

Very common - may affect more than 1 in 10 people:

• appetite change (mainly increased),
• weight gain,
• headache,
• irritability,
• sleep disorders (insomnia, drowsiness, lethargy, unusual dreams, nightmares),
• mood changes,
• anxiety,
• rapid heartbeat,
• high blood pressure (hypertension),
• dry mouth,
• abdominal pain (especially in the upper abdomen),
• nausea,
• rash,
• muscle pain.

Common - may affect up to 1 in 10 people:

• dizziness,
• concentration difficulties,
• slow heartbeat,
• vomiting,
• taste changes,
• constipation,
• diarrhea,
• bloating,
• tongue burning,
• heartburn,
• fatigue,
• malaise.

Uncommon - may affect up to 1 in 100 people:

• feeling of heaviness in the head,
• decreased libido,
• tearfulness,
• shortness of breath,
• increased coughing,
• excessive salivation,
• increased sweating,
• decreased skin elasticity,
• fatigue,
• increased liver enzyme activity.

Most of the above side effects occur mainly in the initial treatment period and subside with its duration. These symptoms may also be a result of quitting smoking (withdrawal symptoms) rather than taking Cerdablan.
Reporting side effects
If any side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C,
02-222 Warsaw,
phone: +48 22 49 21 301,
fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Cerdablan

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine. Do not store in the refrigerator or freeze.
Shelf life after first opening: 6 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Cerdablan contains

• The active substance of Cerdablan is cytisinicline (previously used name: cytisine). One dose (pump activation) contains 1.5 mg of cytisinicline.
• Other ingredients are: xylitol (E 967), sodium dihydrogen phosphate dihydrate, glycerol, propylene glycol, sodium metabisulfite (E 223), liquid peppermint flavor (containing: anhydrous ethanol, propylene glycol (E 1520), purified water, flavoring substances, natural flavoring substances), purified water.

What Cerdablan looks like and contents of the pack

Cerdablan is a colorless to yellowish, clear liquid with a minty taste.
A white HDPE multidose container with a dosing pump and a protective cap. The contents of the solution in the multidose container are 22.0 ml, which corresponds to at least 100 doses. The container is placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Phone: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice
Curtis Health Caps S.A.
Wysogotowo, Batorowska 52
62-081 Przeźmierowo

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

Germany:
Recigar
Poland:
Cerdablan
Sweden:
Minreksav
Spain:
Minreksav

Date of last revision of the leaflet: