CERDABLAN

Package leaflet: Information for the patient

Cerdablan, 1.5 mg/dose, oral solution
Cytisiniclinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Cerdablan is and what it is used for
2. Important information before taking Cerdablan
3. How to take Cerdablan
4. Possible side effects
5. How to store Cerdablan
6. Contents of the pack and other information

1. What Cerdablan is and what it is used for

Cerdablan contains the active substance cytisinicline, also known as cytisine.
This medicine is used to stop smoking and reduce nicotine craving in adult smokers
who wish to quit. The aim of using Cerdablan is to achieve permanent cessation
of nicotine-containing products.
Cerdablan helps achieve a gradual reduction in nicotine dependence by alleviating withdrawal symptoms (e.g. low mood, irritability, anxiety, difficulty concentrating, insomnia, increased appetite).

2. Important information before using Cerdablan

When not to use Cerdablan:

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

Warnings and precautions
Before starting treatment with Cerdablan, consult your doctor or pharmacist if you have:

• ischaemic heart disease,
• heart failure,
• arterial hypertension,
• phaeochromocytoma (adrenal gland tumour),
• atherosclerosis (hardening of the arteries) and other peripheral vascular diseases,
• peptic ulcer disease of the stomach or duodenum,
• gastroesophageal reflux disease,
• hyperthyroidism,
• diabetes,
• schizophrenia,
• renal or hepatic impairment.

Cerdablan should only be used by individuals who are seriously committed to quitting nicotine. Taking Cerdablan while continuing to smoke or using nicotine-containing products may increase the risk of adverse effects associated with nicotine.

Children and adolescents
Due to limited experience, the use of Cerdablan is not recommended in individuals under 18 years of age.

Elderly patients
Due to limited clinical experience, the use of Cerdablan is not recommended in elderly patients over 65 years of age.

Use in patients with renal or hepatic impairment
There is no clinical experience with the use of Cerdablan in patients with impaired renal or liver function; therefore, its use is not recommended in these patient groups.

Cerdablan and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not take Cerdablan together with antituberculosis medicines.
In some cases, after stopping smoking, with or without using Cerdablan, dosage adjustments of other medicines may be necessary. This is particularly important for medicines containing theophylline (used in asthma treatment), tacrine (used in Alzheimer's disease), clozapine (used in schizophrenia), and ropinirole (used in Parkinson's disease).
If in doubt, consult your 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 you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Contraception in women
Women of childbearing potential must use an effective method of 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).
Please consult your doctor for advice.

Pregnancy and breastfeeding
Cerdablan must not be used during pregnancy and breastfeeding.

Driving and operating machinery
Cerdablan has no effect or negligible effect on the ability to drive and operate machinery.

Stopping smoking
Changes in the body associated with stopping smoking, whether using Cerdablan or not, may alter the way other medicines work. Therefore, in some cases, dosage adjustments of other medicines may be necessary. More information can be found above under "Cerdablan and other medicines".

In some individuals, stopping smoking—whether with or without medication—has been associated with an increased risk of changes in thinking or behaviour, feelings of depression and anxiety (including, rarely, suicidal thoughts and suicide attempts), and may be associated with worsening of psychiatric disorders. If you have current or past psychiatric disorders, discuss this with your doctor.

Cerdablan contains ethanol, propylene glycol, sodium, and sodium metabisulphite.
This medicine contains 0.17 mg of alcohol (ethanol) per dose unit (0.19 ml), equivalent to 90.00 mg/100 ml (0.09% w/v). The amount of alcohol in a dose of this medicine is less than that in 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 per dose unit (0.19 ml), corresponding to 237.53 mg/ml.

The medicine contains less than 1 mmol (23 mg) of sodium per dose unit, meaning the medicine is considered "sodium-free".

This medicine contains sodium metabisulphite. It may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Cerdablan

This medicine should always be used according to the recommendations of your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
One package of Cerdablan (100 doses) is sufficient for a complete course of treatment. The duration of treatment is 25 days.

Recommended dosage
Cerdablan should be taken according to the following schedule:

| Days of therapy | Recommended dosing | Maximum daily dose | |-----------------|--------------------|----------------------| | Days 1 to 3 | 1 dose every 2 hours | 6 doses | | Days 4 to 12 | 1 dose every 2.5 hours | 5 doses | | Days 13 to 16 | 1 dose every 3 hours | 4 doses | | Days 17 to 20 | 1 dose every 5 hours | 3 doses | | Days 21 to 25 | 1–2 doses per day | up to 2 doses |

Smoking must be discontinued no later than on day 5 of treatment. A person who has stopped smoking must not smoke even a single cigarette. This is essential for achieving therapeutic success.
If treatment fails, it should be discontinued. Treatment may be restarted after 2 to 3 months have passed.

Use in children and adolescents
Cerdablan is not recommended for use in individuals under 18 years of age.

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

Use in patients with renal or hepatic impairment
There is no clinical experience with Cerdablan in patients with impaired kidney or liver function; therefore, its use is not recommended in these patient groups.

Method of administration
Cerdablan is intended for oral use and may be taken with water/fluid or without water/fluid.

Instructions for unlocking the pump and use

• Remove the protective cap from the applicator.
• Position the container so that the pump is on top of the bottle.
• Prime the pump by pressing the top part of the container (pump) with your index finger 5 times until a full dose is delivered. After initial priming (required only the first time the product is used), each activation of the pump delivers 1.5 mg of cytisine.
• After priming, the patient should place the nozzle as close as possible to the open mouth.
• Press the top part of the dispenser once to release one dose into the mouth, avoiding contact with the lips and oral cavity surfaces.
• After use, replace the protective cap on the applicator.

Use of a higher than recommended dose of Cerdablan
Symptoms of overdose with Cerdablan are characteristic of nicotine poisoning. Symptoms of overdose include: malaise, nausea, vomiting, increased heart rate, blood pressure fluctuations, breathing difficulties, visual disturbances, and seizures.
If any of the described symptoms occur, or any symptom not listed in this leaflet, discontinue use of Cerdablan immediately and contact your doctor or pharmacist.

Missed dose of Cerdablan
Do not use a double dose to make up for a missed dose.
If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Very common – may occur in more than 1 in 10 people:

• change in appetite (mainly increased),
• weight gain,
• headache,
• irritability,
• sleep disturbances (insomnia, drowsiness, somnolence, unusual dreams, nightmares),
• mood changes,
• anxiety,
• increased heart rate,
• elevated blood pressure (hypertension),
• dry mouth,
• abdominal pain (especially in the epigastric region),
• nausea,
• rash,
• muscle pain.

Common – may occur in up to 1 in 10 people:

• dizziness,
• difficulty concentrating,
• slowed heart rate,
• vomiting,
• taste disturbances,
• constipation,
• diarrhoea,
• bloating,
• burning sensation of the tongue,
• heartburn,
• fatigue,
• malaise.

Uncommon – may occur in up to 1 in 100 people:

• feeling of heaviness in the head,
• decreased libido,
• tearing,
• shortness of breath,
• increased sputum production,
• excessive salivation,
• increased sweating,
• reduced skin elasticity,
• fatigue,
• increased liver enzyme activity.

Most of the adverse reactions listed above occur mainly during the initial period of treatment and diminish as treatment continues. These symptoms may also result from smoking cessation (withdrawal symptoms), rather than from taking Cerdablan.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C,
02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.

By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Cerdablan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required. Do not store in the refrigerator or freeze.
Shelf-life after first opening: 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What the medicine contains

• The active substance is cytisine hydrochloride (former name: cytisine). One dose (one pump actuation) contains 1.5 mg of cytisine hydrochloride.
• The other ingredients are: xylitol (E 967), disodium dihydrogen phosphate dihydrate, glycerol, propylene glycol, sodium pyrosulfite (E 223), peppermint flavouring liquid (containing: anhydrous ethanol, propylene glycol (E 1520), purified water, flavouring substances, natural flavouring substances), purified water.

What Cerdablan looks like and contents of the pack
Cerdablan is a colourless to yellow, clear liquid with a mint flavour.
White HDPE multi-dose container with a metering pump and nozzle. The solution volume in the multi-dose container is 22.0 ml, corresponding to at least 100 doses. The container is placed in a cardboard carton.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel.: +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 authorised for sale in the European Economic Area countries under the following names:
Germany: Recigar
Poland: Cerdablan
Sweden: Recigar
Spain: Recigarum, 1.5 mg/dosis solución oral