Cytisinicline adamed

Patient Information Leaflet

Cytisinicline Adamed 1.5 mg, coated tablets
Cytisiniclinum
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask 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 side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Cytisinicline Adamed is and what it is used for

Cytisinicline Adamed contains the active substance cytisinicline.
This medicine is used to help adult smokers stop smoking and reduce nicotine cravings in those who wish to quit.
The aim of treatment with Cytisinicline Adamed is to achieve long-term abstinence from nicotine-containing products.
Treatment with Cytisinicline Adamed helps gradually reduce nicotine dependence without experiencing nicotine withdrawal symptoms (e.g. low mood, irritability, anxiety, difficulty concentrating, insomnia, increased appetite).

2. Important information before using Cytisinicline Adamed

When not to use Cytisinicline Adamed:

• 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,
• following a recent myocardial infarction,
• if the patient has clinically significant cardiac arrhythmias,
• following a recent stroke,
• during pregnancy and breastfeeding.

Warnings and precautions
Cytisinicline Adamed should be used with caution in patients with:

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

Cytisinicline Adamed should only be taken by individuals who are seriously committed to quitting smoking. Continuing to smoke while taking Cytisinicline Adamed or using nicotine-containing products may increase the risk of nicotine-related adverse effects.
Women of childbearing age must use an effective method of contraception. See also section "Pregnancy and breastfeeding".
Children and adolescents
Due to limited experience, Cytisinicline Adamed is not recommended for use in individuals under 18 years of age.
Elderly patients
Due to limited clinical experience, Cytisinicline Adamed is not recommended for use in elderly patients over 65 years of age.
Use in patients with hepatic or renal impairment
There is no clinical experience with Cytisinicline Adamed in patients with hepatic or renal impairment; therefore, its use is not recommended in these patient groups.
Cytisinicline Adamed 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 Cytisinicline Adamed together with antituberculosis medications.
In some cases, cessation of smoking, with or without using Cytisinicline Adamed, may require dose adjustments of other medicines. This is particularly important for medicines containing theophylline (used in asthma), tacrine (used in Alzheimer's disease), clozapine (used in schizophrenia), and ropinirole (used in Parkinson's disease).
If you have any doubts, consult your doctor or pharmacist.
It is currently unknown whether Cytisinicline Adamed 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, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Contraception in women
Women of childbearing age must use an effective method of contraception.
It is currently unknown whether Cytisinicline Adamed 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.
Pregnancy and breastfeeding
Cytisinicline Adamed is contraindicated during pregnancy and breastfeeding.
Driving and operating machinery
Cytisinicline Adamed has no influence on the ability to drive or operate machinery.
Smoking cessation
Changes in the body associated with smoking cessation, whether using Cytisinicline Adamed or not, may alter the effects of other medicines. Therefore, in some cases, dose adjustments of other medicines may be necessary. More information can be found above in the section "Cytisinicline Adamed and other medicines".
In some individuals, smoking cessation, 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 attempts), and may exacerbate psychiatric disorders. Patients with current or past psychiatric disorders should discuss this with their doctor.
Cytisinicline Adamed contains aspartame
This medicine contains 0.12 mg of aspartame per coated tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

3. How to take Cytisinicline Adamed

Always take this medicine exactly as prescribed by your doctor.
If in doubt, consult your doctor or pharmacist.
One package of Cytisinicline Adamed (100 tablets) is sufficient for a full course of treatment. The treatment duration is 25 days. Cytisinicline Adamed is intended for oral use and should be taken with sufficient water according to the following schedule:

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

The blister pack is marked with consecutive days of Cytisinicline Adamed administration.
Smoking should be discontinued no later than on day 5 of treatment. Smoking must not be continued during treatment, as this may worsen adverse effects. If the treatment outcome is unsatisfactory, treatment should be discontinued and may be restarted after 2 to 3 months.
Use in children and adolescents
Cytisinicline Adamed is not recommended for use in patients under 18 years of age.
Taking more Cytisinicline Adamed than recommended
Symptoms of overdose are characteristic of nicotine poisoning. Symptoms include malaise, nausea, vomiting, tachycardia, blood pressure fluctuations, respiratory disturbances, visual disturbances, and seizures.
If any of the described symptoms occur, or any symptom not listed in this leaflet, discontinue taking Cytisinicline Adamed and contact your doctor immediately.
If you miss a dose of Cytisinicline Adamed
Do not take a double dose to make up for a missed dose.
For any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur with the frequency stated below:
Very common – may affect more than 1 in 10 people:
change in appetite (mainly increased),
weight gain,
dizziness,
irritability,
mood changes,
anxiety,
increased blood pressure (hypertension),
dry mouth,
diarrhoea,
rash,
fatigue,
sleep disturbances (insomnia, drowsiness, somnolence, unusual dreams, nightmares),
headache,
rapid heartbeat,
nausea,
taste disturbances,
heartburn,
constipation,
vomiting,
abdominal pain (especially in the upper abdomen),
muscle pain.
Common – may affect up to 1 in 100 people:
difficulty concentrating,
slowed heartbeat,
flatulence,
burning sensation of the tongue,
malaise.
Uncommon – may affect up to 1 in 1,000 people:
feeling of heaviness in the head,
decreased libido,
watery eyes,
shortness of breath,
increased coughing,
excessive salivation,
increased sweating,
decreased skin elasticity,
tiredness,
increased liver enzyme activity.
Most of the adverse effects listed above occur mainly during the initial phase of treatment and diminish as treatment continues. These symptoms may also result from smoking cessation (withdrawal symptoms), rather than from taking Cytisinicline Adamed.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: +48 22 49 21 301,
fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.
Adverse effects may also be reported to the marketing authorization holder.

5. How to store Cytisinicline Adamed

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect from light. There are no special requirements
regarding the storage temperature of the medicine.
Do not use this medicine after the expiry date stated on the blister and carton after EXP.
The expiry date refers to the last day of that month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect
the environment.

6. Contents of the packaging and other information

What Cytisinicline Adamed contains

• The active substance is cytisinicline (previously used name: cytisine). One coated tablet contains 1.5 mg of cytisinicline.
• Other ingredients are:
  Tablet core: hypromellose, mannitol, corn starch, magnesium aluminium metasilicate type A, colloidal anhydrous silica, magnesium stearate.
  Coating:
  hypromellose (E 464),
  microcrystalline cellulose (E 460),
  talc (E 553b),
  glycerol (E 422),
  titanium dioxide (E 171),
  quinoline yellow, lake (E 104),
  indigo carmine, lake (E 132),
  mint flavour powder,
  aspartame.
  See section “Cytisinicline Adamed contains aspartam”.

What Cytisinicline Adamed looks like and contents of the pack
Cytisinicline Adamed is a round, biconvex coated tablet, light green to slightly greenish in colour, with a diameter of 5 mm.
Cytisinicline Adamed is available in blisters containing a total of 100 coated tablets.

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
Poland

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Cytisiniclin Adamed
Poland: Cytisinicline Adamed
Sweden: Belnifrem
Italy: Citisiniclina Adamed
Ireland: Cytisinicline Adamed Pharma 1.5 mg film-coated tablets
Spain: Belnifrem 1,5 mg comprimidos recubiertos con película EFG