Citisinicline Pro-pharma

Leaflet attached to the packaging: patient information

Cytisinicline Pro-Pharma 1.5 mg, coated tablets

Cytisiniclinum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 a specific person. Do not pass it on to others. The medicine may harm another person, 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.

Table of contents of the leaflet

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

1. What is Cytisinicline Pro-Pharma and what is it used for

Cytisinicline Pro-Pharma contains the active substance cytisinicline.
This medicine is used to help adults stop smoking and reduce nicotine cravings.
The goal of using Cytisinicline Pro-Pharma is to permanently stop using nicotine-containing products.
Taking Cytisinicline Pro-Pharma allows for gradual reduction of nicotine dependence without withdrawal symptoms (e.g. low mood, irritability, anxiety, concentration difficulties, insomnia, increased appetite).

2. Important information before taking Cytisinicline Pro-Pharma

When not to take Cytisinicline Pro-Pharma:

• if you are allergic to cytisinicline or any of the other ingredients of this medicine (listed in section 6),
• if you have unstable angina pectoris,
• if you have recently had a myocardial infarction,
• if you have clinically significant heart rhythm disorders,
• if you have recently had a stroke,
• during pregnancy and breastfeeding.

Warnings and precautions

Cytisinicline Pro-Pharma should be used with caution in:

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

Cytisinicline Pro-Pharma should only be taken by people with a strong intention to quit smoking. Taking Cytisinicline Pro-Pharma and continuing to smoke or use nicotine-containing products may increase the risk of nicotine-related side effects.
Women of childbearing age must use effective contraception. See also the section "Pregnancy and breastfeeding".

Children and adolescents

Due to limited experience, Cytisinicline Pro-Pharma is not recommended for use in people under 18 years of age.

Elderly

Due to limited clinical experience, Cytisinicline Pro-Pharma is not recommended for use in the elderly, over 65 years of age.

Use in patients with liver and kidney function disorders

There is no clinical experience with Cytisinicline Pro-Pharma in patients with liver and kidney function disorders, therefore its use is not recommended in this group of patients.

Cytisinicline Pro-Pharma and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Do not take Cytisinicline Pro-Pharma with anti-tuberculosis medicines.
In some cases, quitting smoking, with or without Cytisinicline Pro-Pharma, may require adjusting the doses of other medicines. This is especially important if you are taking medicines containing theophylline (used in asthma), 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 not known whether Cytisinicline Pro-Pharma 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 or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Contraception in women
Women of childbearing age must use effective contraception.
It is not known whether Cytisinicline Pro-Pharma may reduce the effectiveness of systemic hormonal contraceptives. Women using systemic hormonal contraceptives should use an additional barrier method (e.g. condoms).
Ask your doctor for advice.
Pregnancy and breastfeeding
Cytisinicline Pro-Pharma is contraindicated during pregnancy and breastfeeding.

Driving and using machines

Cytisinicline Pro-Pharma has no influence on the ability to drive and use machines.

Quitting smoking

Changes in the body associated with quitting smoking, with or without Cytisinicline Pro-Pharma, may change the way other medicines work. Therefore, in some cases, it may be necessary to adjust the doses of other medicines. See the section "Cytisinicline Pro-Pharma and other medicines" above.
In some people, quitting smoking, with or without medicines, has been associated with an increased risk of changes in thinking or behaviour, depression, and anxiety (including rare suicidal thoughts and attempts) and may be associated with worsening of psychiatric disorders. If you have a history of psychiatric disorders, you should discuss this with your doctor.

Cytisinicline Pro-Pharma contains aspartame

This medicine contains 0.12 mg of aspartame in each 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 its improper elimination.

3. How to take Cytisinicline Pro-Pharma

This medicine should always be taken as directed by your doctor.
If you are unsure, ask your doctor or pharmacist.
One pack of Cytisinicline Pro-Pharma (100 tablets) is sufficient for a full course of treatment. The treatment duration is 25 days. Cytisinicline Pro-Pharma is intended for oral use, to be taken with a sufficient amount of water according to the following schedule.

Days of therapy Recommended dosage Maximum daily dose

From day 1 to 3
1 tablet every 2 hours
6 tablets
From day 4 to 12
1 tablet every 2.5 hours
5 tablets
From day 13 to 16
1 tablet every 3 hours
4 tablets
From day 17 to 20
1 tablet every 5 hours
3 tablets
From day 21 to 25
1-2 tablets per day
up to 2 tablets
The blister is marked with the consecutive days of taking Cytisinicline Pro-Pharma.
You should stop smoking no later than on the 5th day of treatment. During treatment, do not continue smoking, as this may increase the risk of side effects. If the treatment result is unsatisfactory, stop the treatment and restart it after 2 to 3 months.

Use in children and adolescents

Cytisinicline Pro-Pharma is not recommended for use in patients under 18 years of age.

Overdose of Cytisinicline Pro-Pharma

Symptoms of Cytisinicline Pro-Pharma overdose are characteristic of nicotine poisoning symptoms. Overdose symptoms include malaise, nausea, vomiting, rapid heart rate, blood pressure fluctuations, respiratory disorders, vision disorders, seizures.
If you experience any of these symptoms or any symptom not listed in this leaflet, stop taking Cytisinicline Pro-Pharma and contact your doctor.

Missed dose of Cytisinicline Pro-Pharma

Do not take a double dose to make up for a missed dose.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cytisinicline Pro-Pharma can cause side effects, although not everybody gets them.
The following side effects may occur with the frequency shown 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 disorders (insomnia, drowsiness, lethargy, unusual dreams, nightmares),
headache,
rapid heart rate,
nausea,
change in taste,
heartburn,
constipation,
vomiting,
abdominal pain (especially in the upper abdomen),
muscle pain.

Common - may affect up to 1 in 10 people:

concentration difficulties,
slow heart rate,
bloating,
tongue burning sensation,
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,
reduced skin elasticity,
fatigue,
increased liver enzyme activity.
Most of the above side effects occur mainly in the initial treatment period and subside as treatment continues. These symptoms may also be due to quitting smoking (withdrawal symptoms) rather than taking Cytisinicline Pro-Pharma.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorisation holder.

5. How to store Cytisinicline Pro-Pharma

Keep the medicine out of the sight and reach of children.
Store in the original packaging to protect from light. There are no special temperature storage instructions for this 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cytisinicline Pro-Pharma contains

• The active substance is cytisinicline (previously used name: cytisine). One coated tablet contains 1.5 mg of cytisinicline.
• The other ingredients are: Tablet core: hypromellose, mannitol, maize starch, magnesium aluminometasilicate, type A, silicon dioxide, anhydrous, 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 (E132),
peppermint powder,
aspartame.
See the section "Cytisinicline Pro-Pharma contains aspartame".

What Cytisinicline Pro-Pharma looks like and contents of the pack

Cytisinicline Pro-Pharma is a round, biconvex, coated tablet, light green to greenish, with a diameter of 5 mm.
Cytisinicline Pro-Pharma is available in blisters containing 100 coated tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Pro-Pharma'93 Gyógyszeripari Kft.
Furedi Utca 34 1 Em 4
1144 Budapest
Hungary
+48 22 668 68 23

Manufacturer

Adamed Pharma S.A.
Marszałka J. Piłsudskiego 5
95-200 Pabianice
Poland

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

Poland:
Cytisinicline Pro-Pharma
Spain:
Recigarum 1.5 mg coated tablets EFG
Date of last revision of the leaflet:July 2023