Citisinicline Apc Pharmlog

Package Leaflet: Information for the Patient

Cytisinicline APC Pharmlog 1.5 mg, coated tablets

Cytisiniclinum

Read the package 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Cytisinicline APC Pharmlog contains the active substance cytisinicline.
This medicine is used to help adults stop smoking and reduce nicotine cravings.
The goal of using Cytisinicline APC Pharmlog is to permanently stop using nicotine-containing products.
Taking Cytisinicline APC Pharmlog 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 APC Pharmlog

When not to take Cytisinicline APC Pharmlog:

• 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 heart attack,
• if you have clinically significant heart rhythm disorders,
• if you have recently had a stroke,
• during pregnancy and breastfeeding.

Warnings and precautions

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

Children and adolescents

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

Elderly

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

Use in patients with liver and kidney impairment

There is no clinical experience with Cytisinicline APC Pharmlog in patients with liver and kidney impairment, therefore its use is not recommended in this group of patients.

Cytisinicline APC Pharmlog and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Do not take Cytisinicline APC Pharmlog with anti-tuberculosis medicines.
In some cases, quitting smoking, with or without Cytisinicline APC Pharmlog, 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 APC Pharmlog 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 baby, 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 APC Pharmlog 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 APC Pharmlog is contraindicated during pregnancy and breastfeeding.

Driving and using machines

Cytisinicline APC Pharmlog 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 APC Pharmlog, 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 APC Pharmlog 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 APC Pharmlog 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 excretion.

3. How to take Cytisinicline APC Pharmlog

Always take this medicine exactly as your doctor has told you.
If you are not sure, ask your doctor or pharmacist.
One pack of Cytisinicline APC Pharmlog (100 tablets) is enough for a full course of treatment. The treatment lasts for 25 days. Cytisinicline APC Pharmlog is intended for oral use, swallow the tablet with a sufficient amount of water according to the scheme below.

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 APC Pharmlog.
You should stop smoking no later than on the 5th day of treatment. During treatment, do not continue smoking, as this may increase 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 APC Pharmlog is not recommended for use in patients under 18 years of age.

Taking too much Cytisinicline APC Pharmlog

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

Missing a dose of Cytisinicline APC Pharmlog

Do not take a double dose to make up for a forgotten dose.
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.
The following side effects may occur with the frequency shown below:

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

appetite change (mainly increased),
weight gain,
dizziness,
irritability,
mood changes,
anxiety,
high blood pressure (hypertension),
dry mouth,
diarrhoea,
rash,
fatigue,
sleep disorders (insomnia, drowsiness, lethargy, unusual dreams, nightmares),
headache,
rapid heart rate,
nausea,
taste changes,
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 head heaviness,
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 period of treatment and disappear with its continuation. These symptoms may also be the result of quitting smoking (withdrawal symptoms), and not the result of taking Cytisinicline APC Pharmlog.

Reporting side effects

If you experience any side effects, including those 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:
Aleje Jerozolimskie 181C,
02-222 Warsaw,
tel.: + 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 APC Pharmlog

Keep this medicine out of the sight and reach of children.
Store in the original package to protect from light. There are no special storage temperature recommendations 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 APC Pharmlog 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, colloidal anhydrous silica,

and 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),
peppermint powder,
aspartame.
See the section "Cytisinicline APC Pharmlog contains aspartame".

What Cytisinicline APC Pharmlog looks like and contents of the pack

Cytisinicline APC Pharmlog is a round, biconvex, coated tablet, light green to greenish, 5 mm in diameter.
Cytisinicline APC Pharmlog is available in blisters containing 100 coated tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

APC Pharmlog Sp. z o.o.
Aleje Jerozolimskie 146 C
02-305 Warsaw
Poland
+48 22 668 68 23

Manufacturer

Adamed Pharma S.A.
ul. 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:

Germany:
Cytisiniclin APC Pharmlog
Poland, Sweden:
Cytisinicline APC Pharmlog
Italy:
Citisiniclina APC Pharmlog
Ireland:
Cytisinicline APC Pharmlog 1.5 mg film-coated tablets
Spain:
Cytisinicline APC Pharmlog comprimidos recubiertos con película, 1,5 mg

Date of last revision of the leaflet: