Package leaflet: information for the patient

TUXERDIV 1.5 mg, coated tablets
Cytisiniclinum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, 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

What TUXERDIV is and what it is used for
Important information before taking TUXERDIV
How to take TUXERDIV
Possible side effects
How to store TUXERDIV
Contents of the pack and other information

1. What TUXERDIV is and what it is used for

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

2. Important information before using TUXERDIV

When not to use TUXERDIV:

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
TUXERDIV should be used with caution in patients with:

ischaemic heart disease,
heart failure,
arterial hypertension,
phaeochromocytoma (adrenal gland tumour),
atherosclerosis (hardening of arteries) and other peripheral vascular diseases,
gastric or duodenal ulcer,
gastro-oesophageal reflux disease,
hyperthyroidism,
diabetes,
schizophrenia,
renal or hepatic impairment.

TUXERDIV should only be taken by individuals who are seriously committed to quitting smoking. Taking TUXERDIV while continuing to smoke or using nicotine-containing products may increase the risk of adverse effects of nicotine. Women of childbearing potential must use an effective method of contraception. See also section "Pregnancy and breastfeeding".
Children and adolescents
Due to limited experience, TUXERDIV is not recommended for use in individuals under 18 years of age.
Elderly patients
Due to limited clinical experience, TUXERDIV 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 TUXERDIV in patients with hepatic or renal impairment; therefore, its use is not recommended in this patient group.
TUXERDIV and other medicines
Inform your doctor or pharmacist about any other medicines the patient is currently taking, has recently taken, or plans to take.
Do not take TUXERDIV together with antituberculosis medicines.
In some cases, cessation of smoking, with or without using TUXERDIV, 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 in doubt, consult your doctor or pharmacist.
It is currently unknown whether TUXERDIV 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 become pregnant, she should consult her 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 TUXERDIV 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
TUXERDIV is contraindicated during pregnancy and breastfeeding.
Driving and using machines
TUXERDIV has no effect on the ability to drive or operate machinery.
Smoking cessation
Changes in the body associated with smoking cessation, with or without using TUXERDIV, may alter the way other medicines work. Therefore, in some cases, dose adjustments of other medicines may be necessary. More information can be found above in the section "TUXERDIV 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, depression and anxiety (including, rarely, suicidal thoughts and suicide attempts), and may be associated with worsening of psychiatric disorders. Patients with current or past psychiatric disorders should discuss this with their doctor.
TUXERDIV 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 improper excretion.

3. How to take TUXERDIV
Always take this medicine exactly as prescribed by your doctor.
If in doubt, consult your doctor or pharmacist.
One pack of TUXERDIV (100 coated tablets) is sufficient for a full course of treatment. The duration of treatment is 25 days. TUXERDIV is intended for oral use and should be taken with sufficient water according to the following dosing 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 is marked with consecutive days of TUXERDIV use.
Smoking should be discontinued no later than on day 5 of treatment. Smoking must not be continued during treatment, as it may worsen adverse effects. If the treatment outcome is unsatisfactory, treatment should be discontinued and restarted after 2 to 3 months.
Use in children and adolescents
TUXERDIV is not recommended for use in patients under 18 years of age.
Overdose of TUXERDIV
Symptoms of TUXERDIV overdose are characteristic of nicotine poisoning. Symptoms include malaise, nausea, vomiting, tachycardia, blood pressure fluctuations, respiratory disturbances, visual disturbances, and seizures.
If even one of the described symptoms, or any symptom not listed in this leaflet, occurs, discontinue TUXERDIV and contact your doctor immediately.
Missed dose of TUXERDIV
Do not take 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side 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,
high blood pressure (hypertension),
dry mouth,
diarrhoea,
rash,
fatigue,
sleep disorders (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 sputum production,
excessive salivation,
increased sweating,
reduced skin elasticity,
tiredness,
increased liver enzyme activity.
Most of the side effects listed above occur mainly during the initial period of treatment and subside as treatment continues. These symptoms may also result from stopping smoking (withdrawal symptoms), rather than from taking TUXERDIV.
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
By reporting side effects, additional information on the safety of this medicine can be collected.
Side effects may also be reported to the marketing authorisation holder.

5. How to store TUXERDIV

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect from light. There are no special requirements
regarding the storage temperature of this medicine.
Do not use this medicine after the expiry date stated on the blister and carton following 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 the medicine contains TUXERDIV

The active substance is cytisine hydrochloride (former name: cytisine). One coated tablet contains 1.5 mg of cytisine hydrochloride.
Other components are:
Tablet core:
hypromellose,
mannitol,
corn starch,
magnesium aluminum metasilicate, type A,
anhydrous colloidal silicon dioxide,
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 flavour powder,
aspartame.
See section “TUXERDIV contains aspartam”.

What TUXERDIV looks like and contents of the pack
TUXERDIV is a round, biconvex coated tablet, light green to greenish in colour, with a diameter of 5 mm.
TUXERDIV is available in blister packs 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
+48 22 732 77 00

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

This medicine is authorised in the European Economic Area countries under the following names:
Poland: TUXERDIV
Spain: Recigarum 1.5 mg film-coated tablets EFG