Recigar

Package leaflet: Information for the user

Recigar, 1.5 mg, coated tablets
Cytisinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If symptoms do not improve or if the patient feels worse, contact the doctor.

Contents of the leaflet

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

1. What Recigar is and what it is used for

Recigar contains the active substance cytisine.
Recigar is used in the treatment of nicotine dependence. Treatment with Recigar helps gradually reduce dependence on nicotine and enables smoking cessation without experiencing nicotine withdrawal symptoms (e.g. low mood, irritability, anxiety, difficulty concentrating, insomnia, increased appetite). The ultimate goal of using Recigar is permanent abstinence from nicotine-containing products.

2. Important information before using Recigar

When not to use Recigar:

• 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 to take Recigar, discuss with your doctor or pharmacist if:

• the patient has ischaemic heart disease, heart failure, hypertension, phaeochromocytoma, atherosclerosis and other peripheral vascular diseases,

peptic ulcer disease of the stomach and duodenum, gastroesophageal reflux disease, hyperthyroidism,
diabetes, schizophrenia, renal or hepatic impairment;

• if the patient is aged 65 years or older.

Recigar should only be used by individuals with a serious intention to quit nicotine dependence.
Taking this medicine while continuing to smoke or use nicotine-containing products
may lead to an increase in adverse effects of nicotine.
Children and adolescents
Due to limited experience, use of Recigar is not recommended in children and adolescents under 18 years of age.
Recigar and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not take Recigar together with antituberculosis medicines.
In some cases, after stopping smoking or using other nicotine-containing products, with or without using Recigar, it may be necessary to adjust the doses of other medicines. This is particularly important if the patient is taking medicines containing theophylline (used in asthma), tacrine (used in Alzheimer's disease), clozapine (used in schizophrenia), or ropinirole (used in Parkinson's disease). If in doubt, consult your doctor or pharmacist.
It is currently unknown whether Recigar may reduce the effectiveness of systemic hormonal contraceptives. Women using systemic hormonal contraceptives should use an additional barrier method (e.g.
condom).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Women of childbearing potential must use an effective method of contraception during treatment with Recigar. Please seek advice from a doctor.
Recigar is contraindicated during pregnancy and breastfeeding.
Driving and operating machinery
Recigar has no effect or negligible effect on the ability to drive and operate machinery.
Stopping smoking
Changes in the body associated with stopping smoking or using other nicotine-containing products, whether using Recigar or not, may alter the way other medicines work. Therefore, in some cases, adjustment of the doses of other medicines may be necessary. More detailed information is provided above in the section "Recigar and other medicines".
In some individuals, stopping smoking or using other nicotine-containing products, whether using medicines or not, 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 pre-existing psychiatric disorders. If the patient has or has had psychiatric disorders in the past, they should discuss this with their doctor.
Aspartame
The medicine contains 0.12 mg of aspartame in each Recigar 1.5 mg coated tablet.
Aspartame (E951) 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 use Recigar

This medicine should always be taken exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
One package of Recigar (100 tablets) is sufficient for a full course of treatment. The duration of treatment is 25 days.
Recommended dosage
Recigar tablets should be taken orally with an adequate amount of water according to the following schedule:
Therapy days Dosage Maximum daily dose
Days 1 to 3 1 tablet every 2 hours 6 tablets
Days 4 to 12 1 tablet every 2.5 hours 5 tablets
Days 13 to 16 1 tablet every 3 hours 4 tablets
Days 17 to 20 1 tablet every 5 hours 3 tablets
Days 21 to 25 1-2 tablets per day up to 2 tablets
The blister pack is marked with the consecutive days of taking Recigar.
Smokers should completely stop smoking no later than the 5th day of treatment.
A person who has stopped smoking must under no circumstances allow themselves to smoke even a single cigarette. This is crucial for the long-term success of treatment. If the treatment outcome is unsatisfactory, treatment should be discontinued and restarted after 2 to 3 months.
Use of a higher than recommended dose of Recigar
Symptoms following an overdose of Recigar 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 even one of the described symptoms occurs, or any symptom not listed in this leaflet appears, stop taking Recigar immediately and contact your doctor or pharmacist.
Missed dose of Recigar
Do not take a double dose to make up for a missed dose.
Discontinuation of Recigar
If you have any further doubts regarding 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 everybody will experience them.
Very common (affects more than 1 in 10 people): change in appetite (mainly increased), weight gain, headache, irritability, sleep disorders (insomnia, drowsiness, somnolence, strange dreams, nightmares), mood changes, anxiety, increased heart rate, dry mouth, abdominal pain (mainly in the epigastric region), nausea, muscle pain.
Common (affects up to 1 in 10 people): dizziness, difficulty concentrating, slowed heart rate, increased blood pressure, vomiting, taste disturbances, constipation, diarrhoea, bloating, burning sensation of the tongue, heartburn, rash, fatigue, malaise.
Uncommon (affects up to 1 in 100 people): feeling of heaviness in the head, decreased libido, lacrimation, shortness of breath, increased expectoration, excessive salivation, increased sweating, reduced skin elasticity, fatigue, increased aminotransferase activity (liver enzymes).
The above adverse reactions occur mainly during the initial period of treatment and diminish as treatment continues. They may also result from stopping smoking or using nicotine-containing products (withdrawal symptoms), rather than from taking Recigar.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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.: 22 49-21-301,
fax: 22 4921-309,
website: https://smz.ezdrowie.gov.pl .
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Recigar

No special temperature storage requirements for this medicine.
Store in the original packaging to protect from light.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated 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 help protect the environment.

6. Contents of the packaging and other information

What Recigar contains

• The active substance is cytisine. Each tablet contains 1.5 mg of cytisine.
• Other ingredients are:
  Tablet core: hypromellose, mannitol, maize starch, magnesium aluminometasilicate type A, colloidal anhydrous silica, magnesium stearate.
  Coating composition: AquaPolish P green Project 16712 [hypromellose (E464), microcrystalline cellulose (E460), talc (E553b), glycerol, titanium dioxide (E171), quinoline yellow lake (E104), indigo carmine lake (blue 2) (E132)], menthol flavour powder (SC552873), aspartame (E951).

What Recigar looks like and contents of the pack
Film-coated tablets, round, biconvex, light green or greenish in colour.
The cardboard box contains 100 film-coated tablets in PVC/PVDC/Aluminium blisters or in
PVC/PE/PVDC/Aluminium blisters.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel. 22 732 77 00
Manufacturer
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice