Recigar

Package Leaflet: Information for the User

Recigar, 1.5 mg, Coated Tablets

Cytisine

Read the Package Leaflet Carefully Before Taking the Medicinal Product

This medicinal product must be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including any not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

• 1. What is Recigar and What is it 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 Package and Other Information

1. What is Recigar and What is it Used For

Recigar contains the active substance cytisine. Recigar is used for the treatment of nicotine dependence. Taking Recigar allows for gradual reduction of nicotine dependence and weaning from smoking without nicotine withdrawal symptoms (e.g., low mood, irritability, anxiety, difficulty concentrating, insomnia, increased appetite). The ultimate goal of taking Recigar is permanent cessation of using nicotine-containing products.

2. Important Information Before Taking Recigar

When Not to Take Recigar:

• in case of unstable angina pectoris,
• if you have recently had a myocardial infarction,
• in case of clinically significant arrhythmias,
• if you have recently had a stroke,
• during pregnancy and breastfeeding.

Warnings and Precautions:

Before taking Recigar, you should discuss it with your doctor or pharmacist if:

• you have coronary heart disease, heart failure, high blood pressure, pheochromocytoma, atherosclerosis, and other peripheral vascular diseases,

you have gastric or duodenal ulcer disease, gastroesophageal reflux disease, hyperthyroidism, diabetes, schizophrenia, kidney or liver failure;

Recigar should only be taken by people with a serious intention to quit smoking. Taking the medicinal product and continuing to smoke or use nicotine-containing products may lead to increased nicotine side effects.

Children and Adolescents

Due to limited experience, it is not recommended to use Recigar in children and adolescents under 18 years of age.

Recigar and Other Medicinal Products

Tell your doctor or pharmacist about all medicinal products you are taking or have recently taken, and about any medicinal products you plan to take. Do not take Recigar with anti-tuberculosis medicinal products. In some cases, quitting smoking or using other nicotine-containing products, with or without Recigar, may require adjusting the doses of other medicinal products. This is especially important if you are taking medicinal products 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 Recigar can 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, ask your doctor or pharmacist for advice before taking this medicinal product. Women of childbearing age must use effective contraception during treatment with Recigar. Ask your doctor for advice. Recigar is contraindicated during pregnancy and breastfeeding.

Driving and Using Machines

Recigar has no or negligible influence on the ability to drive and use machines.

Quitting Smoking

Changes in the body associated with quitting smoking or using other nicotine-containing products, due to taking Recigar or not, may change the way other medicinal products work. Therefore, in some cases, it may be necessary to adjust the doses of other medicinal products. More detailed information can be found above in the section "Recigar and Other Medicinal Products". In some people, quitting smoking or using other nicotine-containing products, with or without medicinal products, has been associated with an increased risk of changes in thinking or behavior, depression, and anxiety (including rare suicidal thoughts and attempts) and may be associated with worsening of existing psychiatric disorders. If you have or have had psychiatric disorders, you should discuss this with your doctor.

Aspartame

The medicinal product 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 its improper elimination.

3. How to Take Recigar

This medicinal product should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist. One package of Recigar (100 tablets) is sufficient for a full course of treatment. The treatment duration is 25 days. Recommended dose Recigar should be taken orally with a sufficient amount of water according to the following schedule. Treatment days 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 pack is marked with the consecutive days of taking Recigar. A smoker should completely quit smoking no later than the 5th day after starting treatment. A person who has quit smoking should never light a cigarette again. This depends on the durability of the treatment result. If the treatment result is unsatisfactory, the treatment should be discontinued and restarted after 2 to 3 months.

Overdose of Recigar

Symptoms that occur after an overdose of Recigar are characteristic of nicotine poisoning symptoms. Overdose symptoms are: malaise, nausea, vomiting, accelerated heart rate, blood pressure fluctuations, respiratory disorders, vision disorders, convulsions. If any of these symptoms occur or if a symptom not listed in this package leaflet occurs, you should stop taking Recigar and contact your doctor or pharmacist.

Missed Dose of Recigar

Do not take a double dose to make up for a missed dose.

Stopping Recigar Treatment

If you have any further doubts about taking this medicinal product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicinal products, Recigar can cause side effects, although not everybody gets them. Very common (affects more than 1 in 10 people): change in appetite (mainly increased), weight gain, headache, irritability, sleep disorders (insomnia, drowsiness, lethargy, strange dreams, nightmares), mood changes, anxiety, accelerated heart rate, dry mouth, abdominal pain (mainly in the upper abdomen), nausea, muscle pain. Common (affects no more than 1 in 10 people): dizziness, difficulty concentrating, slowed heart rate, increased blood pressure, vomiting, taste changes, constipation, diarrhea, bloating, burning sensation of the tongue, heartburn, rash, fatigue, malaise. Uncommon (affects no more than 1 in 100 people): feeling of heaviness in the head, decreased libido, tearing, shortness of breath, increased coughing, excessive salivation, increased sweating, decreased skin elasticity, fatigue, increased activity of liver enzymes (aminotransferases). The listed side effects occur mainly in the initial treatment period and subside with its duration. They may also be a result of quitting smoking or using nicotine-containing products (withdrawal symptoms), and not taking Recigar. If you experience any side effects, including any not listed in this package leaflet, tell your doctor or pharmacist.

Reporting Side Effects

If you experience any side effects, including any not listed in this package leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to Store Recigar

There are no special recommendations for the storage temperature of the medicinal product. Store in the original package to protect from light. Keep the medicinal product out of the sight and reach of children. Do not use this medicinal product after the expiry date stated on the package. The expiry date refers to the last day of the month stated. Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Recigar Contains

• The active substance of Recigar is cytisine. Each tablet contains 1.5 mg of cytisine.
• The other ingredients are: Tablet core: hypromellose, mannitol, maize starch, magnesium aluminometasilicate, type A, colloidal anhydrous silica, magnesium stearate. Coating: 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 flavor powder (SC552873), aspartame (E951).

What Recigar Looks Like and Contents of the Package

Coated tablets are round, biconvex, light green or greenish in color. A cardboard box contains 100 coated tablets in PVC/PVDC/Aluminum or PVC/PE/PVDC/Aluminum blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

Date of Last Revision of the Package Leaflet: