Recigar

Package leaflet: Information for the user

Recigar 1.5 mg film-coated tablets

Cytisine
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Recigar is and what it is used for
2. What you need to know 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, also known as cytosine.
This medicine is used to help people stop smoking and to reduce nicotine cravings in smokers who
have decided to quit.
Using Recigar helps gradually reduce dependence on nicotine and enables people to stop smoking
without experiencing nicotine withdrawal symptoms (e.g. depressed mood, irritability, anxiety,
difficulty concentrating, insomnia, increased appetite).
The aim of treatment with Recigar is permanent cessation of using nicotine-containing products.

2. What you need to know before taking Recigar

Do not take Recigar

• if you are allergic to cytisine or to any of the other ingredients of this medicine (listed in section 6),
• if you suffer from unstable angina,
• if you have recently had a myocardial infarction,
• if you suffer from clinically significant cardiac arrhythmias,
• if you have recently had a stroke,
• if you are pregnant or breastfeeding.

Warnings and precautions
Recigar should be used with caution in patients with ischemic heart disease, heart failure,
hypertension, pheochromocytoma (a tumour of the adrenal gland), atherosclerosis (hardening of the
arteries), gastric and duodenal ulcers, gastroesophageal reflux disease, hyperthyroidism (overactive
thyroid), diabetes, schizophrenia, or renal and hepatic impairment.
This medicine should only be taken by individuals who are seriously intending to stop smoking.
Continuing to smoke while taking Recigar may lead to aggravated nicotine-related adverse effects.

Children and adolescents
Due to limited clinical experience, the use of this medicine is not recommended in individuals under
18 years of age.

Elderly
Due to limited clinical experience, the use of Recigar is not recommended in individuals over
65 years of age.

Patients with kidney or liver impairment
There is no clinical experience with Recigar in patients with kidney or liver impairment; therefore, the use of
this medicine is not recommended in these patients.

Other medicines and Recigar
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Recigar with anti-tuberculosis medicines.
In some cases, stopping smoking, with or without Recigar, may require an adjustment in the dosage of other medicines. This is particularly important if you are taking medicines containing theophylline (for asthma), tacrine (for Alzheimer's disease), clozapine (for schizophrenia), or ropinirole (for 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. If you are using systemic hormonal contraceptives, you should use a second barrier method (e.g. condoms).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Recigar is contraindicated during pregnancy and breastfeeding.
If you are a woman of childbearing potential, you must use effective contraceptive methods. It is currently unknown whether cytisine may reduce the effectiveness of systemic hormonal contraceptives. If you are using systemic hormonal contraceptives, you should add a second barrier method.

Driving and using machines
Recigar does not impair the ability to drive or operate machinery.

Stopping smoking
Changes in your body following smoking cessation, with or without Recigar, may alter the effects of other medicines. Therefore, in some cases, a dose adjustment may be necessary. See section “Other medicines and Recigar” for further details.
For some people, quitting smoking, with or without treatment, has been associated with an increased risk of experiencing changes in thinking or behaviour, feelings of depression and anxiety (rarely including suicidal ideation and suicide attempts), and may be associated with a worsening of psychiatric disorders. If you have a history of psychiatric disorders, discuss this with your doctor.

Recigar contains aspartame.
This medicine contains 0.12 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate because the body cannot properly metabolize it.

3. How to take Recigar

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
One package of Recigar (100 tablets) is sufficient for a complete course of treatment.
The duration of treatment is 25 days.
Recigar is for oral use and must be taken with an adequate amount of water according to the following
schedule.

You must stop smoking within and no later than the 5th day of treatment. You must not continue smoking during treatment, as this could worsen adverse reactions. In case of treatment failure, treatment should be discontinued and may be restarted after 2-3 months.

Use in children and adolescents
The use of Recigar is not recommended in patients under 18 years of age.

If you take more Recigar than you should
In overdose with Recigar, symptoms of nicotine poisoning occur. Symptoms of overdose include nausea, vomiting, increased heart rate, fluctuations in blood pressure, breathing difficulties, visual disturbances, and seizures.

If you experience even one of the symptoms described, or any symptom not mentioned in this leaflet, stop taking Recigar and contact your doctor.

If you forget to take Recigar
Do not take a double dose to make up for the forgotten dose.

If you stop treatment with RECIGAR
If you have any doubts 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.
Very common (may affect more than 1 in 10 users):

• changes in appetite (especially increased appetite)
• weight gain
• dizziness
• irritability
• mood changes
• anxiety
• increased blood pressure (hypertension)
• dry mouth
• diarrhoea
• skin rash
• fatigue
• sleep disorders (insomnia, drowsiness, lethargy, abnormal dreams, nightmares)
• headache
• increased heart rate
• nausea
• altered taste
• heartburn
• constipation
• vomiting
• abdominal pain (especially in the upper abdomen)
• muscle pain.

The majority of the above-mentioned side effects occur at the beginning of treatment and resolve during its course. These symptoms may also be due to smoking cessation (withdrawal symptoms), rather than treatment with Recigar.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Recigar

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
This medicine does not require any special storage temperature.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Recigar contains

• The active substance is cytisine. One film-coated tablet contains 1.5 mg of cytisine.
• The other components are: Tablet core: hypromellose, mannitol, maize starch, magnesium aluminium silicate type A, anhydrous colloidal silica, magnesium stearate, purified water. Coating: AquaPolish P green [hypromellose (E464), microcrystalline cellulose (E460), talc (E553b), glycerol (E422), titanium dioxide (E171), quinoline yellow aluminium lake (E104), indigo carmine (blue 2) aluminium lake (E132)], menthol flavour powder SC552873, aspartame.

Description of the appearance of Recigar and the contents of the pack
Round, biconvex, light green or greenish film-coated tablets.
The pack contains 100 film-coated tablets in PVC/PVDC/aluminium blisters.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed S.r.l.
Via G. Mazzini, 20
20123 Milan - Italy
Manufacturer
Adamed Pharma S.A.
Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland