Recigarum 1.5 mg/dose oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Recigarum 1.5 mg/dose oral solution
cytisine
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Recigarum is and what it is used for
- What you need to know before taking Recigarum
- How to take Recigarum
- Possible side effects
- How to store Recigarum
- Contents of the pack and other information
1. What Recigarum is and what it is used for
Recigarum contains the active substance citisine, also known as cytisine.
This medicine is used to stop smoking and reduce nicotine cravings in adult smokers who wish to quit. The goal of cytisine treatment is the permanent cessation of using products containing nicotine.
Cytisine use allows for a gradual reduction of nicotine dependence without nicotine withdrawal symptoms (e.g., depressed mood, irritability, anxiety, difficulty concentrating, insomnia, increased appetite).
2. What you need to know before using Recigarum
Do not use Recigarum:
- if you are allergic to cytisine or any of the other components of this medicine (listed in section 6),
- if you have unstable angina,
- if you have a history of recent 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
Consult your doctor or pharmacist before starting to take this medicine if you:
- have ischaemic heart disease,
- have heart failure,
- have hypertension,
- have phaeochromocytoma (a tumour of the adrenal gland),
- have atherosclerosis (hardening of the arteries) or other peripheral vascular diseases,
- have gastric or duodenal ulcer,
- have gastro-oesophageal reflux disease,
- have hyperthyroidism (overactive thyroid),
- have diabetes,
- have schizophrenia,
- have renal or hepatic impairment.
Cytisine should only be taken by individuals who are firmly determined to stop using nicotine. Using cytisine without quitting smoking or discontinuing nicotine-containing products may worsen the adverse effects of nicotine.
Children and adolescents
Due to limited experience, this medicine is not recommended for use in individuals under 18 years of age.
Elderly population
Due to limited clinical experience, cytisine is not recommended for use in patients over 65 years of age.
Patients with hepatic or renal impairment
There is no clinical experience with cytisine in patients with renal or hepatic impairment; therefore, the medicine is not recommended for use in such patients.
Other medicines and Recigarum
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not take cytisine together with antituberculosis medications.
In some cases, as a consequence of stopping smoking, with or without cytisine, a dose adjustment of other medicines may be required. This adjustment is particularly important if you are taking other medicines containing theophylline (for asthma treatment), tacrine (for Alzheimer's disease), clozapine (for schizophrenia), or ropinirole (for Parkinson's disease). If you are unsure, consult your doctor or pharmacist.
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 (e.g., condoms).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Contraception in women
You must use effective contraceptive methods if you are a woman of childbearing age.
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 (e.g., condoms).
Seek advice from your doctor.
Pregnancy and breastfeeding
Cytisine is contraindicated during pregnancy and breastfeeding.
Driving and using machines
Cytisine has no influence on the ability to drive or operate machinery.
Smoking cessation
The effects of physiological changes resulting from quitting smoking, with or without cytisine treatment, may alter the mechanism of action of other medicines. Therefore, in some cases, a dose adjustment may be necessary. For further details, see the section "Other medicines and Recigarum".
In some individuals, 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 (including, rarely, suicidal ideation and suicide 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.
Recigarum contains ethanol, propylene glycol, sodium, and sodium metabisulphite
This medicine contains 0.17 mg of alcohol (ethanol) per dose (0.19 ml), equivalent to 90.00 mg/100 ml (0.09% w/v). The amount in a single dose of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The amount in a single dose of this medicine does not produce any noticeable effect.
This medicine contains 44.87 mg of propylene glycol per dose (0.19 ml), equivalent to 237.53 mg/ml.
This medicine contains less than 1 mmol of sodium (23 mg) per dose; i.e., essentially "sodium-free".
This medicine contains sodium metabisulphite. Rarely, it may cause hypersensitivity reactions and bronchospasm.
The excipient glycerol hydrates the oral mucosa and helps prevent dry mouth.
3. How to take Recigarum
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
One package of Recigarum (100 doses) is sufficient for a complete treatment. The duration of treatment is 25 days.
Recommended dose
Recigarum should be taken according to the following scheme:
Treatment days | Recommended dose | Maximum daily dose |
Days 1 to 3 | 1 dose every 2 hours | 6 doses |
Days 4 to 12 | 1 dose every 2.5 hours | 5 doses |
Days 13 to 16 | 1 dose every 3 hours | 4 doses |
Days 17 to 20 | 1 dose every 5 hours | 3 doses |
Days 21 to 25 | 1-2 doses per day | Up to 2 doses |
You must stop smoking no later than the 5th day of treatment. The person who has stopped smoking must not smoke even a single cigarette. This is essential to achieve therapeutic success. If the treatment fails, it should be discontinued and may be restarted after 2 or 3 months.
Use in children and adolescents
The use of cytisine is not recommended in patients under 18 years of age.
Use in elderly patients
Due to limited clinical experience, this medicine is not recommended for use in elderly patients over 65 years of age.
Use in patients with renal or hepatic impairment
There is no clinical experience with this medicine in patients with renal or hepatic impairment; therefore, the use of this medicine is not recommended in these patients.
Method of administration
This medicine is for oral use and may be taken with or without water/liquid.
Unblocking the pump and usage instructions
- Remove the protective cap from the applicator.
- Position the container so that the pump is on top of the container.
- The pump must be primed by pressing down the top part of the container (pump) with the index finger 5 times, until a dose appears. After the initial priming (which is only necessary the first time the product is used), each subsequent actuation delivers 1.5 mg of cytisine.
- Immediately after priming, the nozzle should be directed as close as possible to the open mouth of the user.
- Press the top of the dispenser once and release one dose into the mouth, avoiding contact with the lips or other parts of the oral cavity.
- After use, replace the protective cap on the applicator.
If you take more Recigarum than you should
Symptoms of nicotine poisoning may occur in case of cytisine overdose. Symptoms of overdose include, among others, general malaise, nausea, vomiting, increased heart rate, fluctuations in blood pressure, breathing difficulties, blurred vision, and seizures.
If you experience even one of the described symptoms or any other symptom not mentioned in this leaflet, stop taking cytisine and consult your doctor or pharmacist.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Recigarum
Do not take a double dose to make up for forgotten doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.
Very common (may affect more than 1 in 10 patients):
- changes in appetite (mainly increased),
- weight gain,
- headaches,
- irritability,
- sleep disorders (insomnia, drowsiness, lethargy, abnormal dreams, nightmares),
- mood changes,
- anxiety,
- increased heart rate,
- increased blood pressure (hypertension),
- dry mouth,
- abdominal pain (especially in the upper abdomen),
- nausea,
- skin rash,
- muscle pain.
Common (may affect up to 1 in 10 patients):
- dizziness,
- difficulty concentrating,
- slow heart rate,
- vomiting,
- taste disturbances,
- constipation,
- diarrhea,
- abdominal distension,
- burning sensation on the tongue,
- heartburn,
- fatigue,
- general malaise.
Uncommon (may affect up to 1 in 100 patients):
- sensation of heaviness in the head,
- decreased libido,
- tearing,
- dyspnea,
- increased sputum,
- excessive salivation,
- sweating,
- decreased skin elasticity,
- tiredness,
- increased serum levels of transaminases (liver enzymes).
Most of the adverse effects listed above occur at the beginning of treatment and disappear over time. These symptoms may also be due to quitting smoking (withdrawal symptoms) rather than the treatment with cytisine.
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Recigarum
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions. Do not refrigerate or freeze.
Validity period after first opening: 6 months.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Recigarum
- The active substance is cytisinicline (previously used name: cytisine). One dose (one pump spray) contains 1.5 mg of cytisinicline.
- The other components are: xylitol (E967), sodium dihydrogen phosphate dihydrate, glycerol, propylene glycol, sodium metabisulfite (E223), liquid mint flavor (containing: ethanol, propylene glycol (E1520), purified water, flavoring preparations, natural flavoring substances), purified water.
Appearance of the product and contents of the pack
Recigarum is a colorless to yellow, transparent liquid with a mint flavor.
White HDPE multidose container with a metering pump and cap. The solution content in the multidose container is 22.0 ml, corresponding to at least 100 doses. The container is placed in a cardboard box.
Marketing Authorization Holder
Adamed Laboratorios, S.L.U.
Calle de las Rosas de Aravaca, 31 - 2nd floor
28023 Madrid
Spain
Manufacturer
Adamed Pharma S.A.
ul. Marszalka Józefa Pilsudskiego 5
95-200 Pabianice
Poland
or
Curtis Health Caps S.A.
Wysogotowo, Batorowska 52 Street
62-081 Przezmierowo
Poland
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Member State | Medicinal Product Name |
Germany | Recigar |
Poland | Cerdablan |
Spain | Recigarum 1.5 mg/dose oral solution |
Sweden | Minreksav |
Date of the most recent review of this leaflet: December 2024
Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/