Recigar active
Poland
Table of Contents
Patient Information Leaflet
Recigar Active, 1.5 mg/dose, oral solution
Cytisiniclinum
Please read all of this leaflet carefully before you start using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your 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 you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- If your condition does not improve or worsens, consult your doctor.
Table of Contents
- What Recigar Active is and what it is used for
- Important information before taking Recigar Active
- How to take Recigar Active
- Possible side effects
- How to store Recigar Active
- Contents of the pack and other information
1. What Recigar Active is and what it is used for
Recigar Active contains the active substance cytisinicline, also known as cytisine.
This medicine is used in nicotine dependence.
Recigar Active is used to help adult smokers stop smoking and reduce nicotine cravings in those who want to quit. The aim of using Recigar Active is to achieve long-term abstinence from nicotine-containing products.
Treatment with Recigar Active helps gradually reduce nicotine dependence by alleviating withdrawal symptoms (e.g. low mood, irritability, anxiety, difficulty concentrating, insomnia, increased appetite).
2. Important information before using Recigar Active
When not to use Recigar Active:
- 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 use Recigar Active, consult your doctor or pharmacist if:
- you have ischaemic heart disease,
- heart failure,
- arterial hypertension,
- pheochromocytoma (adrenal gland tumour),
- atherosclerosis (hardening of the arteries) and other peripheral vascular diseases,
- gastric or duodenal ulcer,
- gastro-oesophageal reflux disease,
- hyperthyroidism,
- diabetes,
- schizophrenia,
- renal or hepatic impairment.
Recigar Active should only be used by individuals who are seriously intending to quit nicotine. Taking Recigar Active while continuing to smoke or using other nicotine-containing products may lead to an increased risk of adverse effects of nicotine.
Children and adolescents
Due to limited experience, the use of Recigar Active is not recommended in individuals under 18 years of age.
Elderly patients
Due to limited clinical experience, the use of Recigar Active is not recommended in elderly patients over 65 years of age.
Use in patients with hepatic or renal impairment
There is no clinical experience with the use of Recigar Active in patients with hepatic or renal impairment; therefore, its use is not recommended in these patient groups.
Recigar Active and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not take Recigar Active together with anti-tuberculosis medicines.
In some cases, after stopping smoking or using other nicotine-containing products, with or without using Recigar Active, it may be necessary to adjust the dosage 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 you have any doubts, consult your doctor or pharmacist.
It is currently unknown whether Recigar Active 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 or 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 Recigar Active 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
Recigar Active is contraindicated during pregnancy and breastfeeding.
Driving and operating machinery
Recigar Active has no effect or negligible effect on the ability to drive vehicles and operate machinery.
Stopping smoking
Changes in the body associated with stopping smoking or using other nicotine-containing products, whether using Recigar Active or not, may alter the way other medicines work. Therefore, in some cases, it may be necessary to adjust the dosage of other medicines. More information can be found above in the section "Recigar Active and other medicines".
In some individuals, stopping smoking or using other nicotine-containing products, whether 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. If the patient has or has had psychiatric disorders in the past, he or she should discuss this with the doctor.
Recigar Active contains alcohol, propylene glycol, sodium, and sodium metabisulphite.
This medicine contains 0.17 mg of alcohol (ethanol) per dose unit (0.19 ml), equivalent to 90.00 mg/100 ml (0.09% w/v). The amount of alcohol in a dose of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.
This medicine contains 44.87 mg of propylene glycol per dose unit (0.19 ml), corresponding to 237.53 mg/ml.
This medicine contains less than 1 mmol (23 mg) of sodium per dose unit, meaning the medicine is considered "sodium-free".
This medicine contains sodium metabisulphite. It may rarely cause severe hypersensitivity reactions and bronchospasm.
3. How to use Recigar Active
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
One package of Recigar Active (100 doses) is sufficient for a complete course of treatment. The treatment duration is 25 days.
Recommended dosage
Recigar Active should be taken according to the following schedule:
| Days of therapy | Recommended dosing | 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 |
Smoking must be discontinued no later than on day 5 of treatment. A person who has stopped smoking must not smoke even a single cigarette. This is essential for achieving therapeutic success.
If treatment fails, it should be discontinued and may be restarted after 2 to 3 months.
Use in children and adolescents
Recigar Active is not recommended for use in individuals under 18 years of age.
Use in elderly patients
Due to limited clinical experience, Recigar Active 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 Recigar Active in patients with impaired kidney or liver function; therefore, its use is not recommended in these patient groups.
Method of administration
Recigar Active is intended for oral use and may be taken with or without water/liquid.
Instructions for unlocking the pump and usage
- Remove the protective cap from the applicator.
- Position the container with the pump on top.
- Prime the pump by pressing the upper part of the container (pump) with your index finger 5 times until a full dose appears. After initial priming (required only the first time the medicine is used), each pump activation delivers 1.5 mg of cytisine.
- After priming, direct the nozzle as close as possible to the open mouth.
- Press the upper part of the dispenser once to release one dose into the mouth, avoiding contact with lips and oral mucosa.
- After use, replace the protective cap on the applicator.
Use of a higher than recommended dose of Recigar Active
Symptoms of overdose with Recigar Active are typical of nicotine poisoning.
Symptoms of overdose include: malaise, nausea, vomiting, tachycardia, blood pressure fluctuations, respiratory disturbances, visual disturbances, and seizures.
If any of the described symptoms occur, or any symptom not listed in this leaflet appears, discontinue use of Recigar Active immediately and contact your doctor or pharmacist.
Missed dose of Recigar Active
Do not use a double dose to make up for a missed dose.
Discontinuation of Recigar Active
For any further questions regarding the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Very common – may affect more than 1 in 10 people:
- change in appetite (mainly increased),
- weight gain,
- headache,
- irritability,
- sleep disturbances (insomnia, drowsiness, somnolence, unusual dreams, nightmares),
- mood changes,
- anxiety,
- increased heart rate,
- elevated arterial pressure (hypertension),
- dry mouth,
- abdominal pain (especially in the epigastric region),
- nausea,
- rash,
- muscle pain.
Common – may affect up to 1 in 10 people:
- dizziness,
- difficulty concentrating,
- slowed heart rate,
- vomiting,
- taste disturbances,
- constipation,
- diarrhoea,
- bloating,
- burning sensation of the tongue,
- heartburn,
- fatigue,
- malaise.
Uncommon – may affect up to 1 in 100 people:
- feeling of heaviness in the head,
- reduced libido,
- lacrimation,
- shortness of breath,
- increased expectoration,
- excessive salivation,
- increased sweating,
- decreased skin elasticity,
- tiredness,
- increased liver enzyme activity.
Most of the adverse effects listed above occur mainly during the initial period of treatment and diminish as treatment continues. These symptoms may also result from smoking cessation (withdrawal symptoms), rather than from taking Recigar Active.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse 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 4921 301,
fax: +48 22 4921 309,
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Recigar Active
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the stated month.
Shelf-life after first opening: 6 months.
No special storage instructions apply. Do not store in the refrigerator or freeze.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Contents of the packaging and other information
What Recigar Active contains
- The active substance is cytisine hydrochloride (previously used name: cytisine). One dose (one pump spray) contains 1.5 mg of cytisine hydrochloride.
- The other ingredients are: xylitol (E 967), disodium dihydrogen diphosphate dihydrate, glycerol, propylene glycol, sodium metabisulfite (E 223), liquid mint flavour (containing: anhydrous ethanol, propylene glycol (E 1520), purified water, flavouring substances, natural flavouring substances), purified water.
What Recigar Active looks like and contents of the pack
Recigar Active is a colourless to yellow, clear liquid with a mint flavour.
White HDPE multidose container with a dosing pump and nozzle. The solution volume in the multidose container is 22.0 ml, corresponding to at least 100 doses. The container is placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel. + 48 22 732 77 00
Manufacturer
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice
Curtis Health Caps S.A.
Wysogotowo, Batorowska 52
62-081 Przeźmierowo