RECIGARUM 1.5 mg/dose ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Recigarum 1.5 mg/dose Oral Solution

citisiniclina

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Recigarum and what is it used for
2. What you need to know before you start using Recigarum
3. How to take Recigarum
4. Possible side effects
5. Storage of Recigarum
6. Contents of the pack and other information

1. What is Recigarum and what is it used for

Recigarum contains the active substance citisiniclina, also known as citisine.

This medicine is used to help smokers quit smoking and reduce the desire for nicotine in adult smokers who want to quit smoking. The goal of citisiniclina treatment is permanent cessation of nicotine-containing product consumption.

The use of citisiniclina allows for a gradual reduction of nicotine dependence without nicotine withdrawal symptoms (such as depressed mood, irritability, anxiety, difficulty concentrating, insomnia, increased appetite).

2. What you need to know before you start using Recigarum

Do not useRecigarum:

• if you are allergic to citisiniclina or any of the other ingredients of this medicine (listed in section 6),
• if you have unstable angina,
• if you have had a 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,
• heart failure,
• hypertension,
• phaeochromocytoma (tumour of the adrenal gland),
• atherosclerosis (hardening of the arteries) and other peripheral vascular diseases,
• gastric and duodenal ulcers,
• gastro-oesophageal reflux disease,
• hyperthyroidism (overactive thyroid),
• diabetes,
• schizophrenia,
• renal and hepatic impairment.

Citisiniclina should only be taken by people who are strongly motivated to quit nicotine. Using citisiniclina without quitting smoking or using nicotine-containing products could worsen the adverse effects of nicotine.

Children and adolescents

Due to limited experience, this medicine is not recommended for use in children under 18 years of age.

Elderly population

Due to limited clinical experience, citisiniclina is not recommended for use in patients over 65 years of age.

Patients with renal and hepatic impairment

There is no clinical experience with citisiniclina in patients with renal or hepatic impairment; therefore, the medicine is not recommended for use in such patients.

Other medicines and Recigarum

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Do not take citisiniclina with anti-tuberculosis medicines.

In some cases, as a result of quitting smoking, with or without citisiniclina, it may be necessary to adjust the dose of other medicines. Such adjustment is particularly important if you are using other medicines that contain theophylline (for asthma treatment), tacrine (for Alzheimer's disease), clozapine (for schizophrenia) or ropinirole (for Parkinson's disease treatment). If you are unsure, consult your doctor or pharmacist.

It is currently unknown whether citisiniclina can reduce the effectiveness of systemic hormonal contraceptives. If you use 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 have a baby, ask your doctor or pharmacist for advice before using this medicine.

Contraception in women

You should use effective contraceptive methods if you are a woman of childbearing age.

It is currently unknown whether citisiniclina can reduce the effectiveness of systemic hormonal contraceptives. If you are using systemic hormonal contraceptives, you should add a second barrier method (e.g. condoms).

Ask your doctor for advice.

Pregnancy and breastfeeding

Citisiniclina is contraindicated during pregnancy and breastfeeding.

Driving and using machines

Citisiniclina has no influence on the ability to drive and use machines.

Quitting smoking

The effects of the changes that occur in the body as a result of quitting smoking, with or without citisiniclina treatment, may alter the mechanism of action of other medicines. Therefore, in some cases, it may be necessary to adjust the dose. For more details, see the section "Other medicines and Recigarum".

In some people, quitting smoking with or without treatment has been associated with an increased risk of experiencing changes in thinking or behaviour, with feelings of depression and anxiety (including, rarely, suicidal ideation and attempted suicide) and may be related to the 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 metabisulfite

This medicine contains 0.17 mg of alcohol (ethanol) in each dose (0.19 ml), which is equivalent to 90.00 mg/100 ml (0.09% p/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 in each dose (0.19 ml), which is equivalent to 237.53 mg/ml.

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is, essentially "sodium-free".

This medicine contains sodium metabisulfite. It can rarely cause hypersensitivity reactions and bronchospasm.

The excipient glycerol hydrates the oral mucosa and prevents the sensation of dryness in the mouth.

3. How to take Recigarum

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

A pack of Recigarum (100 doses) is sufficient for a full treatment course. The duration of treatment is 25 days.

Recommended dose

Recigarum should be taken according to the following scheme:

You should quit smoking no later than the 5th day of treatment. The person who has quit smoking should not smoke even a single cigarette. This is essential to achieve therapeutic success. If the treatment fails, it should be discontinued and may be resumed after 2 or 3 months.

Use in children and adolescents

The use of citisiniclina 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 and hepatic impairment

There is no clinical experience with this medicine in patients with renal or hepatic impairment, therefore, the medicine is not recommended for use in these patients.

Method of administration

This medicine is for oral use and can be taken with or without water/liquid.

Unlocking the pump and recommendations for use

• Remove the protective cap from the applicator.
• Place the container so that the pump is above the container.
• The pump must be charged by pressing the top of the container (pump) with your index finger 5 times, until a dose appears. After the initial charging (which is only necessary when using the product for the first time), each actuation delivers 1.5 mg of citisiniclina.
• Immediately after charging, the nozzle should be pointed as close as possible to the open mouth of the subject.
• Press the top of the dispenser once and release a dose into the mouth, avoiding contact with the lips and parts of the oral cavity.
• After use, replace the protective cap on the applicator.

If you take more Recigarum than you should

Nicotine intoxication symptoms are observed in case of citisiniclina overdose. The symptoms of overdose are, among others, general malaise, nausea, vomiting, increased heart rate, fluctuations in blood pressure, respiratory problems, blurred vision, convulsions.

If you experience any of the symptoms described, even if it is only one of them, or any other symptom that is not mentioned in this leaflet, stop taking citisiniclina and consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):

• changes in appetite (mainly increased),
• weight gain,
• headaches,
• irritability,
• sleep disorders (insomnia, somnolence, 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 people):

• dizziness,
• difficulty concentrating,
• slow heart rate,
• vomiting,
• changes in taste,
• constipation,
• diarrhoea,
• abdominal distension,
• burning sensation in the tongue,
• heartburn,
• fatigue,
• general malaise.

Uncommon (may affect up to 1 in 100 people):

• feeling of heaviness in the head,
• decreased libido,
• tearfulness,
• shortness of breath,
• increased sputum,
• excessive salivation,
• sweating,
• decreased skin elasticity,
• fatigue,
• increased serum levels of transaminases (liver enzymes).

Most of the side effects mentioned occur at the beginning of treatment and disappear during its duration. These symptoms can also be a consequence of quitting smoking (nicotine withdrawal symptoms) and not due to treatment with citisiniclina.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's website: www.notificaram.es. By reporting side 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 pack after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions. Do not refrigerate or freeze.

Shelf-life after first opening: 6 months.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Recigarum

• The active substance is citisiniclina (previously used name: citisine). One dose (one pump actuation) contains 1.5 mg of citisiniclina.
• The other ingredients are: xylitol (E967), sodium dihydrogen phosphate dihydrate, glycerol, propylene glycol, sodium metabisulfite (E223), peppermint liquid flavour (containing: ethanol, propylene glycol (E1520), purified water, flavouring preparations, natural flavouring substances), purified water.

Appearance of the product and pack contents

Recigarum is a colourless to yellowish, transparent liquid with a mint flavour.

Multidose HDPE container with a dosing pump and cap. The solution in a multidose container is 22.0 ml, which corresponds to at least 100 doses. The container is in a cardboard box.

Marketing authorisation holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 - 2ª planta

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 medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: December 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/