Tinqasit

Package leaflet: Information for the user

TINQASIT, 1.5 mg/dose, oral solution
Cytisiniclinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
You should always take this medicine exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If you do not get better or if you feel worse, consult your doctor.

Contents of the leaflet

1. What TINQASIT is and what it is used for
2. Important information before taking TINQASIT
3. How to take TINQASIT
4. Possible side effects
5. How to store TINQASIT
6. Contents of the pack and other information

1. What TINQASIT is and what it is used for

TINQASIT contains the active substance cytisinicline, formerly known as cytisine.
This medicine is used in nicotine dependence.
TINQASIT is used to help adult smokers stop smoking and reduce nicotine cravings in those who wish to quit.
The aim of TINQASIT treatment is the permanent cessation of using nicotine-containing products.
Treatment with TINQASIT 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 TINQASIT

When not to use TINQASIT:

• 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 treatment with TINQASIT, discuss this with your doctor or pharmacist if:

• you have ischaemic heart disease,
• you have heart failure,
• you have hypertension,
• you have a phaeochromocytoma (adrenal gland tumour),
• you have atherosclerosis (hardening of the arteries) or other peripheral vascular diseases,
• you have peptic ulcer disease,
• you have gastro-oesophageal reflux disease,
• you have hyperthyroidism,
• you have diabetes,
• you have schizophrenia,
• you have renal or hepatic impairment.

TINQASIT should only be used by individuals who are seriously committed to quitting nicotine. Taking TINQASIT while continuing to smoke may increase the risk of adverse effects of nicotine.

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

Elderly patients
Due to limited clinical experience, the use of TINQASIT 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 TINQASIT in patients with hepatic or renal impairment; therefore, its use is not recommended in these patient groups.

TINQASIT and other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
Do not take TINQASIT together with anti-tuberculosis medicines.
In some cases, cessation of smoking, with or without the use of TINQASIT, may require dose adjustments 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 TINQASIT 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 you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Contraception in women
Women of childbearing age must use an effective method of contraception.
It is currently unknown whether TINQASIT 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
TINQASIT is contraindicated during pregnancy and breastfeeding.

Driving and operating machinery
TINQASIT has no effect or negligible effect on the ability to drive and operate machinery.

Smoking cessation
Changes in the body associated with smoking cessation, with or without the use of TINQASIT, may alter the way other medicines work. Therefore, in some cases, dose adjustments of other medicines may be necessary. More information can be found above in the section "TINQASIT and other medicines".
In some individuals, smoking cessation, 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 you have current or past psychiatric disorders, you should discuss this with your doctor.

TINQASIT contains alcohol, propylene glycol, sodium, and sodium metabisulphite.
This medicine contains 0.17 mg of alcohol (ethanol) per unit dose (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 unit dose (0.19 ml), corresponding to 237.53 mg/ml.
This medicine contains less than 1 mmol (23 mg) of sodium per unit dose, 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 TINQASIT

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
One pack of TINQASIT (100 doses) is sufficient for a complete course of treatment. The duration of treatment is 25 days.

Recommended dosage
TINQASIT 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 stopped no later than on day 5 of treatment. A person who has quit 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
TINQASIT is not recommended for use in individuals under 18 years of age.

Use in elderly patients
Due to limited clinical experience, TINQASIT 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 TINQASIT in patients with impaired kidney or liver function; therefore, its use is not recommended in these patient groups.

Instructions for use
TINQASIT is intended for oral use and may be taken with or without water/liquid.

Instructions for unlocking and using the pump dispenser

• 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) five times with the index finger until a full dose is dispensed. After initial priming (required only the first time the medicine is used), each activation of the pump delivers 1.5 mg of cytisine.
• After priming, the patient should direct the nozzle as close as possible to the open mouth.
• Press the top part of the dispenser once to release one dose into the mouth, avoiding contact with the lips and oral mucosa.
• After use, replace the protective cap on the applicator.

Use of a higher than recommended dose of TINQASIT
Symptoms of overdose are characteristic of nicotine poisoning.
Symptoms of overdose include: malaise, nausea, vomiting, increased heart rate, fluctuations in blood pressure, breathing difficulties, visual disturbances, and seizures.
If any of the described symptoms occur, or any symptom not listed in this leaflet, discontinue use of TINQASIT immediately and contact your doctor or pharmacist.

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

Discontinuation of TINQASIT
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Very common – may occur in 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 occur in up to 1 in 10 people: dizziness, difficulty concentrating,
slowed heart rate, vomiting, taste disturbances, constipation, diarrhoea, flatulence, burning sensation of the tongue, heartburn, fatigue, malaise.
Uncommon – may occur in 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, fatigue, increased liver enzyme activity.
Most of the adverse reactions listed above occur mainly during the initial period of treatment and subside as treatment continues. These symptoms may also result from smoking cessation (withdrawal symptoms), rather than from taking Tinqasit.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions 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 49 21 301,
fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables further collection of information on the safety of this medicine.

5. How to store TINQASIT

Keep this medicine out of 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 stated month.
No special storage conditions are required. Do not store in the refrigerator or freeze.
Shelf life after first opening: 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What TINQASIT contains

• The active substance is cytisine hydrochloride (previously used name: cytisine). One dose (one pump activation) contains 1.5 mg of cytisine hydrochloride.
• Other ingredients are: xylitol (E 967), disodium dihydrogen diphosphate dihydrate, glycerol, propylene glycol, sodium pyrosulfite (E 223), liquid mint flavour (containing: anhydrous ethanol, propylene glycol (E 1520), purified water, flavouring substances, natural flavouring substances), purified water.

What TINQASIT looks like and contents of the pack
TINQASIT is a colourless to yellowish clear liquid with a mint flavour.
White HDPE multi-dose container with a metering pump and nozzle. The solution volume in the multi-dose 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
Pro-Pharma'93 Gyógyszeripari Kft.
Füredi Utca 34 1 Em 4
1144 Budapest
Hungary
+48 22 668 68 23

Manufacturer
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice
Curtis Health Caps S.A.
Wysogotowo, Batorowska 52
62-081 Przeźmierowo

This medicinal product is authorised in the European Economic Area under the following names:
Austria: Recigar 1.5 mg/Dose Lösung zum Einnehmen
Poland: TINQASIT