Punkamlar

Patient Information Leaflet

PUNKAMLAR, 1.5 mg, coated tablets
Cytisiniclinum
Please read carefully the information in this leaflet before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the physician, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• Consult your pharmacist if you need advice or further information.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse, contact the doctor.

Table of contents

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

1. What PUNKAMLAR is and what it is used for

Smoking cessation and reduction of nicotine craving in adult smokers who wish to stop smoking.
The use of this medicinal product enables gradual reduction of nicotine dependence and
cessation of tobacco smoking without nicotine withdrawal symptoms (e.g. low mood, irritability,
anxiety, difficulty concentrating, insomnia, increased appetite). The aim of using this product is
permanent cessation of using nicotine-containing products.

2. Important information before taking PUNKAMLAR
When not to use the medicine:

• if the patient is allergic to cytisinicline or any of the other ingredients of this medicine (listed in section 6),
• in case of unstable angina pectoris,
• after recent myocardial infarction,
• if the patient has clinically significant cardiac arrhythmias,
• after recent stroke,
• during pregnancy and breastfeeding.

Warnings and precautions
Use with caution in patients with ischemic heart disease, heart failure, arterial hypertension,
pheochromocytoma, atherosclerosis (arterial hardening), and other peripheral vascular diseases,
gastric or duodenal ulcer disease, gastroesophageal reflux disease, hyperthyroidism, diabetes,
schizophrenia, renal or hepatic impairment.
This medicine should only be taken by individuals with a serious intention to quit
smoking. Taking the medicine while continuing to smoke or using nicotine-containing
products may intensify adverse effects of nicotine.
Children and adolescents
Due to limited experience, use in individuals under 18 years of age is not recommended.
Elderly patients
Due to limited clinical experience, use in elderly patients over 65 years of age is not recommended.
Use in patients with hepatic or renal impairment
There is no clinical experience with this medicine in patients with hepatic or renal impairment;
therefore, its use is not recommended in this patient group.
Medicines and other drugs
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any
medicines you plan to take.
Do not take this medicine together with antituberculosis drugs.
In some cases, cessation of smoking, with or without using this medicine, may require adjustment
of doses 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 in doubt, consult your doctor or pharmacist.
It is currently unknown whether this medicine 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 plans to have a child,
she should consult her doctor or pharmacist before using this medicine.
Women of childbearing potential must use an effective method of contraception during treatment
with this medicine. Seek advice from your doctor.
This medicine is contraindicated during pregnancy and breastfeeding.
Driving and operating machinery
has no effect on the ability to drive or operate machinery.
Smoking cessation
Changes in the body associated with smoking cessation, with or without using this medicine, may
alter the way other medicines work. Therefore, in some cases, dose adjustment of other medicines
may be necessary. More information is provided above in the section "Medicines and other drugs".
In some individuals, smoking cessation, with or without using medicines, has been associated
with an increased risk of changes in thinking or behavior, feelings of depression and anxiety (including
rare 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, this should be discussed
with the doctor.
Aspartame
This medicine contains 0.12 mg of aspartame (E 951) per coated tablet. Aspartame is a source of
phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder
in which phenylalanine accumulates in the body due to improper excretion.

3. How to take PUNKAMLAR
This medicine should always be used exactly as described in this patient leaflet or as directed by
the physician or pharmacist.
If in doubt, consult your doctor or pharmacist.
One pack of the medicine (100 tablets) is sufficient for a full course of treatment. The duration of
treatment is 25 days. The medicine is intended for oral use and should be taken with an adequate
amount of water according to the following schedule.

Days of therapy Recommended dosage Maximum daily dose
Days 1 to 3 1 tablet every 2 hours 6 tablets
Days 4 to 12 1 tablet every 2.5 hours 5 tablets
Days 13 to 16 1 tablet every 3 hours 4 tablets
Days 17 to 20 1 tablet every 5 hours 3 tablets
Days 21 to 25 1–2 tablets per day up to 2 tablets

The blister is marked with consecutive days of treatment.
Smoking should be discontinued no later than on day 5 of treatment. Continuing to smoke during
treatment is not recommended, as it may intensify adverse effects. If the patient is unable to
stop smoking within 5 days of starting treatment with this medicine, they should contact their doctor.
If the treatment outcome is unsatisfactory, treatment should be discontinued and restarted after
2 to 3 months.
Use in children and adolescents
This medicine is not recommended for use in individuals under 18 years of age.
Use of a higher than recommended dose
Symptoms of overdose are characteristic of nicotine poisoning.
Symptoms of overdose include malaise, nausea, vomiting, tachycardia, blood pressure fluctuations,
respiratory disturbances, visual disturbances, and seizures.
If even one of the described symptoms occurs, or any symptom not listed in this leaflet, discontinue
taking the medicine and contact your doctor or pharmacist.
Missed dose
Do not take a double dose to make up for a missed dose.
Stopping treatment
For any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur with the frequency specified below:
Very common – may affect more than 1 in 10 people: change in appetite (mainly increased),
weight gain, dizziness, irritability, mood changes, anxiety, increased blood pressure
(hypertension), dry mouth, diarrhoea, rash, fatigue, sleep disturbances
(insomnia, drowsiness, somnolence, unusual dreams, nightmares), headache, rapid heartbeat,
nausea, taste disturbances, heartburn, constipation, vomiting, abdominal pain (especially in the epigastrium), muscle pain.
Common – may affect 1 in 100 people: difficulty concentrating, slowed heart rate,
bloating, burning sensation of the tongue, malaise.
Uncommon – may affect 1 in 1,000 people: feeling of heaviness in the head, decreased libido,
watery eyes, shortness of breath, increased coughing, excessive salivation, increased sweating, reduced 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 stopping smoking (withdrawal symptoms), rather than from taking the medicine.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of 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.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store PUNKAMLAR

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect from light. There are no special requirements
regarding the storage temperature of the medicine.
Do not use this medicine after the expiry date stated on the blister and carton after EXP.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What the medicine contains

• The active substance is cytisine hydrochloride (previously used name: cytisine). One coated tablet contains 1.5 mg of cytisine hydrochloride.
• The other ingredients are:
  Tablet core: hypromellose, mannitol, corn starch, magnesium aluminium metasilicate, colloidal anhydrous silica, magnesium stearate.
  Coating: Aqua Polish P green [hypromellose (type 2910, 6 mPa·s), microcrystalline cellulose (E 460), talc (E 553b), glycerol (E 422), titanium dioxide (E 171), quinoline yellow, lake (E 104), indigo carmine, lake (E132)], peppermint flavour powder SC552873, aspartame.

What the medicine looks like and contents of the pack
The medicine is round, biconvex coated tablets, light green to greenish, with a diameter of 5 mm.
PVC/PVDC/Aluminium blisters placed in a cardboard box containing 100 coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel. 22 732 77 00

Manufacturer
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice

This medicine is authorised in the European Economic Area countries under the following names:
Poland: PUNKAMLAR
Slovakia: Heavis