Patient leaflet - Belnifrem 1.5 mg film-coated tablets

1. What BELNIFREM is and what it is used for

BELNIFREM contains cytisinicline, also known as cytisine.

Smoking cessation and reduction of nicotine cravings in smokers who are willing to stop smoking. Using of medicinal product BELNIFREM allows to gradually decrease nicotine dependence and disaccustom of tobacco smoking without nicotine withdrawal symptoms (e.g. depressed mood, irritability, anxiety, difficulty concentrating, insomnia, increased appetite). The treatment goal of BELNIFREM is the permanent cessation of the nicotine-containing products use.

2. What you need to know before you use BELNIFREM

Do not use BELNIFREM:

if you are allergic to cytisinicline or any of the other ingredients of this medicine (listed in section
6). - if you have unstable angina,
if you have a history of recent myocardial infarction,
if you have clinically significant cardiac arrhythmias,
if you had stroke recently,
if you are pregnant or breast-feeding.

Warnings and precautions

BELNIFREM should be used with caution in case of ischemic heart disease, heart failure, hypertension, pheochromocytoma (a tumour of the adrenal gland), atherosclerosis (hardening of the arteries) and other peripheral vascular diseases, gastric and duodenal ulcer, gastroesophageal reflux disease, hyperthyroidism (overactive thyroid), diabetes, schizophrenia, kidney and liver failure. BELNIFREM should be taken only by those with a serious intention of weaning off nicotine. The use of BELNIFREM and continuation of smoking could lead to aggravated side effects of nicotine.

Children and adolescents

Due to limited experience, the drug is not recommended for use in persons under 18 years of age.

Elderly population

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

Patients with kidney and liver impairment

There is no clinical experience of BELNIFREM in patients with kidney or liver impairment, therefore the medicine is not recommended for use in these patients.

Other medicines and BELNIFREM

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Do not take BELNIFREM with anti-tuberculosis drugs.

In some cases as a result of stopping smoking, with or without BELNIFREM an adjustment of the dose of other medicines may be necessary. This is especially important if you use other medicines which contain theophylline (to treat asthma), tacrine (for Alzheimer’s disease), clozapine (for schizophrenia) and ropinirole (to treat Parkinson’s disease). If you are not sure, talk to your doctor or pharmacist.

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You must use effective methods of contraception if you are a woman of childbearing potential. Ask your doctor for advice.

BELNIFREM is contraindicated during pregnancy and breastfeeding.

Driving and using machines

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

Stopping smoking

The effects of changes in your body resulting from stopping smoking, with or without treatment with BELNIFREM, may alter the way other medicines act. Therefore, in some cases an adjustment of the dose may be necessary. See above under ‘Other medicines and BELNIFREM for further details.

For some people, stopping smoking with or without treatment has been associated with an increased risk of experiencing changes in thinking or behaviour, feelings of depression and anxiety (rarely including suicidal ideation and suicide attempt) and can be associated with a worsening of psychiatric disorder. If you have a history of psychiatric disorder you should discuss this with your doctor.

Belnifrem contains aspartame

This medicine contains 0.12 mg aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

3. How to use BELNIFREM

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

One package of BELNIFREM (100 tablets) is sufficient for a complete therapy. The duration of treatment is 25 days. BELNIFREM is for oral use and it should be taken with a suitable amount of water according to the following schedule.

Days of treatment Recommended dosing Maximum daily dose

From the 1st to the 3rd day 1 tablet every 2 hours 6 tablets From the 4th to the 12th day 1 tablet every 2.5 hours 5 tablets From the 13th to the 16th day 1 tablet every 3 hours 4 tablets From the 17th to the 20th day 1 tablet every 5 hours 3 tablets From the 21st to the 25th day 1-2 tablets a day to 2 tablets

Smoking should be stopped no later than on the 5th day of treatment. Smoking should not be continued during treatment as this may aggravate adverse reactions. In case of treatment failure, the treatment should be discontinued and may be resumed after 2 to 3 months.

If you use more BELNIFREM than you should

Symptoms of nicotine intoxication are observed in BELNIFREM overdose. Symptoms of overdose include malaise, nausea, vomiting, increased heart rate, fluctuations in blood pressure, breathing problems, blurred vision, convulsions.

If you have only one of described symptoms or the symptom, which is not mentioned in this leaflet, stop taking BELNIFREM and contact your doctor or pharmacist.

If you forget to use BELNIFREM

Do not take a double dose to make up for a forgotten dose.

If you stop using BELNIFREM

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.

These side effects may occur with certain frequencies, which are defined as follows:

Very common may affect more than 1 user in 10: change in appetite (mainly increase), weight gain, dizziness, irritability, mood changes, anxiety, increased blood pressure (hypertension), dry mouth, diarrhea, rash, fatigue, sleep disorders (insomnia, drowsiness, lethargy, abnormal dreams, nightmares), headaches, increased heart rate, nausea, changes flavour, heartburn, constipation, vomiting, abdominal pain (especially in the upper abdomen), muscle pain.

Common may affect 1 to 10 users in 100: difficulty in concentration, slow heart rate, abdominal distension, burning tongue, malaise.

Uncommon affects 1 to 10 users in 1,000: feeling of heaviness in the head, decreased libido, tearing, dyspnea, increased sputum, excessive salivation, sweating, decreased elasticity of the skin, tiredness, increase in serum transaminase levels.

Most of above side effects occur at the beginning of the therapy and resolve along with its duration. These symptoms could also be the result of smoking cessation (withdrawal symptoms), not treatment with BELNIFREM.

Reporting of side effects

If you get 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 via the national reporting system: Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store BELNIFREM

Store in the original package in order to protect from light.

This medicinal product does not require any special temperature storage conditions.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What BELNIFREM contains

The active substance is cytisinicline. One film-coated tablet contains 1.5 mg of cytisinicline.
The other ingredients are:

Tablet core: hypromellose, mannitol, maize starch, magnesium aluminometasilicate type A, silica colloidal anhydrous, magnesium stearate.

Film-coat: AquaPolish P green [hypromellose (E464), cellulose microcrystalline (E460), talcum (E553b), glycerol (E422), titanium dioxide (E171), quinoline yellow Al-lake (E104), indigo carmine Al-lake (blue 2) ( E132)], menthol flavour powder (SC552873), aspartame (E951).

What BELNIFREM looks like and contents of the pack

Round, biconvex, light green or greenish film-coated tablets.

Carton includes 100 film-coated tablets in PVC/PVDC/Aluminum blisters.

For information in large print, Braille or on CD, please contact telephone number +48 737 77 00

Marketing Authorisation Holder

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Poland

Manufacturer