Package leaflet: Information for the patient

Iretig, 50 mg, prolonged-release tablets
Mirabegron
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

What Iretig is and what it is used for
Important information before taking Iretig
How to take Iretig
Possible side effects
How to store Iretig
Contents of the pack and other information

1. What Iretig is and what it is used for
The active substance in Iretig is mirabegron. It is a bladder muscle relaxant (a so-called beta-3 adrenergic receptor agonist) that reduces overactivity of the urinary bladder and treats associated symptoms, as well as reduces neurogenic detrusor overactivity.
Iretig is used:

For the treatment of symptoms of overactive bladder in adults.
- These symptoms include: sudden urge to urinate (called urgency), need to urinate more often than usual (called frequency), and loss of control over urination (called urge incontinence).
For the treatment of a condition called neurogenic detrusor overactivity in children and adolescents aged 3 to less than 18 years. Neurogenic detrusor overactivity is a condition in which involuntary detrusor contractions occur due to congenital disease or nerve damage controlling the urinary bladder. Untreated neurogenic detrusor overactivity may lead to damage of the urinary bladder and/or kidneys. Iretig is used to increase the amount of urine the bladder can hold and reduce urine leakage.

2. Important information before taking Iretig
When not to take Iretig

if you are allergic to mirabegron or any of the other ingredients of this medicine (listed in section 6).
if you have very high, uncontrolled blood pressure.

Warnings and precautions
Before starting Iretig, discuss this with your doctor or pharmacist.

if you have problems emptying your bladder or have a weak urine stream, or if you are taking other medicines for overactive bladder or neurogenic detrusor overactivity, such as anticholinergic agents.
if you have kidney or liver disease. Your doctor may reduce your dose or advise you not to take Iretig, especially if you are taking other medicines such as itraconazole, ketoconazole (fungal infections), ritonavir (HIV/AIDS), or clarithromycin (bacterial infections). Inform your doctor about all medicines you are taking.
if you have had an ECG (electrocardiogram) showing abnormalities known as QT prolongation, or if you are taking other medicines that prolong the QT interval, such as:
o medicines used to treat heart rhythm disorders, such as quinidine, sotalol, procainamide, ibutilide, flecainide, dofetilide, and amiodarone;
o medicines used for allergic rhinitis;
o antipsychotic medicines (used to treat mental illnesses), such as thioridazine, mesoridazine, haloperidol, and chlorpromazine;
o medicines used for infections, such as pentamidine, moxifloxacin, erythromycin, and clarithromycin.

Mirabegron may increase blood pressure or worsen existing hypertension. It is recommended that your doctor monitor your blood pressure during treatment with mirabegron.
Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age for the treatment of overactive bladder, as the safety and efficacy of mirabegron have not been established in this age group.
Iretig should not be used in children under 3 years of age for the treatment of neurogenic detrusor overactivity.
Iretig and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Iretig may affect how other medicines work, and other medicines may affect how Iretig works.

Tell your doctor if you are taking thioridazine (a medicine used for mental illness), propafenone or flecainide (medicines used for heart rhythm disorders), imipramine or desipramine (medicines used for depression). Your doctor may need to adjust the dose of these medicines.
Tell your doctor if you are taking digoxin (a medicine used for heart failure and heart rhythm disorders). Your doctor will monitor digoxin blood levels. If levels are abnormal, your doctor may adjust your digoxin dose.
Tell your doctor if you are taking dabigatran etexilate [a medicine used to reduce the risk of blood clots in the brain and body in patients with atrial fibrillation (irregular heartbeat) and additional risk factors]. Your doctor may need to adjust the dose of this medicine.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, do not take Iretig.
During breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine is likely to pass into human milk. You and your doctor should decide whether to take Iretig or to breastfeed. Do not breastfeed and take this medicine at the same time.
Driving and using machines
There is no data indicating the effect of Iretig on the ability to drive or operate machinery.

3. How to take Iretig

Always take this medicine exactly as your doctor has instructed. If in doubt, consult your doctor or pharmacist.
Use in adults with overactive bladder
The recommended dose is one 50 mg tablet taken orally once daily. If you have kidney or liver function impairment, your doctor may reduce the dose to one 25 mg tablet taken orally once daily. If your doctor prescribes 25 mg of mirabegron, you should take another available product containing 25 mg of mirabegron. Do not split the 50 mg tablet, as this may affect the medicine's performance.
Take the tablet with liquid and swallow it whole. Do not chew or crush the tablet. Iretig can be taken with or without food.
Use in children and adolescents (aged 3 to less than 18 years) with neurogenic detrusor overactivity
This medicine should be taken orally once daily. Take the tablet with liquid and swallow it whole. Do not crush or chew the tablet. Iretig should be taken with food. Your doctor will determine the dose appropriate for you/your child. The doctor will calculate the correct dose based on body weight. Follow these instructions exactly.
If you take more Iretig than you should
If you take more tablets than recommended, or if someone else accidentally takes the tablets, contact your doctor, pharmacist, or emergency services immediately.
Symptoms of overdose may include strong heartbeat, rapid pulse, or increased blood pressure.
If you forget to take Iretig
If you miss a dose, take it as soon as possible. If less than 12 hours remain before the next scheduled dose, do not take the missed dose; continue taking the medicine at your usual time.
Do not take a double dose to make up for a missed dose. If you miss several doses, consult your doctor and follow their advice.
Stopping Iretig treatment
Do not stop taking Iretig early if you do not see immediate results. It may take time for your bladder to adjust to the medicine. Continue taking the tablets. Do not stop taking the medicine once your bladder symptoms improve. Stopping treatment may result in a recurrence of overactive bladder or neurogenic detrusor overactivity symptoms.
Do not stop taking Iretig without consulting your doctor first, as symptoms of overactive bladder or neurogenic detrusor overactivity may return.
If you have any further questions about using 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.
The most serious adverse reaction is irregular heartbeat (atrial fibrillation). This is an adverse reaction
that occurs uncommonly (may occur in fewer than 1 in 100 patients). If this symptom occurs,
treatment must be stopped immediately and medical advice should be sought.
If headaches occur, especially sudden, pulsating migraine-type headaches, inform your doctor.
These may be symptoms of a significant increase in blood pressure.

Other adverse reactions:
Common adverse reactions (may occur in fewer than 1 in 10 people)

urinary tract infection
headache
dizziness
rapid heartbeat (tachycardia)
nausea
constipation
diarrhoea

Uncommon adverse reactions (may occur in fewer than 1 in 100 people)

vaginal infection
bladder infection (cystitis)
awareness of heartbeat (palpitations)
heart rhythm disorders (atrial fibrillation)
indigestion (dyspepsia)
stomach infection (gastritis)
itching, rash or urticaria (urticaria, rash, macular rash, papular rash, pruritus)
joint swelling
itching of the vagina or vulva (vaginal and vulval pruritus)
increased blood pressure
increased liver enzyme activity (GGT, AspAT and AlAT)

Rare adverse reactions (may occur in fewer than 1 in 1,000 people)

eyelid swelling (eyelid oedema)
lip swelling (lip oedema)
inflammation of small blood vessels, mainly in the skin (allergic vasculitis)
small purplish spots on the skin (purpura)
swelling of deeper skin layers, which may occur in various parts of the body, including face, tongue, throat, caused by fluid accumulation and possibly leading to breathing difficulties (angioedema)
inability to completely empty the bladder (urinary retention)

Very rare adverse reactions (may occur in fewer than 1 in 10,000 people)

very high blood pressure (hypertensive crisis)

Frequency not known (cannot be estimated from available data)

insomnia
confusion

If the patient has urinary outflow obstruction or is taking other medicines used to treat overactive
bladder symptoms, the medicine Iretig may increase the risk of urinary retention (the patient will
not be able to empty the bladder). If the patient cannot empty the bladder, they should inform their
doctor immediately.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or
pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 authorisation holder or its representative in
Poland.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Iretig

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following: EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Iretig contains

The active substance is mirabegron. Each tablet contains 50 mg of mirabegron.
The other ingredients are:
Tablet core: macrogol 2 000 000; microcrystalline cellulose (E460); hypromellose type 2208, K100 (E464); hydroxypropylcellulose; butylhydroxytoluene (E321); magnesium stearate (E572); colloidal anhydrous silica
Coating: polyvinyl alcohol; titanium dioxide (E171); macrogol 3350; talc (E553b); yellow iron oxide (E172); red iron oxide (E172)

What Iretig looks like and contents of the pack
Iretig 50 mg prolonged-release tablets are light yellow, elongated, biconvex tablets measuring approximately 6 mm × 13 mm.
Iretig is available in aluminium/OPA/aluminium/PVC blisters packed in cardboard boxes.
Pack sizes:
30, 90 or 100 prolonged-release tablets
Not all pack sizes may be marketed in a given country.

Marketing Authorisation Holder
Zentiva, k.s.,
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
PLA 3000, Paola
Malta
Adalvo Limited,
Malta Life Sciences Park, Building 1, Level 4
Sir Temi Zammit Buildings, San Gwann Industrial Estate
San Gwann, SGN 3000
Malta

This medicinal product is authorised in the countries of the European Economic Area under the following names:
Bulgaria, Croatia, Czech Republic, Greece, Iceland, Italy, Poland, Romania, Spain: Iretig (Иретиг)

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00