Iretig

Package Leaflet: Information for the Patient

Iretig, 50 mg, Prolonged-Release Tablets

Mirabegron

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Iretig and what is it used for

The active substance of Iretig is mirabegron. It is a bladder muscle relaxant (a beta-3 adrenergic receptor agonist) that reduces the activity of an overactive bladder and treats its symptoms.
Iretig is used in adults to treat symptoms of an overactive bladder such as:

• sudden need to urinate (called urgent urination)
• need to urinate more often than usual (called frequent urination)
• loss of control over urination (called urgent incontinence)

2. Important information before taking Iretig

When not to take Iretig

Warnings and precautions

Before starting to take Iretig, discuss it with your doctor or pharmacist.

Mirabegron may increase blood pressure or worsen existing high blood pressure.
Your doctor should check your blood pressure while you are taking mirabegron.

Children and adolescents

Do not use Iretig in children and adolescents under 18 years of age, as the safety and efficacy of the medicine in this age group have not been established.

Iretig and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Iretig may affect the way other medicines work, and other medicines may affect the way Iretig works.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, do not take Iretig.
If you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
This medicine may pass into breast milk. You and your doctor should decide whether to take Iretig or breastfeed. You should not do both.

Driving and using machines

There is no data on the effect of Iretig on the ability to drive or use machines.

3. How to take Iretig

Always take this medicine exactly as your doctor has told you.
If you are not sure, ask your doctor or pharmacist.
The recommended dose is one 50 mg tablet taken orally once a day. If you have kidney or liver problems, your doctor may reduce the dose to one 25 mg tablet taken orally once a day. If your doctor has prescribed 25 mg of mirabegron, you should take other mirabegron 25 mg tablets available on the market. Do not split the 50 mg tablets, as this may affect the way the medicine works.
Take the tablet with a drink of water and swallow it whole. Do not chew or crush the tablets. Iretig can be taken with or without food.

Taking more Iretig than prescribed

If you take more tablets than prescribed or if someone else takes your tablets, contact your doctor, pharmacist, or emergency services immediately.
Overdose symptoms may include a strong heartbeat, rapid heartbeat, or increased blood pressure.

Missing a dose of Iretig

If you miss a dose, take it as soon as possible. However, if it is less than 6 hours until your next dose, skip the missed dose and continue with your regular schedule.
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 in the initial period if you do not see its immediate effect. It may take time for your bladder to adjust to the medicine. Continue taking the tablets. Do not stop taking Iretig after your symptoms improve. Stopping treatment may cause your overactive bladder symptoms to return.
Do not stop taking Iretig without consulting your doctor first, as your overactive bladder symptoms may return.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Iretig can cause side effects, although not everybody gets them.
The most serious side effect is irregular heartbeat (atrial fibrillation). This is an uncommon side effect (affects less than 1 in 100 people), but if it happens, stop taking Iretig and see a doctor immediately.
If you experience headaches, especially sudden, pulsating headaches like migraines, tell your doctor. These may be symptoms of significantly increased blood pressure.

Other side effects:

Common side effects (may affect up to 1 in 10 people)

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

Uncommon side effects (may affect up to 1 in 100 people)

• urinary tract infection (cystitis)
• feeling of heartbeat (palpitations)
• vaginal infection
• indigestion (dyspepsia)
• stomach infection (gastritis)
• joint swelling
• vaginal or vulval itching (vulval or vaginal pruritus)
• increased blood pressure
• increased liver enzyme activity (GGT, AspAT, and AlAT)
• itching, rash, or hives (urticaria, rash, erythema, or pruritus)

Rare side effects (may affect up to 1 in 1,000 people)

• swelling of the eyelids (periorbital edema)
• swelling of the lips (lip edema)
• swelling of the deeper layers of the skin, which can occur in various parts of the body, including the face, tongue, or throat, and can cause difficulty breathing (angioedema)
• small purple spots on the skin (purpura)
• inflammation of small blood vessels, mainly in the skin (allergic vasculitis)
• inability to fully empty the bladder (urinary retention)

Very rare side effects (may affect up to 1 in 10,000 people)

• hypertensive crisis

Frequency not known (cannot be estimated from the available data)

• insomnia
• confusion

If you have a blockage of the bladder outlet or if you are taking other medicines for the treatment of overactive bladder symptoms, Iretig may increase the risk of urinary retention (you may not be able to empty your bladder). If you cannot empty your bladder, tell your doctor immediately.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Iretig

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 carton and blister after EXP.
The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Medicines should 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 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, film-coated tablets, approximately 6 mm x 13 mm in size.
Iretig is available in aluminum/OPA/aluminum/PVC blisters in cardboard boxes.
Pack sizes: 30, 90, or 100 prolonged-release tablets.
Not all pack sizes may be marketed in your country.

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Iceland, Czech Republic, Greece, Poland, Italy: Iretig
Bulgaria: Иретиг 50 mg таблетки с удължено освобождаване;
Iretig 50 mg prolonged-release tablets
Spain: Iretig 50 mg comprimidos de liberación prolongada
Croatia: Iretig 50 mg tablete s produljenim oslobađanjem
Romania: Iretig 50mg, comprimate cu eliberare prelungita
For more information about this medicine, contact the local representative of the marketing authorization holder:
Zentiva Polska Sp. z o.o.
Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00

Date of last revision of the leaflet: