IRETIG 50 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Iretig 50 mg prolonged-release tablets EFG

mirabegron

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Iretig and what is it used for
2. What you need to know before you take Iretig
3. How to take Iretig
4. Possible side effects
5. Storing Iretig
6. Contents of the pack and other information

1. What is Iretig and what is it used for

Iretig contains the active substance mirabegron. It is a medicine that relaxes the smooth muscle of the bladder (called a beta 3 adrenergic receptor agonist), which reduces the activity of an overactive bladder and treats the associated symptoms.

Iretig is used to treat the symptoms of an overactive bladder in adults who:

• suddenly need to empty their bladder (called urgency)
• need to empty their bladder more often than normal (called increased urination frequency)
• are unable to control when they empty their bladder (called urge incontinence)

2. What you need to know before you take Iretig

Do not takeIretig

• 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

Tell your doctor or pharmacist before you start taking Iretig:

• if you have problems emptying your bladder or have a weak urine flow or if you are taking other medicines for the treatment of an overactive bladder such as anticholinergic medicines.
• if you have kidney or liver problems. Your doctor may need to reduce the dose or may tell you not to take Iretig, especially if you are taking other medicines such as itraconazole, ketoconazole (for fungal infections), ritonavir (for HIV/AIDS) or clarithromycin (for bacterial infections). Tell your doctor about the medicines you are taking.
• if you have a known abnormality in your ECG (heart study) such as a prolonged QT interval or are taking any medicine known to cause such abnormality such as
• • medicines used for heart rhythm disorders such as quinidine, sotalol, procainamide, ibutilide, flecainide, dofetilide, and amiodarone;
  • medicines used for allergic rhinitis;
  • antipsychotic medicines (for mental illnesses) such as thioridazine, mesoridazine, haloperidol, and chlorpromazine;
  • anti-infective agents such as pentamidine, moxifloxacin, erythromycin, and clarithromycin.

Mirabegron may cause your blood pressure to increase or worsen if you have a history of high blood pressure. It is recommended that your doctor check your blood pressure while you are taking this medicine.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age because the safety and efficacy of mirabegron in this age group have not been established.

Other medicines and Iretig

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Iretig may affect how other medicines work, and other medicines may affect how Iretig works.

• Tell your doctor if you are using thioridazine (a medicine for mental illnesses), propafenone, or flecainide (medicines for heart rhythm disorders), imipramine, or desipramine (medicines used for depression). These specific medicines may require your doctor to adjust the dose.
• Tell your doctor if you are using digoxin (a medicine for heart failure or heart rhythm disorders). Your doctor will measure the levels of this medicine in your blood. If the level is outside the allowed range, your doctor will adjust the dose of digoxin.
• Tell your doctor if you are using dabigatran etexilate (a medicine used to reduce the risk of stroke or systemic embolism in patients with irregular heart rhythm (atrial fibrillation) and additional risk factors). Your doctor may need to adjust the dose of this medicine.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, 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 will decide whether to take Iretig or breastfeed. Do not do both.

Driving and using machines

There is no information to suggest that this medicine affects your ability to drive or use machines.

3. How to take Iretig

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 by mouth once a day. If you have kidney or liver problems, your doctor may need to reduce the dose to 25 mg by mouth once a day. If your doctor recommends you take 25 mg of mirabegron, you should use other medicines that contain 25 mg of mirabegron available on the market. Do not split the 50 mg tablet as this may affect how the medicine works.

Take this medicine with liquid and swallow the tablet whole. Do not crush or chew the tablet. Iretig can be taken with or without food.

If you take moreIretigthan you should

If you take more tablets than you should, or if someone else takes your tablets by mistake, contact your doctor, pharmacist, or hospital immediately.

Symptoms of overdose may include a strong heartbeat, increased heart rate, and increased blood pressure.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to takeIretig

If you forget to take your medicine, take the missed dose as soon as you remember. If it is less than 6 hours until your next scheduled dose, skip the missed dose and continue taking your medicine at the usual time.

Do not take a double dose to make up for a missed dose. If you miss several doses, talk to your doctor and follow their advice.

If you stop taking Iretig

Do not stop taking Iretig early if you do not see an immediate effect. Your bladder may need time to adjust. Keep taking your tablets. Do not stop taking them when your bladder symptoms improve. Stopping treatment may cause the symptoms of an overactive bladder to return.

Do not stop taking Iretig without talking to your doctor first, as your symptoms may return.

If you have any other questions about 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.

One of the more serious side effects can be an irregular heartbeat (atrial fibrillation). This is an uncommon side effect (affecting up to 1 in 100 people), but if this side effect occurs, stop taking the medicine immediately and seek urgent medical advice. Talk to your doctor if you experience headache, especially sudden, migraine-like (palpitations). These may be signs of very high blood pressure.

Other side effects include:

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

• Increased heart rate (tachycardia)
• Infection of the urinary tract (urinary tract infections)
• Nausea
• Constipation
• Headache
• Diarrhea
• Dizziness

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

• Bladder infection (cystitis)
• Feeling of heartbeats (palpitations)
• Vaginal infection
• Indigestion (dyspepsia)
• Stomach infection (gastritis)
• Swelling of the joints
• Itching in the vulva or vagina (vulvovaginal pruritus)
• Increased blood pressure
• Increased liver enzymes (GGT, AST, and ALT)
• Itching, rash, or hives (urticaria, rash, macular rash, papular rash, pruritus)

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

• Swelling of the eyelids (eyelid edema)
• Swelling of the lips (lip edema)
• Swelling of the inner layers of the skin caused by fluid accumulation, which can affect any part 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 that mainly affects the skin (leukocytoclastic vasculitis)
• Inability to empty the bladder completely (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

Iretig may increase the possibility of not being able to empty your bladder if you have a blockage of the bladder outlet or if you are taking other medicines for the treatment of an overactive bladder. Tell your doctor immediately if you are unable to empty your bladder.

Reporting of side effects

If you experience 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 to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What is in Iretig

• The active substance is mirabegron. Each tablet contains 50 mg of mirabegron.
• The other ingredients are:
• • Tablet core: high molecular weight macrogol 2,000,000, microcrystalline cellulose (E460); hypromellose type 2.208, K100 (E464); hydroxypropylcellulose; butylhydroxytoluene; magnesium stearate (E572); anhydrous colloidal silica.
  • Coating: poly(vinyl alcohol); titanium dioxide (E171); macrogol 3,350; talc (E553b); yellow iron oxide (E172) and red iron oxide (E172)

Appearance and packaging

Iretig 50 mg prolonged-release tablets are pale yellow, biconvex, oblong tablets, approximately 6 x 13 mm in length.

Iretig is available in cartons with Alu-OPA/Alu/PVC blisters.

Package sizes:

30, 90, or 100 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Zentiva, k.s.

U Kabelovny 130

Dolní Mecholupy

102 37 Prague 10

Czech Republic

Manufacturer

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

Or

Adalvo Limited,

Life Sciences Park, Building 1, Level 4, Sir Temi Zammit Buildings,

San Gwann, SGN 3000,

Malta

You can ask for more information about this medicine from the local representative of the marketing authorisation holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: July 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/