MIRABEGRON NORMON 50 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Mirabegron Normon50 mgprolonged-release tabletsEFG

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

1. What is Mirabegron Normon and what is it used for

Mirabegron 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 symptoms associated with an overactive bladder.

Mirabegron is used to treat 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 themselves when their bladder is full (called urge incontinence).

2. What you need to know before you take Mirabegron Normon

Do not take Mirabegron Normon

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take mirabegron

• If you have problems emptying your bladder or have a weak urine stream 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 mirabegron, especially if you are taking other medicines such as itraconazole, ketoconazole (for fungal infections), ritonavir (for HIV/AIDS) or clarithromycin (for bacterial infections). Inform 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 increase your blood pressure or worsen your blood pressure if you have a history of high blood pressure. It is recommended that your doctor check your blood pressure while you are taking mirabegron.

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 Mirabegron Normon

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

Mirabegron may affect how other medicines work, and other medicines may affect how mirabegron 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 in your blood 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 non-valvular 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

This medicine is likely to pass into breast milk. You and your doctor should decide whether to take mirabegron or breastfeed. Never 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 Mirabegron Normon

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with 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 one 25 mg tablet by mouth once a day. You should take this medicine with liquid and swallow the tablet whole. Do not crush or chew the tablet. Mirabegron can be taken with or without food.

If you take more Mirabegron Normon than you should

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

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

Among the symptoms of overdose may include a strong heartbeat, increased heart rate, and increased blood pressure.

If you forget to take Mirabegron Normon

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 forgotten dose. If you forget several doses, consult your doctor and follow their advice.

If you stop taking Mirabegron Normon

Do not stop taking mirabegron early if you do not see an immediate effect. Your bladder may need time to adapt. You should continue taking your tablets. Do not stop taking them when your bladder symptoms improve. Stopping treatment may lead to the recurrence of overactive bladder symptoms.

Do not stop taking mirabegron without consulting your doctor first, as your overactive bladder symptoms may return.

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.

Among the most serious side effects may include irregular heartbeat (atrial fibrillation). This is an uncommon side effect (may affect up to 1 in 100 people), but if this side effect occurs, stop taking the medicine immediately and seek urgent medical advice.

Consult your doctor if you experience headache, especially sudden, migraine-type (palpitations). They 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

Side effects of unknown frequency (frequency cannot be estimated from the available data)

• Insomnia
• Confusion

Mirabegron 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 to treat 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, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through their website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mirabegron Normon

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 blister and on the carton after “EXP”. The expiry date is the last day of the month stated.

No special storage conditions are required.

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

Composition of Mirabegron Normon

• The active substance is mirabegron. Each tablet contains 50 mg of mirabegron.
• The other ingredients are:

Core of the tablet: macrogols, hydroxypropylcellulose, butylhydroxytoluene, and magnesium stearate.

Coating: hypromellose, macrogol, talc, and yellow iron oxide (E-172).

Appearance and packaging

Mirabegron Normon 50 mg prolonged-release tablets EFG are yellow, elliptical tablets marked with «MRB» on one side and blank on the other, with dimensions of 12.0 mm ± 10% x 6.0 mm ± 10%.

Mirabegron Normon is available in single-dose blisters of Aluminum/Polyamide-Aluminum-PVC in packs containing 30 prolonged-release tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of last revision of this leaflet: April 2024

Other sources of information

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

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/89487/P_89487.html