BETMIGA 50mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Betmiga 25mg prolonged-release tablets

Betmiga 50mg prolonged-release tablets

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

1. What is Betmiga and what is it used for

Betmiga 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 and reduces neurogenic detrusor overactivity.

Betmiga is used to:

• treat the symptoms of a condition called overactive bladder in adults.

These symptoms include: sudden need to empty your bladder (called urgency), having to empty your bladder more often than normal (called increased urination frequency), being unable to control when you empty your bladder (called urge incontinence).

• treat a condition called neurogenic detrusor overactivity in children aged 3 years and older and less than 18 years. Neurogenic detrusor overactivity is a condition where there are involuntary contractions of the bladder due to a birth defect or injury to the nerves that control the bladder. If left untreated, neurogenic detrusor overactivity can cause damage to the bladder and/or kidneys. Betmiga is used to increase the amount of urine that the bladder can hold and reduce urine leakage.

2. What you need to know before you take Betmiga

Do not take Betmiga:

• 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 Betmiga

• if you have problems emptying your bladder or have a weak stream of urine or if you are taking other medicines for the treatment of overactive bladder or neurogenic detrusor overactivity, 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 Betmiga, 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, for example, quinidine, sotalol, procainamide, ibutilide, flecainide, dofetilide and amiodarone;
• medicines used for allergic rhinitis;
• antipsychotic medicines (medicines for mental illnesses) such as, for example, thioridazine, mesoridazine, haloperidol and chlorpromazine;
• anti-infective agents such as, for example, pentamidine, moxifloxacin, erythromycin and clarithromycin.

Betmiga may make your blood pressure increase or make your high blood pressure worse 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 for the treatment of overactive bladder as the safety and efficacy of Betmiga in this population have not been established.

Betmiga should not be used in children under 3 years for the treatment of neurogenic detrusor overactivity.

Other medicines and Betmiga

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

Betmiga may affect how other medicines work, and other medicines may affect how Betmiga 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 by blood clots in patients with irregular heartbeat (atrial fibrillation) and additional risk factors). Your doctor may need to adjust the dose of this medicine.

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.

If you are breast-feeding, consult your doctor or pharmacist before using this medicine. This medicine is likely to pass into breast milk. You and your doctor should decide whether to take Betmiga or breast-feed. You should 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 Betmiga

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Use in adults with overactive bladder

The recommended dose is one 50 mg tablet once daily. If you have kidney or liver problems, your doctor may need to reduce the dose to one 25 mg tablet once daily. You should take this medicine with liquid and swallow the tablet whole. Do not crush or chew the tablet. Betmiga can be taken with or without food.

Use in children and adolescents (aged 3 and older and less than 18 years) with neurogenic detrusor overactivity

Take this medicine once daily by mouth. You should take this medicine with liquid and swallow the tablet whole. Do not crush or chew the tablet. Betmiga should be taken with food. Your doctor will tell you what dose your child should take. The doctor will calculate the correct dose for the patient based on their body weight. You should follow their instructions carefully.

If you take more Betmiga than you should

If you have taken more tablets than you should, or if someone else has taken your tablets, contact your doctor, pharmacist or hospital immediately.

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

If you forget to take Betmiga

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 Betmiga

Do not stop taking Betmiga early if you do not see an immediate effect. Your bladder may need time to adapt. You should keep taking your tablets. Do not stop taking them when your bladder symptoms improve. Stopping treatment may lead to the return of overactive bladder or neurogenic detrusor overactivity symptoms.

Do not stop taking Betmiga without first talking to your doctor, as your overactive bladder or neurogenic detrusor overactivity symptoms may return.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most serious side effects may include 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.

Tell your doctor if you experience headache, especially sudden, migraine-type (palpitations). These may be signs of very high blood pressure.

Other side effects include:

Common(may affect up to 1 in 10 people)

• infection of the urinary tract (urinary tract infections)
• headache
• dizziness
• increased heart rate (tachycardia)
• feeling sick (nausea)
• constipation
• diarrhoea

Uncommon(may affect up to 1 in 100 people)

• vaginal infection
• bladder infection (cystitis)
• feeling of heartbeat (palpitations)
• heart rhythm problems (atrial fibrillation)
• indigestion (dyspepsia)
• stomach infection (gastritis)
• itching, rash or hives (urticaria, rash, macular rash, papular rash, pruritus)
• swelling of the joints
• itching of the vulva or vagina (vulvovaginal pruritus)
• increased blood pressure
• increased liver enzymes (GGT, AST and ALT)

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

• swelling of the eyelids (eyelid oedema)
• swelling of the lips (lip oedema)
• inflammation of small blood vessels that mainly affects the skin (leucocytoclastic vasculitis)
• small purple spots on the skin (purpura)
• swelling of the deeper layers of the skin caused by a build-up of fluid, which can affect any part of the body including the face, tongue or throat and can cause difficulty breathing (angioedema)
• inability to empty the bladder completely (urinary retention)

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

• very high blood pressure (hypertensive crisis)

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

• insomnia
• confusion

Betmiga may increase the chance of being unable to empty your bladder if you have a blockage of the bladder outlet or if you are taking other medicines for the treatment of overactive bladder or neurogenic detrusor overactivity. Tell your doctor immediately if you are unable to empty your bladder.

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 listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Betmiga

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 or blister after EXP. The expiry date refers to the last day of the month shown.

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 Betmiga contains

• The active substance is mirabegron.

Betmiga 25 mg prolonged-release tablets

Each tablet contains 25 mg of mirabegron.

Betmiga 50 mg prolonged-release tablets

Each tablet contains 50 mg of mirabegron.

• The other ingredients are:

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

Coating: hypromellose, macrogol, yellow iron oxide (E172), red iron oxide (E172) (only 25 mg tablets).

Appearance and packaging

Betmiga 25 mg prolonged-release tablets are brown, oval, film-coated tablets marked with the company logo and «325» on the same side.

Betmiga 50 mg prolonged-release tablets are yellow, oval, film-coated tablets marked with the company logo and «355» on the same side.

Betmiga is available in aluminium-aluminium blister packs containing 10, 20, 30, 50, 60, 90, 100 or 200 tablets.

Not all pack sizes may be marketed in your country.

Marketing authorisation holder

Astellas Pharma Europe B.V.

Sylviusweg 62

2333 BE Leiden

Netherlands

Manufacturer

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

Netherlands

You can get more information on this medicine by contacting the representative of the marketing authorisation holder in your country.

Date of last revision of this leaflet:{MM/AAAA}.

Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu.