Mirabegron Teva

Package Leaflet: Information for the Patient

Mirabegron Teva, 50 mg, Prolonged-Release Tablets

Mirabegron

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains

Important Information for the Patient.
Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medication has been prescribed to you by a doctor. 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

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

The active substance of Mirabegron Teva is mirabegron. It is a urinary bladder muscle relaxant (also known as a beta-3 adrenergic receptor agonist), which reduces the activity of an overactive urinary bladder and treats its associated symptoms.
Mirabegron Teva is used in adults to treat symptoms of an overactive bladder, such as:
sudden urge to urinate (called urgency)
need to urinate more often than usual (called frequency)
loss of control over urination (called urge incontinence)

2. Important information before taking Mirabegron Teva

When Not to Take Mirabegron Teva

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

Warnings and Precautions

Before starting to take Mirabegron Teva, discuss it with your doctor or pharmacist:
if you have a problem with emptying your bladder or if your urine flow is weak, or if you are taking other medications for the treatment of overactive bladder symptoms, such as anticholinergic medications.
if you have kidney or liver problems. Your doctor may reduce the dose or tell you not to take Mirabegron Teva, especially if you are taking other medications, such as itraconazole, ketoconazole (fungal infections), ritonavir (HIV/AIDS), or clarithromycin (bacterial infections). You should inform your doctor about all medications you are taking.
if you have been diagnosed with irregular heartbeats (known as QT interval prolongation) or if you are taking other medications that prolong the QT interval, such as:
o
medications used to treat heart rhythm disorders, such as quinidine, sotalol, procainamide, ibutilide, flecainide, dofetilide, and amiodarone;
o
medications used to treat allergic rhinitis;
o
antipsychotic medications (used to treat mental illnesses), such as thioridazine, mesoridazine, haloperidol, and chlorpromazine;
o
medications used to treat infections, such as pentamidine, moxifloxacin, erythromycin, and clarithromycin.
Mirabegron may increase blood pressure or worsen existing high blood pressure. It is recommended that your doctor measures your blood pressure while taking this medication.

Children and Adolescents

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

Mirabegron Teva and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Mirabegron Teva may affect the way other medications work, and other medications may affect the way Mirabegron Teva works.
Tell your doctor if you are taking thioridazine (a medication used to treat mental illness), propafenone, or flecainide (medications used to treat heart rhythm disorders), imipramine or desipramine (medications used to treat depression). Your doctor may need to adjust the dose of these medications.
Tell your doctor if you are taking digoxin (a medication used to treat heart failure and heart rhythm disorders). Your doctor will monitor your digoxin levels in your blood. If the levels are abnormal, your doctor may adjust the dose of digoxin.
Tell your doctor if you are taking dabigatran etexilate (a medication used to reduce the risk of blood clots in the brain and body in adults with irregular heartbeats). Your doctor may need to adjust the dose of this medication.

Pregnancy and Breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, do not take Mirabegron Teva.
During breastfeeding, consult your doctor or pharmacist before taking this medication. This medication is likely to pass into breast milk. You and your doctor should decide whether to take Mirabegron Teva or breastfeed. Do not do both at the same time.

Driving and Using Machines

There is no data on the effect of Mirabegron Teva on the ability to drive and use machines.

3. How to Take Mirabegron Teva

Always take this medication exactly as your doctor has told you. If you are unsure, consult 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 recommends taking 25 mg of mirabegron, you should use other available medicinal products containing a 25 mg dose of mirabegron. Do not split the 50 mg tablet, as this may affect the medication's action.
Take this medication with a drink of water and swallow the tablet whole. Do not chew or crush the tablets. Mirabegron Teva can be taken with or without food.

Taking More Mirabegron Teva Than Recommended

If you have taken more tablets than recommended or if someone else has taken your tablets, contact your doctor, pharmacist, or emergency services immediately.
Overdose symptoms may include a feeling of a strong heartbeat, rapid heartbeat, or increased blood pressure.

Missing a Dose of Mirabegron Teva

If you miss a dose, take it as soon as possible. If it is less than 6 hours before your next dose, do not take the missed dose, just continue with your regular dosing 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 Mirabegron Teva Treatment

Do not stop taking Mirabegron Teva in the initial period if you do not see its immediate effect. It may take time for your bladder to adjust to the medication.
Continue taking the tablets. Do not stop taking the medication after your symptoms improve. Stopping treatment may result in the return of overactive bladder symptoms.
Do not stop taking Mirabegron Teva without consulting your doctor first, as your overactive bladder symptoms may return.
If you have any further doubts about taking this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Mirabegron Teva 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 no more than 1 in 100 people), but if it occurs, stop treatment and consult your doctor immediately.
If you experience a headache, especially a sudden, throbbing headache like a migraine, tell your doctor. This may be a sign of significantly increased blood pressure.

Common Side Effects (May Affect Up to 1 in 10 People)

• -rapid heartbeat (tachycardia) urinary tract infections (UTIs) nausea constipation headache diarrhea dizziness

Uncommon Side Effects (May Affect Up to 1 in 100 People)

urinary bladder infection (cystitis)
palpitations (heart pounding)
vaginal infection
indigestion
stomach infection (gastritis)
joint swelling
itching of the vulva or vagina (vulvar or vaginal itching)
increased blood pressure
increased liver enzyme activity (GGT, AspAT, and AlAT)
itching, rash, or hives (hives, rash, erythema, urticaria, 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 deeper layers of the skin, which may occur in various parts of the body, including the face, tongue, or throat, caused by fluid accumulation and may cause difficulty breathing (angioedema)
small purple spots on the skin (purpura)
inflammation of small blood vessels, mainly in the skin (allergic vasculitis)
inability to completely 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 disorientation

If you have a narrowing of the urethra or are taking other medications for the treatment of overactive bladder symptoms, Mirabegron Teva may increase the risk of urinary retention. If you are unable to empty your bladder, tell your doctor immediately.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, PL-02-222 Warsaw
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Mirabegron Teva

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the carton or blister after EXP.
There are no special storage instructions for this medication.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Mirabegron Teva 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; hypromellose type 2208, K100; hydroxypropyl cellulose; butylhydroxytoluene (E 321); magnesium stearate; silica, colloidal anhydrous.
Tablet coating: polyvinyl alcohol; titanium dioxide (E 171), macrogol 3350, talc; iron oxide yellow (E 172), iron oxide red (E 172).

What Mirabegron Teva Looks Like and Contents of the Pack

Mirabegron Teva, 50 mg, prolonged-release tablets are light yellow, oval, biconvex, film-coated tablets, approximately 6 x 13 mm in size.
Mirabegron Teva is available in blisters of aluminum/OPA/aluminum/PVC, packaged in cardboard boxes.
Pack sizes: 10, 30, 50, 90, or 100 prolonged-release tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany

Manufacturer

Pharmadox Healthcare Limited
Kw20a Kordin Industrial Park
Paola, PLA 3000
Malta
Adalvo Limited
Malta Life Sciences Park Building 1 Level 4
Sir Temi Zammit Buildings
San Gwann Industrial Estate
San Gwann, SGN 3000
Malta
To obtain more detailed information, please contact the local representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw
phone: (22) 345 93 00

Date of Last Revision of the Leaflet: