Package leaflet: Information for the user

Mirabegron Teva, 50 mg, prolonged-release tablets
mirabegron
Please read all of this leaflet carefully before 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 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.
Contents of the leaflet:
What Mirabegron Teva is and what it is used for
What you need to know 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 Mirabegron Teva is and what it is used for

The active substance in Mirabegron Teva is mirabegron. It is a drug that relaxes the bladder muscles
(a so-called beta 3-adrenergic receptor agonist), which reduces overactivity of the bladder and treats
the associated symptoms.
Mirabegron Teva is used in adults to treat the symptoms of a condition called overactive bladder.
These symptoms include a sudden need to pass urine (called urgency), needing to pass urine more
often than usual (called frequency), and loss of control over passing urine (called urge incontinence).

2. Important information before taking Mirabegron Teva

When not to take Mirabegron Teva
if the patient is allergic to mirabegron or any of the other ingredients of this
medicine (listed in section 6),
if the patient has very high, uncontrolled blood pressure.

Warnings and precautions
Before starting Mirabegron Teva, discuss with your doctor or pharmacist if:
the patient has problems emptying the bladder or has a weak urine stream,
the patient is taking other medicines used to treat symptoms of overactive bladder
or neurogenic detrusor overactivity (a condition in which involuntary bladder contractions occur due to a congenital disease or nerve damage affecting bladder control), such as anticholinergic medicines,
the patient has kidney or liver problems. The doctor may reduce the dose or advise the patient not to take Mirabegron Teva, especially if the patient is taking other medicines such as itraconazole, ketoconazole (for fungal infections), ritonavir (for HIV/AIDS), or clarithromycin (for bacterial infections). Inform the doctor about all medicines being taken.
the patient has abnormalities in an ECG (electrocardiogram) test known as QT interval prolongation, or if the patient is taking other medicines that prolong the QT interval, such as:

medicines used to treat heart rhythm disorders, such as quinidine, sotalol, procainamide, ibutilide, flecainide, dofetilide, and amiodarone;
medicines used for allergic rhinitis;
antipsychotic medicines (medicines used to treat psychiatric disorders), such as thioridazine, mesoridazine, haloperidol, and chlorpromazine;
medicines used for infections, such as pentamidine, moxifloxacin, erythromycin, and clarithromycin.

Mirabegron Teva may increase blood pressure or worsen pre-existing hypertension. It is recommended that the doctor monitor blood pressure during treatment with this medicine.

Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age for the treatment of overactive bladder, as the safety and efficacy of the medicine have not been established in this patient group.
Mirabegron should not be used in children under 3 years of age for the treatment of neurogenic detrusor overactivity.

Mirabegron Teva and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Mirabegron Teva may affect how other medicines work, and other medicines may affect how this medicine works.
Tell the doctor if the patient is taking thioridazine (a medicine used for psychiatric disorders), propafenone, or flecainide (medicines used for heart rhythm disorders), imipramine, or desipramine (medicines used for depression). The doctor may need to adjust the dose of these medicines.
Tell the doctor if the patient is taking digoxin (a medicine used for heart failure and heart rhythm disorders). The doctor will monitor digoxin levels in the blood. If blood levels are abnormal, the doctor may adjust the digoxin dose.
Tell the doctor if the patient is taking dabigatran etexilate [a medicine used to reduce the risk of blood clots in the brain and body in patients with atrial fibrillation (irregular heartbeat) and additional risk factors]. The doctor may need to adjust the dose of this medicine.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she must not take Mirabegron Teva.
During breastfeeding, consult a doctor or pharmacist before taking this medicine.
This medicine is likely to pass into human milk. The patient and her doctor should decide whether to take Mirabegron Teva or to breastfeed. The patient should not breastfeed and take this medicine at the same time.

Driving and operating machinery
There are no data indicating an effect of Mirabegron Teva on the ability to drive or operate machinery.

3. How to take Mirabegron Teva

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

The recommended dose is one 50 mg tablet taken orally once daily. If the patient has impaired kidney or liver function, the treating physician may reduce the dose to one 25 mg tablet taken orally once daily. If your doctor recommends taking 25 mg of mirabegron, the patient should use another medicinal product available on the market containing 25 mg of mirabegron. Do not split the 50 mg tablet, as this may affect the medicine's performance.

This medicine should be taken with liquid and swallowed whole. Do not chew or crush the tablets. Mirabegron Teva can be taken independently of meals.

Taking more Mirabegron Teva than recommended
If more tablets have been taken than recommended, or if someone else accidentally takes the tablets, contact your doctor, pharmacist, or call emergency services immediately.

Symptoms of overdose may include a sensation of strong heartbeat, increased heart rate, or elevated blood pressure.

Missing a dose of Mirabegron Teva
If a dose is missed, take it as soon as possible. However, if less than 6 hours remain before the next scheduled dose, skip the missed dose and continue with the regular dosing schedule. Do not take a double dose to make up for a missed dose. If several doses have been missed, consult your doctor and follow their advice.

Stopping treatment with Mirabegron Teva
Do not discontinue treatment with Mirabegron Teva early if immediate effects are not observed. It may take time for the bladder to adjust to the medicine. Continue taking the tablets as prescribed. Do not stop taking the medicine once bladder symptoms improve. Discontinuing treatment may result in a recurrence of overactive bladder symptoms.

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

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The most serious adverse reaction is irregular heartbeat (atrial fibrillation). This is an adverse reaction that occurs uncommonly (may occur in no more than 1 in 100 people). If this symptom occurs, treatment must be stopped immediately and medical advice must be sought.
If headache occurs, especially sudden, pulsating migraine-type headache, inform your doctor. This may be a sign of significant increase in blood pressure.

Other adverse reactions:
Common adverse reactions (may occur in no more than 1 in 10 people)
urinary tract infection (urinary tract infections)
headache
dizziness
increased heart rate (tachycardia)
nausea
constipation
diarrhea

Uncommon adverse reactions (may occur in no more than 1 in 100 people)
vaginal infection
bladder infection (cystitis)
palpitations
heart rhythm disorders (atrial fibrillation)
dyspepsia
gastric infection (gastritis)
itching, rash or urticaria (urticaria, rash, macular rash, papular rash, pruritus)
joint swelling
itching of the vulva or vagina (vulvar and vaginal pruritus)
elevated blood pressure
increased liver enzyme activity (GGT, AspAT and AlAT)

Rare adverse reactions (may occur in no more than 1 in 1,000 people)
eyelid swelling (periorbital edema)
lip swelling (angioedema of lips)
inflammation of small blood vessels, mainly in the skin (allergic vasculitis)
small purplish spots on the skin (purpura)
swelling of deeper layers of skin, which may occur in various parts of the body, including face, tongue or throat, caused by fluid accumulation and potentially causing breathing difficulties (angioedema)
inability to completely empty the bladder (urinary retention)

Very rare adverse reactions (may occur in no more than 1 in 10,000 people)
very high blood pressure (hypertensive crisis)

Frequency not known (cannot be estimated from available data)

insomnia
disorientation

If a patient has urinary outflow obstruction from the bladder or is taking other medications used to treat overactive bladder symptoms, Mirabegron Teva may increase the risk of inability to empty the bladder. If the patient cannot empty the bladder, they should immediately inform their doctor.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, PL-02-222 Warsaw
Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Mirabegron Teva

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack following:
Expiry date (EXP). The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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: polyethylene glycol 2 000 000; microcrystalline cellulose; hypromellose type 2208,
K100; hydroxypropylcellulose; butylhydroxytoluene (E 321); magnesium stearate;
colloidal anhydrous silica.
Tablet coating: polyvinyl alcohol; titanium dioxide (E 171); polyethylene glycol 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, elongated, biconvex coated tablets, approximately 6 x 13 mm in size.
Mirabegron Teva is available in blisters made of Aluminium/OPA/Aluminium/PVC, packed in cardboard boxes.
Pack sizes:
10, 30, 50, 90 or 100 prolonged-release tablets.
Not all pack sizes may be marketed in every country.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

For further information, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw
tel.: (22) 345 93 00