Begirax

Package Leaflet: Information for the Patient

Begirax, 50 mg, Prolonged-Release Tablets

Mirabegron

Read the package leaflet carefully before taking the medicine, as 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Begirax and what is it used for
• 2. Important information before taking Begirax
• 3. How to take Begirax
• 4. Possible side effects
• 5. How to store Begirax
• 6. Contents of the pack and other information

1. What is Begirax and what is it used for

The active substance of Begirax is mirabegron. It is a bladder muscle relaxant (a beta-3 adrenergic receptor agonist) that reduces the activity of an overactive bladder and treats its associated symptoms.
Begirax 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 Begirax

When not to take Begirax:

• 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

Before taking Begirax, discuss with your doctor or pharmacist:

• if you have a problem with emptying your bladder or a weak urine stream, or if you are taking other medicines for overactive bladder symptoms, such as anticholinergic medicines.
• if you have kidney or liver problems. Your doctor may reduce your dose or tell you not to take Begirax, especially if you are taking other medicines, such as: itraconazole, ketoconazole (for fungal infections), ritonavir (for HIV/AIDS) or clarithromycin (for bacterial infections). You should tell your doctor about all medicines you are taking.
• if you have been told that you have an abnormality of the heart rhythm (called QT interval prolongation) or if you are taking other medicines that prolong the QT interval, such as: medicines used to treat irregular heartbeats, such as quinidine, sotalol, procainamide, ibutilide, flecainide, dofetilide and amiodarone; medicines used to treat allergic rhinitis; antipsychotic medicines (used to treat mental illnesses), such as thioridazine, mesoridazine, haloperidol and chlorpromazine; medicines used to treat infections, such as pentamidine, moxifloxacin, erythromycin and clarithromycin.

Mirabegron may increase your blood pressure or make high blood pressure worse. Your doctor should check your blood pressure while you are taking this medicine.

Children and adolescents

Do not take this medicine if you are under 18 years old, as the safety and efficacy of Begirax in this age group have not been established.

Begirax and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Begirax may affect the way other medicines work, and other medicines may affect the way Begirax works.

• Tell your doctor if you are taking thioridazine (a medicine used to treat mental illness), propafenone or flecainide (medicines used to treat irregular heartbeats), imipramine or desipramine (medicines used to treat depression). Your doctor may need to adjust the dose of these medicines.
• Tell your doctor if you are taking digoxin (a medicine used to treat heart failure and irregular heartbeats). Your doctor will monitor your digoxin levels. If the levels are abnormal, your doctor may adjust your digoxin dose.
• Tell your doctor if you are taking dabigatran etexilate (a medicine used to reduce the risk of blood clots in the brain and body in adults with irregular heartbeats and additional risk factors). Your doctor may need to adjust the dose of this medicine.

Pregnancy and breastfeeding

Do not take Begirax if you are pregnant or think you may be pregnant, or if you are planning to become pregnant.
If you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Begirax may pass into breast milk.
You and your doctor should decide whether you should take Begirax or breastfeed. You should not do both.

Driving and using machines

There is no data to suggest that Begirax affects your ability to drive or use machines.

3. How to take Begirax

Always 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 taken orally once a day. If you have kidney or liver problems, your doctor may reduce your dose to one 25 mg tablet taken orally once a day. If your doctor prescribes mirabegron 25 mg, you should use a different medicine containing 25 mg mirabegron.
Do not divide the 50 mg tablets, as this may affect the way the tablet works.
Take the tablet with a drink of water and swallow it whole. Do not chew or crush the tablet. Begirax can be taken with or without food.

If you take more Begirax 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.
Overdose symptoms may include a fast or irregular heartbeat, or high blood pressure.

If you forget to take Begirax

If you miss a dose, take it as soon as you remember. If it is less than 6 hours until your next dose, skip the missed dose and continue with your regular schedule.
Do not take a double dose to make up for a forgotten dose. If you miss several doses, consult your doctor.

If you stop taking Begirax

Do not stop taking Begirax during the initial treatment period, even if you do not see its effect. It may take time for your bladder to adjust to the medicine. Continue taking the tablets. Do not stop taking Begirax after your symptoms improve, as stopping treatment may cause your symptoms to return.
Do not stop taking Begirax without consulting your doctor, as your 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, Begirax can cause side effects, although not everybody gets them.
The most serious side effect is an irregular heartbeat (atrial fibrillation). This is an uncommon side effect (affects less than 1 in 100 people), but if it happens, you should stop taking the medicine and see your doctor immediately.
If you experience a headache, especially a sudden, severe, throbbing headache (migraine), tell your doctor. This could be a sign of a significant increase in blood pressure.
Other side effects:

• fast heart rate (tachycardia)
• urinary tract infection
• nausea
• constipation
• headache
• diarrhea
• dizziness.

Uncommon side effects (affects less than 1 in 100 people):

• bladder infection (cystitis)
• awareness of heartbeat (palpitations)
• vaginal infection
• indigestion
• stomach infection (gastritis)
• joint swelling
• itching of the vulva or vagina (pruritus vulvae or vagina)
• high blood pressure
• increased activity of liver enzymes (GGT, AspAT and AlAT)
• itching, rash or hives (urticaria, rash, erythema, rash papular, rash maculopapular, pruritus).

Rare side effects (affects less than 1 in 1000 people):

• swelling of the eyelids (periorbital oedema)
• swelling of the lips (lip oedema)
• swelling of the deeper layers of the skin, which can occur in various parts of the body, including the face, tongue, throat, 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 empty the bladder completely (urinary retention).

Very rare side effects (affects less than 1 in 10,000 people):

• hypertensive crisis.

Frequency not known: frequency cannot be estimated from the available data

• insomnia
• disorientation.

If you have a narrow urethra or are taking other medicines for overactive bladder symptoms, Begirax may increase the risk of urinary retention (you may not be able to empty your bladder). If you are unable to empty your bladder, you should tell your doctor immediately.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Begirax

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
There are no special storage conditions for this medicine.
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 Begirax 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; hydroxypropylcellulose, butylhydroxytoluene (E 321), magnesium stearate, silica colloidal anhydrous. Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172).

What Begirax looks like and contents of the pack

Begirax, 50 mg, prolonged-release tablets are yellow, oval, biconvex, film-coated tablets, approximately 6 mm in width and 13 mm in length.
Begirax is available in Aluminium/OPA/Aluminium/PVC blisters in a carton box.
Pack sizes:
10, 30, 50, 90 or 100 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Aristo Pharma Sp. z o.o.
Baletowa 30
02-867 Warsaw
Phone: +48 22 855 40 93
Manufacturer
Pharmadox Healthcare Ltd.
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

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

Iceland, Czech Republic, Poland
Begirax

Date of last revision of the leaflet: