Begirax

Patient Information Leaflet

Begirax, 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, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm other people, 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 this leaflet:

1. What Begirax is and what it is used for
2. What you need to know 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 Begirax is and what it is used for

The active substance in Begirax is mirabegron. It is a medicine that relaxes the bladder muscles (a so-called beta 3-adrenergic receptor agonist), which reduces overactivity of the bladder and treats associated symptoms.
Begirax is used in adults to treat symptoms of overactive bladder such as:

• sudden urge to urinate (called urgency)
• need to urinate more often than usual (called frequency)
• loss of bladder control (called urge incontinence)

2. Important information before using Begirax

When not to use Begirax:

• 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 treatment with Begirax, discuss this with a doctor or pharmacist:

• if the patient has difficulty emptying the bladder or has a weak urine stream, or if the patient is taking other medicines for overactive bladder symptoms, such as anticholinergic medicines,
• if the patient has kidney or liver problems. The doctor may reduce the dose or advise against using Begirax, especially if the patient is taking other medicines such as: itraconazole, ketoconazole (for fungal infections), ritonavir (HIV/AIDS), or clarithromycin (bacterial infections). Inform the doctor about all medicines being taken.
• if the patient has been diagnosed with abnormalities on ECG (electrocardiogram) 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;
  – antipsychotics (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 may increase blood pressure or worsen existing hypertension. It is recommended that the doctor regularly monitor blood pressure during treatment with this medicine.

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

Begirax and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Begirax may affect how other medicines work, and other medicines may affect how Begirax works.

• Inform 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). Dose adjustments of these medicines may be necessary.
• Inform the doctor if the patient is taking digoxin (a medicine used for heart failure and heart rhythm disorders). The doctor will monitor digoxin blood levels. If blood levels are abnormal, the doctor may adjust the digoxin dose.
• Inform 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 adult patients with atrial fibrillation and additional risk factors). Dose adjustment of this medicine may be necessary.

Pregnancy and breastfeeding
Do not use Begirax during pregnancy, if pregnancy is suspected, or when planning a pregnancy.
During breastfeeding, consult a doctor or pharmacist before using this medicine. This medicine is likely to pass into human milk.
The patient and doctor should decide whether to take Begirax or to breastfeed.
Do not breastfeed and take this medicine at the same time.

Driving and operating machinery
There are no data indicating any influence of Begirax on the ability to drive or operate machinery.

3. How to use Begirax

This medicine should always be taken exactly as prescribed by the 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 renal or hepatic function, the prescribing doctor may reduce the dose to one
25 mg tablet taken orally once daily. In cases where mirabegron 25 mg is prescribed, another
available medicinal product containing 25 mg of mirabegron should be used.
The 50 mg tablets must not be divided, as this may affect the way the tablet works.
The tablet should be taken with liquid and swallowed whole. The tablets must not be
chewed or crushed. Begirax may be taken independently of meals.
Taking more Begirax than recommended
If more tablets than prescribed have been taken, or if someone else accidentally takes the tablets,
seek immediate medical advice from a doctor or pharmacist, or call emergency services.
Symptoms of overdose may include a sensation of strong heartbeat, increased heart rate, or
elevated blood pressure.
If you miss a dose of Begirax
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.
Stopping treatment with Begirax
Do not stop taking Begirax during the initial phase of treatment if no effect is seen. It may take time
for the bladder to adjust to the medication. Continue taking the tablets as prescribed. Do not
discontinue treatment once bladder symptoms have improved. Stopping treatment may result in
a recurrence of overactive bladder symptoms.
Do not discontinue treatment with Begirax without first consulting your doctor, as overactive
bladder symptoms may return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
The most serious adverse effect is irregular heartbeat (atrial fibrillation). This is an adverse effect that occurs uncommonly (may occur less frequently than in 1 out of 100 patients). If this symptom occurs, treatment must be stopped immediately and medical advice must be sought.
If headache occurs, especially a sudden, pulsating migraine-type headache, inform your doctor. This may be a sign of a significant increase in blood pressure.

Other adverse effects:
Common adverse effects (may occur in no more than 1 in 10 patients):

• increased heart rate (tachycardia)
• urinary tract infection
• nausea
• constipation
• headache
• diarrhoea
• dizziness.

Uncommon adverse effects (may occur in no more than 1 in 100 patients):

• bladder infection (cystitis)
• palpitations (awareness of heartbeat)
• vaginal infection
• dyspepsia
• stomach infection (gastritis)
• joint swelling
• itching of the vulva or vagina (vulvar and vaginal pruritus)
• increased blood pressure
• increased liver enzyme activity (GGT, AspAT and AlAT)
• itching, rash or urticaria (urticaria, rash, macular rash, papular rash, pruritus).

Rare adverse effects (may occur in no more than 1 in 1,000 patients):

• eyelid swelling (periorbital oedema)
• lip swelling (angioedema of the lips)
• swelling of deeper skin layers, which may occur in various parts of the body, including the face, tongue, and throat, caused by fluid accumulation and potentially leading to breathing difficulties (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 adverse effects (may occur in no more than 1 in 10,000 patients):

• hypertensive crisis.

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

• insomnia
• disorientation.

In patients with bladder outflow obstruction or in those taking other medicines used to treat overactive bladder symptoms, the medicine Begirax may increase the risk of urinary retention (the patient may be unable to empty the bladder). If the patient cannot empty the bladder, they should immediately inform their doctor.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring of Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Begirax

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
pack after EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This 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: polyethylene glycol 2,000,000, microcrystalline cellulose, hypromellose type 2208, K100; hydroxypropyl cellulose, butylhydroxytoluene (E 321), magnesium stearate, colloidal anhydrous silica.
  Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol 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 light yellow, oval, biconvex coated tablets with approximate dimensions of 6 mm by 13 mm.
Begirax is available in aluminium/OPA/aluminium/PVC blisters packed in a cardboard box.
Pack sizes:
10, 30, 50, 90 or 100 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa 30
02-867 Warsaw
tel: +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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Iceland, Czech Republic, Poland: Begirax