MIRABEGRON 50 mg Extended-Release Tablet

Зміст інструкції

1. MIRABEGRON DOC 50 mg prolonged-release tablets
   1. What is MIRABEGRON DOC and what it is used for
   2. What you need to know before taking MIRABEGRON DOC
   3. How to use MIRABEGRON DOC
   4. Possible side effects
   5. How to store MIRABEGRON DOC
   6. Contents of the pack and other information
2. MIRABEGRON DOC 50 mg prolonged-release tablets are oblong, biconvex,

MIRABEGRON DOC 50 mg prolonged-release tablets

Generic medicine

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1.What MIRABEGRON DOC is and what it is used for
• 2.What you need to know before you use MIRABEGRON DOC
• 3.How to use MIRABEGRON DOC
• 4.Possible side effects
• 5.How to store MIRABEGRON DOC
• 6.Contents of the pack and other information

1. What is MIRABEGRON DOC and what it is used for

MIRABEGRON DOC contains the active substance mirabegron. It is a bladder muscle relaxant (a so-called beta 3-adrenergic receptor agonist), which reduces the activity of an overactive bladder and treats its related symptoms.
MIRABEGRON DOC is used for the treatment of symptoms of overactive bladder syndrome in adults, such as:

• sudden need to empty the bladder (so-called urgency)
• need to empty the bladder more frequently than normal (so-called increased urinary frequency)
• inability to control bladder emptying (so-called urgency incontinence).

2. What you need to know before taking MIRABEGRON DOC

Do not take MIRABEGRON DOC:

• if you are allergic to mirabegron or any of the other ingredients of this medicine (listed in section 6).
• if you have very high blood pressure that is not controlled.

Warnings and precautions
Talk to your doctor or pharmacist before taking MIRABEGRON DOC:

• if you have problems emptying your bladder or if you have a weak urine flow or if you are taking other medicines for overactive bladder, such as antimuscarinic drugs
• if you have kidney or liver problems. Your doctor may need to reduce the dose or may tell you not to take MIRABEGRON DOC, especially if you are taking other medicines such as itraconazole, ketoconazole (antifungal infections), ritonavir (HIV/AIDS) or clarithromycin (bacterial infections). Tell your doctor if you are taking any other medicines.
• if you show an abnormality on an ECG (heart activity tracing) known as prolonged QT interval or if you are taking a medicine known to cause such abnormality such as:
• medicines used to treat heart rhythm disorders, such as quinidine, sotalol, procainamide, ibutilide, flecainide, dofetilide and amiodarone;
• medicines used to treat allergic rhinitis;
• antipsychotic medicines (medicines used to treat mental illnesses), such as thioridazine, mesoridazine, haloperidol and chlorpromazine;
• antimicrobials, such as pentamidine, moxifloxacin, erythromycin and clarithromycin.

If you have a history of high blood pressure, mirabegron may increase or worsen blood pressure. It is
recommended that your doctor checks your blood pressure when you are taking this medicine.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age as the
safety and efficacy of MIRABEGRON DOC in this age group has not yet been demonstrated.

Other medicines and MIRABEGRON DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
MIRABEGRON DOC can affect the action of other medicines and other medicines can have
effects on the way MIRABEGRON DOC works.

• Tell your doctor if you are taking thioridazine (a medicine used to treat mental illnesses), propafenone or flecainide (medicines used to treat heart rhythm disorders), imipramine or desipramine (medicines used to treat depression). These specific medicines may require a dose adjustment by your doctor.
• Tell your doctor if you are taking digoxin, a medicine used to treat heart failure or heart rhythm disorders. Your doctor will measure the blood levels of this medicine. If the blood levels are abnormal, your doctor may choose to adjust the dose of digoxin.
• Tell your doctor if you are taking dabigatran etexilate (a drug that is used to reduce the risk of blockage of blood vessels in the brain or body, caused by the formation of clots in adult patients with heart rhythm abnormalities (atrial fibrillation) and with additional risk factors). This drug may require a dose adjustment by your doctor.

Pregnancy and breastfeeding
If you are pregnant, if you suspect you are pregnant or are planning a pregnancy, you should not take
MIRABEGRON DOC.
If you are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine. It is likely that this medicine will pass into breast milk. Together with your doctor you will
decide whether to take MIRABEGRON DOC or to breastfeed. You cannot do both.

Driving and using machines
There is no data available to indicate that this medicine impairs the ability to drive or
use machines.

3. How to use MIRABEGRON DOC

Take this medicine following the instructions of your doctor exactly. If you have any doubts, 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 need to reduce the dose to one 25 mg
tablet taken orally once a day. If your doctor advises you to take 25 mg of
mirabegron, you must use other medicines available on the market containing 25 mg of mirabegron.
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Do not split the 50 mg tablet as this could affect how this
medicine works.
Take this medicine with liquids and swallow the tablet whole. Do not break or chew the
tablet. MIRABEGRON DOC can be taken with or without food.

If you take more MIRABEGRON DOC than you should
If you have taken more tablets than you have been prescribed, or if someone else has accidentally
taken your tablets, seek immediate medical attention from your doctor, pharmacist or hospital.
Symptoms of overdose may include a rapid heartbeat, increased
pulse or increased blood pressure.

If you forget to take MIRABEGRON DOC
If you forget to take a dose, take it as soon as you remember, unless it is 6 hours or
less until your next dose. Then continue to take the medicine at the usual time.
Do not take a double dose to make up for a missed dose. If you forget to take
more doses, contact your doctor and follow their advice.

If you stop taking MIRABEGRON DOC
Do not stop treatment with MIRABEGRON DOC prematurely if you do not see an immediate
effect. The bladder may need some time to adjust. Continue to take the
tablets.
Do not stop treatment when the condition of the bladder improves. Stopping
treatment may lead to the reappearance of symptoms of overactive bladder syndrome.
Do not stop treatment with MIRABEGRON DOC without first talking to your doctor,
as symptoms of overactive bladder syndrome may return.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Among the most serious side effects may be irregular heartbeat (atrial fibrillation). This is a
rare side effect (may affect up to 1 in 100 people), but if this side effect occurs, stop taking
the medicine and consult a doctor immediately.
If headache occurs, especially sudden, headache similar to migraine (pulsating), consult
your doctor. These may be symptoms of a severe increase in blood pressure.
Other side effects include:

Common (may affect up to 1 in 10 people)

• Increased heart rate (tachycardia)
• Infection of the channels that carry urine (urinary tract infections)
• Nausea
• Constipation
• Headache
• Diarrhea
• Dizziness

Uncommon (may affect up to 1 in 100 people)

• Bladder infection (cystitis)

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• Awareness of heartbeat (palpitations)
• Vaginal infection
• Indigestion (dyspepsia)
• Stomach infection (gastritis)
• Joint swelling
• Itching of the vulva or vagina (vulvovaginal pruritus)
• Increased blood pressure
• Increased liver enzymes (GGT, AST and ALT)
• Itching, rash or skin eruptions (urticaria, rash, macular rash, papular rash, pruritus)

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

• Swelling of the eyelid (eyelid edema)
• Swelling of the lips (lip edema)
• Swelling of the deeper layers of the skin, caused by an increase in fluids that can affect any part of the body including the face, tongue or throat and can cause difficulty breathing.
• Small, purple skin spots (purpura)
• Inflammation of small blood vessels mostly affecting the skin (leucocytoclastic vasculitis)
• Inability to completely empty the bladder (urinary retention)

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

• Hypertensive crisis

Not known(frequency cannot be estimated from available data)

• Insomnia
• Confusion

MIRABEGRON DOC may increase difficulty emptying the bladder if you have
bladder obstruction or if you are taking other medicines to treat overactive bladder. Call
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, pharmacist or nurse. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . By reporting side effects you can help provide more information
about the safety of this medicine.

5. How to store MIRABEGRON DOC

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 package and on the blister after
Exp.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 MIRABEGRON DOC contains

• The active ingredient is mirabegron. Each tablet contains 50 mg of mirabegron.

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• The other ingredients are: Tablet core:macrogol 2 000 000; microcrystalline cellulose (E460); hypromellose type 2 208, K100 (E464); hydroxypropylcellulose; butylhydroxytoluene; magnesium stearate (E572); anhydrous colloidal silica Coating:poly(vinyl alcohol); titanium dioxide (E171); macrogol; talc (E553b); yellow iron oxide (E172) and red iron oxide (E172)

Description of the appearance of MIRABEGRON DOC and contents of the pack

MIRABEGRON DOC 50 mg prolonged-release tablets are oblong, biconvex,

light yellow tablets approximately 6 × 13 mm coated with a film.
MIRABEGRON DOC is available in aluminium-aluminium blisters in cardboard packs of 30
prolonged-release tablets.

Marketing Authorisation Holder:
DOC Generici Srl -Via Turati 40, 20121 Milano -Italy
Pharmadox Healthcare Ltd. -KW20A Kordin Industrial Park -Paola PLA 3000 - Malta
Adalvo Limited -Life Sciences Park, Building 1, Level 4 -Sir Temi Zammit Buildings, San Gwann,
SGN 3000 -Malta

This medicinal product is authorised in the Member States of the European Economic Area with the
following designations:
Iceland: Mirabegron DOC
Italy: MIRABEGRON DOC
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