Mirabegron Doc Generici

Patient Information Leaflet: Information for the user

MIRABEGRON DOC 50 mg prolonged-release tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking MIRABEGRON DOC
3. How to take MIRABEGRON DOC
4. Possible side effects
5. How to store MIRABEGRON DOC
6. Contents of the pack and other information

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

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

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

2. What you need to know before taking MIRABEGRON DOC

Do not take MIRABEGRON DOC:

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

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 your dose or may advise you not to take MIRABEGRON DOC, especially if you are taking other medicines such as itraconazole, ketoconazole (for fungal infections), ritonavir (for HIV/AIDS), or clarithromycin (for bacterial infections). Inform your doctor if you are taking any other medicines.
• if you have a known abnormality on your ECG (electrocardiogram) called QT prolongation, or if you are taking any medicine known to cause this 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;
• antipsychotics (medicines used to treat mental illnesses), such as thioridazine, mesoridazine, haloperidol, and chlorpromazine;
• anti-infective agents, such as pentamidine, moxifloxacin, erythromycin, and clarithromycin.

If you have a history of high blood pressure, mirabegron may increase or worsen your blood pressure. Your doctor is advised to monitor your blood pressure while 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 have not been established.

Other medicines and MIRABEGRON DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
MIRABEGRON DOC may affect the action of other medicines, and other medicines may affect how MIRABEGRON DOC works.

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are planning to become pregnant, do not take MIRABEGRON DOC.
If you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. This medicine may pass into breast milk. Together with your doctor, you will need to decide whether to take MIRABEGRON DOC or to breastfeed. You should not do both.

Driving and using machines
There are no data indicating that this medicine impairs the ability to drive or use machinery.

3. How to use MIRABEGRON DOC

Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one 50 mg tablet taken orally once daily. If you have renal or hepatic impairment, your doctor may need to reduce the dose to one 25 mg tablet taken orally once daily. If your doctor advises you to take 25 mg of mirabegron, you must use other medicinal products available on the market containing 25 mg of mirabegron.
Do not split the 50 mg tablet, as this may affect how the medicine works.
Take this medicine with liquid and swallow the tablet whole. Do not break or chew the tablet. MIRABEGRON DOC may be taken with or without food.

If you take more MIRABEGRON DOC than you should
If you have taken more tablets than prescribed, or if someone else has accidentally taken your tablets, contact your doctor, pharmacist, or hospital immediately.
Symptoms of overdose may include increased heart rate, increased pulse, or elevated blood pressure.

If you forget to take MIRABEGRON DOC
If you forget to take a dose, take it as soon as you remember, unless there are 6 hours or less before your next scheduled dose. Then continue taking the medicine at your usual time.
Do not take a double dose to make up for a forgotten dose. If you forget to take several 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. Your bladder may need some time to adjust. Continue taking the tablets.
Do not stop treatment when your bladder condition improves. Stopping treatment may cause symptoms of overactive bladder syndrome to return.
Do not stop treatment with MIRABEGRON DOC without first speaking to your doctor, as symptoms of overactive bladder syndrome may recur.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
One of the more serious side effects may be irregular heartbeat (atrial fibrillation). This is an uncommon 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 you develop a headache, especially sudden, migraine-type headache (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)
• Urinary tract infection
• Nausea
• Constipation
• Headache
• Diarrhoea
• 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)
• Swelling of joints
• 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 oedema)
• Swelling of the lips (lip oedema)
• Swelling of deeper layers of skin due to fluid accumulation, which may affect any part of the body including the face, tongue or throat, and may cause breathing difficulties (angioedema)
• Small purple skin spots (purpura)
• Inflammation of small blood vessels, mainly affecting the skin (leucocytoclastic vasculitis)
• Inability to empty the bladder completely (urinary retention)

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

• Hypertensive crisis

Not known (frequency cannot be estimated from the available data)

• Insomnia
• Confusion

MIRABEGRON DOC may increase the difficulty in emptying the bladder if you have a bladder obstruction or if you are taking other medicines for overactive bladder. Contact your doctor immediately if you are unable to empty your bladder.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on 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 carton and on the blister after
Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MIRABEGRON DOC contains

• The active substance 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; butylated hydroxytoluene; magnesium stearate (E572); colloidal anhydrous 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 package contents
MIRABEGRON DOC 50 mg prolonged-release tablets are oblong, biconvex, film-coated tablets of light yellow colour, approximately 6 × 13 mm in size.
MIRABEGRON DOC is available in aluminium-aluminium blisters packed in cardboard cartons containing 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 under the following names:
Iceland: Mirabegron DOC
Italy: MIRABEGRON DOC
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