IRETIG

Patient Information Leaflet

Iretig 50 mg prolonged-release tablets

mirabegron
Generic medicine
Please read all of this leaflet carefully before you take 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Iretig is and what it is used for

Iretig contains the active substance mirabegron. It is a relaxant of the bladder muscle
(a so-called beta-3 adrenergic receptor agonist) that reduces the activity of an overactive bladder
and treats the associated symptoms and neurogenic detrusor overactivity.
Iretig is used for:

• the treatment of symptoms of a condition called overactive bladder in adults. These symptoms include:
• sudden urge to empty the bladder (so-called urgency);
• need to empty the bladder more often than normal (so-called increased urinary frequency);
• inability to control bladder emptying (so-called urgency incontinence);
• the treatment of a condition called neurogenic detrusor overactivity in children aged 3 to less than 18 years. Neurogenic detrusor overactivity is a condition in which involuntary contractions of the bladder occur due to a congenital condition or nerve injury affecting bladder control. If left untreated, neurogenic detrusor overactivity can cause damage to the bladder and/or kidneys. Iretig is used to increase the amount of urine the bladder can hold and to reduce urine leakage.

2. What you should know before taking Iretig

Do not take Iretig:

• 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 Iretig:

• if you have problems emptying your bladder or have a weak urine flow, or if you are taking other medicines for the treatment of overactive bladder or neurogenic detrusor overactivity, such as anticholinergic medicines.
• if you have kidney or liver problems. Your doctor may need to reduce your dose or may advise you not to take Iretig, 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, a recording of heart activity) called QT prolongation, or if you are taking a 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 for the treatment of overactive bladder, as the safety and efficacy of mirabegron in this population has not been established.
Iretig must not be used in children under 3 years of age for the treatment of neurogenic detrusor overactivity.

Other medicines and Iretig
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Iretig may affect the action of other medicines, and other medicines may affect how this medicine 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), 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 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, you must not take Iretig.
If you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. This medicine is likely to pass into breast milk. Together with your doctor, you will need to decide whether to take Iretig or to breastfeed. You cannot 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 take Iretig

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Use in adults with overactive bladder
The recommended dose is one 50 mg tablet taken orally once daily. If you have kidney or liver problems, your doctor may reduce the dose to one 25 mg tablet taken orally once daily. If your doctor advises you to take 25 mg of mirabegron, you should use other available medicinal products containing 25 mg of mirabegron. Do not split the 50 mg tablet, as this may affect how the medicine works.
Take this medicine with fluids and swallow the tablet whole. Do not break or chew the tablet.
Iretig can be taken with or without food.
Use in children and adolescents (aged between 3 and less than 18 years) with neurogenic detrusor overactivity
Take this medicine orally once daily. Take this medicine with fluids and swallow the tablet whole. Do not break or chew the tablet. Iretig must be taken with food. Your doctor will tell you what dose to take/what dose your child should take. The doctor will calculate the correct dose based on body weight. You must follow their instructions carefully.
If you take more Iretig 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 rapid heartbeat, increased heart rate, or elevated blood pressure.
If you forget to take Iretig
If you forget to take a dose, take it as soon as you remember, unless there are 12 hours or less until your next 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 multiple doses, contact your doctor and follow their advice.
If you stop taking Iretig
Do not stop treatment with Iretig prematurely if you do not see an immediate effect. The bladder may need some time to adjust. Continue taking the tablets. Do not stop treatment when bladder condition improves. Stopping treatment may cause symptoms of overactive bladder or neurogenic detrusor overactivity to return.
Do not stop treatment with Iretig without first talking to your doctor, as symptoms of overactive bladder or neurogenic detrusor overactivity 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 everyone will experience them.
Among the more serious side effects is 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), contact 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)
Urinary tract infection (urinary tract infections)
Headache
Dizziness
Increased heart rate (tachycardia)
Feeling unwell (nausea)
Constipation
Diarrhea
Uncommon (may affect up to 1 in 100 people)

• Vaginal infection
• Bladder infection (cystitis)
• Awareness of heartbeat (palpitations)
• Heart rhythm problems (atrial fibrillation)
• Indigestion (dyspepsia)
• Stomach infection (gastritis)
• Itching, skin rashes or hives (urticaria, rash, macular rash, papular rash, pruritus)
• Swelling of the joints
• Itching of the vulva or vagina (vulvovaginal pruritus)
• Increased blood pressure
• Increased liver enzymes (GGT, AST and ALT)

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

• Swelling of the eyelid (eyelid edema)
• Swelling of the lips (lip edema)
• Inflammation of small blood vessels, mostly affecting the skin (leukocytoclastic vasculitis)
• Small purple skin spots (purpura)
• Swelling of deeper layers of the 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)
• Inability to completely empty the bladder (urinary retention)

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

• Severely high blood pressure (hypertensive crisis)

Frequency not known (frequency cannot be estimated from the available data)

• Insomnia
• Confusion

Iretig may increase the difficulty in emptying the bladder if you have a 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 experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 Iretig

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or 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 Iretig contains

• The active substance is mirabegron. Each tablet contains 50 mg of mirabegron.
• The other components 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 film: polyvinyl alcohol; titanium dioxide (E171); macrogol 3350; talc (E553b); yellow iron oxide (E172) and red iron oxide (E172)

Description of the appearance of Iretig and pack sizes
Iretig 50 mg prolonged-release tablets are oblong, biconvex tablets, approximately 6 × 13 mm in size, light yellow in colour.
Iretig is available in Al-OPA/Al/PVC blisters packed in cardboard cartons.
Pack sizes:
30, 90 or 100 prolonged-release tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l
Via P. Paleocapa, 7
20121 Milano
Italy

Manufacturers
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:
Bulgaria, Croatia, Czech Republic, Greece, Iceland, Italy, Poland, Romania, Spain: Iretig (Иретиг)