IRETIG 50 mg Extended-Release Tablet

Зміст інструкції

1. Iretig 50 mg prolonged-release tablets
   1. What is Iretig and what is it 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. Package contents and other information What Iretig contains

Iretig 50 mg prolonged-release tablets

mirabegron
Generic medicine

Read this leaflet carefully before you start to use 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Iretig and what is it used for

Iretig 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.
Iretig 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 Iretig

Do not take Iretig:

• 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 precautionsTalk 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, such as anticholinergic medicines.
• if you have kidney or liver problems. Your doctor may need to reduce the dose or may tell you not to take Iretig, 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 this abnormality such as: o medicines used to treat heart rhythm disorders, such as quinidine, sotalol,

procainamide, ibutilide, flecainide, dofetilide and amiodarone;
o medicines used to treat allergic rhinitis;
o antipsychotic medicines (medicines used to treat mental illnesses), such as thioridazine,
mesoridazine, haloperidol and chlorpromazine;
o anti-infectives, such as pentamidine, moxifloxacin, erythromycin and clarithromycin.
If you have a history of high blood pressure, mirabegron may increase or worsen blood pressure. Your
doctor is recommended to check 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 in this age group has not been demonstrated.

Other medicines and Iretig
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Iretig can affect the action of other medicines and other medicines can have effects on
the way this medicine 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, suspect you may be pregnant or are planning a pregnancy, you should not take Iretig.
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 Iretig 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 take Iretig

Take this medicine following exactly the instructions of your doctor. If you have any doubts, 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 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 containing 25 mg of mirabegron available on the market. Do not split the
50 mg tablet as this could affect how this medicine works.
Take this medicine with liquid and swallow the tablet whole. Do not break or chew the tablet.
Iretig can be taken with or without food.

If you take more Iretig than you should
If you have taken more tablets than you have been prescribed, or if someone else has accidentally
taken your tablets, contact your doctor, pharmacist or hospital immediately.
Symptoms of overdose may include a fast heartbeat, increased
pulse or increased blood pressure.

If you forget to take Iretig
If you forget to take a dose, take it as soon as you remember, unless it is less than 6 hours
before 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 Iretig
Do not stop taking Iretig 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 your bladder condition improves. Stopping treatment may
lead to the reappearance of symptoms of overactive bladder syndrome.
Do not stop treatment with Iretig without first talking to your doctor, as the symptoms of
overactive bladder syndrome may return.
If you have any further questions on 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, there 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 headache occurs, 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)
Infection of the urinary tract (urinary tract infections)
Nausea
Constipation
Headache
Diarrhea
Dizziness

Uncommon (may affect up to 1 in 100 people)

• Bladder infection (cystitis)
• 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, skin rashes or hives (urticaria, rash, maculopapular 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 fluid that can affect any part of the body including the face, tongue or throat and can cause difficulty breathing (angioedema)
• 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

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

• Insomnia
• Confusion

Iretig may increase the difficulty of 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 get any side effects, talk to your doctor or pharmacist. 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 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 which is stated on the package 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 in 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 ingredient is mirabegron. Each tablet contains 50 mg of mirabegron.
• 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

Film coating: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 package contents
Iretig 50 mg prolonged-release tablets are film-coated, oblong, biconvex tablets of
approximately 6 × 13 mm, light yellow in colour.
Iretig is available in Al-OPA/Al/PVC blisters in cardboard packaging.
Packs:
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

Manufacturer
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 denominations:
Iceland, Czech Republic, Greece, Italy, Poland: Iretig
Bulgaria: Иретиг 50 mg таблетки с удължено освобождаване – Iretig 50 mg prolonged-release tablets
Spain: Iretig 50 mg comprimidos de liberación prolongada EFG
Croatia: Iretig 50 mg tablete s produljenim oslobađanjem
Romania: Iretig 50mg, comprimate cu eliberare prelungita