Uronorm

Patient Information Leaflet

Uronorm, 5 mg, film-coated tablets
Uronorm, 10 mg, film-coated tablets
Solifenacin succinate
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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Uronorm is and what it is used for

The active substance in Uronorm belongs to a group of medicines called anticholinergics. These medicines reduce the activity of an overactive bladder. This effect allows longer intervals between urinations and increases the amount of urine the bladder can hold.
Uronorm is used to treat the symptoms of an overactive bladder. These symptoms include urgency, which is a sudden, compelling need to pass urine, urinary frequency, and urinary incontinence, occurring when the patient is unable to reach the toilet in time.

2. Information before using Uronorm

When not to use Uronorm:

• if the patient is allergic to solifenacin succinate or any of the other ingredients of this medicine (listed in section 6)
• if the patient is unable to pass urine or empty the bladder (urinary retention)
• if the patient has severe stomach or intestinal disorders (including toxic megacolon, a complication associated with ulcerative colitis)
• in patients suffering from a muscle disease called myasthenia gravis, which may cause significant weakness of certain muscles
• if the patient has increased pressure of fluid in the eye leading to gradual loss of vision (angle-closure glaucoma)
• if the patient is undergoing hemodialysis
• in patients with severe liver function disorders
• if the patient has severe kidney disease or moderate liver disease and is also taking medicines that may delay elimination of Uronorm from the body (e.g. ketoconazole). Your doctor will provide information on this.

Before starting treatment with Uronorm, inform your doctor if any of the above situations apply or have occurred in the past.

Warnings and precautions

Before starting treatment with Uronorm, discuss with your doctor or pharmacist if:

• the patient has difficulty emptying the bladder (obstruction of urinary outflow) or difficulty passing urine (weak urinary stream). In such cases, the risk of urine accumulation in the bladder (urinary retention) is much higher.
• the patient has gastrointestinal tract motility disorders (constipation)
• there is a risk of slowed gastrointestinal motility (peristalsis). Your doctor will provide further information.
• there are severe kidney function disorders
• there are moderate liver function disorders
• the patient suffers from severe stomach pain (hiatal hernia) or heartburn
• the patient has nervous system disorders (autonomic neuropathy).

Before starting treatment with Uronorm, inform your doctor if any of the above conditions apply or have occurred in the past.

Before initiating Uronorm treatment, your doctor will assess whether there are other possible causes of frequent urination, such as heart failure (insufficient cardiac muscle strength to pump blood adequately) or kidney disease. If a urinary tract infection occurs, your doctor will prescribe an antibiotic (an antibacterial agent effective against the specific bacteria).

Children and adolescents

Uronorm must not be used in children or adolescents under 18 years of age.

Uronorm with other medicines

Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.

It is especially important to inform your doctor if the patient is taking:

• other anticholinergic medicines, as concomitant use with Uronorm may enhance both therapeutic effects and adverse reactions of both drugs
• cholinergic receptor agonists, as they may reduce the effectiveness of Uronorm
• drugs that enhance gastrointestinal motility, such as metoclopramide and cisapride, as Uronorm may reduce their effectiveness
• drugs such as ketoconazole, itraconazole (used to treat fungal infections), ritonavir, nelfinavir (used to treat HIV infections), verapamil, diltiazem (used to treat high blood pressure and heart conditions), as they may slow down the metabolism of Uronorm
• drugs such as rifampicin (used to treat tuberculosis and other bacterial infections), phenytoin, carbamazepine (used to treat epilepsy), as they may accelerate the metabolism of Uronorm
• bisphosphonates, as they may cause or worsen esophagitis.

Uronorm with food and drink

Uronorm may be taken during meals or independently of meals, depending on patient preference.

Pregnancy and breastfeeding

Uronorm must not be used during pregnancy unless absolutely necessary.

Uronorm must not be used during breastfeeding, as solifenacin passes into breast milk.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery

Uronorm may cause blurred vision, dizziness, drowsiness, and fatigue. If these adverse effects occur, the patient should not drive or operate any machinery.

Uronorm contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.

3. How to use Uronorm

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose is 5 mg daily, unless the doctor recommends a dose of 10 mg daily.
The tablet should be swallowed whole with liquid, for example a glass of water.
The medicine may be taken during meals or independently of meals, according to patient preference.
Do not crush the tablets.
Use in children and adolescents
Uronorm must not be used in children or adolescents under 18 years of age.
Taking more Uronorm than recommended
If too many Uronorm tablets have been taken, or if Uronorm has been accidentally swallowed by
a child, contact a doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and visual disturbances,
hallucinations, excessive excitement, seizures (convulsions), breathing difficulties, rapid heartbeat
(tachycardia), urinary retention (inability to pass urine), and dilated pupils.
Missing a dose of Uronorm
If a dose of Uronorm is missed, take the next dose as soon as possible, unless it is almost time for
the next scheduled dose. Do not take the medicine more often than once daily. If in doubt, consult
a doctor or pharmacist. Do not take a double dose to make up for a missed dose.
Stopping Uronorm
If treatment with Uronorm is stopped, symptoms of overactive bladder may return or worsen.
Any discontinuation of treatment should always be discussed with a doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If you notice any of the following adverse effects, you must
immediately stop treatment with Uronorm and immediately seek medical help from a doctor:

• An allergic attack or hypersensitivity reaction, including severe anaphylactic reactions and severe skin reactions (e.g. blistering and peeling of the skin), which have been reported in some cases.
• Angioedema (a type of allergic skin reaction causing swelling of the tissue just beneath the skin surface), with swelling of the airways (difficulty breathing), reported in some patients taking solifenacin succinate.

Other adverse effects:
Very common (may affect more than 1 in 10 people):

• Dry mouth.

Common (may affect less than 1 in 10 people):

• Blurred vision,
• Constipation, nausea, dyspepsia with symptoms such as: feeling of fullness in the stomach, abdominal pain, belching, nausea, heartburn, feeling of stomach discomfort.

Uncommon (may affect less than 1 in 100 people):

• Urinary tract infection, cystitis,
• Drowsiness, taste disturbances,
• Dry eye syndrome,
• Nasal dryness,
• Gastroesophageal reflux (heartburn), throat dryness,
• Dry skin,
• Difficulty passing urine,
• Fatigue, fluid retention in the lower limbs (oedema).

Rare (may affect less than 1 in 1,000 people):

• Dizziness, headache,
• Accumulation of hard stool in the colon; bowel obstruction (intestinal blockage), vomiting,
• Itching, rash,
• Difficulty urinating despite a full bladder (urinary retention).

Very rare (may affect less than 1 in 10,000 people):

• Hallucinations, confusion,
• Urticaria (hives).

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

• Decreased appetite, increased blood potassium levels which may lead to heart rhythm disturbances,
• Sudden onset of confusion (delirium),
• Increased intraocular pressure,
• Irregular heartbeat (Torsade de Pointes), changes in heart's electrical activity (ECG), palpitations, rapid heartbeat,
• Voice disturbances,
• Intestinal obstruction, feeling of abdominal discomfort,
• Liver function disorders,
• Decreased muscle strength,
• Kidney function disorders.

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 of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported directly to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Uronorm
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister pack, and label after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Uronorm contains

• The active substance in Uronorm is solifenacin succinate. Each coated tablet contains 5 mg or 10 mg of solifenacin succinate, equivalent to 3.8 mg or 7.5 mg of solifenacin.
• The other ingredients are:
• Tablet core: monohydrate lactose, corn starch, hypromellose 2910 (5 cp), colloidal anhydrous silica, magnesium stearate
• Coating: hypromellose 2910 (6 cp), macrogol 4000, titanium dioxide (E 171), talc; and for:
  5 mg: iron oxide, yellow (E 172),
  10 mg: iron oxide, red (E 172).

What Uronorm looks like and contents of the pack
Coated tablet (tablet)
5 mg: light yellow, round, biconvex coated tablets marked with "CC" on one side and "31" on the other side. The tablet diameter is 7.6 mm.
10 mg: light pink, round, biconvex coated tablets marked with "CC" on one side and "32" on the other side. The tablet diameter is 7.6 mm.
Pack sizes:
3, 5, 10, 20, 30, 50, 60, 90, 100 or 200 tablets in blister packs.
100 tablets in a plastic container.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer/Importer
Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]