Uronorm

Package Leaflet: Information for the User

Uronorm, 5 mg, coated tablets

Uronorm, 10 mg, coated tablets

Solifenacin succinate

Before taking the medicine, carefully read the contents of this leaflet, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Uronorm and what is it used for
• 2. Important information 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 is Uronorm and what is it used for

The active substance of Uronorm belongs to a group of cholinolytic medicines. These medicines reduce the activity of an overactive bladder. This action allows for longer intervals between using the toilet and increases the amount of urine held in the bladder. Uronorm is used to treat symptoms of an overactive bladder. These include: urgent urination, i.e., episodes of sudden, urgent need to urinate, frequent urination, and urinary incontinence, related to the fact that the patient did not have time to use the toilet.

2. Important information before taking Uronorm

When not to take 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 cannot urinate or cannot empty their bladder (urinary retention)
• if the patient has severe stomach or intestinal disorders (including toxic megacolon, a complication associated with ulcerative colitis)
• in patients with a muscle disease called myasthenia, which can cause significant weakness of some muscles
• if the patient has increased fluid pressure in the eyeball, which can lead to gradual vision loss (narrow-angle glaucoma)
• if the patient is undergoing hemodialysis
• in patients with severe liver dysfunction
• if the patient has severe kidney disease or moderate liver disease and is taking medicines that may delay the elimination of Uronorm from the body (e.g., ketoconazole). The doctor will provide information on this.

Before starting treatment with Uronorm, the patient should inform their doctor if any of the above situations occur or have occurred in the past.

Warnings and precautions

Before starting to take Uronorm, the patient should discuss it with their doctor or pharmacist:

• if the patient has difficulty emptying their bladder (narrowing of the urine outflow from the bladder) or urinating (weak urine stream). In such cases, the risk of urine accumulation in the bladder (urinary retention) is much higher.
• if the patient has gastrointestinal motility disorders (constipation)
• if there is a risk of slowing down the movement of the digestive tract (peristalsis). The doctor will provide information on this.
• if the patient has severe kidney dysfunction
• if the patient has moderate liver dysfunction
• if the patient has a tearing stomach pain (hiatal hernia) or heartburn
• if the patient has nervous system disorders (autonomic nervous system neuropathy).

Before starting treatment with Uronorm, the patient should inform their doctor if any of the above situations occur or have occurred in the past. Before starting treatment with Uronorm, the doctor will assess whether there are other causes of frequent urination, for example, heart failure (insufficient strength of the heart muscle to pump blood) or kidney disease. If a urinary tract infection occurs, the doctor will prescribe an antibiotic (an antibacterial medicine).

Children and adolescents

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

Uronorm and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take. It is especially important to inform the doctor if the patient is taking:

• other cholinolytic medicines, as taking such a medicine with Uronorm may lead to an increase in both the therapeutic effect and the side effects of both medicines
• medicines from the group of cholinergic receptor agonists, as they may weaken the effect of Uronorm
• medicines that enhance gastrointestinal motility, such as metoclopramide and cisapride, as Uronorm may weaken their effect
• medicines such as ketoconazole, itraconazole (medicines used to treat fungal infections), ritonavir, nelfinavir (medicines used to treat HIV infections), verapamil, diltiazem (medicines used to treat high blood pressure and heart disease), as they slow down the metabolism of Uronorm
• medicines such as rifampicin (a medicine used to treat tuberculosis and other bacterial infections), phenytoin, carbamazepine (medicines used to treat epilepsy), as they may accelerate the metabolism of Uronorm
• medicines such as bisphosphonates, as they may cause or exacerbate esophagitis.

Uronorm with food and drink

Uronorm can be taken during meals or independently of meals, depending on the patient's preferences.

Pregnancy and breastfeeding

Uronorm should not be used during pregnancy, unless it is absolutely necessary. Uronorm should not be used during breastfeeding, as solifenacin passes into breast milk. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

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

Uronorm contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Uronorm

This medicine should always be taken exactly as advised by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The recommended dose is 5 mg once daily, unless the doctor advises taking a dose of 10 mg once daily. The tablet should be swallowed whole, with a drink of water. Uronorm can be taken during meals or independently of meals, depending on the patient's preferences. The tablets should not be crushed.

Use in children and adolescents

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

Overdose of Uronorm

In case of taking too many Uronorm tablets or if Uronorm is accidentally swallowed by a child, the patient should immediately contact their doctor or pharmacist. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, hallucinations, excessive stimulation, seizures, breathing difficulties, rapid heartbeat, urinary retention, and dilated pupils.

Missed dose of Uronorm

In case of missing a dose, the patient should take the next dose as soon as possible, unless it is almost time for the next dose. Uronorm should not be taken more than once daily. In case of doubts, the patient should consult their doctor or pharmacist. A double dose should not be taken to make up for a missed dose.

Stopping Uronorm treatment

If the treatment with Uronorm is stopped, the symptoms of an overactive bladder may return or worsen. Stopping the treatment should always be consulted with the doctor. In case of any further doubts regarding the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Uronorm can cause side effects, although not everybody gets them.

In case of observing any of the following side effects, the patient should immediately stop taking Uronorm and seek medical help:

• allergic reaction or hypersensitivity reaction, with severe anaphylactic reactions and severe skin reactions (e.g., blistering and peeling of the skin), which have been reported.
• angioedema (a form of skin allergy that causes swelling of the tissue just beneath the skin surface) with swelling of the airways (difficulty breathing), which has been reported in some patients taking solifenacin succinate.

Other side effects:

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

• dry mouth.

Common (may affect up to 1 in 10 people):

• blurred vision,
• constipation, nausea, dyspepsia with symptoms such as: feeling of a full stomach, abdominal pain, belching, nausea, heartburn, feeling of discomfort in the stomach.

Uncommon (may affect up to 1 in 100 people):

• urinary tract infection, cystitis
• drowsiness, taste disturbances,
• dry eye syndrome,
• dryness in the nasal cavity,
• gastroesophageal reflux disease (heartburn), dry throat,
• dry skin,
• difficulty urinating,
• fatigue, fluid retention in the lower limbs (edema).

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

• dizziness, headaches,
• accumulation of a large amount of hard stool in the colon; obstruction (obstruction) of the colon, vomiting,
• itching, rash,
• difficulty urinating despite a full bladder (urinary retention).

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

• hallucinations, confusion,
• hives.

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

• decreased appetite, increased potassium levels in the blood, which can cause heart rhythm disturbances,
• sudden confusion (delirium),
• increased pressure in the eyeball,
• irregular heartbeat (Torsade de Pointes), changes in the electrical activity of the heart (ECG), palpitations, rapid heartbeat,
• voice disorders,
• intestinal obstruction, feeling of discomfort in the abdominal cavity,
• liver dysfunction,
• muscle weakness,
• kidney dysfunction.

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Uronorm

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton, blister, and label after: EXP. The expiry date refers to the last day of the month. There are no special precautions for storage. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Uronorm contains

• The active substance of Uronorm is solifenacin succinate. Each coated tablet contains 5 mg or 10 mg of solifenacin succinate, which corresponds to 3.8 mg or 7.5 mg of solifenacin.
• The other ingredients are:
• Core: lactose monohydrate, maize starch, hypromellose 2910 (5 cp), colloidal anhydrous silica, magnesium stearate
• Coating: hypromellose 2910 (6 cp), macrogol 4000, titanium dioxide (E 171), talc, and: 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 with the marking "CC" on one side and "31" on the other side. The diameter of the tablet is 7.6 mm.
10 mg: light pink, round, biconvex coated tablets with the marking "CC" on one side and "32" on the other side. The diameter of the tablet is 7.6 mm.
Pack sizes:
3, 5, 10, 20, 30, 50, 60, 90, 100, or 200 tablets in blisters.
100 tablets in a plastic container.
Not all pack sizes may be marketed.

Marketing authorization 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
To obtain more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
kontakt@orionpharma.info.pl

Date of last revision of the leaflet: