Urocare

Package Leaflet: Information for the Patient

Urocare, 5 mg, coated tablets

Solifenacin succinate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Urocare and what is it used for

The active substance of Urocare belongs to a group of cholinergic antagonists. These medicines reduce the activity of an overactive urinary bladder. This action allows for longer intervals between visits to the toilet and increases the amount of urine held in the bladder. Urocare 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 incontinence associated with not being able to reach the toilet in time.

2. Important information before taking Urocare

When not to take Urocare:

• if the patient is unable to urinate or empty their bladder (urinary retention);
• if the patient has severe gastrointestinal disorders (toxic megacolon, a complication associated with ulcerative colitis);
• if the patient has a muscle disease called myasthenia gravis, which can cause significant weakness of some muscles;
• if the patient has narrow-angle glaucoma (increased pressure of the fluid in the eyeball, which can lead to gradual loss of vision);
• if the patient is allergic (hypersensitive) to solifenacin or any of the other ingredients of this medicine (listed in section 6);
• 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 taking medicines that may delay the elimination of Urocare from the body (e.g., ketoconazole). The doctor or pharmacist will provide information on this.

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

Warnings and precautions

Before starting Urocare, discuss with your doctor or pharmacist:

• if the patient has difficulty emptying their bladder (narrowing of the urethra) 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 disorders (constipation);
• if there is a risk of slowed gastrointestinal motility (movement of the stomach and intestines); the doctor will provide information on this;
• if the patient has severe kidney function disorders;
• if the patient has moderate liver function disorders;
• if the patient has a hiatal hernia (a condition where the stomach bulges into the chest) or heartburn;
• if the patient has autonomic nervous system disorders (autonomic neuropathy).

Before starting treatment with Urocare, inform your doctor if any of the above situations apply or have applied in the past. Before starting treatment with Urocare, the doctor will assess whether there are other causes of frequent urination (e.g., 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, effective against specific bacteria).

Children and adolescents

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

Urocare and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. It is particularly important to inform your doctor if you are taking:

• other cholinergic antagonists, as taking such a medicine with Urocare may lead to increased therapeutic and adverse effects of both medicines;
• cholinergic receptor agonists, as they may weaken the effect of Urocare;
• gastrointestinal motility enhancers, such as metoclopramide and cisapride, as Urocare may weaken their effect;
• ketoconazole, itraconazole, ritonavir, nelfinavir, verapamil, diltiazem, as they slow down the metabolism of Urocare;
• medicines such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of Urocare;
• medicines such as bisphosphonates, as they may cause or exacerbate esophagitis.

Urocare with food and drink

Urocare can be taken with or without food.

Pregnancy and breastfeeding

Urocare should not be used during pregnancy, unless it is absolutely necessary. Urocare should not be used during breastfeeding, as solifenacin passes into breast milk. Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Urocare may cause blurred vision, and less frequently, drowsiness and fatigue. If such side effects occur, do not drive or operate machinery.

Urocare contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is considered "sodium-free".

3. How to take Urocare

Instructions for proper use: Urocare should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist. Swallow the tablet whole with a drink of water. The medicine can be taken with or without food, as preferred. Do not crush the tablets. The usual dose is 5 mg once daily, unless your doctor advises you to take a dose of 10 mg once daily.

Overdose of Urocare

If you have taken too many Urocare tablets or if a child accidentally swallows Urocare, contact your doctor or pharmacist immediately. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, hallucinations, excessive stimulation, seizures (convulsions), breathing difficulties, rapid heartbeat (tachycardia), and urinary retention.

Missed dose of Urocare

If you miss a dose, take the next dose as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose. Do not take the medicine more than once a day. If you are unsure, consult your doctor or pharmacist.

Stopping Urocare treatment

If you stop taking Urocare, the symptoms of an overactive bladder may return or worsen. Stopping treatment should always be discussed with your doctor. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Urocare can cause side effects, although not everybody gets them. If you experience symptoms of an allergic reaction or a severe skin reaction (e.g., blistering and peeling of the skin), contact your doctor or nurse immediately. In some patients taking solifenacin succinate (the active substance of Urocare), angioedema (a form of allergic skin reaction that causes swelling of the tissue just beneath the skin surface) with swelling of the airways (difficulty breathing, wheezing) has been reported.

If you experience angioedema, stop taking solifenacin succinate (Urocare) immediately and contact your doctor, who will initiate appropriate treatment and/or take appropriate measures.

Urocare may cause other side effects, including:

• Very common (affecting more than 1 in 10 people): dry mouth.

Common (affecting less than 1 in 10 people):

• blurred vision,
• constipation, nausea, indigestion with symptoms such as: feeling of fullness, abdominal pain, belching, nausea, heartburn (dyspepsia), feeling of discomfort in the abdomen.

Uncommon (affecting less than 1 in 100 people):

• urinary tract infection, cystitis,
• drowsiness,
• taste disturbances,
• dry eye syndrome,
• nasal dryness,
• gastroesophageal reflux (heartburn),
• throat dryness,
• skin dryness,
• difficulty urinating,
• fatigue,
• swelling of the lower limbs.

Rare (affecting less than 1 in 1,000 people):

• impaction of large amounts of hard stool in the colon (fecal impaction), obstruction (blockage) of the colon,
• difficulty urinating despite a full bladder (urinary retention),
• dizziness, headaches,
• vomiting,
• itching, rash.

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

• hallucinations, disorientation,
• 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 disorders,
• increased eye pressure (glaucoma),
• ECG changes, irregular heartbeat, palpitations, rapid heartbeat,
• voice disorders,
• abdominal discomfort,
• liver function disorders, abnormal liver function test results,
• muscle weakness,
• kidney function disorders,
• disorders of consciousness (confusion).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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, you can help provide more information on the safety of this medicine.

5. How to store Urocare

Keep the medicine out of the sight and reach of children. Do not store above 30°C. Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Urocare contains

• The active substance is solifenacin succinate. Each coated tablet contains 5 mg of solifenacin succinate, which corresponds to 3.77 mg of solifenacin.
• The other ingredients are: Tablet core: maize starch, pregelatinized; lactose monohydrate; sodium stearyl fumarate. Tablet coating: hypromellose (6 mPa.s); titanium dioxide (E 171); lactose monohydrate; macrogol 3350; triacetin; yellow iron oxide (E 172).

What Urocare looks like and contents of the pack

Urocare is yellow, round, biconvex coated tablets. The tablets are packaged in aluminum/PVC blisters in a cardboard box. The pack contains 30 coated tablets.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Date of last revision of the leaflet: