UROCARE

Package leaflet: Information for the patient

Urocare, 5 mg, coated tablets
Solifenacin succinate
Please read all of this leaflet carefully before taking this medicine because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Urocare is and what it is 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 Urocare is and what it is used for

The active substance in Urocare belongs to the group of anticholinergic drugs. 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.
Urocare is used in the treatment of symptoms of an overactive bladder.
These symptoms include urgency, which is a sudden, compelling need to pass urine, frequency, and urge incontinence—leakage of urine due to inability to reach the toilet in time.

2. Important information before using Urocare

When not to use Urocare:

• if the patient is unable to pass urine or empty the urinary 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 may cause significant weakness of certain muscles;
• if the patient has narrow-angle glaucoma (increased fluid pressure in the eyeball leading 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 haemodialysis;
• in patients with severe liver function disorders;
• in patients with severe kidney disease or moderate liver disease who are also taking medicines that may delay elimination of Urocare from the body (e.g. ketoconazole). Your doctor or pharmacist will provide information on this.

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

Warnings and precautions

Before starting treatment with Urocare, discuss the following with your doctor or pharmacist:

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

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

Before starting treatment with Urocare, your doctor will assess whether there are other possible causes of frequent urination (e.g. 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

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

Urocare 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 the patient intends to take.

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

• other anticholinergic medicines, as concomitant use with Urocare may enhance both the therapeutic effects and adverse reactions of both drugs;
• cholinergic receptor agonists, as they may reduce the effectiveness of Urocare;
• drugs that enhance gastrointestinal motility, such as metoclopramide and cisapride, as Urocare may reduce their effectiveness;
• ketoconazole, itraconazole, ritonavir, nelfinavir, verapamil, diltiazem, as they may slow down the metabolism of Urocare;
• drugs such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of Urocare;
• drugs such as bisphosphonates, as they may cause or worsen oesophagitis.

Urocare with food and drink

Urocare may be taken during or between meals.

Pregnancy and breastfeeding

Urocare must not be used during pregnancy unless absolutely necessary.
Urocare must not be used during breastfeeding, as solifenacin passes into breast milk.

Before taking any medicine, consult your doctor or pharmacist.

Driving and operating machinery

Urocare may cause blurred vision, and less frequently drowsiness and fatigue. If these adverse effects occur, patients should not drive or operate machinery.

Urocare contains lactose and sodium

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

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Urocare

Instructions for proper use:
Urocare should always be taken as directed by the physician.
If in doubt, consult your doctor or pharmacist.
The tablet should be swallowed whole with liquid.
Urocare may be taken during or between meals, depending on patient preference.
Do not crush the tablets.
The usual dose is 5 mg once daily, unless the doctor recommends a dose of 10 mg once daily.

Taking more Urocare than prescribed
If too many Urocare tablets have been taken, or if Urocare has been accidentally swallowed by a child, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, visual disturbances, hallucinations, excessive excitement, seizures, breathing difficulties, rapid heartbeat (tachycardia), urine retention in the bladder (urinary retention), and dilated pupils.

Missing a dose of Urocare
If a dose of Urocare is missed, take the next dose as soon as possible, unless it is almost time for the next scheduled dose. Do not take a double dose to make up for a missed dose. Do not take Urocare more than once a day. If in doubt, consult your doctor or pharmacist.

Stopping Urocare treatment
If treatment with Urocare is stopped, symptoms of overactive bladder may return or worsen. Discontinuation of Urocare should always be discussed with your 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 experiences them.
If the patient develops symptoms of allergy or a severe skin reaction (e.g. blistering and peeling of the skin), seek immediate medical advice from a doctor or nurse.
Angioedema (a type of allergic skin reaction causing swelling of the tissue just beneath the skin surface) with swelling of the airways (difficulty breathing, wheezing) has been reported in some patients taking solifenacin succinate (the active substance in Urocare).
If the patient develops angioedema, treatment with solifenacin succinate (Urocare) must be stopped immediately and the doctor should be contacted for appropriate treatment and/or necessary countermeasures.
Urocare may cause other adverse effects listed below:

Very common (affects more than 1 in 10 patients):

• dry mouth.

Common (affects less than 1 in 10 patients):

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

Uncommon (affects less than 1 in 100 patients):

• urinary tract infection, cystitis,
• somnolence,
• taste disturbances,
• dry eye syndrome,
• dryness of the nasal passages,
• gastroesophageal reflux (heartburn),
• dry throat,
• dry skin,
• difficulty in urination,
• fatigue,
• peripheral oedema.

Rare (affects less than 1 in 1,000 patients):

• faecal impaction (large amount of hard stool in the colon), intestinal obstruction,
• difficulty passing urine despite a full bladder (urinary retention),
• dizziness, headache,
• vomiting,
• itching, rash.

Very rare (affects less than 1 in 10,000 patients):

• hallucinations, disorientation,
• urticaria.

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

• decreased appetite, increased blood potassium levels which may cause cardiac arrhythmias,
• increased intraocular pressure (glaucoma),
• changes in ECG, irregular heartbeat, palpitations, tachycardia,
• voice disorders,
• feeling of discomfort in the abdominal cavity,
• liver function disorders, abnormal liver function test results,
• decreased muscle strength,
• renal function disorders,
• disturbances of consciousness (delirium).

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

5. How to store the medicine Urocare

Keep the medicine out of 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 pack. The expiry date refers to the last day of the stated month.
The marking on the packaging following EXP indicates the expiry date, and following Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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, equivalent to 3.77 mg of solifenacin.
• The other ingredients are:
  Tablet core: pregelatinized starch, corn; lactose monohydrate; sodium stearyl fumarate.
  Tablet coating: hypromellose (6 mPas); 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, film-coated tablets.
The tablets are packed in aluminum/PVC blisters, in a cardboard box.
The pack contains 30 film-coated tablets.

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