SOLIFENACIN 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Solifenacin US Pharmacia, 5 mg, Chewable Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents
3. What is Solifenacin US Pharmacia and what is it used for
4. Important information before taking Solifenacin US Pharmacia
   1. When not to take Solifenacin US Pharmacia:
   2. Warnings and precautions
   3. Children and adolescents
   4. Do not use this medicine in children or adolescents under 18 years of age.
   5. Solifenacin US Pharmacia and other medicines
   6. Solifenacin US Pharmacia with food and drink
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Solifenacin US Pharmacia contains lactose and sorbitol
5. How to take Solifenacin US Pharmacia
   1. Instructions for proper use:
   2. Taking more Solifenacin US Pharmacia than prescribed
   3. Missing a dose of Solifenacin US Pharmacia
   4. Stopping Solifenacin US Pharmacia treatment
6. Possible side effects
   1. Reporting side effects
7. How to store Solifenacin US Pharmacia
8. Contents of the pack and other information
   1. What Solifenacin US Pharmacia contains
   2. What Solifenacin US Pharmacia looks like and contents of the pack
   3. Marketing authorization holder and manufacturer:
   4. Marketing authorization holder
   5. Manufacturer
   6. Other sources of information
   7. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Solifenacin US Pharmacia, 5 mg, Chewable 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

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

1. What is Solifenacin US Pharmacia and what is it used for

The active substance of Solifenacin US Pharmacia belongs to a group of medicines called anticholinergics. 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. Solifenacin US Pharmacia is used to treat the symptoms of an overactive bladder. These symptoms include:

urinary urgency, which means a sudden, compelling need to urinate, frequent urination, and involuntary urination, which may occur because the patient is unable to reach the toilet in time.

2. Important information before taking Solifenacin US Pharmacia

When not to take Solifenacin US Pharmacia:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you have difficulty emptying your bladder (urinary retention);
• if you have severe gastrointestinal disorders (toxic megacolon, a complication of ulcerative colitis);
• if you have a muscle disorder called myasthenia gravis, which may cause significant weakness of certain muscles;
• if you have narrow-angle glaucoma (increased pressure in the eye, which can lead to gradual vision loss);
• if you are undergoing hemodialysis;
• if you have severe liver impairment;
• if you have severe kidney disease or moderate liver disease and are taking medicines that may delay the elimination of Solifenacin US Pharmacia from the body (e.g., ketoconazole).

Page 1 6
Pharmacia with your doctor or pharmacist. Before starting treatment with Solifenacin US Pharmacia, tell your doctor if any of the above situations are currently present or have occurred in the past.

Warnings and precautions

Before taking Solifenacin US Pharmacia, discuss with your doctor or pharmacist:

• if you have difficulty emptying your 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 you have gastrointestinal disorders (constipation).
• if there is a risk of slowing down the movement of the digestive tract (peristalsis). Your doctor will provide information on this.
• if you have severe kidney impairment.
• if you have moderate liver impairment.
• if you have a hiatus hernia (hiatus hernia) or heartburn.
• if you have autonomic nervous system disorders (autonomic neuropathy).

Children and adolescents

Do not use this medicine in children or adolescents under 18 years of age.

Before starting treatment with Solifenacin US Pharmacia, tell your doctor if any of the above situations are currently present or have occurred in the past. Before starting treatment with Solifenacin US Pharmacia, your 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, your doctor will prescribe an antibiotic (an antibacterial medicine that acts on specific bacteria).

Solifenacin US Pharmacia and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. This is important because Solifenacin US Pharmacia may affect the action of some medicines, and some medicines may affect the action of Solifenacin US Pharmacia. It is especially important to inform your doctor before taking Solifenacin US Pharmacia if you are taking any of the following medicines:

• other anticholinergic medicines, as taking such a medicine with Solifenacin US Pharmacia may lead to an increase in both the therapeutic and adverse effects of both medicines;
• cholinergic receptor agonists, as they may weaken the effect of Solifenacin US Pharmacia;
• medicines that accelerate the movement of the digestive tract, such as metoclopramide and cisapride, as Solifenacin US Pharmacia may weaken their effect;
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they slow down the metabolism of Solifenacin US Pharmacia;
• medicines such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of Solifenacin US Pharmacia;
• medicines such as bisphosphonates, as they may increase the risk of esophagitis.

Page 2 6

Solifenacin US Pharmacia with food and drink

The medicine can be taken with or without food.

Pregnancy and breastfeeding

Do not take Solifenacin US Pharmacia during pregnancy, as there are no data on the use of solifenacin in pregnant women, and the potential risk to humans is unknown. Do not take Solifenacin US Pharmacia during breastfeeding, as there are no data on the excretion of solifenacin into human milk, and solifenacin is excreted into mouse milk. Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Solifenacin US Pharmacia may cause blurred vision, and less often, drowsiness and fatigue. If you experience these side effects, do not drive or operate any machines.

Solifenacin US Pharmacia contains lactose and sorbitol

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially sodium-free. The medicine contains 0.042 mg of sorbitol (E 420) per tablet.

3. How to take Solifenacin US Pharmacia

Instructions for proper use:

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Take orally. Chew and crush the tablet until it dissolves. Do not swallow the tablets whole. The medicine can be taken with or without food, depending on the patient's preference. The usual dose is 5 mg once daily, unless your doctor recommends a dose of 10 mg once daily.

Taking more Solifenacin US Pharmacia than prescribed

If you have taken too many Solifenacin US Pharmacia tablets or if a child has accidentally taken this medicine, contact your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, hallucinations, excessive stimulation, seizures (convulsions), breathing difficulties, rapid heartbeat (tachycardia), urine accumulation in the bladder (urinary retention), and dilated pupils. Particular caution should be exercised in patients with a risk of QT interval prolongation or significant, concomitant heart diseases (e.g., myocardial ischemia, arrhythmias, congestive heart failure).

Missing a dose of Solifenacin US Pharmacia

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 more than one dose per day. If you are unsure, consult your doctor or pharmacist. Do not take a double dose to make up for a missed dose.

Stopping Solifenacin US Pharmacia treatment

If you stop taking Solifenacin US Pharmacia, 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, Solifenacin US Pharmacia can cause side effects, although not everybody gets them. If you experience an allergic reaction or severe skin reaction (e.g., blistering and peeling of the skin), inform your doctor or nurse immediately. Some patients taking solifenacin succinate have reported angioedema (a form of allergic skin reaction that causes swelling of the tissue just beneath the skin). If you experience angioedema, stop taking solifenacin succinate and initiate appropriate treatment and/or take appropriate measures. Solifenacin US Pharmacia may cause other side effects, including:

• dry mouth.

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

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

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

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

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

• dizziness, headache,
• accumulation of a large amount of hard stool in the colon; obstruction (blockage) 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) side effects include:

• hallucinations, disorientation,
• hives.

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

• decreased appetite, increased potassium levels in the blood, which may cause heart rhythm disturbances,
• increased eye pressure,
• changes in ECG, irregular heartbeat, palpitations, rapid heartbeat,
• voice disorders,
• liver function disorders,
• muscle weakness,
• kidney function disorders.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: (22) 49-21-301, fax: (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 Solifenacin US Pharmacia

Keep the medicine out of the sight and reach of children. There are no special storage instructions for this medicine. Store in the original packaging to protect from light. Do not use this medicine after the expiry date stated on the carton and blister packaging (month/year). The expiry date is stated on the blister packaging as EXP - expiry date, Lot - batch number.

6. Contents of the pack and other information

What Solifenacin US Pharmacia contains

• The active substance of Solifenacin US Pharmacia is solifenacin succinate. Each tablet contains 5 mg of solifenacin succinate, which corresponds to 3.8 mg of solifenacin.
• The other ingredients are maize starch, microcrystalline cellulose, lactose monohydrate, mannitol, sucralose, strawberry-vanilla flavor (flavoring substances, natural flavoring substances, natural flavoring preparations, caramel (E 150c), maltodextrin, ammonium glycyrrhizate, arabic gum (E 414), sorbitol (E 420)), croscarmellose sodium, magnesium stearate.

What Solifenacin US Pharmacia looks like and contents of the pack

Solifenacin US Pharmacia chewable tablets are round, flat, white or almost white, and marked with "5" on one side. The blister pack is made of aluminum/aluminum in a cardboard box. The pack contains 7 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder

US Pharmacia Sp. z o.o.
ul. Ziębicka 40, 50-507 Wrocław

Manufacturer

Genepharm S.A
18th km Marathonos Avenue
153 51 Pallini Attiki, Greece

Other sources of information

For more detailed information, please contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
tel.+48 (22) 543 60 00

Date of last revision of the leaflet:

Page 6 6