Patient Information Leaflet

Solifenacin US Pharmacia, 5 mg, chewable tablets
Solifenacini succinas
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, 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 those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What Solifenacin US Pharmacia is and what it is used for
Important information before taking Solifenacin US Pharmacia
How to take Solifenacin US Pharmacia
Possible side effects
How to store Solifenacin US Pharmacia
Contents of the pack and other information

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

The active substance in Solifenacin US Pharmacia belongs to a group of medicines called anticholinergics. These medicines reduce the activity of an overactive bladder. This effect allows longer intervals between bathroom visits and increases the amount of urine the bladder can hold.
Solifenacin US Pharmacia is used to treat symptoms of overactive bladder. These symptoms include urgency, which is a sudden, compelling need to urinate, frequent urination, and urinary incontinence resulting from the inability to reach the toilet in time.

2. Important information before using Solifenacin US Pharmacia

When not to use Solifenacin US Pharmacia:

if the patient is allergic to the active substance or to 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 (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 eye leading to progressive loss of vision);
if the patient is undergoing hemodialysis;
in patients with severe liver function impairment;
in patients with severe kidney disease or moderate liver disease who are also taking medicines that may delay elimination of Solifenacin US Pharmacia from the body (e.g. ketoconazole). Your doctor or pharmacist will provide information on this.

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Pharmacia from the body (e.g., ketoconazole). Your doctor or
pharmacist will provide information on this.
Before starting treatment with Solifenacin US Pharmacia, inform your doctor if
any of the above conditions are currently present or have occurred in the past.
Warnings and precautions
Before starting treatment with Solifenacin US Pharmacia, discuss with your doctor or
pharmacist:

if the patient has difficulty emptying the bladder (obstruction of urinary outflow) or difficulty passing urine (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 slowed gastrointestinal motility (peristalsis). Your doctor will provide information on this.
if there are severe kidney function impairments.
if there are moderate liver function impairments.
if the patient has severe stomach pain (hiatal hernia) or heartburn.
if the patient has disorders of the nervous system (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, inform your doctor if
any of the above conditions are present or have occurred in the past.
Before initiating treatment with Solifenacin US Pharmacia, the doctor will assess whether there are other possible causes of frequent urination (e.g., heart failure – insufficient pumping strength of the heart muscle – or kidney disease). If a urinary tract infection occurs, the doctor will prescribe an antibiotic (an antibacterial agent effective against the specific bacteria).
Solifenacin US Pharmacia and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
This is important because Solifenacin US Pharmacia may affect the action of certain medicines, and certain medicines may affect the action of Solifenacin US Pharmacia.
It is particularly important to inform your doctor before taking Solifenacin US Pharmacia if the patient is taking any of the following medicines:

other anticholinergic medicines, as using such medicines together with Solifenacin US Pharmacia may increase both the therapeutic effects and adverse reactions of both medicines;
medicines belonging to the group of cholinergic receptor agonists, as they may reduce the effectiveness of Solifenacin US Pharmacia;
medicines that increase gastrointestinal motility, such as metoclopramide and cisapride, as Solifenacin US Pharmacia may reduce their effectiveness;
medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, which slow down the metabolism of Solifenacin US Pharmacia;
medicines such as rifampicin, phenytoin, carbamazepine, which may accelerate the metabolism of Solifenacin US Pharmacia;
medicines such as bisphosphonates, which may increase the risk of esophagitis.

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Solifenacin US Pharmacia with food and drink
This medicine can be taken with or without food.
Pregnancy and breastfeeding
Do not use Solifenacin US Pharmacia during pregnancy, as there are no data available on the use of solifenacin in human pregnancy, and the potential risk associated with its use in humans is unknown.
Do not use Solifenacin US Pharmacia during breastfeeding, as there are no data on passage of the medicine into human breast milk, although solifenacin passes into the milk of mice.
Before taking any medicine, consult your doctor or pharmacist.
Driving and operating machinery
Solifenacin US Pharmacia may cause blurred vision, and less frequently drowsiness and fatigue. If these adverse effects occur, the patient should not drive or operate any machinery.
Solifenacin US Pharmacia contains lactose and sorbitol
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 1 tablet, meaning the medicine is considered "sodium-free".
The medicine contains 0.042 mg of sorbitol (E 420) in each single tablet.

3. How to use Solifenacin US Pharmacia

Instructions for proper use:
This medicine should always be taken exactly as prescribed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
Take orally. The tablet should be chewed thoroughly until dissolved. Do not swallow the tablets whole.
The medicine may be taken with food or independently of meals, depending on patient preference.
The usual dose is 5 mg once daily, unless your doctor prescribes a dose of 10 mg once daily.

Taking more Solifenacin US Pharmacia than prescribed
If you take too many Solifenacin US Pharmacia tablets or if a child accidentally swallows the 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, visual disturbances, hallucinations, excessive agitation, seizures (convulsions), difficulty breathing, rapid heartbeat (tachycardia), urinary retention (inability to urinate), and dilated pupils.

Special caution is required in patients at risk of QT interval prolongation or with significant concomitant heart diseases (e.g., myocardial ischemia, arrhythmias, congestive heart failure).

Missed 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 scheduled dose. Do not take the medicine more often than once daily. If in doubt, consult your doctor or pharmacist. Do not take a double dose to make up for a missed dose.

Stopping Solifenacin US Pharmacia
If you stop taking Solifenacin US Pharmacia, symptoms of 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, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this one may cause adverse reactions, although not everyone experiences them.
If the patient experiences an allergic attack or a severe skin reaction (e.g. blistering and
peeling of the outer skin layer), the doctor or nurse should be informed immediately.
In some patients taking solifenacin succinate, angioedema (a type of allergic skin reaction causing swelling of tissue just beneath the skin surface) with swelling of the airways (difficulty breathing) has been reported. If angioedema occurs in the patient, treatment with solifenacin succinate should be stopped immediately and appropriate treatment and/or corrective measures initiated.
Solifenacin US Pharmacia may cause other adverse reactions listed below.

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 full stomach, abdominal pain, belching, nausea, heartburn, feeling of discomfort in the abdominal cavity.

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

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

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

dizziness, headache,
accumulation of hard stool in the colon; colon obstruction (bowel blockage),
vomiting,
itching, rash,
difficulty passing urine despite a full bladder (urinary retention).

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

hallucinations, disorientation,
urticaria.

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

decreased appetite, increased blood potassium levels which may cause cardiac arrhythmia,
increased intraocular pressure,
ECG changes, irregular heartbeat, palpitations, rapid heartbeat,
voice disorders,
liver function disorders,
muscle weakness,
kidney function disorders.

Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Medicinal Products' Adverse Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: (22) 49-21-301, fax: (22) 49-21-309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Solifenacin US Pharmacia

Keep the medicine out of the sight and reach of children.
There are no special storage temperature requirements for this medicine. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the outer carton and on the immediate packaging (month/year). The blister labelling used: EXP – expiry date, Lot – batch number.

6. Contents of the packaging and other information

What Solifenacin US Pharmacia contains

The active substance in Solifenacin US Pharmacia is solifenacin succinate. Each coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin.
The other ingredients are pregelatinized corn starch, microcrystalline cellulose, lactose monohydrate, mannitol, sucralose, strawberry-vanilla flavor (flavoring substances, natural flavoring substances, natural flavoring preparations, caramel (E 150c), maltodextrin, ammonium salt of licorice acid, gum arabic (E 414), sorbitol (E 420)), sodium croscarmellose, 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, marked "5" on one side.
Aluminum/Aluminum foil blister pack in a cardboard box.
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Pack contains 7 tablets.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation 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
Further information
For further information, please contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
tel. +48 (22) 543 60 00
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