Anturin

Leaflet attached to the packaging: patient information

ANTURIN, 5 mg, coated tablets

Solifenacin succinate

Read the leaflet carefully before taking the medicine, 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 side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents

• 1. What is ANTURIN and what is it used for
• 2. Important information before taking ANTURIN
• 3. How to take ANTURIN
• 4. Possible side effects
• 5. How to store ANTURIN
• 6. Package contents and other information

1. What is ANTURIN and what is it used for

ANTURIN contains the active substance solifenacin succinate. The medicine 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.
ANTURIN is used to treat symptoms of an overactive bladder, including: 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 ANTURIN

When not to take ANTURIN:

• if the patient is allergic to the active substance 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 (toxic megacolon, a complication associated with ulcerative colitis);
• in patients with a muscle disease called myasthenia gravis, which can cause significant weakness of some muscles;
• if the patient has glaucoma with a narrow angle of filtration (increased fluid pressure in the eyeball, progressing with gradual vision loss);
• if the patient is undergoing hemodialysis;
• if the patient has 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 ANTURIN from the body (e.g., ketoconazole). The doctor or pharmacist will provide information on this.

Before starting treatment with ANTURIN, 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 ANTURIN, the patient should discuss it with their doctor or pharmacist.

• if the patient has difficulty emptying their bladder (narrowing of the urine outflow tract from the bladder) or urinating (weak urine stream). In such a case, 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 function disorders
• if the patient has moderate liver function disorders
• if the patient has a burning stomach pain (hiatal hernia) or heartburn
• if the patient has autonomic nervous system disorders (autonomic neuropathy)

Children and adolescents

ANTURIN should not be used in children and adolescents under 18 years of age.

Before starting treatment with ANTURIN, the patient should inform their doctor if any of the above situations occur or have occurred in the past.
Before starting treatment with ANTURIN, 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). In case of a urinary tract infection, the doctor will prescribe an antibiotic (an antibacterial medicine, acting on specific bacteria).

ANTURIN 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 ANTURIN 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 ANTURIN;
• medicines that enhance gastrointestinal motility, such as metoclopramide and cisapride, as ANTURIN may weaken their effect;
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they slow down the metabolism of ANTURIN;
• medicines such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of ANTURIN;
• medicines such as bisphosphonates, as they may cause or exacerbate esophagitis.

ANTURIN with food and drink

The medicine can be taken during meals or independently of meals.

Pregnancy and breastfeeding

ANTURIN should not be used during pregnancy unless it is absolutely necessary.
ANTURIN should not be used during breastfeeding, as the medicine passes into breast milk.
Before taking any medicine, the patient should consult their doctor or pharmacist.
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Driving and using machines

ANTURIN may cause blurred vision, and less frequently, drowsiness and fatigue. If such side effects occur, the patient should not drive or operate any mechanical devices.

ANTURIN contains lactose

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

3. How to take ANTURIN

Instructions for proper use:

ANTURIN should always be taken according to the doctor's recommendations.
In case of doubts, the patient should contact their doctor or pharmacist.
Adults, including the elderly
ANTURIN should be taken orally once a day, with a large amount of liquid. The tablet should be swallowed whole, without crushing. The medicine can be taken during meals or independently of meals, depending on the patient's preferences.
Usually, a dose of 5 mg per day is used, unless the doctor recommends a dose of 10 mg per day.
Patient with kidney function disorders
In patients with mild to moderate kidney function disorders (creatinine clearance > 30 ml/min), there is no need to modify the dosage of the medicine. In patients with severe kidney function disorders (creatinine clearance ≤ 30 ml/min), caution should be exercised and the dose of solifenacin succinate should not exceed 5 mg once a day.
Patient with liver function disorders
In patients with mild liver function disorders, there is no need to modify the dosage. In patients with moderate liver function disorders (7 to 9 on the Child-Pugh scale), caution should be exercised and the dose should not exceed 5 mg once a day.

Taking a higher dose of ANTURIN than recommended

In case of taking too many ANTURIN tablets or if ANTURIN 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 (convulsions), breathing difficulties, rapid heartbeat (tachycardia), urine accumulation in the bladder (urinary retention), and dilated pupils.
Missing a dose of ANTURINIf a dose of the medicine is missed, the patient should take the next dose as soon as possible, unless it is almost time for the next dose. The medicine should not be taken more than once a day. In case of doubts, the patient should consult their doctor or pharmacist.

Stopping treatment with ANTURIN

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

Like all medicines, ANTURIN can cause side effects, although not everybody gets them.
If the patient experiences an allergic reaction or a severe skin reaction (e.g., blistering and peeling of the skin), they should immediately inform their doctor or nurse.
In some patients taking solifenacin succinate, angioedema (a form of skin allergy that causes swelling of the tissue just below the skin surface) with swelling of the airways (difficulty breathing) has been reported. If the patient experiences angioedema, they should immediately stop taking solifenacin succinate and initiate appropriate treatment and/or take appropriate measures.
The following side effects may occur when taking ANTURIN:
Very common (may affect more than 1 in 10 people) side effects include:

• dry mouth.

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

• blurred vision,
• constipation, nausea, dyspepsia (symptoms: feeling of fullness in the stomach, belching, abdominal pain, nausea), abdominal pain.

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

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

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

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

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

• hallucinations, confusion,
• hives.

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

• decreased appetite, increased potassium levels in the blood, which may cause heart rhythm disorders,
• increased eye pressure,
• ECG changes, irregular heartbeat (Torsade de Pointes),
• voice disorders,

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• liver function disorders,
• muscle weakness,
• kidney function disorders.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Product 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, more information can be collected on the safety of the medicine.

5. How to store ANTURIN

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the carton and blister packaging (month/year). The applied labeling for the blister is: EXP - expiry date, LOT - batch number.

6. Package contents and other information

What ANTURIN contains

• The active substance of ANTURIN is solifenacin succinate. Each coated tablet contains 5 mg of solifenacin succinate (Solifenacini succinas), which corresponds to 3.8 mg of solifenacin.
• The other ingredients are lactose monohydrate, cornstarch, hypromellose 3 mPa·s, magnesium stearate. The composition of the Opadry yellow 02F520011 coating: hypromellose 5 mPa·s, talc, titanium dioxide E 171, macrogol 6000, yellow iron oxide E 172.

What ANTURIN looks like and what the package contains

ANTURIN coated tablets are round, biconvex, light yellow in color, marked on one side with "EG", on the other side with "1".
The medicine is packaged in PVC/PVDC/Aluminum blisters and a carton box.
The package contains 7 coated tablets.

Marketing authorization holder and importer:

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

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