Anturin

Package leaflet: Information for the patient

ANTURIN, 5 mg, coated tablets
Solifenacin succinate
Read this leaflet carefully before using this medicine, as it contains important information for you.

• 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 share it with others. This medicine may harm others, 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.

Contents

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

1. What ANTURIN is and what it is used for

ANTURIN contains the active substance solifenacin succinate. It belongs to a group of medicines called anticholinergics.
These medicines reduce the activity of an overactive bladder. This effect allows longer intervals between toilet visits and increases the volume of urine the bladder can hold.
ANTURIN is used to treat symptoms of overactive bladder. These include urgency, which is a sudden, compelling need to pass urine, urinary frequency, and urge incontinence, when the person is unable to reach the toilet in time.

2. Important information before using ANTURIN

When not to use ANTURIN:

• 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 gastrointestinal disorders (toxic megacolon, a complication associated with ulcerative colitis);
• in patients suffering from 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 gradual loss of vision);
• if the patient is undergoing hemodialysis;
• if the patient has severe liver function impairment;
• if the patient has severe kidney disease or moderate liver disease and is taking medicines that may delay elimination of ANTURIN from the body (e.g. ketoconazole). Your doctor or pharmacist will provide information on this.

Before starting treatment with ANTURIN, inform your doctor if any of the above conditions are present or have occurred in the past.
Warnings and precautions
Discuss with your doctor or pharmacist before taking ANTURIN.

• if the patient has difficulty emptying the bladder (obstruction of urinary outflow from the bladder) or difficulty passing urine (weak urinary stream). In such cases, the risk of urine retention 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 disorders
• if there are 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)

Children and adolescents
ANTURIN must not be used in children and adolescents under 18 years of age.
Before starting treatment with ANTURIN, inform your doctor if any of the above conditions are present or have occurred in the past.
Before initiating treatment with ANTURIN, the doctor will assess whether there are other possible causes of frequent urination (e.g. heart failure – insufficient pumping strength of the heart muscle to circulate blood – or kidney disease). If a urinary tract infection occurs, the doctor will prescribe an antibiotic (an antibacterial agent effective against specific bacteria).
ANTURIN with 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.
It is particularly important to inform your doctor if the patient is taking:

• other anticholinergic medicines, as concomitant use with ANTURIN may enhance both the therapeutic effects and adverse reactions of both drugs;
• cholinergic receptor agonists, as they may reduce the effectiveness of ANTURIN;
• medicines that enhance gastrointestinal motility, such as metoclopramide and cisapride, as ANTURIN may reduce their effectiveness;
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they may 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 worsen esophagitis.

ANTURIN with food and drink
This medicine may be taken during meals or independently of food.
Pregnancy and breastfeeding
ANTURIN should not be used during pregnancy unless absolutely necessary.
ANTURIN should not be used during breastfeeding, as the drug passes into breast milk.
Before taking any medicine, consult your doctor or pharmacist.
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Driving and operating machinery
ANTURIN may cause blurred vision, and less commonly drowsiness and fatigue. If these adverse effects occur, the patient should not drive or operate any mechanical equipment.
ANTURIN contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use ANTURIN

Instructions for proper use:
ANTURIN should always be used as directed by the physician.
If in doubt, contact your doctor or pharmacist.

Adults, including elderly patients
ANTURIN should be taken orally once daily, with a large amount of fluid. The tablet should be
swallowed whole and must not be crushed. The medication may be taken with or without food,
depending on patient preference.
The usual dose is 5 mg once daily, unless the physician prescribes a dose of 10 mg once daily.

Patients with renal impairment
In patients with mild to moderate renal impairment (creatinine clearance > 30 ml/min), no dose
adjustment is required. In patients with severe renal impairment (creatinine clearance ≤ 30 ml/min),
caution is advised and the dose of solifenacin succinate should not exceed 5 mg once daily.

Patients with hepatic impairment
In patients with mild hepatic impairment, no dose adjustment is necessary. In patients with
moderate hepatic impairment (Child-Pugh score 7 to 9), caution is advised and the dose should not
exceed 5 mg once daily.

Taking more ANTURIN than recommended
If too many ANTURIN tablets are taken or if a child accidentally swallows ANTURIN, contact a
doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and visual
disturbances, hallucinations, excessive excitation, seizures (convulsions), breathing difficulties,
rapid heartbeat (tachycardia), urine retention in the bladder (urinary retention), and dilated pupils.

Missing a dose of ANTURIN
If a dose is missed, take the next dose as soon as possible, unless it is almost time for the next
scheduled dose. Do not take the medication more often than once daily. If in doubt, consult your
doctor or pharmacist.

Stopping treatment with ANTURIN
If treatment with ANTURIN is discontinued, symptoms of overactive bladder may return or worsen.
Discontinuation of the medication should always be discussed with a physician.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
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4. Possible adverse reactions

Like all medicines, ANTURIN 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 skin), the doctor or nurse should be informed immediately.

In some patients taking solifenacin succinate, angioedema (a type of allergic skin reaction causing swelling of the tissue just beneath the skin surface) with swelling of the airways (difficulty breathing) has been reported. If angioedema occurs, treatment with solifenacin succinate should be stopped immediately and appropriate treatment and/or corrective measures should be initiated.

The following adverse reactions may occur during treatment with ANTURIN:

Very common (may affect more than 1 in 10 people):

• dry mouth.

Common (may affect less than 1 in 10 people):

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

Uncommon (may affect less than 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,
• peripheral oedema.

Rare (may affect less than 1 in 1,000 people):

• faecal impaction; colonic obstruction,
• difficulty passing urine despite a full bladder (urinary retention),
• dizziness, headache,
• vomiting,
• itching, rash.

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

• hallucinations, confusion,
• urticaria.

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

• decreased appetite, increased blood potassium levels which may lead to cardiac arrhythmia,
• increased intraocular pressure,
• changes in ECG, irregular heartbeat ( Torsade de Pointes ),
• voice disorders,
• hepatic function abnormalities,
• muscle weakness,
• renal function abnormalities.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Medicinal Products at the 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
Adverse reactions can also be reported to the marketing authorisation holder.

Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store ANTURIN

Keep this medicine out of sight and reach of children.
No special storage conditions required.
Do not use this medicine after the expiry date stated on the outer carton and
on the immediate packaging (month/year). The labelling on the blister reads: EXP – expiry date, LOT – batch number.

6. Contents of the packaging and other information

What Anturin contains

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

What Anturin looks like and contents of the pack
Anturin coated tablets are round, biconvex, light yellow in colour,
marked “EG” on one side and “1” on the other.
The medicine is packaged in PVC/PVDC/Aluminium blisters and a cardboard box.
The pack contains 7 coated tablets.
Marketing Authorisation Holder and Importer:
US Pharmacia Sp. z o.o.
ul. Ziębicka 40, 50-507 Wrocław
For further information, please contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
tel. +48 (22) 543 60 00
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