Aurosolin

Package leaflet: Information for the user

Aurosolin, 5 mg, film-coated tablets
Aurosolin, 10 mg, film-coated tablets
Solifenacin succinate
Read the entire leaflet before taking 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 share it with others. This medicine may harm others, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Aurosolin is and what it is used for

The active substance in Aurosolin belongs to the group of medicines known as anticholinergics (cholinolytics). 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.
Aurosolin is used to treat symptoms of overactive bladder. These symptoms include urgency, which refers to sudden, compelling urges to pass urine, urinary frequency, and urinary incontinence resulting from the inability to reach the toilet in time.

2. Important information before taking Aurosolin

When not to take Aurosolin:

• if the patient is unable to pass urine or empty the urinary bladder (urinary retention),
• if the patient has severe stomach or intestinal disorders (toxic megacolon, a complication associated with ulcerative colitis),
• if the patient suffers from a muscle disease called myasthenia gravis, which may cause significant weakening of certain muscles,
• if the patient has increased intraocular pressure leading to progressive loss of vision (glaucoma),
• if the patient is undergoing dialysis procedures,
• if the patient is allergic to solifenacin or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe liver disease,
• if the patient has severe kidney disease or moderate liver disease and is simultaneously taking medicines that may delay elimination of Aurosolin from the body (e.g. ketoconazole). Your doctor or pharmacist will provide information on this matter.

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

Warnings and precautions

Before starting to take Aurosolin, discuss with your doctor or pharmacist:

• if the patient has difficulty emptying the urinary 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 higher,
• if the patient has gastrointestinal motility disorders (constipation),
• if there is a risk of slowed gastrointestinal motility (peristalsis, stomach and intestinal movements). 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 disorders of the nervous system (autonomic neuropathy).

Children and adolescents

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

Consult your doctor before starting treatment with Aurosolin if any of the above warnings apply to your current condition or have occurred in the past.

Before starting treatment with Aurosolin, your 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, your doctor will prescribe an antibiotic (an antibacterial agent effective against the specific bacteria).

Aurosolin and other medicines

Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

It is particularly important to inform your doctor if you are taking:

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

Aurosolin with food, drink and alcohol

Aurosolin may be taken during meals or between meals, depending on patient preference.

Pregnancy, breastfeeding and fertility

Do not take Aurosolin during pregnancy unless your doctor considers it absolutely necessary.

Do not take Aurosolin while breastfeeding, as solifenacin passes into human milk.

If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

Aurosolin may cause blurred vision and occasionally drowsiness or fatigue. If these adverse effects occur, do not drive or operate any machinery.

Aurosolin contains lactose

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

3. How to take Aurosolin

Instructions for proper use
This medicine should always be taken exactly as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
The tablet should be swallowed whole with liquid. Aurosolin may be taken during meals or
independently of meals, depending on patient preference. Tablets must not be crushed.
The usual dose is 5 mg daily, unless the doctor recommends a dose of 10 mg.
Taking more Aurosolin than recommended
If an excessive dose of Aurosolin has been taken, or if Aurosolin is accidentally swallowed by
a child, contact a doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, visual disturbances,
perceiving things that are not there (hallucinations), excessive excitation, seizures (convulsions),
difficulty breathing, rapid heartbeat (tachycardia), excessive urine retention in the bladder (urinary retention), and pupil dilation.
Missing a dose of Aurosolin
If a dose of Aurosolin is missed, take the next dose as soon as possible, unless it is almost time for the next scheduled dose. Do not take the medicine more than once a day. If in doubt, consult the doctor or pharmacist.
Stopping treatment with Aurosolin
If treatment with Aurosolin is discontinued, symptoms of overactive bladder may return or worsen. Always consult the doctor if considering stopping treatment.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences severe allergic symptoms or a serious skin reaction (e.g. blistering and peeling of the skin), a doctor or pharmacist should be informed immediately.
In some patients taking solifenacin succinate (Aurosolin), 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 occurred.
If angioedema occurs in the patient, treatment with solifenacin succinate (Aurosolin) must be stopped immediately and appropriate treatment and/or emergency measures should be initiated.
Aurosolin may cause other adverse reactions listed below:
Very common (may occur in more than 1 in 10 people):

• dry mouth.

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

• blurred vision,
• constipation, nausea, dyspepsia with symptoms such as bloating, abdominal pain, belching, nausea and heartburn (dyspepsia), abdominal discomfort.

Uncommon (may occur in less than 1 in 100 people):

• urinary tract infection, cystitis,
• somnolence, taste disturbances,
• dry (irritated) eye syndrome,
• dry nose,
• gastroesophageal reflux disease (acid reflux),
• dry throat,
• dry skin,
• difficulty in urination,
• fatigue, fluid accumulation in the lower limbs (oedema).

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

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

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

• hallucinations, disorientation,
• allergic urticaria.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported directly to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Aurosolin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label, carton, and bottle after EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Aurosolin contains

• The active substance is solifenacin succinate. Each coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.77 mg of solifenacin. Each coated tablet contains 10 mg of solifenacin succ在玩家中, equivalent to 7.54 mg of solifenacin.

The other ingredients are:
Tablet core: monohydrate lactose, corn starch, hypromellose (5 mPa s), colloidal silicon dioxide, magnesium stearate.
Tablet coating: hypromellose (6 mPa s), macrogol 4000, titanium dioxide (E 171), talc, iron oxide yellow (E 172) (only for Aurosolin 5 mg coated tablets), iron oxide red (E 172) (only for Aurosolin 10 mg coated tablets).

What Aurosolin looks like and contents of the pack

Coated tablet.
Aurosolin 5 mg coated tablets:
light yellow, round, 7.6 mm in diameter, biconvex coated tablet, embossed with "CC" on one side and "31" on the other.
Aurosolin 10 mg coated tablets:
light pink, round, 7.6 mm in diameter, biconvex coated tablet, embossed with "CC" on one side and "32" on the other.
Aurosolin coated tablets are packed in blisters containing: 30 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
Poland

Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Aurosolin
Portugal: Solifenacina Generis Phar
Czech Republic: Solifenacin Aurovitas