Aurosolin

Leaflet accompanying the packaging: information for the user

Aurosolin, 5 mg, coated tablets

Aurosolin, 10 mg, coated tablets

Solifenacin succinate

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Aurosolin and what is it 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 packaging and other information

1. What is Aurosolin and what is it used for

The active substance of Aurosolin belongs to a group of cholinolytic medicines. These medicines reduce the activity of an overactive urinary bladder. This action allows for longer intervals between using the toilet and increases the amount of urine held in the bladder. Aurosolin is used to treat symptoms of an overactive bladder. These include: 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 Aurosolin.

When not to take Aurosolin:

• if the patient cannot urinate or cannot empty the urinary bladder (urinary retention),
• if the patient has severe stomach or intestinal diseases (toxic megacolon, a complication associated with ulcerative colitis),
• if the patient has a muscle disease called myasthenia, which can cause significant weakness of some muscles,
• if the patient has increased pressure in the eyeball, which can lead to gradual vision loss (glaucoma),
• if the patient is undergoing dialysis procedures,
• if the patient is allergic to solifenacin or 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 taking medicines that may delay the elimination of Aurosolin from the body (e.g. ketoconazole). The doctor or pharmacist will provide information on this.

Before starting treatment with Aurosolin, 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 Aurosolin, the patient should discuss it with their doctor or pharmacist:

• if the patient has difficulty emptying the urinary bladder (narrowing of the urine outflow 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, movements of the stomach and intestines). 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 nervous system disorders (autonomic nervous system neuropathy).

Children and adolescents

Aurosolin should not be used in children or adolescents under the age of 18. The patient should consult a doctor before starting to take Aurosolin if the above warnings apply to their current or past situation. Before starting treatment with Aurosolin, 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). If a urinary tract infection occurs, the doctor will prescribe an antibiotic (an antibacterial medicine).

Aurosolin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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 Aurosolin 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 Aurosolin,
• medicines that enhance gastrointestinal motility, such as metoclopramide and cisapride, as Aurosolin may weaken their effect,
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they slow down the metabolism of Aurosolin in the body,
• medicines such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of Aurosolin in the body,
• medicines such as bisphosphonates, as they may cause or exacerbate esophagitis.

Aurosolin with food, drink, and alcohol

Aurosolin can be taken during meals or between meals, depending on the patient's preference.

Pregnancy, breastfeeding, and fertility

Aurosolin should not be used during pregnancy, unless the doctor considers it absolutely necessary. Aurosolin should not be used during breastfeeding, as solifenacin passes into human milk. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.

Driving and using machines

Aurosolin may cause blurred vision and sometimes drowsiness or fatigue. If such side effects occur, the patient should not drive vehicles or operate any machines.

Aurosolin contains lactose

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

3. How to take Aurosolin

Instructions for proper use

This medicine should always be used in accordance with the doctor's or pharmacist's recommendations. If in doubt, the patient should consult a doctor or pharmacist. The tablet should be swallowed whole, with a drink of water. The medicine can be taken during meals or independently of meals, depending on the patient's preference. The tablets should not be crushed. The usual dose is 5 mg once daily, unless the doctor recommends a dose of 10 mg.

Using a higher dose of Aurosolin than recommended

In case of taking too much Aurosolin or if a child accidentally swallows Aurosolin, the patient should immediately contact a doctor or pharmacist. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, hallucinations, excessive stimulation, seizures, breathing difficulties, rapid heartbeat (tachycardia), excessive accumulation of urine in the bladder (urinary retention), and dilated pupils.

Missing a dose of Aurosolin

In case of missing a dose, 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 often than once a day. If in doubt, the patient should consult a doctor or pharmacist.

Stopping treatment with Aurosolin

If treatment with Aurosolin is stopped, the symptoms of an overactive bladder may return or worsen. The patient should always consult a doctor if they are considering stopping treatment. If the patient has any further doubts about using this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Aurosolin can cause side effects, although not everybody gets them. If the patient experiences sudden allergic symptoms or a severe skin reaction (e.g. blistering and peeling of the skin), they should immediately inform their doctor or pharmacist. In some patients taking solifenacin succinate (Aurosolin), angioedema (a form of skin allergy that causes swelling of the tissue just beneath the skin surface) with swelling of the airways (difficulty breathing) has occurred. If the patient experiences angioedema, they should immediately stop treatment with solifenacin succinate (Aurosolin) and initiate appropriate treatment and/or take appropriate measures. Aurosolin may cause other side effects, including:

• 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, indigestion with symptoms such as a feeling of fullness in the abdominal cavity, abdominal pain, belching, nausea, and heartburn (indigestion), discomfort in the abdominal cavity.

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

• urinary tract infection, cystitis,
• drowsiness, taste disorders,
• dry eye syndrome,
• dryness in the nasal cavity,
• gastroesophageal reflux disease (gastroesophageal reflux),
• dryness in the throat,
• dry skin,
• difficulty urinating,
• fatigue, fluid accumulation in the lower limbs (edema).

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

• accumulation of a large amount of hard stool in the colon; obstruction (obstruction) 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):

• hallucinations, disorientation,
• urticaria.

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

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

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. 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 Aurosolin

The medicine should be stored out of sight and reach of children. This medicine should not be used after the expiry date stated on the label, carton, and bottle after EXP. The expiry date refers to the last day of the specified month. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Aurosolin contains

• The active substance of Aurosolin is solifenacin succinate. Each coated tablet contains 5 mg of solifenacin succinate, which corresponds to 3.77 mg of solifenacin. Each coated tablet contains 10 mg of solifenacin succinate, which corresponds to 7.54 mg of solifenacin.

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

What Aurosolin looks like and what the pack contains

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

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw

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 authorized in the Member States of the European Economic Area under the following names:

Poland:
Aurosolin
Portugal:
Solifenacina Generis Phar
Czech Republic:
Solifenacin Aurovitas

Date of last revision of the leaflet: