Belaristo

Leaflet attached to the packaging: patient information

Belaristo, 5 mg, film-coated tablets

Belaristo, 10 mg, film-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 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 Belaristo and what is it used for
• 2. Important information before taking Belaristo
• 3. How to take Belaristo
• 4. Possible side effects
• 5. How to store Belaristo
• 6. Contents of the pack and other information

1. What is Belaristo and what is it used for

The active substance of Belaristo belongs to a group of anticholinergic medicines. These medicines reduce the activity of an overactive urinary bladder. This action allows for longer intervals between visits to the toilet and increases the amount of urine held in the bladder. Belaristo is used to treat symptoms of an overactive bladder. These symptoms include: a sudden and urgent need to urinate without prior warning (urinary urgency), frequent urination, or involuntary loss of urine due to the fact that the patient did not have time to use the toilet.

2. Important information before taking Belaristo

When not to take Belaristo:

• if the patient is allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6);
• if the patient is unable to urinate or empty their bladder (urinary retention);
• if the patient has severe stomach or intestinal diseases (including toxic megacolon, a complication associated with ulcerative colitis);
• if the patient has a muscle disease called myasthenia gravis, which can cause significant weakness of some muscles;
• if the patient has increased pressure in the eyeball, progressing with gradual loss of vision (glaucoma);
• if the patient is undergoing dialysis;
• if the patient has severe liver disease;
• if the patient has severe kidney disease or moderate liver disease and is taking medicines that may slow down the elimination of Belaristo from the body (e.g., ketoconazole). The doctor or pharmacist will provide information on this.

Before starting to take Belaristo, 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 Belaristo, the patient should discuss it with their doctor or pharmacist:

• if the patient has difficulty emptying their bladder (narrowing of the urethra) or urinating (e.g., 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). The patient should consult their doctor before starting to take Belaristo if the above warnings apply to their current or past situation. Before starting to take Belaristo, the doctor will assess whether there are other causes of frequent urination (e.g., heart failure or kidney disease). If a urinary tract infection occurs, the doctor will prescribe an antibiotic.

Children and adolescents

Belaristo should not be used in children or adolescents under 18 years of age.

Belaristo 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 anticholinergic medicines, as taking such a medicine with Belaristo may lead to an increase in both the therapeutic effect and side effects of both medicines;
• cholinergic receptor agonist medicines, as they may weaken the effect of Belaristo;
• gastrointestinal motility enhancers such as metoclopramide and cisapride, as Belaristo may weaken their effect;
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, as they slow down the metabolism of Belaristo in the body;
• medicines such as rifampicin, phenytoin, and carbamazepine, as they may accelerate the metabolism of Belaristo in the body;
• medicines such as bisphosphonates, as they may cause esophagitis or worsen it.

Belaristo with food, drink, and alcohol

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

Pregnancy and breastfeeding

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

Driving and using machines

Belaristo may cause blurred vision and sometimes drowsiness or fatigue. If such side effects occur, the patient should not drive or operate machinery.

Belaristo contains lactose

Each 5 mg film-coated tablet of Belaristo contains 105 mg of lactose. Each 10 mg film-coated tablet of Belaristo contains 209 mg of lactose. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Belaristo

This medicine should always be taken exactly as advised by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist. The tablet should be swallowed, with a small amount of liquid. The tablets should not be chewed. Belaristo can be taken during or between meals, depending on the patient's preference. The usual dose is 5 mg once daily, unless the doctor recommends a dose of 10 mg. The 10 mg film-coated tablet of Belaristo can be divided into equal doses.

Taking more Belaristo than prescribed

In case of overdose, the patient should immediately contact their doctor or pharmacist. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, perceiving things that are not there (hallucinations), excessive excitement, seizures (convulsions), breathing difficulties, rapid heartbeat (tachycardia), excessive urine accumulation in the bladder (urinary retention), and pupil dilation (mydriasis).

Missing a dose of Belaristo

In case of a missed dose, the patient should take the next dose as soon as possible, unless it is almost time for the next dose. The patient should never take the medicine more than once a day. If in doubt, the patient should consult their doctor or pharmacist.

Stopping Belaristo treatment

If the patient stops taking Belaristo, the symptoms of an overactive bladder may return or worsen. The patient should always consult their doctor if they are considering stopping treatment. If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Belaristo can cause side effects, although not everybody gets them. If the patient experiences sudden symptoms of an allergic reaction 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, angioedema (an allergic skin reaction that causes swelling of the tissue just below the surface of the skin) with swelling of the airways (difficulty breathing) has occurred. If the patient experiences angioedema, they should immediately stop taking solifenacin succinate and initiate appropriate treatment and/or take appropriate corrective measures. Belaristo may cause the following side effects: 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: 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
• dry nose
• gastroesophageal reflux disease
• dry 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
• allergic rash (hives) 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 the electrical activity of the heart (ECG), irregular heartbeat, palpitations, rapid heartbeat
• voice disorders
• 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 tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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 Belaristo

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated. There are no special precautions for storage. Medicines should not be disposed of via wastewater or household waste. 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 pack and other information

What Belaristo contains

The active substance of Belaristo is solifenacin succinate. Each 5 mg film-coated tablet of Belaristo contains 5 mg of solifenacin succinate. Each 10 mg film-coated tablet of Belaristo contains 10 mg of solifenacin succinate. The other ingredients are: cornstarch, lactose anhydrous, hypromellose 2910 (E 464), magnesium stearate, colloidal silicon dioxide, macrogol, talc, titanium dioxide (E 171), and iron oxide red (E 172).

What Belaristo looks like and contents of the pack

Belaristo, 5 mg, film-coated tablets Round, light pink film-coated tablet. Belaristo, 10 mg, film-coated tablets Round, light pink film-coated tablet with a dividing line. The 5 mg film-coated tablets of Belaristo are packaged in blisters containing: 10, 30, 50, 90, or 100 film-coated tablets. The 10 mg film-coated tablets of Belaristo are packaged in blisters containing: 20, 30, 50, 90, or 100 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aristo Pharma Sp. z o.o. ul. Baletowa 30, 02-867 Warsaw

Manufacturer/Importer:

Laboratorios Medicamentos Internacionales S.A. Calle Solana, 26, 28850 Torrejón De Ardoz (Madrid), Spain Aristo Pharma GmbH, Wallenroder Strasse 8-10, 13435 Berlin, Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Portugal Solifenacina Aristo Norway Solifenacin Aristo Romania Solifenacin Aristo 5 mg film-coated tablets Solifenacin Aristo 10 mg film-coated tablets Czech Republic Solifenacin Aristo Sweden Solifenacin Aristo Slovakia Arisissa Denmark Solifenacin Aristo Ireland Solifenacin succinate Aristo 5 mg film-coated tablets Solifenacin succinate Aristo 10 mg film-coated tablets Poland Belaristo Date of last revision of the leaflet:March 2023