Belaristo

Package Leaflet: Information for the Patient

Belaristo, 5 mg, Film-Coated Tablets

Belaristo, 10 mg, Film-Coated Tablets

Solifenacin Succinate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medication Has Been Prescribed Specifically for You. Do Not Pass it on to Others. The Medication May Harm Them, Even if Their Symptoms are the Same as Yours.
• If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Table of Contents of the Package 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 Package and Other Information

1. What is Belaristo and What is it Used for

The Active Substance of Belaristo Belongs to the Group of Anticholinergic Medications. These Medications 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 the Symptoms of an Overactive Bladder. These Symptoms Include: Sudden and Urgent Need to Urinate Without Prior Warning (Urgency), Frequent Urination or Incontinence Associated with Not Being Able to Reach the Toilet in Time.

2. Important Information Before Taking Belaristo

When Not to Take Belaristo:

• If You are Allergic to Solifenacin or Any of the Other Ingredients of this Medication (Listed in Section 6);
• If You Have Difficulty Urinating or Cannot Empty Your Bladder (Urinary Retention);
• If You Have Severe Stomach or Intestinal Diseases (Including Toxic Megacolon, a Complication of Ulcerative Colitis);
• If You Have a Muscle Disease Called Myasthenia Gravis, Which Can Cause Significant Weakness of Some Muscles;
• If You Have Increased Pressure in the Eye, Which Can Lead to Gradual Vision Loss (Glaucoma);
• If You are Undergoing Dialysis;
• If You Have Severe Liver Disease;
• If You Have Severe Kidney Disease or Moderate Liver Disease and Are Taking Medications that May Slow Down the Elimination of Belaristo from the Body (e.g., Ketoconazole). Your Doctor or Pharmacist Will Provide You with More Information on this.

Before Starting to Take Belaristo, Tell Your Doctor if Any of the Above Situations Apply or Have Applied in the Past.

Warnings and Precautions

Before Starting to Take Belaristo, Discuss the Following with Your Doctor or Pharmacist:

• If You Have Difficulty Emptying Your Bladder (Narrowing of the Urinary Outflow) or Urinating (e.g., Weak Urine Stream). In Such Cases, the Risk of Urine Accumulation in the Bladder (Urinary Retention) is Much Higher.
• If You Have Gastrointestinal Motility Disorders (Constipation);
• If There is a Risk of Slowing Down the Movement of the Gastrointestinal Tract (Peristalsis, Movements of the Stomach and Intestines). Your Doctor Will Provide You with More Information on this.
• If You Have Severe Kidney Function Disorders;
• If You Have Moderate Liver Function Disorders;
• If You Have a Hiatus Hernia (Hiatal Hernia) or Heartburn;
• If You Have Nervous System Disorders (Autonomic Neuropathy). You Should Consult Your Doctor Before Starting Belaristo if Any of the Above Warnings Apply to Your Current or Past Situation. Before Starting Belaristo, Your Doctor Will Assess Whether There are Any Other Causes of Frequent Urination (e.g., Heart Failure or Kidney Disease). If a Urinary Tract Infection Occurs, Your 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 Medications

Tell Your Doctor or Pharmacist About All Medications You are Currently Taking or Have Recently Taken, as Well as Any Medications You Plan to Take. It is Especially Important to Inform Your Doctor if You are Taking:

• Other Anticholinergic Medications, as Taking Such a Medication with Belaristo May Increase Both the Therapeutic Effect and the Side Effects of Both Medications;
• Medications from the Group of Cholinergic Receptor Agonists, as They May Weaken the Effect of Belaristo;
• Medications that Enhance Gastrointestinal Motility, Such as Metoclopramide and Cisapride, as Belaristo May Weaken Their Effect;
• Medications Such as Ketoconazole, Ritonavir, Nelfinavir, Itraconazole, Verapamil, and Diltiazem, as They May Slow Down the Metabolism of Belaristo in the Body;
• Medications Such as Rifampicin, Phenytoin, and Carbamazepine, as They May Accelerate the Metabolism of Belaristo in the Body;
• Medications Such as Bisphosphonates, as They May Cause Esophageal Inflammation or Worsen it.

Belaristo with Food, Drink, and Alcohol

Belaristo Can be Taken with or Without Food, Depending on the Patient's Preference.

Pregnancy and Breastfeeding

If You are Pregnant or Breastfeeding, Think You May be Pregnant, or Plan to Have a Child, Ask Your Doctor or Pharmacist for Advice Before Taking this Medication. Belaristo Should Not be Used During Pregnancy, Unless Your Doctor Considers it Absolutely Necessary. Belaristo Should Not be Used During Breastfeeding, as Solifenacin Passes into Human Milk.

Driving and Operating Machines

Belaristo May Cause Blurred Vision and Sometimes Drowsiness or Fatigue. If Such Side Effects Occur, Do Not Drive or Operate Machines.

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 You Have Been Diagnosed with an Intolerance to Some Sugars, Contact Your Doctor Before Taking Belaristo.

3. How to Take Belaristo

Always Take this Medication Exactly as Your Doctor or Pharmacist Has Told You. If You are Not Sure, Ask Your Doctor or Pharmacist. The Tablet Should be Swallowed with a Small Amount of Liquid. The Tablets Should Not be Chewed. Belaristo Can be Taken with or Without Food, Depending on the Patient's Preference. The Usual Dose is 5 mg Once a Day, Unless Your Doctor Recommends a Dose of 10 mg. The 10 mg Tablet of Belaristo Can be Divided into Equal Doses.

Taking More Than the Recommended Dose of Belaristo

If You Take More Belaristo Than You Should or if a Child Accidentally Swallows Some, Contact Your Doctor or Pharmacist Immediately. Symptoms of Overdose May Include: Headache, Dry Mouth, Dizziness, Drowsiness, and Vision Disturbances, Hallucinations, Excessive Excitement, Seizures, Breathing Difficulties, Rapid Heartbeat, Urinary Retention, and Pupil Dilation.

Missing a Dose of Belaristo

If You Miss a Dose, Take the Next Dose as Soon as Possible, Unless it is Almost Time for the Next Dose. Never Take More Than One Dose a Day. If You are Not Sure, Ask Your Doctor or Pharmacist.

Stopping Treatment with Belaristo

If You Stop Taking Belaristo, the Symptoms of an Overactive Bladder May Return or Worsen. Always Consult Your Doctor if You Consider Stopping Treatment. If You Have Any Further Questions on the Use of this Medication, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, Belaristo Can Cause Side Effects, Although Not Everybody Gets Them. If You Experience Sudden Allergic Symptoms or a Severe Skin Reaction (e.g., Blisters and Peeling of the Skin), Tell Your Doctor or Pharmacist Immediately. 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 has Occurred. If You Experience Angioedema, Stop Taking Solifenacin Succinate and Initiate Appropriate Treatment and/or 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 Full in the Abdomen, Abdominal Pain, Belching, Nausea, and Heartburn (Indigestion), Discomfort in the Abdomen Uncommon(May Affect Up to 1 in 100 People):
• Urinary Tract Infection, Cystitis
• Drowsiness
• Taste Disturbances
• 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 Hard Stool in the Colon; Obstruction (Intestinal Obstruction)
• Difficulty Urinating Despite a Full Bladder (Urinary Retention)
• Dizziness, Headache
• Vomiting
• Itching, Rash Very Rare(May Affect Up to 1 in 10,000 People):
• Hallucinations, Disorientation
• Allergic Rash (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 Eye
• 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 You Experience Any Side Effects, Including Those Not Listed in the Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects Can be Reported Directly to the Department for Monitoring of Adverse Reactions to Medicinal Products 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. Side Effects Can Also be Reported to the Marketing Authorization Holder. By Reporting Side Effects, You Can Help Provide More Information on the Safety of this Medication.

5. How to Store Belaristo

Keep this Medication Out of the Sight and Reach of Children. Do Not Use this Medication After the Expiration Date Stated on the Carton and Blister After EXP. The Expiration Date Refers to the Last Day of the Month Stated. There are No Special Precautions for Storage. Medications Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications No Longer Required. This Will Help Protect the Environment.

6. Contents of the Package and Other Information

What Belaristo Contains

The Active Substance 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: Corn Starch, Lactose Anhydrous, Hypromellose 2910 (E 464), Magnesium Stearate, Colloidal Silica Anhydrous, Macrogol, Talc, Titanium Dioxide (E 171), and Iron Oxide Red (E 172).

What Belaristo Looks Like and Contents of the Package

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 Score 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 Package Leaflet:March 2023