Package leaflet: Information for the patient

Belaristo, 5 mg, film-coated tablets
Belaristo, 10 mg, film-coated tablets
Solifenacin succinate
Please read the entire leaflet before taking this medicine, as it contains important information for
the patient.

Keep this leaflet, as you may need to read it again.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Belaristo is and what it is used for
Important information before taking Belaristo
How to take Belaristo
Possible side effects
How to store Belaristo
Contents of the pack and other information

1. What Belaristo is and what it is used for

The active substance in Belaristo 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 amount of urine retained in the bladder.
Belaristo is used in the treatment of symptoms of overactive bladder. These symptoms include a strong and sudden need to pass urine without prior warning (urgency), frequent urination, or urinary incontinence due to the patient being unable to reach the toilet in time.

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 pass urine or empty the bladder (urinary retention);
if the patient has severe stomach or intestinal disorders (including toxic megacolon, a complication associated with ulcerative colitis);
if the patient suffers from a muscle disorder called myasthenia gravis, which may cause significant weakness of certain muscles;
if the patient has increased intraocular pressure leading to 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 also 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 matter.

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

Warnings and precautions

Before starting treatment with Belaristo, discuss with the doctor or pharmacist:

if the patient has difficulty emptying the bladder (obstruction of urinary outflow) or difficulty passing urine (e.g. weak urine stream). In such cases, the risk of urine retention in the bladder (urinary retention) is significantly higher;
if the patient suffers from gastrointestinal motility disorders (constipation);
if there is a risk of slowed gastrointestinal motility (peristalsis, stomach and intestinal movements). The doctor will provide further information;
if the patient has severe kidney function impairment;
if the patient has moderate liver function impairment;
if the patient suffers from severe stomach pain (hiatal hernia) or heartburn;
if the patient has disorders of the nervous system (autonomic neuropathy). Consult the doctor before starting treatment with Belaristo if any of the above warnings apply to current or past conditions.

Before starting treatment with Belaristo, the doctor will assess whether there are other causes of frequent urination (e.g. heart failure (insufficient cardiac muscle strength to pump blood) or kidney disease). If a urinary tract infection occurs, the doctor will prescribe an antibiotic (a medicine effective against specific bacterial infections).

Children and adolescents
Belaristo must not be used in children or adolescents under 18 years of age.

Belaristo with other medicines
Inform the doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.
It is particularly important to inform the doctor if the patient is taking:

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

Belaristo with food, drink, and alcohol
Belaristo may be taken with or without food, depending on patient preference.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Belaristo must not be used during pregnancy unless the doctor considers it absolutely necessary.
Belaristo must not be used during breastfeeding, as solifenacin passes into human milk.

Driving and operating machinery
Belaristo may cause blurred vision and occasionally drowsiness or fatigue. If these adverse 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 previously diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Belaristo

This medicine should always be taken as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
The tablet should be swallowed whole with a small amount of liquid. Do not chew the tablet.
Belaristo may be taken during meals or independently of meals, depending on patient preference.
The usual dose is 5 mg once daily, unless the physician prescribes a dose of 10 mg.
The Belaristo 10 mg film-coated tablet may be divided into equal doses.
Taking more Belaristo than recommended
If an excessive dose of Belaristo is taken or if a child accidentally swallows the medicine,
contact a physician or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, visual disturbances,
perception of things that are not present (hallucinations), excessive excitation, seizures (convulsions),
difficulty breathing, rapid heartbeat (tachycardia), excessive urine retention in the bladder (urinary retention),
and pupil dilation (mydriasis).
Missing a dose of Belaristo
If a dose of Belaristo is missed, take the next dose as soon as possible, unless it is almost time for the next scheduled dose.
Never take Belaristo more than once a day. If in doubt, consult a physician or pharmacist.
Stopping Belaristo treatment
If treatment with Belaristo is discontinued, symptoms of overactive bladder may return or worsen.
Always consult a physician before stopping treatment.
If there are any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If the patient experiences sudden symptoms of an allergic reaction or a severe skin reaction (e.g. blistering and peeling of the outer layer of skin), a doctor or pharmacist should be contacted immediately.
In some patients taking solifenacin succinate, angioedema (a skin allergy causing swelling of the tissue just beneath the skin surface) with swelling of the airways (difficulty breathing) has occurred.
If the patient develops angioedema, treatment with solifenacin succinate must be stopped immediately and appropriate treatment and/or corrective measures must be initiated.
Belaristo may cause the following adverse effects:
Very common (may occur in more than 1 in 10 patients):

dry mouth
Common (may occur in less than 1 in 10 patients):
blurred vision
constipation, nausea, dyspepsia with symptoms such as: feeling of fullness in the abdomen, abdominal pain, belching, nausea and heartburn (dyspepsia), abdominal discomfort
Uncommon (may occur in less than 1 in 100 patients):
urinary tract infection, cystitis
somnolence
taste disturbances
dry (irritated) eye syndrome
nasal dryness
gastroesophageal reflux disease (acid reflux)
dry throat
dry skin
difficulty passing urine
fatigue
fluid accumulation in the lower limbs (oedema)
Rare (may occur in less than 1 in 1,000 patients):
faecal impaction; intestinal 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 patients):
hallucinations, disorientation
allergic skin rash (urticaria)
Frequency not known (frequency cannot be estimated from available data):
decreased appetite, increased blood potassium levels which may cause heart rhythm disturbances
increased intraocular pressure
changes in electrical activity of the heart (ECG), irregular heartbeat, palpitations, rapid heartbeat
voice disorders
liver function abnormalities
decreased muscle strength
kidney function disorders.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 effects can also be reported to the marketing authorisation holder. Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Belaristo

Keep this medicine 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 stated month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

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

What Belaristo looks like and contents of the pack
Belaristo 5 mg, coated tablets
Round, light pink, coated tablet.
Belaristo 10 mg, coated tablets
Round, light pink, coated tablet with a score line.
Belaristo 5 mg coated tablets are packed in blisters containing: 10, 30, 50, 90 or 100 coated tablets.
Belaristo 10 mg coated tablets are packed in blisters containing: 20, 30, 50, 90 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aristo Pharma Sp. z o.o.
ul. Baletowa 30
02-867 Warsaw
Poland

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 authorised for marketing in 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 Aristissa
Denmark Solifenacin Aristo
Ireland Solifenacin succinate Aristo 5 mg film-coated tablets
Solifenacin succinate Aristo 10 mg film-coated tablets
Poland Belaristo