BELOFLOW 5 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Beloflow, 5 mg, film-coated tablets
3. Beloflow, 10 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Beloflow and what is it used for
5. Important information before taking Beloflow
   1. When not to take Beloflow:
   2. Warnings and precautions
   3. Children and adolescents
   4. Beloflow should not be used in children or adolescents under 18 years of age.
   5. Beloflow and other medicines
   6. Beloflow with food and drink
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Beloflow contains lactose
6. How to take Beloflow
   1. Instructions for proper use:
   2. Taking a higher dose of Beloflow than recommended
   3. Missing a dose of Beloflow
   4. Stopping treatment with Beloflow
7. Possible side effects
   1. Reporting side effects
8. How to store Beloflow
9. Contents of the pack and other information
   1. What Beloflow contains
   2. What Beloflow looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Croatia:
   7. Date of last revision of the leaflet:

Leaflet accompanying the packaging: information for the user

Beloflow, 5 mg, film-coated tablets

Beloflow, 10 mg, film-coated tablets

Solifenacin succinate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Beloflow and what is it used for

The active substance of Beloflow belongs to a group of medicines called anticholinergics. These medicines reduce the activity of an overactive urinary bladder. The action of the medicine increases the amount of urine held in the bladder, resulting in longer intervals between visits to the toilet. Beloflow is used to treat the symptoms of a condition called overactive bladder. These symptoms include: episodes of sudden, strong, and urgent need to urinate, increased frequency of urination, and involuntary loss of urine, as the patient may not reach the toilet in time.

2. Important information before taking Beloflow

When not to take Beloflow:

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

Before starting treatment with Beloflow, the patient should inform their doctor if any of the above situations apply or have applied in the past.

Warnings and precautions

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

• if the patient has difficulty emptying their bladder (narrowing of the urethra) or urinating (weak urine stream). In such cases, the risk of urine accumulation in the bladder (urinary retention) is much higher,
• if the patient has gastrointestinal disorders (constipation),
• if there is a risk of slowed gastrointestinal motility (movement 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 tearing chest pain (hiatal hernia) or heartburn,
• if the patient has nervous system disorders (autonomic neuropathy).

Children and adolescents

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

Before starting treatment with Beloflow, the patient should inform their doctor if any of the above situations apply or have applied in the past. Before starting treatment with Beloflow, 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).

Beloflow and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or 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 Beloflow may lead to increased therapeutic and adverse effects of both medicines,
• cholinergic medicines, as they may weaken the effect of Beloflow,
• medicines that speed up gastrointestinal motility, such as metoclopramide and cisapride, as Beloflow may weaken their effect,
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they slow down the elimination of Beloflow from the body,
• medicines such as rifampicin, phenytoin, carbamazepine, as they may accelerate the elimination of Beloflow from the body,
• medicines such as bisphosphonates, as they may cause or exacerbate esophagitis.

Beloflow with food and drink

Beloflow can be taken with or without food.

Pregnancy and breastfeeding

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

Driving and using machines

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

Beloflow contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Beloflow

Instructions for proper use:

This medicine should always be taken according to the doctor's recommendations. If in doubt, the patient should consult their doctor or pharmacist. The tablet should be swallowed whole, with a drink of water. The medicine can be taken with or without food, depending on the patient's preferences. The tablets should not be crushed. The usual dose is 5 mg once daily, unless the doctor recommends a dose of 10 mg once daily. The 10 mg tablet can be divided into equal doses.

Taking a higher dose of Beloflow than recommended

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

Missing a dose of Beloflow

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 than once a day. If in doubt, the patient should consult their doctor or pharmacist.

Stopping treatment with Beloflow

If the patient stops taking Beloflow, the symptoms of overactive bladder may return or worsen. Stopping treatment with Beloflow should always be discussed with the doctor. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Beloflow can cause side effects, although not everybody gets them. If the patient experiences an allergic reaction or severe skin reaction (e.g., blistering and peeling of the skin), they should immediately inform their doctor or pharmacist. Some patients taking solifenacin have reported angioedema (a form of allergic skin reaction that causes swelling of the tissue just beneath the skin surface) with swelling of the airways (difficulty breathing). If the patient experiences angioedema, they should immediately stop taking Beloflow and initiate appropriate treatment and/or take appropriate measures. Beloflow 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: feeling of a full stomach, abdominal pain, belching, nausea, heartburn (dyspepsia), feeling of discomfort in the abdominal cavity.

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

• urinary tract infection, cystitis,
• drowsiness, taste disturbances,
• dry eyes,
• dry nose,
• gastroesophageal reflux (heartburn), dry throat,
• dry skin,
• difficulty urinating,
• fatigue, fluid accumulation (edema) in the lower limbs.

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

• accumulation of large amounts of hard stool (fecal impaction) in the large intestine,
• urine accumulation in the bladder due to difficulties in emptying it (urinary retention),
• dizziness, headaches,
• vomiting,
• itching, rash.

Very rare (may affect up to 1 in 10,000 people):

• hallucinations, confusion,
• allergic rash.

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

• decreased appetite, increased potassium levels in the blood, which may cause heart rhythm disturbances,
• increased eye pressure,
• changes in the electrical activity of the heart (ECG), irregular heartbeat, palpitations, rapid heartbeat (Torsade de Pointes),
• 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 inform their doctor or pharmacist. Side effects can be reported directly to: Department of Drug Safety Monitoring, 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, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Beloflow

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 after: Expiry Date (EXP) or blister after: EXP. The expiry date refers to the last day of the month. There are no special precautions for storage. If the patient notices that the medicine has changed color or if there are any other signs of deterioration, they should contact their pharmacist. 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 Beloflow contains

• The active substance of Beloflow is solifenacin succinate (Solifenacini succinas). Beloflow 5 mg: one film-coated tablet contains 5 mg of solifenacin succinate, which corresponds to 3.8 mg of solifenacin. Beloflow 10 mg: one film-coated tablet contains 10 mg of solifenacin succinate, which corresponds to 7.5 mg of solifenacin.
• Other ingredients are:

Core:
Lactose monohydrate
Corn starch
Corn starch, pregelatinized
Magnesium stearate
Coating:
5 mg:
Hypromellose 5 cP
Titanium dioxide (E 171)
Macrogol 8000
Talc
Yellow iron oxide (E 172)
10 mg:
Hypromellose 5 cP
Titanium dioxide (E 171)
Macrogol 8000
Talc
Red iron oxide (E 172)
Yellow iron oxide (E 172)

What Beloflow looks like and contents of the pack

Beloflow 5 mg: light yellow, round, biconvex film-coated tablets with a diameter of 5.8 mm.
Beloflow 10 mg: light pink, round, biconvex film-coated tablets with a score line on one side, smooth on the other side, with a diameter of 7.9 mm. The tablet can be divided into equal doses.
Beloflow tablets are packaged in blisters of 30 and 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Belupo d.o.o.
Ulica Danica 5
48000 Koprivnica
Croatia

Manufacturer

Belupo d.o.o.
Ulica Danica 5
48000 Koprivnica
Croatia

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

Croatia:

BELOFLUX
Poland:
BELOFLOW
Portugal:
BELOFLUX

Date of last revision of the leaflet: