Beloflov

Package Leaflet: Information for the User

Beloflow, 5 mg, film-coated tablets

Beloflow, 10 mg, film-coated tablets

Solifenacin succinate

Read the package leaflet carefully before taking the medicine, 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 medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 that can be held in the bladder, which means that the intervals between emptying the bladder are longer. Beloflow is used to treat the symptoms of a condition called overactive urinary bladder. These symptoms include: episodes of sudden, intense, and urgent need to urinate, increased frequency of urination, and involuntary loss of urine, because the patient is unable to reach the toilet in time.

2. Important information before taking Beloflow

When not to take Beloflow:

• if the patient has difficulty emptying the bladder (urinary retention),
• if the patient has severe gastrointestinal disorders (toxic megacolon, a complication of 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 loss of vision (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 impairment - 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 the 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 this with the doctor or pharmacist:

• if the patient has difficulty emptying the 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 (gastrointestinal movements). The doctor will provide information on this,
• if the patient has severe kidney impairment,
• if the patient has moderate liver impairment,
• if the patient has a tearing chest pain (hiatus hernia) or heartburn,
• if the patient has nervous system disorders (autonomic nervous system neuropathy).

Children and adolescents

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

Before starting treatment with Beloflow, the patient should inform the 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 the doctor or pharmacist about all medicines they are taking, have recently taken, or might 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 speed up the elimination of Beloflow from the body,
• medicines such as bisphosphonates, as they may cause or worsen 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 or breastfeeding, thinks she may be pregnant, or plans to have a baby, she should consult her doctor or pharmacist before taking 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 exactly as prescribed by the doctor. If the patient has any doubts, they 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, as preferred by the patient. 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

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

Missing a dose of Beloflow

If a dose is missed, 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 daily. If the patient has any doubts, they should consult their doctor or pharmacist.

Stopping treatment with Beloflow

If treatment with Beloflow is stopped, 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 type of allergic skin reaction that causes swelling of the tissue just below the surface of the skin) 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 fullness, abdominal pain, belching, nausea, heartburn (dyspepsia), feeling of discomfort in the abdomen.

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 hard stool (fecal impaction) in the large intestine,
• urine accumulation in the bladder due to difficulty 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 (cannot be estimated from the available data):

• decreased appetite, increased potassium levels in the blood, which may cause heart rhythm disturbances,
• increased pressure in the eyeball,
• 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 not listed in the package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to: Department for 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, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, the patient can help provide 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 discolored or if there are any other signs of deterioration, they should consult 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.
• The 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, 5.8 mm in diameter. Beloflow 10 mg: light pink, round, biconvex film-coated tablets with a dividing line on one side, smooth on the other side, 7.9 mm in diameter. 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 pharmaceuticals and cosmetics Inc.

Ulica Danica 5

48 000 Koprivnica

Croatia

Manufacturer

Belupo pharmaceuticals and cosmetics Inc.

Ulica Danica 5

48 000 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 package leaflet: