Beloflow

Package leaflet: Information for the user

Beloflow, 5 mg, coated tablets
Beloflow, 10 mg, coated tablets
Solifenacin succinate
Please read this leaflet carefully 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Leaflet contents

1. What Beloflow is and what it is 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 Beloflow is and what it is used for

The active substance in Beloflow belongs to a group of medicines called anticholinergics (cholinolytics). These medicines reduce the activity of an overactive bladder. The effect of the medicine increases the amount of urine retained in the bladder, thereby extending the intervals between toilet visits.
Beloflow is used to treat symptoms of a condition called overactive bladder. These symptoms include episodes of sudden, strong and urgent need to urinate, increased frequency of urination, and urinary incontinence occurring because the patient could not reach the toilet in time.

2. Important information before taking Beloflow

When not to take Beloflow:

• if the patient is unable to pass urine or empty the urinary bladder (urinary retention),
• if the patient has severe stomach or intestinal disorders (toxic megacolon, a complication associated with ulcerative colitis),
• in patients suffering from a muscle disease called myasthenia gravis, which may cause significant weakness of certain muscles,
• if the patient has increased fluid pressure in the eye leading 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 haemodialysis,
• in patients with severe liver function disorders – if the patient has severe kidney disease or moderate liver disease and is simultaneously taking medicines that

may delay elimination of Beloflow from the body (e.g. ketoconazole). Your doctor or pharmacist will provide information on this.
Before starting treatment with Beloflow, you must inform your doctor if any of the above situations apply or have occurred in the past.
Warnings and precautions
Before starting to take Beloflow, discuss this with your doctor or pharmacist:

• if the patient has difficulty emptying the bladder (obstruction of urinary outflow) or difficulty passing urine (weak urinary stream). In such cases, 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 slowed gastrointestinal tract function (gastric and intestinal motility). Your doctor will provide further information on this,
• if there are severe kidney function disorders,
• if there are moderate liver function disorders,
• if the patient suffers from severe stomach pain (hiatal hernia) or heartburn,
• if the patient has disorders of the nervous system (autonomic neuropathy).

Children and adolescents
Beloflow must not be used in children or adolescents under 18 years of age.
Before starting treatment with Beloflow, inform your doctor if any of the above conditions apply or have occurred in the past.
Before starting treatment with Beloflow, your doctor will assess whether there are other possible causes of frequent urination (e.g. heart failure – insufficient heart muscle strength to pump blood adequately – or kidney disease). If a urinary tract infection occurs, your doctor will prescribe an antibiotic (an antibacterial agent effective against the specific bacteria).
Interaction of Beloflow with other medicines
You must tell your doctor or pharmacist about all medicines currently being taken, recently taken, or planned for use.
It is particularly important to inform your doctor if the patient is taking:

• other anticholinergic medicines, as using such drugs together with Beloflow may enhance both the therapeutic effects and the side effects of both medicines,
• cholinergic medicines, as they may reduce the effectiveness of Beloflow,
• medicines that increase gastrointestinal motility, such as metoclopramide and cisapride, as Beloflow may reduce their effectiveness,
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, which slow down the elimination of Beloflow from the body,
• medicines such as rifampicin, phenytoin, carbamazepine, which may accelerate the elimination of Beloflow from the body,
• medicines such as bisphosphonates, which may cause or worsen oesophagitis.

Beloflow with food and drink
Beloflow may be taken during meals or independently of food.
Pregnancy and breastfeeding
Beloflow must not be used during pregnancy unless absolutely necessary.
Beloflow must not be used during breastfeeding, as solifenacin passes into breast milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Beloflow may cause blurred vision, and occasionally drowsiness or fatigue. If these side effects occur, the patient should not drive or operate any machinery.
Beloflow contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to take Beloflow

Instructions for proper use:
This medicine should always be taken as prescribed by the physician. If in doubt, consult your
doctor or pharmacist.
The tablet should be swallowed whole with liquid. Beloflow may be taken with food or
independently of meals, according to patient preference. Do not crush the tablets.
The usual dose is 5 mg once daily, unless the doctor prescribes a dose of 10 mg once daily.
The 10 mg tablet may be divided into equal doses.

Taking more Beloflow than prescribed
If too many Beloflow tablets have been taken, or if a child accidentally swallows the medicine,
contact a doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and visual disturbances,
hallucinations, excessive excitation, seizures (convulsions), difficulty breathing, rapid heartbeat
(tachycardia), urinary retention (urine accumulation in the bladder), and dilated pupils.

Missing a dose of Beloflow
If a dose of Beloflow is missed, take the next dose as soon as possible, unless it is almost time for
the next scheduled dose. Do not take the medicine more than once a day. If in doubt, consult your
doctor or pharmacist.

Stopping Beloflow treatment
If treatment with Beloflow is discontinued, symptoms of overactive bladder may return or worsen.
Stopping the medicine should always be discussed with a doctor. If you have any further questions
regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences an allergic attack or a severe skin reaction (e.g. blistering
and peeling of the skin), the doctor or pharmacist should be informed immediately.
Angioedema (a type of allergic skin reaction causing swelling of the tissue just beneath the skin surface) with swelling of the airways (difficulty breathing) has been reported in some patients taking solifenacin. If angioedema occurs, treatment with Beloflow should be stopped immediately and appropriate treatment and/or corrective measures initiated.
Beloflow may cause other adverse reactions listed below:

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 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,
• somnolence, taste disturbances,
• dryness (irritation) of the eyes,
• dryness of the nasal passages,
• gastroesophageal reflux (heartburn), dryness of the throat,
• dry skin,
• difficulty in passing urine,
• fatigue, fluid accumulation (oedema) in the lower parts of the legs.

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

• accumulation of hard stool (faecal impaction) in the large intestine,
• urinary retention due to difficulty in emptying the bladder,
• dizziness, headache,
• 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 blood potassium levels which may cause cardiac arrhythmias,
• increased intraocular pressure,
• changes in the heart's electrical activity (ECG), irregular heartbeat, palpitations, rapid heartbeat ( Torsade de Pointes ),
• voice disorders,
• liver function abnormalities,
• muscle weakness,
• kidney function disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, 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]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Beloflow

Keep this medicine 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 on the blister after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
If you notice any change in colour or any other signs of deterioration, consult your pharmacist.
Medicines must 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 pack and other information

What Beloflow contains

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

Tablet core
Monohydrate lactose
Corn starch
Pregelatinized corn starch
Magnesium stearate

Coating
5 mg:
Hypromellose 5 cP
Titanium dioxide (E 171)
Macrogol 8000
Talc
Iron oxide yellow (E 172)

10 mg:
Hypromellose 5 cP
Titanium dioxide (E 171)
Macrogol 8000
Talc
Iron oxide red (E 172)
Iron oxide yellow (E 172)

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

Marketing Authorisation Holder
Belupo lijekovi i kozmetika d.d.
Ulica Danica 5
48 000 Koprivnica
Croatia

Manufacturer
Belupo lijekovi i kozmetika d.d.
Ulica Danica 5
48 000 Koprivnica
Croatia

This medicinal product is authorised in the member countries of the European Economic Area under the following names:
Croatia: BELOFLUX
Poland: BELOFLOW
Portugal: BELOFLUX