Beplasot

Package leaflet: Information for the patient

Beplasot, 6 mg + 0,4 mg, modified-release tablets
succinate solifenacin + hydrochloride tamsulosin
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet for future reference.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Beplasot is and what it is used for

Beplasot is a combination of two different medicines – solifenacin and tamsulosin – in a single tablet.
Solifenacin belongs to a group of medicines called anticholinergics, and tamsulosin belongs to a group of medicines known as alpha-adrenoceptor blockers.
Beplasot is used in men for the treatment of both moderate and severe lower urinary tract symptoms related to urine storage and voiding caused by bladder problems and enlarged prostate (benign prostatic enlargement). Beplasot is used when previous treatment with monotherapy for this condition has not sufficiently relieved symptoms.
Enlargement of the prostate may lead to voiding problems (symptoms related to passing urine), such as difficulty starting urination, problems with passing urine (reduced urine stream), post-micturition dribbling, and a sensation of incomplete bladder emptying. At the same time, it negatively affects the urinary bladder, which contracts spontaneously when the patient does not feel the need to urinate. This leads to storage symptoms such as bladder sensation disorders, urgency (a sudden, strong need to pass urine without prior warning), and increased frequency of urination.
Solifenacin reduces unwanted contractions of the urinary bladder and increases the amount of urine the bladder can hold. Therefore, you can delay going to the toilet for longer. Tamsulosin enables free flow of urine through the urethra, thus facilitating urination.

2. Important information before using Beplasot

When not to use Beplasot:

• if the patient is allergic to solifenacin or tamsulosin, or to any of the other ingredients of this medicine (listed in section 6),
• if the patient is undergoing kidney dialysis,
• if the patient has severe liver disease,
• if the patient has severe kidney disease and is simultaneously taking medicines that may delay elimination of Beplasot from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). The doctor or pharmacist will advise whether this warning applies to the patient.
• if the patient has moderate liver disease and is simultaneously taking medicines that may delay elimination of Beplasot from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). The doctor or pharmacist will advise whether this warning applies to the patient.
• if the patient has severe stomach or intestinal disorders (including toxic megacolon, a complication associated with ulcerative colitis),
• if the patient has a muscle disorder called myasthenia gravis, which may cause significant weakness of certain muscles,
• if the patient has increased pressure of fluid in the eye (glaucoma), with progressive loss of vision,
• if the patient experiences fainting due to a drop in blood pressure when changing body position (when standing up from sitting or lying down), known as orthostatic hypotension.

The patient should inform the doctor if any of the above conditions apply.

Warnings and precautions

Before starting Beplasot, discuss with the doctor or pharmacist if:

• the patient is unable to urinate (urinary retention),
• the patient has gastrointestinal obstruction,
• the patient is at risk of slowed gastrointestinal motility (stomach and intestinal movements). The doctor will inform the patient whether this warning applies.
• the patient has severe stomach pain (hiatal hernia) or heartburn and/or is taking medicines that may cause or worsen oesophagitis,
• the patient has nervous system disorders (autonomic neuropathy),
• the patient has severe kidney disease,
• the patient has moderate liver disease.

Regular medical check-ups are necessary to monitor the condition for which the patient is being treated.
Beplasot may affect blood pressure, causing dizziness, a feeling of emptiness in the head, or, rarely, fainting (orthostatic hypotension). If any of these symptoms occur, the patient should sit or lie down until symptoms subside.
If the patient is undergoing or scheduled for eye surgery due to cataract or elevated eye pressure (glaucoma), inform the ophthalmologist about current or past use of Beplasot, or if the patient plans to use this medicine in the future.
The specialist may take appropriate precautions regarding medications and surgical techniques. Ask the doctor whether the patient should delay or temporarily discontinue Beplasot before undergoing eye surgery for cataract or elevated intraocular pressure (glaucoma).

Children and adolescents

Beplasot must not be used in children and adolescents.

Beplasot with other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform the doctor if the patient is taking:

• medicines such as ketoconazole, erythromycin, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, and paroxetine, which reduce the rate of elimination of Beplasot from the body,
• other anticholinergic medicines, as taking two medicines of the same type may increase the effect and side effects of both,
• cholinergic medicines, as they may reduce the effect of Beplasot,
• medicines such as metoclopramide and cisapride, which accelerate gastrointestinal motility. Beplasot may reduce their effect.
• other alpha-adrenergic receptor blockers, due to the risk of undesirable lowering of blood pressure,
• medicines such as bisphosphonates, which may cause or worsen oesophagitis.

Taking Beplasot with food and drink

Beplasot may be taken with food or between meals, according to patient preference.

Pregnancy, breastfeeding and fertility

Beplasot is not indicated for use in women.
Cases of abnormal ejaculation (ejaculation disorders) have been reported in men. This means that semen does not exit the body through the urethra but flows back into the urinary bladder (retrograde ejaculation), semen volume is reduced, or ejaculation does not occur (anejaculation). This phenomenon is harmless.

Driving and operating machinery

Beplasot may cause dizziness, blurred vision, fatigue, and less frequently, somnolence. Patients experiencing these symptoms should not drive or operate machinery.

Beplasot contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Beplasot

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The maximum recommended daily dose is one tablet taken orally containing 6 mg of solifenacin
and 0.4 mg of tamsulosin. The medicine may be taken with food or between meals.
Tablets must not be crushed or chewed.
Taking more Beplasot than prescribed
If more tablets than prescribed have been taken, or if tablets have been accidentally ingested by
another person, seek immediate medical advice by contacting a doctor or pharmacist or going to a hospital.
In case of overdose, a doctor may administer activated charcoal. In emergency situations, gastric lavage
may also be helpful if performed within 1 hour after overdose. Do not induce vomiting.
Symptoms of overdose may include, among others: dry mouth, dizziness and blurred vision, perception of
non-existent things (hallucinations), excessive excitement, seizures (convulsions), difficulty breathing,
rapid heartbeat (tachycardia), inability to fully or partially empty the bladder or inability to urinate
(urinary retention), and/or undesirable lowering of blood pressure.
Missing a dose of Beplasot
Take the next dose of Beplasot at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Beplasot treatment
Discontinuation of Beplasot may cause recurrence or worsening of symptoms related to the underlying
condition. Any intention to stop treatment should always be discussed with a doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Beplasot can cause adverse reactions, although not everyone experiences them.
The most serious adverse reaction observed not very frequently (may occur in no more than 1 in 100 men) during clinical trials with solifenacin succinate and tamsulosin hydrochloride is acute urinary retention, meaning sudden inability to pass urine. If a patient suspects this condition, they should immediately consult a doctor. Discontinuation of Beplasot may be necessary.

Allergic reactions may occur after taking Beplasot:

• A severe allergic reaction (anaphylactic reaction) of unknown frequency may occur.
• Not very common symptoms of allergic reactions may include skin rash (which may be itchy) or urticaria.
• Rarely observed symptoms include swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing (angioedema). Angioedema has been reported rarely with tamsulosin and very rarely with solifenacin. If angioedema occurs, Beplasot must be discontinued immediately and must not be restarted.

If a patient experiences sudden symptoms of allergy or a severe skin reaction (e.g., blistering and peeling of the skin), the doctor must be informed immediately and treatment with Beplasot must be discontinued. Appropriate treatment and (or) other necessary measures should be initiated.

Common adverse reactions (may occur in no more than 1 in 10 men)

• dizziness
• blurred vision
• dry mouth, dyspepsia, constipation, nausea, abdominal pain
• abnormal ejaculation (ejaculation disorders). This means that semen does not exit through the urethra but instead flows backward into the bladder (retrograde ejaculation), the volume of semen is reduced, or ejaculation does not occur (absence of ejaculation). This phenomenon is harmless.
• fatigue (tiredness)

Not very common adverse reactions (may occur in no more than 1 in 100 men)

• urinary tract infection, infection (inflammation) of the urinary bladder
• somnolence (drowsiness), taste disturbances, headache
• dry eyes
• rapid or irregular heartbeat (palpitations)
• dizziness or weakness, especially when standing up (orthostatic hypotension)
• catarrh or nasal congestion (nasal mucosal inflammation), dry nose
• gastroesophageal reflux disease (gastroesophageal reflux), diarrhoea, dry throat, nausea (vomiting)
• itching (pruritus), dry skin
• difficulty in passing urine
• fluid accumulation in the lower legs (oedema)
• fatigue (asthenia)

Rare adverse reactions (may occur in no more than 1 in 1,000 men)

• feeling faint (loss of consciousness)
• accumulation of large amounts of hard stool in the large intestine (faecal impaction), colonic obstruction
• skin allergy leading to swelling in the tissue just beneath the skin surface (angioedema)

Very rare adverse reactions (may occur in no more than 1 in 10,000 men)

• hallucinations, disorientation
• allergic skin reactions (erythema multiforme), rash, inflammation and blistering of the skin and (or) mucous membranes of the lips, eyes, mouth, nostrils, or genital organs (Stevens-Johnson syndrome)
• prolonged and painful penile erection (usually not during sexual activity) (priapism)

Frequency not known (cannot be estimated from available data)

• severe allergic reaction causing difficulty in breathing or dizziness (anaphylactic reaction)
• decreased appetite, high blood potassium levels (hyperkalemia), which may cause heart rhythm disturbances
• rapid decline in consciousness and overall mental function (delirium)
• during eye surgery due to lens clouding (cataract) or elevated intraocular pressure (glaucoma), the pupil (black area in the center of the eye) may not dilate properly. Additionally, the iris (colored part of the eye) may become floppy during surgery, elevated intraocular pressure (glaucoma), visual disturbances
• irregular or unusual heartbeat (QT interval prolongation, torsade de pointes ventricular tachycardia, atrial fibrillation, arrhythmia), increased heart rate (tachycardia)
• shortness of breath, voice disturbances, nosebleeds
• intestinal disorders (intestinal obstruction), abdominal discomfort
• liver function disorders
• severe skin allergy causing skin peeling (exfoliative dermatitis)
• muscle weakness
• kidney function disorders.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist, or nurse.
Adverse reactions 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 reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Beplasot

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after the abbreviation
"EXP". The expiry date refers to the last day of the indicated month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Beplasot contains

• The active substances are: solifenacin succinate and tamsulosin hydrochloride. Each tablet contains 6 mg of solifenacin succinate, equivalent to 4.5 mg of solifenacin, and 0.4 mg of tamsulosin hydrochloride, equivalent to 0.37 mg of tamsulosin.
• Other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, hypromellose 2910, iron oxide red (E 172), magnesium stearate, macrogol 7,000,000, macrogol, colloidal anhydrous silica, titanium dioxide (E 171).

What Beplasot looks like and contents of the pack
Beplasot 6 mg + 0.4 mg tablets are red, round, biconvex, coated tablets with the imprint "T7S" on one side.
The tablets are packed in oPA/Aluminium/PVC/Aluminium blisters in cardboard boxes containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 tablets.
The tablets are also available in oPA/Aluminium/PVC/Aluminium blister packs divided into single doses, in cardboard boxes containing 10 x 1, 14 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1, 90 x 1, 100 x 1 or 200 x 1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstrasse 211
8054 Graz
Austria

Manufacturer
Synthon Hispania S.L.
Calle De Castelló 1
08830 Sant Boi De Llobregat
Spain
Synthon B.V.
Microweg 22
6545 CM Nijmegen
The Netherlands
Synthon, s.r.o.
Brněnská 32/čp. 597
678 01 Blansko
Czech Republic
Genericon Pharma Gesellschaft m.b.H
Hafnerstrasse 211
8054 Graz
Austria

This medicinal product is authorised for sale in the European Economic Area under the following names:
Poland: Beplasot
Austria: Solicomp 6 mg/0.4 mg Tabletten mit veränderter Wirkstofffreisetzung
Croatia: Beplasot 6 mg/0.4 mg tablete s prilagođenim oslobađanjem
Czech Republic: Beplasot
The Netherlands: Solifenacinesuccinaat/Tamsulosinehydrochloride Genericon 6 mg/0.4 mg, tabletten met gereguleerde afgifte

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków
Poland
tel: +48 12 262 32 36
e-mail: [email protected]