BEPLASOT 6 mg /0.4 Mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Beplasot, 6 mg + 0,4 mg, modified-release 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
3. What is Beplasot and what is it used for
4. Important information before taking Beplasot
   1. When not to take Beplasot:
   2. Warnings and precautions
   3. Children and adolescents
   4. Beplasot and other medicines
   5. Taking Beplasot with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Beplasot contains sodium
5. How to take Beplasot
   1. Overdose of Beplasot
   2. Missed dose of Beplasot
   3. Stopping Beplasot treatment
6. Possible side effects
   1. Common side effects (may occur in up to 1 in 10 men)
   2. Uncommon side effects (may occur in up to 1 in 100 men)
   3. Rare side effects (may occur in up to 1 in 1,000 men)
   4. Very rare side effects (may occur in up to 1 in 10,000 men)
   5. Frequency not known (cannot be estimated from the available data)
   6. Reporting side effects
7. How to store Beplasot
8. Contents of the pack and other information
   1. What Beplasot contains
   2. What Beplasot 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. For further information about this medicine, contact the representative of the marketing authorization holder:
   7. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Beplasot, 6 mg + 0,4 mg, modified-release tablets

solifenacin succinate + tamsulosin hydrochloride

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

• Keep this 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 a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Beplasot and what is it used for
• 2. Important information 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 is Beplasot and what is it used for

Beplasot is a combination of two different medicines - solifenacin and tamsulosin - in one tablet.
Solifenacin belongs to a group of medicines called anticholinergics, and tamsulosin belongs to a group of medicines called alpha-adrenergic receptor blockers.
Beplasot is used in men to treat moderate to severe symptoms of lower urinary tract symptoms associated with urine storage and voiding, caused by bladder problems and prostate enlargement (benign prostatic hyperplasia). Beplasot is used when previous treatment with monotherapy in this indication has not sufficiently alleviated the symptoms.
Prostate enlargement can lead to urinary problems (symptoms related to urination), such as difficulty starting urination, difficulty urinating (reduced urine flow), post-micturition dribbling, and a feeling of incomplete bladder emptying. At the same time, it has an adverse effect on the bladder, which contracts on its own when the patient does not feel the need to urinate. This causes the occurrence of symptoms related to urine storage, such as bladder sensitivity disorders, sudden urge to urinate (strong, sudden desire to urinate without prior signs), and the need to urinate more frequently.
Solifenacin reduces unwanted bladder contractions and increases the amount of urine that the bladder can hold. Therefore, you can wait longer before going to the toilet. Tamsulosin allows for smooth urine flow through the urethra, making it easier to urinate.

2. Important information before taking Beplasot

When not to take 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 dialysis,
• if the patient has severe liver disease,
• if the patient has severe kidney disease and is taking medicines that may delay the elimination of Beplasot from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). The doctor or pharmacist will inform you if this warning applies to you.
• if the patient has moderate liver disease and is taking medicines that may delay the elimination of Beplasot from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). The doctor or pharmacist will inform you if this warning applies to you.
• if the patient has severe stomach or intestinal disorders (including toxic megacolon, a complication of ulcerative colitis),
• if the patient has a muscle disease called myasthenia, which can cause significant weakness of some muscles,
• if the patient has increased eye pressure (glaucoma) with progressive vision loss,
• if the patient experiences fainting spells caused by a drop in blood pressure when changing body position (when standing up or sitting up), which is called orthostatic hypotension.

Tell your doctor if you think any of the above conditions apply to you.

Warnings and precautions

Before taking Beplasot, discuss it with your doctor or pharmacist:

• if the patient has difficulty urinating (urinary retention),
• if the patient has intestinal obstruction,
• if the patient is at risk of delayed intestinal movement (gastrointestinal motility). The doctor will inform you if this warning applies to you.
• if the patient has a burning stomach pain (hiatus hernia) or heartburn and (or) if the patient is taking medicines that may cause or worsen esophagitis,
• if the patient has autonomic nervous system disorders (autonomic neuropathy),
• if the patient has severe kidney disease,
• if the patient has moderate liver disease.

Regular medical check-ups are necessary to monitor the progression of the disease for which the patient is being treated.
Beplasot may affect blood pressure, which can cause dizziness, lightheadedness, or rarely fainting (orthostatic hypotension). If you experience any of these symptoms, sit or lie down until they pass.
If you are undergoing or are to undergo eye surgery for cataracts or increased eye pressure (glaucoma), tell your ophthalmologist about your current or past use of Beplasot, or if you plan to use it in the future.
The specialist doctor may take appropriate precautions regarding the medicines and surgical techniques used. Ask your doctor if you should delay or temporarily stop taking Beplasot if you are undergoing eye surgery for cataracts or increased eye pressure (glaucoma).

Children and adolescents

This medicine should not be used in children and adolescents.

Beplasot and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
In particular, inform your doctor about the use of the following medicines:

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

Taking Beplasot with food and drink

Beplasot can be taken with or without food, as preferred by the patient.

Pregnancy, breastfeeding, and fertility

Beplasot is not indicated for use in women.
There have been reports of abnormal ejaculation (ejaculation disorders) in men. This means that semen does not come out through the urethra, but instead flows back into the bladder (retrograde ejaculation), the semen volume is reduced, or ejaculation does not occur (absence of ejaculation). This phenomenon is harmless.

Driving and using machines

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

Beplasot contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Beplasot

Take this medicine always as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
The maximum daily dose is one tablet containing 6 mg of solifenacin and 0,4 mg of tamsulosin, taken orally. The medicine can be taken with or without food.
Do not crush or chew the tablets.

Overdose of Beplasot

In case of taking more tablets than prescribed or accidental ingestion by another person, contact your doctor or pharmacist immediately or go to the hospital for advice.
In case of overdose, the doctor may administer activated charcoal. In an emergency, gastric lavage may also be helpful if performed within 1 hour of overdose. Do not induce vomiting.
Overdose symptoms may include: dry mouth, dizziness, and blurred vision, perception of non-existent things (hallucinations), excessive stimulation, seizures (convulsions), breathing difficulties, rapid heartbeat (tachycardia), inability to fully or partially empty the bladder or inability to urinate (urinary retention), and (or) undesirable lowering of blood pressure.

Missed dose of Beplasot

Take the next tablet at the usual time. Do not take a double dose to make up for the missed dose.

Stopping Beplasot treatment

Stopping Beplasot treatment may cause a relapse or worsening of the symptoms associated with the original complaints. The intention to stop treatment should always be discussed with your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Beplasot can cause side effects, although not everybody gets them.
The most serious side effect, which has been observed not very frequently (may occur in less than 1 in 100 men) during treatment with solifenacin and tamsulosin hydrochloride in clinical trials, is acute urinary retention, which means sudden inability to urinate. If you think this applies to you, seek medical attention immediately. It may be necessary to stop taking Beplasot.
After taking Beplasot, allergic reactions may occur:

• A severe allergic reaction (anaphylactic reaction) of unknown frequency may occur.
• Uncommon symptoms of allergic reactions may include skin rash (which may be itchy) or hives.
• Rare symptoms include swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema). Rarely, during treatment with tamsulosin and very rarely during treatment with solifenacin, angioedema has been reported. If angioedema occurs, stop taking Beplasot immediately and do not restart treatment.

If you experience sudden symptoms of allergy or severe skin reaction (e.g. blistering and peeling of the skin), tell your doctor immediately and stop taking Beplasot. Appropriate treatment and (or) other necessary measures should be taken.

Common side effects (may occur in up to 1 in 10 men)

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

Uncommon side effects (may occur in up to 1 in 100 men)

• urinary tract infection, cystitis
• drowsiness (drowsiness), taste disorders, headache
• dry eyes
• rapid or irregular heartbeat (palpitations)
• dizziness or weakness, especially when standing up (orthostatic hypotension)
• runny nose or stuffy nose (rhinitis), dry nose
• gastroesophageal reflux disease (gastroesophageal reflux), diarrhea, dry throat, nausea (vomiting)
• itching (pruritus), dry skin
• difficulty urinating
• fluid accumulation in the legs (edema)
• fatigue (asthenia)

Rare side effects (may occur in up to 1 in 1,000 men)

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

Very rare side effects (may occur in up to 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, nose, or genitals (Stevens-Johnson syndrome)
• prolonged and painful erection of the penis (usually not during sexual activity) (priapism)

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

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Beplasot

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after "EXP". The expiry date refers to the last day of that month.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help 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, which corresponds to 4.5 mg of solifenacin, and 0.4 mg of tamsulosin hydrochloride, which corresponds to 0.37 mg of tamsulosin.
• The other ingredients are calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, hypromellose 2910, red iron oxide (E 172), magnesium stearate, macrogol 7,000,000, macrogol, silica colloidal anhydrous, titanium dioxide (E 171).

What Beplasot looks like and contents of the pack

Beplasot 6 mg + 0,4 mg tablets are red, round, biconvex, film-coated, with the inscription "T7S" on one side.
Blister pack (OPA/Al/PVC/Al) in a cardboard box containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, or 200 tablets.
Blister pack (OPA/Al/PVC/Al) in a cardboard box 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 authorization 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
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 authorized in the Member States of 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
Netherlands:
Solifenacinesuccinaat/Tamsulosinehydrochloride Genericon 6 mg/0,4 mg, tabletten met gereguleerde afgifte

For further information about this medicine, contact the representative of the marketing authorization holder:

+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków
Poland
tel: +48 12 262 32 36
e-mail: [email protected]

Date of last revision of the leaflet: