Mingerlan

Leaflet included in the packaging: patient information

Mingerlan, 6 mg+0,4 mg, tablets with modified release

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 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Mingerlan and what is it used for

Mingerlan is a combination of two different medicines - solifenacin and tamsulosin - in one tablet. Solifenacin belongs to a group of anticholinergic medicines, and tamsulosin belongs to a group of alpha-adrenergic receptor blockers.
Mingerlan 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). Mingerlan is used when previous monotherapy treatment for this indication has not sufficiently alleviated 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 unfavorable 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 urge 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 Mingerlan

When not to take Mingerlan:

• if you are allergic to solifenacin or tamsulosin, or to any of the other ingredients of this medicine (listed in section 6),
• if you are undergoing dialysis,
• if you have severe liver disease,
• if you have severe kidney disease and are taking medicines that may slow down the removal of Mingerlan from your body (such as ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this warning applies to you.
• if you have moderate liver disease and are taking medicines that may slow down the removal of Mingerlan from your body (such as ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this warning applies to you.
• if you have severe gastrointestinal disorders (including toxic megacolon, a complication associated with ulcerative colitis),
• if you have a muscle disease called myasthenia gravis, which can cause significant weakness of certain muscles,
• if you have increased eye pressure (glaucoma) with progressive vision loss,
• if you experience 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 starting treatment with Mingerlan, discuss it with your doctor or pharmacist:

• if you have difficulty urinating (urinary retention),
• if you have gastrointestinal motility disorders,
• if you have a risk of gastrointestinal motility disorders (gastrointestinal movements). Your doctor will inform you if this warning applies to you.
• if you have a burning sensation in the stomach (hiatus hernia) or heartburn and (or) if you are taking medicines that can cause or worsen esophageal inflammation,
• if you have autonomic nervous system disorders (autonomic neuropathy),
• if you have severe kidney disease,
• if you have moderate liver disease.

Regular medical check-ups are necessary to monitor the progression of the disease for which you are being treated.
Mingerlan may affect blood pressure, which can cause dizziness, a feeling of emptiness in the head, or, in rare cases, fainting (orthostatic hypotension). If you experience any of these symptoms, you should sit or lie down and wait for them to pass.
If you are going to have eye surgery for cataract (cataract) or increased eye pressure (glaucoma), you should inform your ophthalmologist about your current or past use of Mingerlan, or if you plan to use it in the future. The specialist doctor may take appropriate precautions regarding the medications and surgical techniques used. You should ask your doctor if you should delay or temporarily stop taking Mingerlan in case of eye surgery for cataract or increased eye pressure.

Children and adolescents

This medicine should not be used in children and adolescents.

Mingerlan and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as any medicines you 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 rate of removal of Mingerlan from the body,
• other anticholinergic medicines, as there is a possibility of increased action and side effects of both medicines when taking two medicines of the same type,
• cholinergic medicines, as they may weaken the action of Mingerlan,
• medicines such as metoclopramide and cisapride, which speed up gastrointestinal movements. Mingerlan may weaken their action.
• other alpha-adrenergic receptor blockers, due to the possibility of undesirable blood pressure lowering,
• medicines such as bisphosphonates, which can cause or worsen esophageal inflammation.

Mingerlan with food and drink

Mingerlan can be taken with or without food, as you prefer.

Pregnancy, breastfeeding, and fertility

Mingerlan 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 amount of semen is reduced, or ejaculation does not occur (absence of ejaculation). This phenomenon is harmless.

Driving and using machines

Mingerlan may cause dizziness, blurred vision, fatigue, and, less frequently, somnolence. Patients who experience such symptoms should not drive or operate machines.

Mingerlan contains sodium

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

3. How to take Mingerlan

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, 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. The tablets should not be crushed or chewed.

Overdose of Mingerlan

If you have taken more tablets than you should, or if someone else has taken your tablets, contact your doctor or pharmacist immediately or go to the hospital for advice.
In the event of an overdose, the doctor may administer activated charcoal. In an emergency, gastric lavage may also be helpful if it is performed within 1 hour of the overdose. Do not induce vomiting.
Overdose symptoms may include: dry mouth, dizziness, and blurred vision, perception of non-existent things (hallucinations), excessive stimulation, convulsions (seizures), breathing difficulties, rapid heartbeat (tachycardia), inability to fully or partially empty the bladder or inability to urinate (urinary retention), and (or) undesirable decrease in blood pressure.

Missed dose of Mingerlan

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

Stopping treatment with Mingerlan

Stopping treatment with Mingerlan may cause a relapse or worsening of the symptoms associated with the original condition. 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, Mingerlan can cause side effects, although not everybody gets them.
The most serious side effect that has been observed, although not very frequently (may occur in less than 1 in 100 men), during clinical trials with solifenacin and tamsulosin hydrochloride, is acute urinary retention, which means sudden inability to urinate. If you think this applies to you, you should see your doctor immediately. It may be necessary to stop taking Mingerlan.
After taking Mingerlan, allergic reactions may occur:

• Uncommon symptoms of allergic reactions may include skin rash (which may be itchy) or hives.
• Rarely occurring symptoms include swelling of the face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing (angioedema). Angioedema has been reported rarely during treatment with tamsulosin and very rarely during treatment with solifenacin. If angioedema occurs, you should stop taking Mingerlan immediately and not restart it.

If you experience sudden symptoms of an allergic reaction or a severe skin reaction (e.g., blistering and peeling of the skin), you should inform your doctor immediately and stop taking Mingerlan. You should receive appropriate treatment and (or) other necessary measures.

Common side effects (may occur in less than 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 amount of semen is reduced, or ejaculation does not occur (absence of ejaculation). This phenomenon is harmless.
• fatigue (tiredness)

Uncommon side effects(may occur in less than 1 in 100 men)

• urinary tract infections, 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)
• gastroesophageal reflux disease (gastroesophageal reflux), diarrhea, dry throat, vomiting
• flushing (flushing), dry skin
• urination difficulties
• fluid accumulation in the legs (edema), fatigue (asthenia)

Rare side effects(may occur in less than 1 in 1,000 men)

• feeling of fainting (loss of consciousness)
• accumulation of a large amount of hard stool in the large intestine (fecal impaction),
• skin allergy that leads to swelling in the tissue under the skin surface (angioedema)

Very rare side effects(may occur in less than 1 in 10,000 men)

• hallucinations, disorientation
• rash, inflammation, and blistering on the skin and (or) mucous membranes of the lips, eyes, mouth, nostrils, or genitals (Stevens-Johnson syndrome), skin allergy (erythema multiforme)
• 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 can cause heart rhythm disorders
• rapid loss of consciousness and overall mental function (delirium)
• in the case of eye surgery for cataract or increased eye pressure, 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-type ventricular tachycardia, atrial fibrillation, arrhythmia), rapid heartbeat (tachycardia)
• shortness of breath, voice disorders, nosebleeds
• intestinal motility disorders, abdominal discomfort
• liver function disorders
• severe skin allergy causing redness and peeling of large areas of skin (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 Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Mingerlan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month stated.
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 that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Mingerlan contains

• The active substances are solifenacin succinate and tamsulosin hydrochloride. Each modified-release tablet contains 6 mg of solifenacin succinate and 0.4 mg of tamsulosin hydrochloride.
• The other ingredients are calcium hydrogen phosphate, microcrystalline cellulose (E 460), sodium croscarmellose (E 468), hypromellose 2910 (E 464), red iron oxide (E 172), magnesium stearate (E 470b), macrogol 7,000,000, macrogol, silica colloidal anhydrous, titanium dioxide (E 171).

What Mingerlan looks like and contents of the pack

Mingerlan is a red, round, biconvex tablet with modified release, with the symbol "T7S" embossed on one side.
The medicine is available in blisters of oPA/Alu/PVC/Alu containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, or 200 modified-release tablets, or in single-dose blisters of oPA/Alu/PVC/Alu 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 modified-release tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer

Synthon Hispania S.L.
C/ Castelló, nº1, Sant Boi de Llobregat,
08830 Barcelona,
Spain
Synthon BV
Microweg 22, 6545 CM Nijmegen
Netherlands
Synthon s.r.o.
Brn ě nská 32/ č p. 597,
678 01 Blansko,
Czech Republic

This medicinal product has been authorized in the EEA Member States under the following names:

Netherlands: Mingerlan 6 mg/0,4 mg, tabletten met gereguleerde afgifte
Austria: Vesiglandin comp. 6 mg/0,4 mg-Tabletten mit veränderter Wirkstofffreisetzung
Bulgaria: Мингерлан 6 mg/0,4 mg таблетки с изменено освобождаване
Czech Republic: Mintorlan
Hungary: Mingerlan 6 mg/0,4 mg módosított hatóanyag-leadású tabletta
Poland: Mingerlan
Romania: Mingerlan 6 mg/0,4 mg comprimate cu eliberare modificat ă

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

G.L. PHARMA POLAND Sp. z o.o.
Jana Pawła II Avenue 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
biuro@gl-pharma.pl

Date of last revision of the leaflet: