Mingerlan

Package leaflet: Information for the patient

Mingerlan, 6 mg + 0.4 mg, modified-release tablets
Solifenacin succinate + Tamsulosin hydrochloride
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Mingerlan is and what it is used for

Mingerlan 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.

Mingerlan is used in men for the treatment of moderate to severe lower urinary tract symptoms related to urine storage and voiding caused by bladder problems and enlargement of the prostate gland (benign prostatic hyperplasia). Mingerlan is used when prior treatment with monotherapy for this indication has not sufficiently relieved symptoms.

Enlargement of the prostate gland may lead to voiding problems (symptoms related to urine passage), such as difficulty starting urination, problems with urine flow (reduced urinary stream), post-micturition dribbling, and a sensation of incomplete bladder emptying. At the same time, it negatively affects the bladder, which contracts spontaneously even when the patient does not feel the need to urinate. This leads to storage symptoms such as bladder hypersensitivity, urgency (a sudden, strong need to urinate without prior warning), and increased frequency of urination.

Solifenacin reduces unwanted bladder contractions and increases the amount of urine the bladder can hold. Therefore, you can wait longer before going to the toilet. Tamsulosin allows urine to flow more freely through the urethra, making urination easier.

2. Important information before using Mingerlan

When not to use Mingerlan:

• 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 Mingerlan 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 Mingerlan 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 serious 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 intraocular pressure (glaucoma), with progressive loss of vision,
• if the patient experiences fainting due to low blood pressure upon 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 treatment with Mingerlan, discuss the following with the doctor or pharmacist:

• if the patient has inability to urinate (urinary retention),
• if the patient has gastrointestinal obstruction,
• if the patient is at risk of slowed gastrointestinal motility (gastric and intestinal movements). The doctor will inform the patient whether this warning applies.
• if the patient has persistent stomach pain (hiatal hernia) or heartburn and/or if the patient is concurrently taking medicines that may cause or worsen oesophagitis,
• if the patient has 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 condition for which the patient is being treated.
Mingerlan may affect blood pressure, which may cause 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 is scheduled to undergo eye surgery due to cataract or elevated intraocular pressure (glaucoma), the ophthalmologist should be informed about current or past use of Mingerlan, or if the patient plans to use this medicine in the future. The specialist may take appropriate precautions regarding medications and surgical techniques. The patient should ask the doctor whether treatment with Mingerlan should be postponed or temporarily discontinued before undergoing eye surgery for cataract or elevated intraocular pressure (glaucoma).
Children and adolescents
This medicine must not be used in children and adolescents.
Mingerlan and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the 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 elimination of Mingerlan from the body,
• other anticholinergic medicines, because taking two medicines of the same type may increase the effects and side effects of both,
• cholinergic medicines, because they may reduce the effectiveness of Mingerlan,
• medicines such as metoclopramide and cisapride, which accelerate gastrointestinal motility. Mingerlan may reduce their effectiveness.
• 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.

Mingerlan with food and drink
Mingerlan may be taken with or without food, according to the patient's preference.
Pregnancy, breastfeeding and fertility
Mingerlan 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 instead flows backward into the bladder (retrograde ejaculation), ejaculate volume is reduced, or ejaculation does not occur (absence of ejaculation). This phenomenon is harmless.
Driving and operating machinery
Mingerlan may cause dizziness, blurred vision, fatigue, and less frequently, somnolence. Patients experiencing these symptoms should not drive or operate machinery.
Mingerlan contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to take Mingerlan

This medicine should always be taken as directed by a physician or pharmacist. If in doubt,
consult a doctor or pharmacist.
The maximum 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 independently of meals. Tablets must not be crushed or chewed.

Taking more Mingerlan than recommended
If more tablets than recommended have been taken, or if another person accidentally ingests the tablets,
seek immediate medical advice by contacting a doctor or pharmacist, or go to a hospital.
In case of overdose, a doctor may administer activated charcoal. 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 excitation, seizures (convulsions),
difficulty breathing, rapid heartbeat (tachycardia), inability to completely or partially empty the bladder,
or inability to urinate (urinary retention), and/or undesirable lowering of blood pressure.

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

Stopping treatment with Mingerlan
Discontinuing treatment with Mingerlan may cause recurrence or worsening of symptoms related to the underlying condition.
Any intention to discontinue treatment should always be discussed with a doctor.
If you have any further doubts 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 they do not occur in everyone.

The most common adverse reaction observed not frequently (may occur in less than 1 in 100 men) during treatment with solifenacin succinate and tamsulosin hydrochloride in clinical trials is acute urinary retention, meaning sudden inability to pass urine. If the patient believes this situation applies to him, he should contact his doctor immediately. It may be necessary to discontinue treatment with Mingerlan.

Allergic reactions may occur after administration of Mingerlan:

• Not frequent symptoms of hypersensitivity reactions may include skin rash (which may be itchy) or urticaria.
• Rare symptoms include swelling of the face, lips, oral cavity, 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, treatment with Mingerlan must be stopped immediately and must not be restarted.

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

Common adverse reactions (may occur in 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 externally 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 (lassitude)

Not common adverse reactions (may occur in less 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)
• cold symptoms or stuffy nose (nasal mucosal inflammation)
• gastroesophageal reflux disease (gastroesophageal reflux), diarrhoea, dry throat, vomiting
• itching (pruritus), dry skin
• difficulty in passing urine
• fluid accumulation in lower limbs (oedema), fatigue (asthenia)

Rare adverse reactions (may occur in less than 1 in 1,000 men)

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

Very rare adverse reactions (may occur in less than 1 in 10,000 men)

• hallucinations, disorientation
• rash, inflammation and blistering of the skin and (or) mucous membranes of the lips, eyes, oral cavity, nostrils or genital organs (Stevens-Johnson syndrome), skin allergy (erythema multiforme)
• 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 (hyperkalaemia), which may cause heart rhythm disturbances
• sudden loss of consciousness and general mental function (delirium)
• during eye surgery due to cataract or increased 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, increased intraocular pressure (glaucoma), visual disturbances
• irregular or unusual heartbeat (prolonged QT interval, ventricular tachycardia of the type torsade de pointes, atrial fibrillation, arrhythmia), increased heart rate (tachycardia)
• shortness of breath, voice disturbances, nosebleeds
• intestinal obstruction, abdominal discomfort
• liver function disorders
• severe skin allergy causing redness and peeling of large areas of skin (toxic epidermal necrolysis)
• muscle weakness
• kidney function disorders

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181C,
02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the responsible entity.

Reporting adverse reactions helps to increase knowledge about the safety of the medicine.

5. How to store Mingerlan

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
package after: "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 in use. This will help
protect the environment.

6. Contents of the pack 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.
• Other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose (E 460), sodium croscarmellose (E 468), hypromellose 2910 (E 464), iron oxide red (E 172), magnesium stearate (E 470b), polyethylene glycol 7,000,000, polyethylene glycol, colloidal anhydrous silica, titanium dioxide (E 171).

What Mingerlan looks like and contents of the pack
Mingerlan is a red, round, biconvex modified-release tablet with the imprint "T7S" on one side.
Mingerlan is available in blisters made of oPA/Alu/PVC/Alu foil, containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 modified-release tablets in a cardboard box, or in unit-dose blisters made of oPA/Alu/PVC/Alu foil, 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 in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation 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
The Netherlands

Synthon s.r.o.
Brněnská 32/c.p. 597,
678 01 Blansko,
Czech Republic

This medicinal product has been authorised for marketing 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 modificată

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]