Ranlosin Duo

Package Leaflet: Information for the User

Ranlosin Duo, 6 mg + 0,4 mg, Modified Release Tablets

Solifenacin succinate + tamsulosin hydrochloride
You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.
for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

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

1. What is Ranlosin Duo and what is it used for

Ranlosin Duo 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-blockers.
Ranlosin Duo is used in men for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH), which are associated with both the filling and emptying of the bladder. Ranlosin Duo is used when a single-component medicine previously used for the same condition did not provide the expected improvement.
Benign prostatic hyperplasia can lead to problems with urination (symptoms related to the emptying phase), such as difficulty starting urination, difficulty urinating (narrowed urine stream), or a feeling of incomplete bladder emptying.
At the same time, the bladder is irritated and contracts on its own, even when the patient does not want to empty it. As a result, there are symptoms related to the filling phase, such as changes in the sensation of bladder filling, urgent urination (strong and sudden need to urinate without prior signs), or frequent urination.
Solifenacin inhibits unwanted contractions of the bladder and increases the volume of urine that can be stored in the bladder. This allows the patient to urinate less frequently. Tamsulosin improves urine flow through the urethra and facilitates urination.

2. Important information before taking Ranlosin Duo

When not to take Ranlosin Duo:

• if you are allergic to solifenacin or tamsulosin or 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 if you are taking medicines that may cause slower elimination of Ranlosin Duo from the body (e.g., ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this applies to you;
• if you have moderate liver disease AND if you are taking medicines that may cause slower elimination of Ranlosin Duo from the body (e.g., ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this applies to you;
• if you have severe stomach or intestinal disease (including toxic megacolon, a complication of ulcerative colitis);
• if you have a muscle disease called myasthenia gravis, which can cause extreme weakness of some muscles;
• if you have increased pressure in the eyes (glaucoma) with progressive vision loss;
• if you have fainting spells caused by a sudden decrease in blood pressure when changing body position (when sitting or standing); this is called orthostatic hypotension.

You should tell your doctor if you have any of the above conditions.

Warnings and precautions

Before starting treatment with Ranlosin Duo, you should discuss it with your doctor or pharmacist:

• if you have difficulty urinating (urinary retention);
• if you have any obstruction of the gastrointestinal tract;
• if you have a risk of decreased gastrointestinal motility (gastrointestinal movements). Your doctor or pharmacist will inform you if this applies to you;
• if you have a displaced stomach (hiatus hernia), heartburn, and/or if you are taking medicines that may cause or exacerbate esophageal inflammation;
• if you have a certain type of nervous system disease (autonomic neuropathy);
• if you have severe kidney disease;
• if you have moderate liver disease.

Regular check-ups are necessary to monitor the progress of the patient's condition for which treatment was initiated.
Ranlosin Duo may affect blood pressure, which can cause dizziness, drowsiness, or rarely fainting (orthostatic hypotension). If the patient experiences any of these symptoms, they should sit or lie down and wait for the symptoms to pass.
If the patient is undergoing eye surgery or a planned eye surgery due to cataracts or increased eye pressure (glaucoma), they should inform the ophthalmologist that they have taken, are taking, or plan to take Ranlosin Duo. This will allow the doctor to take appropriate precautions during treatment and surgical procedures. The patient should consult their doctor about whether to stop taking the medicine before the eye surgery or temporarily discontinue it.

Children and adolescents

This medicine should not be used in children and adolescents.

Ranlosin Duo and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
It is especially important to inform your doctor if you are taking:

• medicines such as ketoconazole, erythromycin, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, and paroxetine, which slow down the elimination of Ranlosin Duo from the body;
• other anticholinergic medicines, as the effects of both medicines and their side effects may be enhanced when taken together;
• cholinergic medicines, as they may reduce the effect of Ranlosin Duo;
• medicines such as metoclopramide and cisapride, which speed up gastrointestinal motility. Ranlosin Duo may reduce their effect;
• other alpha-blockers, as this may cause unwanted sudden drops in blood pressure;
• medicines such as bisphosphonates, which may cause or exacerbate esophageal inflammation.

Ranlosin Duo with food and drink

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

Pregnancy, breastfeeding, and fertility

Ranlosin Duo is not indicated for use in women.
In men, cases of ejaculatory disorders have been reported. This means that semen does not come out through the urethra but instead enters the bladder (retrograde ejaculation) or the semen volume is smaller or there is no ejaculation at all. These symptoms are not harmful.

Driving and using machines

Ranlosin Duo may cause dizziness, blurred vision, fatigue, and, less frequently, drowsiness. If the patient experiences these side effects, they should not drive or operate machinery.

3. How to take Ranlosin Duo

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, consult 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 tablet can be taken with or without food, as preferred by the patient. Do not crush or chew the tablet.

Take more Ranlosin Duo than prescribed

If you have taken more tablets than your doctor prescribed, or if someone has taken your tablets by mistake, consult your doctor, pharmacist, or go to the hospital immediately.
In case of overdose, your doctor may use activated charcoal; stomach lavage may help if performed within an hour of overdose. Do not induce vomiting.
Symptoms of overdose may include: dry mouth, dizziness, blurred vision, hallucinations, excessive excitement, seizures, difficulty breathing, rapid heartbeat (tachycardia), inability to fully or partially empty the bladder or urinate (urinary retention), and/or unwanted decrease in blood pressure.

Miss a dose of Ranlosin Duo

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

Stop taking Ranlosin Duo

If you stop taking Ranlosin Duo, your symptoms may return or worsen. You should always consult your doctor if you are considering stopping treatment.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effect that occurred infrequently (may occur less often than in 1 in 100 men) during clinical trials with the combination of solifenacin and tamsulosin was acute urinary retention, which is a sudden inability to urinate. If you suspect you have this side effect, you should see your doctor immediately. It may be necessary to stop taking Ranlosin Duo.
During treatment with Ranlosin Duo, allergic reactions may occur:

• severe allergic reactions (anaphylactic shock) may occur with an unknown frequency
• infrequent allergic reactions may include skin rash (which may be itchy) or hives;
• rare allergic reactions may include: swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema). Angioedema has been reported rarely with tamsulosin and very rarely with solifenacin. If angioedema occurs, you should stop taking Ranlosin Duo immediately and not take it again.

If you experience sudden symptoms of an allergic reaction or a severe skin reaction (e.g., blistering of the skin or peeling), you should inform your doctor immediately and stop taking Ranlosin Duo.
Appropriate treatment and/or other necessary measures should be taken.

Very common side effects (may affect more than 1 in 10 men)

• Dry mouth.

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

• Constipation.
• Indigestion.
• Dizziness.
• Blurred vision.
• Fatigue (tiredness).
• Abnormal ejaculation (ejaculatory disorders). This means that semen does not come out through the urethra but instead enters the bladder (retrograde ejaculation) or the semen volume is smaller or there is no ejaculation at all. These symptoms are not harmful.
• Nausea.
• Abdominal pain.

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

• Drowsiness.
• Itching.
• Urinary tract infection, cystitis.
• Abnormal taste.
• Dry eyes.
• Dryness of the nasal mucosa.
• Gastroesophageal reflux disease (gastroesophageal reflux).
• Dry throat.
• Dry skin.
• Difficulty urinating.
• Fluid accumulation in the lower limbs (edema).
• Headache.
• Rapid or irregular heartbeat (palpitations).
• Dizziness or weakness, especially when standing up (orthostatic hypotension).
• Rhinitis or stuffy nose (nasopharyngitis).
• Diarrhea.
• Nausea (vomiting).
• Fatigue (weakness).

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

• Accumulation of a large amount of hard stool in the large intestine (fecal impaction), intestinal obstruction.
• Fainting (syncope).
• Allergic skin reaction causing swelling of the tissues under the skin (angioedema).

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

• Hallucinations, disorientation.
• Skin allergic reaction (erythema multiforme).
• Prolonged and painful erection (usually not related to sexual activity) (priapism).
• Rash, inflammation, and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nostrils, or genitals (Stevens-Johnson syndrome).

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

• Decreased appetite.
• High potassium levels in the blood (hyperkalemia), which can cause irregular heartbeat.
• Increased eye pressure (glaucoma).
• Irregular or abnormal heartbeat (QT prolongation, Torsade de Pointes, atrial fibrillation, arrhythmia).
• Rapid heartbeat (tachycardia).
• Shortness of breath (dyspnea).
• During eye surgery due to cataracts or increased eye pressure (glaucoma), the pupil (the black circle in the center of the eye) may not dilate as it should. The iris (the colored part of the eye) may also become flaccid during the procedure.
• Voice disorders.
• Liver disorders.
• Muscle weakness.
• Kidney disorders.
• Vision disorders.
• Nosebleeds.
• Confusion.
• Intestinal disorders (obstruction).
• Abdominal discomfort.
• Severe skin allergy causing peeling of the skin (exfoliative dermatitis).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocides
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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ranlosin Duo

Medicines should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storage.
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 Ranlosin Duo contains

• The active substances are solifenacin succinate and tamsulosin hydrochloride. Each modified-release 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.
• The other ingredients are: microcrystalline cellulose, high molecular weight macrogol, macrogol, silicon dioxide, magnesium stearate, calcium hydrogen phosphate, siliconized microcrystalline cellulose, low-substituted hydroxypropylcellulose, hypromellose, red iron oxide (E172).

What Ranlosin Duo looks like and contents of the pack

Ranlosin Duo 6 mg + 0,4 mg tablets are round, approximately 9 mm in diameter, biconvex, red, film-coated tablets with the symbol "6 04" embossed on one side.
Ranlosin Duo modified-release tablets are available in packs containing 30 tablets in PA/Aluminum/PVC/Aluminum blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
tel.: +48-22/ 785 27 60

Manufacturer

Adamed Pharma S.A.
Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

Date of last revision of the leaflet: