Package leaflet: Information for the user

Ranlosin Duo, 6 mg + 0,4 mg, modified-release tablets
succinate solifenacin + hydrochloride tamsulosin
Please read all of 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, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people. It may harm them, 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

What Ranlosin Duo is and what it is used for
What you need to know before taking Ranlosin Duo
How to take Ranlosin Duo
Possible side effects
How to store Ranlosin Duo
Contents of the pack and other information

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

Ranlosin Duo is a combination of two different medicines called solifenacin and tamsulosin, contained in a single 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 the lower urinary tract related to both bladder filling and bladder emptying phases, caused by bladder disorders and enlargement of the prostate gland (benign prostatic hyperplasia). Ranlosin Duo is used when previous treatment with a single-component medicine for the same condition has not provided the expected improvement.
Enlargement of the prostate gland may lead to problems with urination (symptoms related to the voiding phase), such as difficulty starting urination, straining during urination, a weak or interrupted urine stream, dribbling at the end of urination, or a sensation of incomplete bladder emptying.
At the same time, the urinary bladder is overactive and contracts spontaneously even when the patient does not intend to empty it. This results in symptoms related to the bladder filling phase, such as altered sensation during bladder filling, urgency (a sudden, strong need to urinate without prior warning), and increased frequency of urination.
Solifenacin reduces unwanted contractions of the urinary bladder and increases the volume of urine that can be stored in the bladder. As a result, the patient may need to use the toilet less frequently. Tamsulosin improves urine flow through the urethra and facilitates urination.

2. Important information before using Ranlosin Duo

When not to use Ranlosin Duo:

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 at the same time is taking medicines that may slow down the elimination of Ranlosin Duo from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). The doctor or pharmacist will inform the patient whether this applies;
if the patient has moderate liver disease AND at the same time is taking medicines that may slow down the elimination of Ranlosin Duo from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). The doctor or pharmacist will inform the patient whether this applies;
if the patient has severe stomach or intestinal disease (including toxic megacolon, a complication of ulcerative colitis);
if the patient has a muscle disorder called myasthenia gravis, which may cause extreme weakness of certain muscles;
if the patient has increased intraocular pressure (glaucoma) with progressive loss of vision;
if the patient experiences fainting due to a sudden drop in blood pressure upon changing body position (when sitting or standing up); this is known as orthostatic hypotension.

Tell the doctor if any of the above conditions apply to the patient.
Warnings and precautions
Before starting treatment with Ranlosin Duo, discuss with the doctor or pharmacist:

if the patient is unable to pass urine (urinary retention);
if the patient has any gastrointestinal obstruction;
if the patient is at risk of reduced gastrointestinal motility (peristalsis of the stomach and intestines). The doctor or pharmacist will inform the patient whether this applies;
if the patient has displacement of part of the stomach (hiatal hernia), heartburn, and/or is taking medicines that may cause or worsen oesophagitis;
if the patient has a certain type of nervous system disorder (autonomic neuropathy);
if the patient has severe kidney disease;
if the patient has moderate to severe liver disease.

Regular follow-up examinations are necessary to monitor the patient's condition for which treatment was initiated.
Ranlosin Duo may affect blood pressure, resulting in dizziness, lightheadedness, or rarely fainting (orthostatic hypotension). If the patient experiences any of these symptoms, the patient should sit or lie down and wait until the symptoms subside.
If the patient is undergoing or is scheduled for ophthalmic surgery due to cataract (clouding of the eye lens) or increased intraocular pressure (glaucoma), inform the ophthalmologist that the patient has previously used, is currently using, or plans to use Ranlosin Duo. This will allow the specialist to take appropriate precautions during treatment and surgical procedures. Consult the doctor whether treatment with Ranlosin Duo should be withheld or temporarily discontinued prior to eye surgery due to cataract or increased intraocular pressure (glaucoma).
Children and adolescents
Do not use this medicine in children and adolescents.
Ranlosin Duo with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
It is especially important to inform the doctor if the patient is 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 intensified when used together;
cholinergic medicines, as they may reduce the effect of Ranlosin Duo;
medicines such as metoclopramide and cisapride, which accelerate gastrointestinal motility. Ranlosin Duo may reduce their effectiveness;
other alpha-blocker medicines, as this may lead to an undesirable sudden drop in blood pressure;
medicines such as bisphosphonates, as they may cause or worsen oesophagitis.

Ranlosin Duo with food and drink
Ranlosin Duo can be taken with food or independently of meals, according to the patient's preference.
Pregnancy, breastfeeding and fertility
Ranlosin Duo is not indicated for use in women.
In men, cases of ejaculation disorders have been reported. This means that semen does not exit through the urethra but enters the bladder (retrograde ejaculation), or the volume of semen is reduced or ejaculation does not occur (anejaculation). These symptoms are not harmful.
Driving and operating machinery
Ranlosin Duo may cause dizziness, blurred vision, fatigue, and not infrequently, somnolence. If the patient experiences any of these adverse effects, the patient should not drive or operate machinery.

3. How to take Ranlosin Duo

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a 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 may be taken with food or independently of meals, according to patient preference. The tablet must not be crushed or chewed.
Taking more Ranlosin Duo than recommended
If more tablets have been taken than prescribed, or if someone has accidentally taken the tablets, consult a doctor, pharmacist, or go to hospital immediately.
In case of overdose, the doctor may administer activated charcoal; gastric lavage may be helpful if performed within one hour of the overdose. Do not induce vomiting.
Symptoms of overdose may include: dry mouth, dizziness, blurred vision, perception of things that are not really there (hallucinations), excessive excitement, seizures, difficulty breathing, rapid heartbeat (tachycardia), inability to completely or partially empty the bladder or pass urine (urinary retention), and (or) unwanted decrease in blood pressure.
Missing a dose of Ranlosin Duo
Take the next dose of Ranlosin Duo at the usual time. Do not take a double dose to make up for a missed tablet.
Stopping Ranlosin Duo
If the patient stops taking Ranlosin Duo, symptoms may return or worsen. Always consult a doctor if the patient is considering stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The most serious adverse effect observed not frequently (may occur less often than in 1 in 100
men) during clinical trials of the medicine containing solifenacin with tamsulosin was
acute urinary retention, i.e. sudden inability to pass urine. If a patient suspects this effect,
they should immediately consult a doctor. It may be necessary to discontinue treatment with
Ranlosin Duo.
Allergic reactions may occur during treatment with Ranlosin Duo:

Severe allergic reactions (anaphylactic shock) may occur with unknown frequency.
Not frequently occurring symptoms of allergic reactions may include skin rash (which may be itchy) or urticaria.
Rarely occurring symptoms may 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 during treatment with tamsulosin and very rarely during treatment with solifenacin. If angioedema occurs, Ranlosin Duo must be discontinued immediately and must not be taken again.

If a patient experiences sudden symptoms of allergy or severe skin reaction (e.g. blistering or peeling of the skin), they should immediately inform a doctor and discontinue treatment with Ranlosin Duo. Appropriate treatment and (or) other necessary measures should be initiated.

Very common adverse effects (may occur in more than 1 in 10 men)

Dry mouth.

Common adverse effects (may occur in less than 1 in 10 men)

Constipation.
Dyspepsia.
Dizziness.
Blurred vision.
Fatigue (tiredness).
Abnormal ejaculation. This means that semen does not exit through the urethra but enters the bladder (retrograde ejaculation), or the volume of semen is reduced, or there is no ejaculation. These symptoms are not harmful.
Nausea.
Abdominal pain.

Other not frequently occurring adverse effects (may occur in less than 1 in 100 men)

Somnolence.
Itching.
Urinary tract infection, cystitis.
Taste disturbances.
Dry eyes.
Dryness of nasal mucosa.
Gastroesophageal reflux disease (acid reflux).
Dry throat.
Dry skin.
Difficulty in passing urine.
Fluid accumulation in the lower limbs (edema).
Headache.
Rapid or irregular heartbeat (palpitations).
Dizziness or weakness, especially when standing up (orthostatic hypotension).
Nasal congestion or runny nose (rhinitis).
Diarrhea.
Nausea (vomiting).
Fatigue (weakness).

Adverse effects occurring rarely (may occur in less than 1 in 1,000 men)

Accumulation of hard stool in the large intestine (fecal impaction), colonic obstruction.
Feeling faint (fainting).
Skin allergy causing subcutaneous tissue swelling (angioedema).

Adverse effects occurring very rarely (may occur in less than 1 in 10,000 men)

Hallucinations, feeling of disorientation.
Allergic skin reaction (erythema multiforme).
Prolonged and painful erection (usually unrelated to sexual activity) (priapism).
Rash, inflammation, and blistering of the skin and (or) mucous membranes of the lips, eyes, mouth, nasal passages, or genital organs (Stevens-Johnson syndrome).

Frequency unknown (cannot be estimated from available data)

Decreased appetite.
High blood potassium levels (hyperkalemia), which may cause irregular heart rhythm.
Increased intraocular pressure (glaucoma).
Irregular or unusual heart rhythm (QT interval prolongation, Torsade de Pointes arrhythmia, atrial fibrillation, arrhythmia).
Rapid heartbeat (tachycardia).
Shortness of breath (dyspnea).
During eye surgery due to cataract or increased intraocular pressure (glaucoma), the pupil (black circle in the center of the eye) may not dilate as expected. Also, the iris (colored part of the eye) may become floppy during the procedure.
Voice disturbances.
Liver disorders.
Muscle weakness.
Kidney disorders.
Vision disturbances.
Nosebleeds.
Delirium.
Intestinal disorders (obstruction).
Abdominal discomfort.
Severe skin allergy causing skin peeling (exfoliative dermatitis).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse effects 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store Ranlosin Duo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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.
Other ingredients: microcrystalline cellulose, high molecular weight polyethylene glycol, polyethylene glycol, colloidal anhydrous silica, magnesium stearate, calcium hydrogen phosphate, silicified microcrystalline cellulose, low-substituted hydroxypropylcellulose, hypromellose, iron oxide red (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, coated red tablets with the marking "6 04" imprinted on one side.
Ranlosin Duo modified-release tablets are available in packs containing 30 tablets in PA/Aluminum/PVC/Aluminum blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
LEK-AM Sp. z o.o. Pharmaceutical Company
Ostrzykowizna 14A
05-170 Zakroczym
tel.: +48-22/ 785 27 60

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