Solitombo

PACKAGE LEAFLET

Package leaflet: information for the patient

Solitombo, 6 mg/0,4 mg, prolonged-release tablets

solifenacin succinate + tamsulosin hydrochloride

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

• Keep this package 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 package leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the package leaflet

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

1. What is Solitombo and what is it used for

Solitombo 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.
Solitombo is used in men to treat moderate to severe symptoms of urinary retention and urination, caused by problems with the bladder and prostate enlargement (benign prostatic hyperplasia). Solitombo is used when previous treatment with monotherapy in this indication has not sufficiently alleviated the symptoms.
Prostate enlargement can lead to urination problems (symptoms related to urination), such as difficulty starting urination, difficulty urinating (decreased urine flow), post-micturition dribbling, and a feeling of incomplete emptying of the bladder. 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 symptoms related to urine retention, such as bladder sensitivity disorders, sudden urge to urinate (strong, sudden urge to urinate without prior signs), and frequent urination.
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 Solitombo

When not to take Solitombo:

• 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 kidney dialysis,
• if you have severe liver disease,
• if you have severe kidney disease and are taking medicines that may delay the elimination of Solitombo from the body (e.g., 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 delay the elimination of Solitombo from the body (e.g., ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this warning applies to you.
• if you have severe stomach or intestinal disorders (including toxic megacolon, a complication of ulcerative colitis),
• if you have a muscle disease called myasthenia, which can cause significant weakness of some 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 taking Solitombo, discuss it with your doctor or pharmacist:

• if you have difficulty urinating (urinary retention),
• if you have intestinal obstruction,
• if you have a risk of delayed intestinal movement (gastrointestinal motility). Your doctor will inform you if this warning applies to you.
• if you have a burning stomach pain (hiatus hernia) or heartburn and (or) if you are taking medicines that may 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.
Solitombo 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 until they pass.
If you are undergoing or are going to undergo eye surgery for cataracts or increased eye pressure (glaucoma), you should inform your ophthalmologist about your current or past use of Solitombo, 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 postpone or temporarily stop taking Solitombo in case of eye surgery for cataracts or increased eye pressure (glaucoma).

Children and adolescents

This medicine should not be used in children and adolescents.

Solitombo and other medicines

Tell your doctor or pharmacist about all the 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 rate of elimination of Solitombo from the body,
• other anticholinergic medicines, as there is a possibility of increased action and side effects of both medicines when two medicines of the same type are taken,
• cholinergic medicines, as they may weaken the action of Solitombo,
• medicines such as metoclopramide and cisapride, which accelerate gastrointestinal motility. Solitombo may weaken their action.
• other alpha-adrenergic receptor blockers, due to the possibility of undesirable blood pressure lowering,
• medicines such as bisphosphonates, which may cause or worsen esophageal inflammation.

Taking Solitombo with food and drink

Solitombo can be taken with or without food, according to the patient's preference.

Pregnancy, breastfeeding, and fertility

Solitombo 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

Solitombo may cause dizziness, blurred vision, fatigue, and, less often, sleepiness. Patients who experience such symptoms should not drive or operate machinery.

3. How to take Solitombo

This medicine should always be taken exactly as prescribed 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.
The tablets should not be crushed or chewed.

Overdose of Solitombo

In case of taking more tablets than prescribed or accidental ingestion by another person, you should immediately contact your doctor or pharmacist 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, seeing things that are not there (hallucinations), excessive excitement, convulsions (seizures), difficulty breathing, 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 Solitombo

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

Stopping Solitombo treatment

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

4. Possible side effects

Like all medicines, Solitombo can cause side effects, although not everybody gets them.
The most serious side effect, which has been observed not very often (may occur in less than 1 in 100 men) during treatment with solifenacin succinate and tamsulosin hydrochloride in clinical trials, is acute urinary retention, which means sudden inability to urinate. If you think this situation applies to you, you should immediately consult your doctor. It may be necessary to stop taking Solitombo.
After taking Solitombo, 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 can 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, you should immediately stop taking Solitombo and not restart it.

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

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

• dry mouth

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

• constipation
• indigestion
• dizziness
• blurred vision
• fatigue (tiredness)
• 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.
• nausea (nausea)
• abdominal pain

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

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

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

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

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

• hallucinations, disorientation
• allergic skin reactions (erythema multiforme)
• prolonged and painful erection of the penis (usually not during 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 heart rhythm disorders
• increased eye pressure (glaucoma)
• irregular or abnormal heartbeat (QT interval prolongation, torsades de pointes, atrial fibrillation, arrhythmia)
• rapid heartbeat (tachycardia)
• shortness of breath
• 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.
• voice disorders
• liver function disorders
• muscle weakness
• kidney function disorders
• vision disorders
• nosebleeds
• delirium (delirium)
• intestinal disorders (intestinal obstruction)
• abdominal discomfort
• severe skin allergy causing skin peeling (exfoliative dermatitis).

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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
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 Solitombo

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 the abbreviation "EXP". The expiry date refers to the last day of the month stated.
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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Solitombo contains

• The active substances of Solitombo 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 microcrystalline cellulose, high molecular weight macrogol, macrogol, anhydrous colloidal silica, magnesium stearate, calcium hydrogen phosphate, siliconized microcrystalline cellulose, low-substituted hydroxypropylcellulose, hypromellose, red iron oxide (E172).

What Solitombo looks like and contents of the pack

Solitombo 6 mg/0,4 mg tablets are round, 9 mm in diameter, biconvex, red, film-coated, with the inscription "6 04" on one side.
PA/Aluminum/PVC/Aluminum blister pack in a cardboard box, containing 30, 90, or 100 tablets.
PA/Aluminum/PVC/Aluminum blister pack, divided into single doses, in a cardboard box, containing 30 x 1, 90 x 1, or 100 x 1 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Phone: +48 22 732 77 00

Manufacturer

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

European Economic Area:

Poland:
Solitombo
Germany:
Solifenacin/Tamsulosin Adamed
Czech Republic:
STILIAD
Slovakia:
STILIAD

Date of last revision of the package leaflet: