Prospecto:Information for the User

Solifenacina/Tamsulosina pensa 6 mg/0.4 mg Modified Release EFG Tablets

Solifenacina succinate/Tamsulosina hydrochloride

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctor or pharmacist-

-This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you, as it may harm them.

• If you experience adverse effects,consult your doctor or pharmacist,evenif they are not listed in this prospectus. See section 4.

1.What is Solifenacina/Tamsulosina pensa and what is it used for

2.What you need to knowbeforestarting totake Solifenacina/Tamsulosina pensa

3.How to take Solifenacina/Tamsulosina pensa

4.Possible adverse effects

5Storage of Solifenacina/Tamsulosina pensa

6.Contents of the package and additional information

Solifenacina/Tamsulosina pensais a combination of two different medications called solifenacina and tamsulosina in a single tablet. Solifenacina belongs to a group of medications called anticholinergics and tamsulosina belongs to a group of medications called alpha-blockers.

Solifenacina/Tamsulosinais used in men to treat both moderate to severe filling symptoms and emptying symptoms of the lower urinary tract caused by problems related to the bladder and by an enlarged prostate (benign prostatic hyperplasia). This medication is used when previous monotherapy treatment for this condition did not adequately alleviate symptoms.

When the prostate becomes enlarged, urinary problems (emptying symptoms) such as delayed urination (difficulty starting urination), reduced urine flow (weak stream), dripping, and sensation of incomplete bladder emptying may occur. At the same time, the bladder is also affected and contracts spontaneously at times when urination is not desired. This causes filling symptoms such as changes in bladder sensation, urgency (having a strong and sudden desire to urinate without prior warning) and having to urinate more frequently.

Solifenacina reduces involuntary bladder contractions and increases the amount of urine that the bladder can store. Therefore, you can expect to wait longer before having to go to the bathroom. Tamsulosina allows urine to pass more easily through the urethra and facilitates urination.

Do not take Solifenacina/Tamsulosina pensa if:

• You are allergic to solifenacina or tamsulosina or any of the other components of this medication (listed in section 6).
• You are undergoing renal dialysis.
• You have severe liver disease.
• You have severe kidney disease and are being treated with medications that can reduce the elimination of Solifenacina/Tamsulosina pensa from the body (for example, ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this is the case.
• You have moderate liver disease and are being treated with medications that can reduce the elimination of Solifenacina/Tamsulosina pensa from the body (for example, ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this is the case.
• You have a severe stomach or intestinal condition (including toxic megacolon, a complication associated with ulcerative colitis).
• You have a muscle condition called myasthenia gravis, which can cause extreme weakness in certain muscles.
• You have increased pressure in the eyes (glaucoma), with gradual loss of vision.
• You experience dizziness due to a decrease in blood pressure when changing positions (sitting or standing); this is known as orthostatic hypotension.

Inform your doctor if you think you have any of these conditions.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Solifenacina/Tamsulosina pensa if:

• You have difficulty eliminating liquid (urinary retention).
• You have any obstruction of the digestive system.
• You are at risk of decreased activity of the digestive system (gastrointestinal motility). Your doctor will inform you if this is the case.
• You have a hiatal hernia or stomach burning and/or are taking medications that can cause or worsen esophagitis.
• You have a certain type of nervous system disorder (autonomic neuropathy).
• You have severe kidney disease.
• You have moderate liver disease.

Regular medical check-ups are necessary to monitor the development of the condition being treated.

This medication may affect blood pressure, which can cause dizziness, drowsiness, or rarely, fainting (orthostatic hypotension). You should sit or lie down if you experience any of these symptoms until they have disappeared.

If you are scheduled to undergo eye surgery due to cataracts or increased pressure in the eyes (glaucoma), please inform your ophthalmologist that you have previously used, are currently using, or plan to use Solifenacina/Tamsulosina pensa. The specialist can then take the necessary precautions regarding medication and surgical techniques. Ask your doctor if you should or should not temporarily stop taking this medication when undergoing eye surgery for cataracts or increased pressure in the eye (glaucoma).

Use in children and adolescents

Do not administer this medication to children and adolescents.

Other medications and Solifenacina/Tamsulosina pensa

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

It is especially important to inform your doctor if you are using:

• Medications such as ketoconazole, erythromycin, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, and paroxetine that reduce the rate at which solifenacina/tamsulosina is eliminated from the body.
• Other anticholinergic medications, as the effects and adverse effects of both medications can be intensified if you are taking two medications of the same type.
• Cholinergic medications, as they can reduce the effect of Solifenacina/Tamsulosina pensa.
• Medications such as metoclopramide and cisapride, which can accelerate the functioning of the digestive system. Solifenacina/Tamsulosina pensa may reduce their effect.
• Other alpha-blockers, as they can cause an undesirable decrease in blood pressure.
• Medications such as bisphosphonates, which can cause or exacerbate inflammation of the esophagus (esophagitis).

Use of Solifenacina/Tamsulosina pensa with food and beverages

Solifenacina/Tamsulosina pensa can be taken with or without food, according to your preferences.

Pregnancy,breastfeeding, and fertility

Solifenacina/Tamsulosina pensa is not indicated for use in women.

In men, abnormal ejaculation (alteration of ejaculation) has been reported. This means that semen does not release through the urethra, but rather goes to the bladder (retrograde ejaculation) or the volume of semen is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and operating machinery

Solifenacina/Tamsulosina pensa may cause dizziness, blurred vision, fatigue, and, less frequently, drowsiness. If you experience these adverse effects, do not drive or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The maximum daily dose is one tablet containing 6 mg of solifenacina and 0.4 mg of tamsulosina, taken orally. It can be taken with or without food, according to your preferences. Do not crush or chew the tablet.

If you take more Solifenacina/Tamsulosina pensa than you should

If you have taken more tablets than you were told to, or if someone else takes your tablets by accident, contact your doctor, pharmacist, or hospital immediately for advice.

In case of overdose, your doctor may treat you with activated charcoal; emergency gastric lavage may be useful if performed within one hour of the overdose. Do not induce vomiting.

Overdose symptoms may include: dry mouth, dizziness, and blurred vision, seeing things that are not there (hallucinations), over-excitement, seizures, difficulty breathing, increased heart rate (tachycardia), inability to completely or partially empty the bladder or to urinate (urinary retention), and/or unwanted increase in blood pressure.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Solifenacina/Tamsulosina pensa

Take your next Solifenacina/Tamsulosina pensa tablet as usual. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Solifenacina/Tamsulosina pensa

If you stop taking this medication, your initial symptoms may reappear or worsen. Always consult your doctor if you are considering interrupting treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most serious side effect that has been observed with a low frequency (which may affect up to 1 in 100 men) during treatment with solifenacin succinate/hydrochloride tamsulosin in clinical studies is acute urinary retention, which consists of a sudden inability to urinate. If you think you may be experiencing it, go to your doctor immediately. You may need to stop taking this medicine.

Solifenacina/Tamsulosina pensamay cause allergic reactions:

• Less common signs of allergic reactions may include skin rash (which may cause itching) or hives (urticaria).
• Rare symptoms include swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema). Angioedema has been reported in rare cases with tamsulosin and in very rare cases with solifenacin. In the event of angioedema, treatment with this medicine should be stopped immediately and definitively.

If you experience an allergic crisis or a severe skin reaction (for example, blistering and peeling of the skin), you should inform your doctor immediately, and stop using this medicine. Appropriate treatment and/or measures should be applied.

Other side effects:

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

• Dry mouth
• Constipation
• Indigestion (dyspepsia)
• Dizziness
• Blurred vision
• Fatigue
• Abnormal ejaculation (ejaculatory disorder). This means that semen is not released through the urethra, but rather into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless
• Feeling of dizziness (nausea)
• Abdominal pain

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

• Drowsiness
• Itching (pruritus)
• Skin rash
• Urinary tract infection, bladder infection (cystitis)
• Disorder of the sense of taste (dysgeusia)
• Dry eyes
• Runny nose
• Gastroesophageal reflux disease (GERD)
• Throat dryness
• Dry skin
• Difficulty urinating
• Swelling of the legs (peripheral edema)
• Headache
• Irregular or rapid heartbeat (palpitations)
• Sensation of dizziness or weakness, especially when standing up (orthostatic hypotension)
• Runny or blocked nose (rhinitis)
• Diarrhea
• Vomiting
• Weakness (asthenia)

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

• Accumulation of a large amount of hardened feces in the large intestine (fecal impaction)
• Sensation of fainting (syncope)
• Allergy in the skin that causes swelling in the tissue under the skin surface (angioedema)

Very rare side effects (may affect up to 1 in 10,000 men)

• Illusions, confusion
• Allergic reaction in the skin (erythema multiforme)
• Durable and painful erection (usually not during sexual activity) (priapism)
• Inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages, or genitals (Stevens-Johnson syndrome)

Frequency not known (cannot be estimated from available data)

• Anaphylactic reaction (sudden and severe allergic reaction with difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, and loss of consciousness)
• Decreased appetite
• Elevated potassium levels in the blood (hyperkalemia) that may cause irregular heartbeat
• Increased pressure in the eyes (glaucoma)
• Irregular or abnormal heartbeat (prolonged QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia)
• Rapid heartbeat
• Difficulty breathing (dyspnea)
• During eye surgery for cataracts or increased eye pressure (glaucoma), it is possible that the pupil (the black circle in the center of the eye) will not dilate sufficiently. Additionally, the iris (the colored part of the eye) may become flaccid during surgery.
• Voice disorder
• Liver disorder
• Muscle weakness
• Kidney disorder
• Visual disturbance
• Nasal bleeding (epistaxis)
• Psychiatric disorders such as confusion (delirium)
• Abdominal pain

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box or blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment

Composition of Solifenacina/Tamsulosina pensa

• The active principles 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 components are: high molecular weight macrogol, anhydrous colloidal silica (E551), magnesium stearate (E470b), calcium hydrogen phosphate (E341), microcrystalline cellulose (E460), low-substituted hydroxypropylcellulose (E463), hypromellose (E464), red iron oxide (E172), macrogol, butylhydroxytoluene (E321).

Appearance of the product and content of the packaging

Solifenacina/Tamsulosina pensa 6 mg/0.4 mg modified-release tablets are round, biconvex, red-colored, film-coated tablets, marked with "6 04" on one side, and have a diameter of 9 mm.

Solifenacina/Tamsulosina pensa is available in packaging with PA/Aluminum/PVC/Aluminum blisters or in perforated single-dose blisters of PA/Aluminum/PVC/Aluminum.

Available in packaging of 30, 90, or 100 tablets (in blisters or perforated single-dose blisters).

Only some package sizes may be marketed.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

or

Adalvo Limited

Malta Life Sciences Park, Building 1 Level 4

Sir Temi Zammit Buildings

San Gwann SGN 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Denmark: Besotmi

Spain: Solifenacina/Tamsulosina pensa 6 mg/0.4 mg modified-release tablets EFG

Last review date of this prospectus: January 2023.

Further detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/ )