SOLIFENACIN/TAMSULOSIN PENSA 6 mg/0.4 mg PROLONGED-RELEASE TABLETS

Introduction

Leaflet: information for the user

Solifenacin/Tamsulosin pensa 6 mg/0.4 mg modified-release tablets EFG

solifenacin, succinate/tamsulosin, hydrochloride

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Solifenacin/Tamsulosin pensa is and what it is used for
2. What you need to know before taking Solifenacin/Tamsulosin pensa
3. How to take Solifenacin/Tamsulosin pensa
4. Possible side effects

5 Storage of Solifenacin/Tamsulosin pensa

1. Package contents and additional information

1. What Solifenacin/Tamsulosin pensa is and what it is used for

Solifenacin/Tamsulosin pensa is a combination of two different medications called solifenacin and tamsulosin in one tablet. Solifenacin belongs to a group of medications called anticholinergics, and tamsulosin belongs to a group of medications called alpha-blockers.

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

When the prostate size increases, urinary problems (emptying symptoms) such as delayed urination (difficulty starting urination), reduced urine flow (weak stream), dripping, and a feeling 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 warning), and having to urinate more frequently.

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

2. What you need to know before taking Solifenacin/Tamsulosin pensa

Do not take Solifenacin/Tamsulosin pensa if:

• you are allergic to solifenacin or tamsulosin or any of the other ingredients 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 may decrease the elimination of Solifenacin/Tamsulosin pensa from the body (e.g., 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 may decrease the elimination of Solifenacin/Tamsulosin pensa from the body (e.g., 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 disease called myasthenia gravis, which can cause extreme weakness of certain muscles.
• you have increased eye pressure (glaucoma) with gradual vision loss.
• you experience fainting due to a decrease in blood pressure when changing positions (when sitting or standing up); this is called orthostatic hypotension.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Solifenacin/Tamsulosin pensa if:

• you have difficulty eliminating fluid (urinary retention).
• you have any obstruction of the digestive system.
• you are at risk of decreased digestive system activity (stomach and intestinal movements). Your doctor will inform you if this is the case.
• you have a tear in the diaphragm (hiatal hernia) or heartburn and/or are taking medications that can cause or worsen esophagitis.
• you have a certain type of nervous system disease (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 for which you are 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 going to undergo or have scheduled eye surgery due to cataracts or increased eye pressure (glaucoma), please inform your ophthalmologist that you have previously used, are using, or plan to use Solifenacin/Tamsulosin pensa. The specialist can then take the necessary precautions regarding medication and surgical techniques to be used. Ask your doctor if you should postpone or temporarily interrupt taking this medication when undergoing eye surgery for cataracts or increased eye pressure (glaucoma).

Use in children and adolescents

Do not administer this medication to children and adolescents.

Other medications and Solifenacin/Tamsulosin pensa

Tell your doctor or pharmacist if you are using, have recently used, 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, which reduce the rate at which solifenacin/tamsulosin is eliminated from the body.
• other anticholinergic medications, as the effects and side 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 Solifenacin/Tamsulosin pensa.
• medications such as metoclopramide and cisapride, which can accelerate digestive system function. Solifenacin/Tamsulosin 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 esophagitis.

Use of Solifenacin/Tamsulosin pensa with food and beverages

Solifenacin/Tamsulosin pensa can be taken with or without food, according to your preferences.

Pregnancy, breastfeeding, and fertility

Solifenacin/Tamsulosin pensa is not indicated for use in women.

In men, abnormal ejaculation (ejaculation disorder) has been reported. This means that semen is not released through the urethra but instead goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory failure). This phenomenon is harmless.

Driving and using machines

Solifenacin/Tamsulosin pensa may cause dizziness, blurred vision, fatigue, and less frequently, drowsiness. If you experience these side effects, do not drive or use machines.

3. How to take Solifenacin/Tamsulosin pensa

Follow the administration instructions for this medication exactly 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 solifenacin and 0.4 mg of tamsulosin, taken orally. It can be taken with or without food, depending on your preferences. Do not crush or chew the tablet.

If you take more Solifenacin/Tamsulosin pensa than you should

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

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

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

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

If you forget to take Solifenacin/Tamsulosin pensa

Take your next Solifenacin/Tamsulosin pensa tablet as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking Solifenacin/Tamsulosin pensa

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

The most serious side effect that has been observed with a frequency of less than 1 in 100 men during treatment with solifenacin/tamsulosin in clinical trials is acute urinary retention, which is a sudden inability to urinate. If you think you may have this, go to your doctor immediately. You may need to stop taking this medication.

Solifenacin/Tamsulosin pensa can cause allergic reactions:

• Uncommon signs of allergic reactions may include skin rash (which can be itchy) or hives (urticaria).
• Rare symptoms include swelling of the face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing (angioedema). Angioedema has been reported rarely with tamsulosin and very rarely with solifenacin. In case of angioedema, treatment with this medication should be permanently and immediately discontinued.

If you experience an allergic reaction or a severe skin reaction (e.g., blistering and peeling of the skin), you should inform your doctor immediately and stop using this medication. Treatment and/or appropriate measures should be applied.

Other side effects:

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

• Dry mouth
• Constipation
• Indigestion (dyspepsia)
• Dizziness
• Blurred vision
• Fatigue
• Abnormal ejaculation (ejaculation disorder). This means that semen is not released through the urethra but instead goes into the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or nonexistent (ejaculatory failure). This phenomenon is harmless.
• Feeling of nausea
• Abdominal pain

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

• Drowsiness
• Itching (pruritus)
• Skin rash
• Urinary tract infection, bladder infection (cystitis)
• Taste disorder (dysgeusia)
• Dry eyes
• Dry nasal passages
• Gastroesophageal reflux disease
• Dry throat
• Dry skin
• Difficulty urinating
• Fluid accumulation in the legs (peripheral edema)
• Headache
• Fast or irregular heartbeat (palpitations)
• Feeling of dizziness or weakness, especially when standing up (orthostatic hypotension)
• Nasal congestion (rhinitis)
• Diarrhea
• Vomiting
• Fatigue (asthenia)

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

• A large amount of hardened feces accumulating in the large intestine (fecal impaction)
• Feeling of fainting (syncope)
• Allergic reaction 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)

• Hallucinations, confusion
• Severe allergic reaction in the skin (erythema multiforme)
• Prolonged 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
• High levels of potassium in the blood (hyperkalemia) that can cause abnormal heart rhythm
• Increased eye pressure (glaucoma)
• Abnormal heart rhythm (prolonged QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia)
• Rapid heartbeat (tachycardia)
• Breathing difficulties (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) may not increase in size properly. Additionally, the iris (the colored part of the eye) may become flaccid during surgery.
• Voice disorder
• Liver disorder
• Muscle weakness
• Kidney disorder
• Vision changes
• Nosebleeds (epistaxis)
• Psychiatric disorders such as confusion (delirium)
• Abdominal pain

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Solifenacin/Tamsulosin pensa

Keep this medication out of sight and reach of children.

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

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Solifenacin/Tamsulosin pensa

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

Appearance of the product and package contents

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

Solifenacin/Tamsulosin pensa is available in PA/Aluminum/PVC/Aluminum or PA/Aluminum/PVC/Aluminum unidose blister packs.

Packages of 30, 90, or 100 tablets (in blisters or unidose blisters) are available.

Not all pack sizes may be marketed.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

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 medication is authorized in the Member States of the European Economic Area under the following names:

Denmark: Besotmi

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

Date of the last revision of this leaflet:January 2023.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)