Solifenacin/tamsulosin Pensa 6 mg/0.4 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

solifenacin, succinate/tamsulosin, hydrochloride

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Solifenacina/Tamsulosina pensa is and what it is used for
2. What you need to know before taking Solifenacina/Tamsulosina pensa
3. How to take Solifenacina/Tamsulosina pensa
4. Possible side effects
5. How to store Solifenacina/Tamsulosina pensa
6. Contents of the pack and other information

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

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

Solifenacin/Tamsulosin is used in men to treat both moderate to severe filling symptoms and voiding symptoms of the lower urinary tract caused by bladder-related problems and benign prostatic enlargement (benign prostatic hyperplasia). This medicine is used when previous treatment with monotherapy for this condition did not adequately relieve symptoms.

When the prostate gland enlarges, urinary problems (voiding symptoms) may occur, such as delayed urination (difficulty starting to pass urine), reduced urine flow (weak stream), dribbling, and a sensation of incomplete bladder emptying. 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 (a sudden, strong need to urinate without warning), and increased frequency of urination.

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

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

Do not take Solifenacin/Tamsulosin pensa if:

• you are allergic to solifenacin or tamsulosin or to any of the other components of this medicine (listed in section 6).
• you are undergoing renal dialysis.
• you have severe liver disease.
• you have severe renal impairment AND at the same time are being treated with medicines that may reduce the elimination of Solifenacin/Tamsulosin pensa from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this applies.
• you have moderate liver disease AND at the same time are being treated with medicines that may reduce the elimination of Solifenacin/Tamsulosin pensa from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this applies.
• you have a severe stomach or intestinal condition (including toxic megacolon, a complication associated with ulcerative colitis).
• you have a muscle disorder called myasthenia gravis, which can cause extreme weakness of certain muscles.
• you have increased pressure in the eyes (glaucoma), with gradual loss of vision.
• you experience fainting due to a drop in blood pressure when changing position (sitting or standing up); 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 Solifenacin/Tamsulosin pensa if:

• you have difficulty passing urine (urinary retention).
• you have any obstruction of the gastrointestinal tract.
• you are at risk of reduced gastrointestinal motility (stomach and intestinal movements). Your doctor will inform you if this applies.
• you have a diaphragmatic hernia (hiatal hernia) or heartburn and/or are simultaneously taking medicines that may cause or worsen esophagitis.
• you have a certain type of nerve disorder (autonomic neuropathy).
• you have severe renal impairment.
• you have moderate liver disease.

Periodic medical check-ups are necessary to monitor the condition for which you are being treated.

This medicine may affect blood pressure, which could cause dizziness, lightheadedness, or rarely, fainting (orthostatic hypotension). You should sit or lie down if you experience any of these symptoms until they resolve.

If you are scheduled for or undergoing eye surgery due to clouding of the lens (cataracts) or increased pressure in the eye (glaucoma), please inform your ophthalmologist that you have previously used, are currently using, or plan to use Solifenacin/Tamsulosin pensa. The specialist can then take appropriate precautions regarding medication and surgical techniques. Ask your doctor whether you should delay or temporarily discontinue taking this medicine prior to eye surgery for lens clouding (cataracts) or increased eye pressure (glaucoma).

Use in children and adolescents

Do not give this medicine to children or adolescents.

Other medicines and Solifenacin/Tamsulosin pensa

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is especially important that you inform your doctor if you are taking:

• medicines 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 medicines, as the effects and adverse effects of both medicines may be intensified when taking two medicines of the same type.
• cholinergics, as they may reduce the effect of Solifenacin/Tamsulosin pensa.
• medicines such as metoclopramide and cisapride, which may accelerate gastrointestinal motility. Solifenacin/Tamsulosin pensa may reduce their effect.
• other alpha-blockers, as they may cause an undesirable drop in blood pressure.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

Taking Solifenacin/Tamsulosin pensa with food and drink

Solifenacin/Tamsulosin pensa may be taken with or without food, according to your preference.

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 does not exit through the urethra but instead enters the bladder (retrograde ejaculation), or that the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and using machines

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

3. How to take Solifenacin/Tamsulosin pensa

Always follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, 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, according to your preference. Do not crush or chew the tablet.

If you take more Solifenacin/Tamsulosin pensa than you should

If you have taken more tablets than prescribed, or if someone accidentally takes your tablets, 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 beneficial if performed within one hour of the overdose. Do not induce vomiting.

Symptoms of overdose may include: dry mouth, dizziness and blurred vision, seeing things that are not there (hallucinations), over-excitability, 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 Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Solifenacin/Tamsulosin pensa

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

If you stop taking Solifenacin/Tamsulosin pensa

If you stop taking this medicine, your original symptoms may return or worsen. Always consult your doctor if you are considering stopping treatment.

If you have any further questions about the use of this medicine, ask 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 infrequently (affecting up to 1 in 100 men) during clinical studies with solifenacin succinate/tamsulosin hydrochloride is acute urinary retention, which consists of a sudden inability to urinate. If you think you may be experiencing this, seek immediate medical attention. You may need to stop taking this medicine.

Solifenacina/Tamsulosina pensa may cause allergic reactions:

• Uncommon signs of allergic reactions may include rash (which may be itchy) or hives (urticaria).
• Rare symptoms 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. In case of angioedema, treatment with this medicine must be permanently and immediately discontinued.

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

Other adverse effects:

Frequent adverse 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 does not exit through the urethra but goes into the bladder (retrograde ejaculation), or that the volume ejaculated is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless
• Feeling of dizziness (nausea)
• Abdominal pain

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

• Somnolence
• Itching (pruritus)
• Rash
• Urinary tract infection, bladder infection (cystitis)
• Disturbance of taste sensation (dysgeusia)
• Dry eyes
• Dry nose
• Reflux disease (gastroesophageal reflux)
• Dry throat
• Dry skin
• Difficulty urinating
• Fluid accumulation in the legs (peripheral edema)
• Headache
• Rapid or irregular heartbeat (palpitations)
• Feeling of dizziness or weakness, especially when standing up (orthostatic hypotension)
• Runny or stuffy nose (rhinitis)
• Diarrhea
• Vomiting
• Tiredness (asthenia)

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

• Accumulation of hardened feces in the large intestine (fecal impaction)
• Feeling of fainting (syncope)
• Skin allergy causing swelling in the tissue beneath the skin surface (angioedema)

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

• Hallucinations, confusion
• Skin allergic reaction (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 breathing difficulty, swelling, dizziness, rapid heartbeat, sweating, and loss of consciousness)
• Decreased appetite
• Elevated blood potassium levels (hyperkalemia), which may cause abnormal heart rhythm
• Increased pressure in the eyes (glaucoma)
• Irregular or abnormal heartbeat (prolongation of QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia)
• Rapid heartbeat (tachycardia)
• Breathing difficulty (dyspnea)
• During eye surgery for clouding of the lens (cataracts) or increased eye pressure (glaucoma), the pupil (the black circle in the center of the eye) may not dilate properly. In addition, the iris (the colored part of the eye) may become floppy during surgery.
• Voice disorder
• Liver disorder
• Muscle weakness
• Kidney disorder
• Vision disturbance
• Nosebleed (epistaxis)
• Psychiatric disorders such as confusion (delirium)
• Abdominal pain

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Solifenacina/Tamsulosina pensa Storage

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 EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Solifenacina/Tamsulosina pensa

• The active substances 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 polyethylene glycol, anhydrous colloidal silica (E551), magnesium stearate (E470b), calcium hydrogen phosphate (E341), microcrystalline cellulose (E460), low-substituted hydroxypropylcellulose (E463), hypromellose (E464), red iron oxide (E172), polyethylene glycol, butylated hydroxytoluene (E321).

Nature of the product and contents of the pack

Solifenacina/Tamsulosina 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.

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

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

Only certain 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 medicinal product is authorized in the European Economic Area member states under the following names:

Denmark: Besotmi

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

Date of the most recent review of this summary: January 2023.

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