Package Insert: Information for the User

Vesolta 6 mg/0.4 mg Modified Release EFG Tablets

solifenacin succinate/tamsulosin hydrochloride

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

What isVesolta

Vesolta is a combination of two different medications called solifenacina and tamsulosina in a tablet. Solifenacina belongs to a group of medications called anticholinergics and tamsulosina belongs to a group of medications called alpha-blockers.

What is Vesolta used forVesolta

This medication is 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 relieve 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 Vesolta:

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

• if you have difficulty eliminating liquid (urinary retention).
• if you have any obstruction of the digestive system.
• if you are at risk of decreased activity of the digestive system (gastrointestinal motility). Your doctor will inform you if this is the case.
• if you have a hiatal hernia or stomach burning and/or if, at the same time, you are taking medications that can cause or worsen esophagitis.
• if you have a certain type of nervous system disease (autonomic neuropathy).
• if you have severe kidney disease.
• if 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 using, or plan to use this medication. The specialist will then take the necessary precautions regarding medication and surgical techniques. Ask your doctor if you should or should not postpone or interrupt temporary use of this medication when undergoing eye surgery for cataracts or increased pressure in the eye (glaucoma).

Children and adolescents

Do not administer this medication to children and adolescents.

Other medications and Vesolta

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 this medication 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 this medication.
• medications such as metoclopramide and cisapride, which can accelerate the functioning of the digestive system. This medication can reduce its 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 Vesolta with food and drinks

This medication can be taken with or without food, according to your preferences.

Pregnancy, breastfeeding, and fertility

This medication 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 goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and operating machines

This medication may cause dizziness, blurred vision, fatigue, and, less frequently, drowsiness. If you experience these adverse effects, do not drive or operate machines.

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 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 Vesolta 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 gastric lavage may be useful if performed within one hour of the overdose. Do not induce vomiting.

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

If you forget to take Vesolta

Take your next tablet of this medication as usual. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Vesolta

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.

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

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 low frequency (which may affect up to 1 in 100 men) during treatment with this medicine 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.

This medicine may 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.

Inform your doctor or pharmacist if you experience any of the following side effects:

Frequent (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 volume of semen is reduced or nonexistent (ejaculatory insufficiency). This phenomenon is harmless.
• Nausea.
• Abdominal pain.

Less common (may affect up to 1 in 100 men):

• Drowsiness.
• Itching (pruritus).
• Urinary tract infection, bladder infection (cystitis).
• Disorder of the sense of taste (dysgeusia).
• Dry eyes.
• Runny nose.
• Reflux disease (gastroesophageal reflux).
• Dry throat.
• Dry skin.
• Difficulty urinating.
• Swelling of the legs (edema).
• Headache.
• Irregular or rapid heartbeat (palpitations).
• Dizziness or weakness, especially when standing up (orthostatic hypotension).
• Runny or blocked nose (rhinitis).
• Diarrhea.
• Vomiting.
• Weakness (asthenia).

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

• Accumulation of a large amount of hardened feces in the large intestine (fecal impaction).
• Syncope (fainting).
• Allergic reaction in the skin that causes swelling in the tissue under the skin surface (angioedema).

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

• Hallucinations, confusion.
• Allergic reaction in the skin (erythema multiforme).
• Prolonged and painful erection (usually not during sexual activity) (priapism).
• Skin rash, inflammation, and blistering on 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):

• Decreased appetite.
• Elevated potassium levels in the blood (hyperkalemia) that may cause abnormal heart rhythm.
• Increased pressure in the eyes (glaucoma).
• Irregular or abnormal heart rhythm (prolongation of the QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia).
• Rapid heartbeat (tachycardia).
• Difficulty breathing (dyspnea).
• During eye surgery for cataracts or increased pressure in the eye (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).

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 prospectus. 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.

Keep this medication out of the sight and reach of children.

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

No special storage conditions are required.

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

Composition of Vesolta

• The active principles are 6 mg of solifenacin succinate and 0.4 mg of hydrochloride of tamsulosin.
• The other components are microcrystalline cellulose, high molecular weight macrogol, anhydrous colloidal silica, magnesium stearate, anhydrous calcium hydrogen phosphate, microcrystalline cellulose silicified (anhydrous colloidal silica and microcrystalline cellulose); coating material: hypromellose; macrogol; red iron oxide (E172).

Appearance of the product and content of the container

Vesolta 6 mg/0.4 mg tablets are coated with a film, red, round with a diameter of 9 mm, biconvex, and marked with "6 0.4" on one face.

Vesolta modified-release tablets are available in containers with sealed PA/Al/PVC blisters containing 30 tablets.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona Spain

Responsible for manufacturing

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice, Lodzkie

Poland

Adalvo Limited

Malta Life Sciences Park,

Building 1, Level 4, Sir Temi Zammit Buildings,

SGN 3000, San Gwann

Malta

Last review date of this leaflet:

The detailed information of this medicine is available on the website of the Spanish Agency of Medicaments and Sanitary Products (AEMPS) http://www.aemps.gob.es/