Package Insert: Information for the User

Vesomni 6 mg/0.4 mg Modified Release 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 may 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.

Vesomni is a combination of two different medications called solifenacin and tamsulosin in a single tablet. Solifenacin belongs to a group of medications known as anticholinergics and tamsulosin belongs to a group of medications known as alpha-blockers.

Vesomni 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). Vesomni is used when previous treatment with monotherapy for this condition did not adequately alleviate symptoms.

When the prostate becomes enlarged, urinary problems (emptying symptoms) such as delayed urination (difficulty initiating 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.

Solifenacin 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. Tamsulosin allows urine to pass more easily through the urethra and facilitates urination.

Do not use Vesomni if:

• You are allergic to solifenacin or tamsulosin or any of the other components of this medication (listed in section 6).
• You are undergoing renal dialysis.
• You have a severe liver disease.
• You have a severe kidney disease and, at the same time, are being treated with medications that can reduce the elimination of Vesomni from the body (for example, ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this is the case.
• You have a moderate liver disease and, at the same time, are being treated with medications that can reduce the elimination of Vesomni 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 disease 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 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 Vesomni 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 if, at the same time, you are taking medications that can cause or worsen esophagitis.
• You have a certain type of nervous disease (autonomic neuropathy).
• You have a severe kidney disease.
• You have a moderate liver disease.

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

Vesomni 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 Vesomni. 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 temporarily the 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.

Use of Vesomni with other medications

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 Vesomni 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 Vesomni.
• Medications such as metoclopramide and cisapride, which can accelerate the functioning of the digestive system. Vesomni 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 Vesomni with food and drinks

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

Pregnancy, breastfeeding, and fertility

Vesomni 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

Vesomni 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. If in 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 Vesomni than you should

If you have taken more tablets than you were instructed 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 forgot to take Vesomni

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

If you interrupt treatment with Vesomni

If you stop taking Vesomni, 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.

Like all medications, Vesomni may cause side effects, although not everyone will experience them.

The most serious side effect observed with low frequency (which may affect up to 1 in 100 men) during treatment with Vesomni 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 Vesomni.

Vesomni 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 Vesomni should be stopped immediately and permanently.

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 Vesomni. Appropriate treatment and/or measures should be applied.

Common 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 does not release through the urethra, but rather goes to the bladder (retrograde ejaculation) or that the ejaculated volume is reduced or non-existent (ejaculatory insufficiency). This phenomenon is harmless
• Sensation of dizziness (nausea)
• Abdominal pain

Rare side effects (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
• Gastroesophageal reflux disease (GERD)
• Dry throat
• Dry skin
• Difficulty urinating
• Swelling of the legs (edema)
• Headache
• Irregular or rapid heartbeat (palpitations)
• Sensation of dizziness or weakness, especially when standing up (orthostatic hypotension)
• Runny or obstructed 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)
• 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
• Allergic reaction in the skin (erythema multiforme)
• Long-lasting 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 irregular heartbeat
• Increased pressure in the eyes (glaucoma)
• Irregular or abnormal heartbeat (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 Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 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 Vesomni

• The active principles are solifenacin succinate 6 mg and tamsulosin hydrochloride 0.4 mg.
• The other components are mannitol (E421), maltose, macrogol, magnesium stearate (E470b), butylhydroxytoluene (E321), anhydrous colloidal silica (E551), hypromellose (E464), and iron oxide red (E172).

Appearance of the product and contents of the packaging

Vesomni 6 mg/0.4 mg tablets are round, coated with a red film, and marked with "6/0.4".

Vesomni modified-release tablets are available in aluminum blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, or 200 tablets.

Only some package sizes may be available in your country.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Astellas Pharma, S.A.

Paseo de la Castellana, 259 D - 31st Floor

28046 Madrid (Spain)

Responsible manufacturer

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

Netherlands

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

Austria, Greece, Ireland, Luxembourg, Slovakia, Spain, United Kingdom, Netherlands: Vesomni

Belgium: Vesomni 6 mg/0.4 mg tablets with regulated release

Czech Republic: Urizia 6 mg/0.4 mg

Denmark, Finland, Norway, Sweden: Urizia

Last review date of this leaflet: March 2018

Other sources of information

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