Vesomni 6 mg/0.4 mg modified-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vesomni 6 mg/0,4 mg modified release tablets

solifenacin succinate/tamsulosin hydrochloride

Read the entire leaflet carefully before you start using 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Vesomni is and what it is used for

Vesomni 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.

Vesomni 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 by enlargement of the prostate (benign prostatic hyperplasia). Vesomni is used when previous treatment with monotherapy for this condition has not provided adequate symptom relief.

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 may be able to wait longer before needing to go to the bathroom. Tamsulosin helps urine pass more easily through the urethra and makes urination easier.

2. What you need to know before using Vesomni

Do not use Vesomni if:

• you are allergic to solifenacin or tamsulosin or to any of the other ingredients of this medicine (listed in section 6).
• you are undergoing renal dialysis.
• you have severe liver disease.
• you have severe renal disease AND at the same time are being treated with medicines that may reduce the elimination of Vesomni from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this applies to you.
• you have moderate liver disease AND at the same time are being treated with medicines that may reduce the elimination of Vesomni from the body (e.g. ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will inform you if this applies to you.
• 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 suffer from fainting due to a drop in blood pressure when changing position (when sitting or standing up); this is called orthostatic hypotension.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Vesomni 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 to you.
• you have a tear in the diaphragm (hiatal hernia) or heartburn and/or are simultaneously taking medicines that may cause or worsen esophagitis.
• you suffer from a certain type of nerve disorder (autonomic neuropathy).
• you have severe renal disease.
• you have moderate liver disease.

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

Vesomni may affect blood pressure, which may 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 undergoing or have scheduled 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 Vesomni. The specialist can then take appropriate precautions regarding medication and surgical techniques. Ask your doctor whether you should delay or temporarily interrupt taking this medicine when undergoing eye surgery for clouding of the lens (cataracts) or increased eye pressure (glaucoma).

Children and adolescents

Do not give this medicine to children or adolescents.

Using Vesomni with other medicines

Tell 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 that reduce the rate at which Vesomni is eliminated from the body.
• other anticholinergic medicines, since the effects and side effects of both medicines may be intensified if you are taking two medicines of the same type.
• cholinergics, as they may reduce the effect of Vesomni.
• medicines such as metoclopramide and cisapride, which may speed up gastrointestinal function. Vesomni 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).

Use of Vesomni with food and drink

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

Pregnancy, breastfeeding and fertility

Vesomni 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 goes into the bladder (retrograde ejaculation), or that the ejaculated volume is reduced or absent (ejaculatory insufficiency). This phenomenon is harmless.

Driving and using machines

Vesomni may cause dizziness, blurred vision, fatigue, and less frequently, somnolence. If you experience these side effects, do not drive or operate machinery.

3. How to use Vesomni

Follow exactly the administration instructions for this medicine given 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, depending on your preference. Do not crush or chew the tablet.

If you take more Vesomni than you should

If you have taken more tablets than prescribed, or if someone else 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 helpful 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.

If you forget to take Vesomni

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

If you stop taking Vesomni

If you stop taking Vesomni, 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, Vesomni may cause adverse effects, although not everyone experiences them.

The most serious adverse effect observed infrequently (which may affect up to 1 in 100 men) during clinical studies with Vesomni is acute urinary retention, characterized by a sudden inability to urinate. If you think you may be experiencing this, seek immediate medical attention. You may need to stop taking Vesomni.

Vesomni can cause allergic reactions:

• Uncommon signs of allergic reactions may include skin 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 Vesomni must be immediately and permanently discontinued.

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

Common adverse 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 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
• Feeling of dizziness (nausea)
• Abdominal pain

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

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

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

• Accumulation of a large amount of hardened feces in the colon (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)
• Skin rash, 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)

• 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 heart rate (tachycardia)
• Difficulty breathing (dyspnea)
• During eye surgery for lens clouding (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)

Reporting of adverse effects

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

5. Storage of Vesomni

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 refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be taken to the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Vesomni

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

Appearance of the product and contents of the pack

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

Modified-release Vesomni tablets are available in packs with aluminium blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 tablets.

Only certain pack sizes may be available in your country.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Astellas Pharma, S.A.

Paseo de la Castellana, 259 D - 31st Floor

28046 Madrid (Spain)

Manufacturer

Delpharm Meppel B.V.

Hogemaat 2

7942 JG Meppel

The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

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

Belgium: Vesomni 6 mg/0,4 mg tabletten met gereguleerde afgifte

Czech Republic: Urizia 6 mg/0.4 mg

Denmark, Finland, Norway, Sweden: Urizia

Date of the most recent revision of this leaflet: March 2018

Other sources of information

Detailed and up-to-date 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/.