VESOMNI 6 mg/0.4 mg MODIFIED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Vesomni 6 mg/0.4 mg Modified Release Tablets

solifenacin, succinate/tamsulosin, hydrochloride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Vesomni and what is it used for

Vesomni is a combination of two different medicines called solifenacin and tamsulosin in one tablet. Solifenacin belongs to a group of medicines called anticholinergics and tamsulosin belongs to a group of medicines called 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 bladder problems and by an enlarged prostate (benign prostatic hyperplasia). Vesomni is used when previous monotherapy treatment for this condition did not sufficiently relieve the symptoms.

When the prostate gland enlarges, urinary problems (emptying symptoms) such as delayed urination (difficulty starting urination), reduced urine flow (weak stream), dripping, and a feeling of incomplete emptying of the bladder 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 the involuntary contractions of the bladder and increases the amount of urine that your bladder can hold. Therefore, you can wait longer before you have 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 you take Vesomni

Do not take Vesomni if:

• you are allergic to solifenacin or tamsulosin or 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 kidney disease AND you are being treated with medicines that may decrease the elimination of Vesomni 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 you are being treated with medicines that may decrease the elimination of Vesomni 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 disorder (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 decrease in blood pressure when changing position (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 taking Vesomni if:

• you have difficulty emptying your bladder (urinary retention).
• you have any obstruction of the digestive tract.
• you are at risk of decreased digestive tract activity (stomach and intestine movements). Your doctor will inform you if this is the case.
• you have a tear in the diaphragm (hiatal hernia) or heartburn and/or you are taking medicines that may cause or worsen esophagitis.
• you have a certain type of nerve 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.

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 going to have or have scheduled eye surgery for cataracts or glaucoma, please inform your ophthalmologist that you have previously used, are using, or plan to use Vesomni. The specialist can then take the necessary precautions regarding medication and surgical techniques. Ask your doctor if you should delay or temporarily stop taking this medicine when you are going to have eye surgery for cataracts or glaucoma.

Children and adolescents

Do not give this medicine to children and adolescents.

Using Vesomni with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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, as 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 the functioning of the digestive tract. Vesomni may reduce their effect.
• other alpha-blockers, as they may cause an undesirable decrease in blood pressure.
• medicines such as bisphosphonates, which may cause or exacerbate inflammation of the esophagus (esophagitis).

Using Vesomni with food and drink

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

Driving and using machines

Vesomni 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 Vesomni

Follow exactly the administration instructions of this medicine given 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 preferences. Do not crush or chew the tablet.

If you take more Vesomni than you should

If you have taken more tablets than you were told to, or if someone else has taken your tablets, 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.

Symptoms of overdose 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 empty the bladder completely or partially or to urinate (urinary retention), and/or undesirable increase in blood pressure.

If you forget to take Vesomni

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

If you stop taking 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vesomni can cause side effects, although not everybody gets 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 Vesomni in clinical studies is acute urinary retention, which is a sudden inability to urinate. If you think you may have this, see your doctor immediately. You may need to stop taking Vesomni.

Vesomni may cause allergic reactions:

• Uncommon 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 rarely with tamsulosin and very rarely with solifenacin. In case of angioedema, treatment with Vesomni should be stopped immediately and permanently.

If you experience an allergic reaction or a severe skin reaction (e.g. formation of blisters 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 (ejaculation disorder). This means that the semen is not released through the urethra, but instead goes into the bladder (retrograde ejaculation) or 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)
• Urinary tract infection, bladder infection (cystitis)
• Taste disorder (dysgeusia)
• Dry eyes
• Dry nose
• Gastroesophageal reflux disease
• Dry throat
• Dry skin
• Difficulty urinating
• Fluid accumulation in the legs (edema)
• Headache
• Fast or irregular heartbeat (palpitations)
• Feeling of dizziness or weakness, especially when standing up (orthostatic hypotension)
• Nasal congestion or runny nose (rhinitis)
• Diarrhea
• Vomiting
• Weakness (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
• Allergic skin reaction (erythema multiforme)
• Prolonged and painful erection (usually not during sexual activity) (priapism)
• Severe skin reaction with blistering and peeling 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 the available data)

• Decreased appetite
• High levels of potassium in the blood (hyperkalemia) that may cause abnormal heart rhythm
• Increased pressure in the eyes (glaucoma)
• Irregular or abnormal heartbeat (prolonged QT interval, Torsades de Pointes, atrial fibrillation, arrhythmia)
• Fast heart rate (tachycardia)
• Breathing difficulties (dyspnea)
• During eye surgery for cataracts or 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 disturbance
• Nosebleed (epistaxis)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Vesomni

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

Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and other information

What Vesomni contains

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

Appearance and packaging

Vesomni 6 mg/0.4 mg tablets are round, film-coated, and red in color, marked with «6/0.4».

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

Not all pack sizes may be available in your country.

Marketing authorization holder and manufacturer

Marketing authorization 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

Netherlands

This medicine is authorized 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 tablets with regulated release

Czech Republic: Urizia 6 mg/0.4 mg

Denmark, Finland, Norway, Sweden: Urizia

Date of last revision of this leaflet:March 2018

Other sources of information

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.