Package leaflet: Information for the user

Vesomni 6 mg/0.4 mg modified release tablets

Solifenacin succinate/tamsulosin hydrochloride
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Vesomni is and what it is used for
What you need to know before taking Vesomni
How to take Vesomni
Possible side effects
How to store Vesomni
Contents of the pack and other information

1. What Vesomni is and what it is used for

Vesomni is the combination of two different medicines called solifenacin and tamsulosin in a single 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 moderate to severe filling symptoms and voiding symptoms of the lower urinary tract caused by bladder problems and an enlarged prostate (benign prostatic hyperplasia). Vesomni is used for this condition when previous monotherapy treatments have not adequately relieved the symptoms.
An enlarged prostate can cause urinary problems (voiding symptoms) such as hesitancy (difficulty starting urination), difficulty in passing urine (weak stream), dribbling, and a sensation of incomplete bladder emptying. At the same time, the bladder is also involved and contracts spontaneously even when you do not intend to empty it. This causes filling symptoms such as altered bladder sensation, urgency (a strong and sudden need to urinate without prior warning signals), and the need to urinate more frequently.
Solifenacin reduces involuntary contractions of your bladder and increases the amount of urine that your bladder can hold. This helps delay the need to go to the bathroom.
Tamsulosin allows urine to pass more easily through the urethra and facilitates urination.

2. What you should know before taking Vesomni

Do not take Vesomni

if you are allergic to solifenacin or tamsulosin or to any of the other ingredients of this medicine (listed in section 6).
if you are undergoing renal dialysis
if you have severe liver disease
if you have severe kidney disease AND are simultaneously 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.
if you have moderate liver problems AND are simultaneously 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.
if you have a serious stomach or intestinal condition (including toxic megacolon, a complication associated with ulcerative colitis).
if you have the muscle disease called myasthenia gravis, which causes extreme weakness of certain muscles.
if you have increased eye pressure (glaucoma), with gradual loss of vision.
if you experience fainting due to low blood pressure when changing body position (sitting down or standing up), called orthostatic hypotension.

Inform your doctor if you have any of the conditions listed above.
Warnings and precautions
Talk to your doctor or pharmacist before using Vesomni if:

you have difficulty passing urine (urinary retention)
you have obstructions in the digestive system (constipation).
you are at risk of reduced gastrointestinal motility (gastric and intestinal movements). Your doctor will advise you about this possibility.
you have stomach pain (hiatal hernia), heartburn and/or are simultaneously taking medicines that cause or worsen oesophagitis.
you suffer from certain nervous system disorders (autonomic neuropathy).
you have severe kidney disease
you have moderate liver disease.

Regular medical check-ups are necessary to monitor the condition for which you are being treated.
Vesomni may affect blood pressure and 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 scheduled for or on a waiting list for eye surgery due to clouding of the lens (cataract) or increased eye pressure (glaucoma), inform your ophthalmologist if you have previously taken, are currently taking, or plan to take Vesomni. The specialist may then take appropriate precautions regarding the medicine and the surgical technique to be used. Ask your doctor whether you should postpone or temporarily discontinue treatment with this medicine before undergoing eye surgery for clouding of the lens (cataract) or increased eye pressure (glaucoma).
Children and adolescents
Do not give this medicine to children or adolescents.
Other medicines and Vesomni
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important to inform your doctor if you are taking:

medicines such as ketoconazole, erythromycin, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, and paroxetine, which decrease the rate of elimination of Vesomni from the body,
other anticholinergic medicines, as the effectiveness and side effects of both medicines may increase when taking two medicines of the same type,
cholinergic agents, which may reduce the effectiveness of Vesomni,
medicines such as metoclopramide and cisapride, which stimulate gastrointestinal motility, as Vesomni may reduce their effectiveness,
other alpha-blockers, as this may cause an unwanted drop in blood pressure,
medicines such as bisphosphonates, which may cause or worsen inflammation of the throat (oesophagitis).
Vesomni with food and drink
Vesomni can be taken with or without food, as preferred.
Pregnancy, breastfeeding and fertility
Vesomni is not indicated for use in women.
In men, abnormal ejaculation (ejaculation disorders) has been reported. This means that semen does not exit the body through the urethra but enters the bladder (retrograde ejaculation), or that the volume of ejaculate is reduced or absent (anejaculation). This event is harmless.
Driving and using machines
Vesomni may cause dizziness, blurred vision, fatigue and, uncommonly, somnolence. Avoid driving or operating machinery if you experience these side effects.

3. How to take Vesomni

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The maximum daily dose is one tablet containing 6 mg of solifenacin and 0.4 mg of tamsulosin, taken orally. You may take Vesomni with or without food, as desired. Do not crush or chew the tablet.
If you take more Vesomni than you should
If you have taken more tablets than recommended, or if someone else has accidentally taken your tablets, contact a doctor, pharmacist, or hospital immediately.
In case of overdose, the doctor may administer treatment with activated charcoal. 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, perception of non-existent objects (hallucinations), over-excitement, seizures, breathing difficulties, increased heart rate (tachycardia), difficulty completely or partially emptying the bladder or difficulty urinating (urinary retention), and/or unwanted drop in blood pressure.
If you forget to take Vesomni
Take the next dose of Vesomni at your regular time. Do not take a double dose to make up for the missed tablet.
If you stop taking Vesomni
If you stop treatment with Vesomni, your symptoms may return or worsen.
Always consult your doctor if you intend to stop treatment.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vesomni can cause side effects, although not everyone experiences them.
The most serious side effect observed during clinical studies with Vesomni treatment, occurring with uncommon frequency (may affect up to 1 in 100 men), is urinary retention, which is a sudden difficulty in urination.
If you think you are experiencing this side effect, contact your doctor immediately. You may need to stop taking Vesomni.

Allergic reactions may occur with Vesomni:

Uncommon symptoms of allergic reactions may include skin rashes (which may be itchy) or hives (urticaria).
Rare symptoms include swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing (angioedema). Angioedema has been reported rarely with tamsulosin and very rarely with solifenacin. If angioedema occurs, Vesomni must be stopped immediately and must not be used again. If you experience an allergic attack or a severe skin reaction (e.g. blistering and peeling of the skin), you must contact your doctor immediately and stop using Vesomni. Appropriate treatment and/or measures must be taken.

Common side effects (may affect up to 1 in 10 men)

Dry mouth
Constipation
Indigestion (dyspepsia)
Dizziness
Blurred vision
Tiredness (fatigue)
Abnormal ejaculation (ejaculation disorders). This means that seminal fluid does not exit through the urethra but enters the urinary bladder (retrograde ejaculation), or that the volume of seminal fluid is reduced or absent (failure to ejaculate).
Feeling unwell (nausea)
Abdominal pain

Other uncommon side effects (may affect up to 1 in 100 men)

Drowsiness
Itching
Urinary tract infections, bladder infections (cystitis)
Altered taste sensation (dysgeusia)
Dry eyes
Dry nose
Reflux disease (gastro-oesophageal reflux)
Dry throat
Dry skin
Difficulty in urination
Fluid accumulation in the lower leg (oedema)
Headache
Fast or irregular heartbeat (palpitations)
Feeling dizzy or weak, especially when standing up (orthostatic hypotension)
Blocked or runny nose (rhinitis)
Diarrhoea
Feeling unwell (vomiting)
Weakness (asthenia)

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

Accumulation of large amounts of faeces in the large intestine (faecal impaction)
Feeling of fainting (syncope)
Allergic reactions consisting of swelling of the tissue just beneath the skin surface (angioedema)

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

Hallucinations, confusion
Skin allergic reactions (Erythema multiforme)
Prolonged and painful erection (usually not occurring during sexual activity) (priapism)
Skin rash, inflammation, blistering of the skin and/or mucosa of the lips, eyes and mouth, nostrils or genitals (Stevens-Johnson syndrome)

Side effects not known (frequency cannot be estimated from the available data)

Decreased appetite
High levels of potassium in the blood (hyperkalaemia), which may cause abnormal heart rhythm
Increased eye pressure (glaucoma)
Abnormal and irregular heartbeat (QT prolongation, torsade de pointes, atrial fibrillation, arrhythmia)
Fast heartbeat (tachycardia)
Breathing difficulty (dyspnoea)
During eye surgery for cataract (clouding of the lens) or for increased eye pressure (glaucoma), the pupil (the black circle in the middle of your eye) may dilate poorly. Also, the iris (the coloured part of your eye) may become floppy during surgery.
Voice disorders
Liver disorders
Muscle weakness
Kidney disorders
Visual impairment
Nosebleeds (epistaxis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Vesomni contains

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

Description of the appearance of Vesomni and pack contents
Vesomni 6 mg/0.4 mg are round, red film-coated tablets, marked with “6/0.4”. Vesomni modified-release tablets are available in aluminium blisters in packs containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Astellas Pharma S.p.A.
Viale Don Luigi Sturzo, 43
20154 Milan (MI)
Italy

Manufacturer
Delpharm Meppel B.V.
Hogemaat 2
7942 JG Meppel
The Netherlands

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Greece, Ireland, Luxembourg, Slovakia, Spain, United Kingdom, Netherlands, Bulgaria, Croatia, Germany, Hungary, Italy, Poland, Portugal, Slovenia: Vesomni
Belgium: Vesomni 6 mg/0.4 mg tabletten met gereguleerde afgifte
Romania: Vesomni 6 mg/0.4 mg comprimat cu eliberare modificată
Czech Republic: Urizia 6 mg/0.4 mg
Lithuania: Urizia 6 mg / 0,4 mg modifikuoto atpalaidavimo tabletės
Denmark, Finland, Norway, Sweden: Urizia

This patient information leaflet was last approved on