The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00166/0404.
Vesomni 6 mg/0.4 mg modified release tablets
Vesomni 6 mg/0.4 mg modified release tablets
solifenacin succinate/tamsulosin hydrochloride
1. What Vesomni is and what it is used for
2. What you need to know before you use Vesomni
3. How to use Vesomni
4. Possible side effects
5. How to store Vesomni
6. Contents of the pack and other information
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 storage symptoms and voiding symptoms of the lower urinary tract which are caused by bladder problems and an enlarged prostate (benign prostatic hyperplasia). Vesomni is used when previous treatment with a monoproduct for this condition did not relieve symptoms adequately.
As the prostate grows, it can lead to urinary problems (voiding symptoms) such as hesitancy (difficulty to start urinating), difficulty urinating (poor stream), dribbling and feeling of incomplete bladder emptying. At the same time, the bladder is also affected and contracts spontaneously at times you do not want to void. This causes storage symptoms such as changes in bladder sensation, urgency (having a strong, sudden desire to urinate without prior warning), and having to urinate more frequently.
Solifenacin reduces the undesired contractions of your bladder and increases the amount of urine that your bladder can hold. Therefore you can wait longer before you have to go to the toilet. Tamsulosin enables urine to pass more readily through the urethra and facilitates urination.
Tell your doctor if you think that any of these conditions apply to you.
Talk to your doctor or pharmacist before using Vesomni if:
Periodic medical examinations are necessary to monitor the development of the condition you are being treated for.
Vesomni can affect your blood pressure which can make you feel dizzy, light headed or rarely can make you faint (orthostatic hypotension). You should sit or lie down if you experience any of these symptoms until they disappear.
If you are undergoing or have been scheduled for eye surgery because of cloudiness of the lens (cataract) or increased pressure in the eyes (glaucoma), please inform your eye specialist that you have previously used, are using or are planning to use Vesomni. The specialist can then take appropriate precautions with respect to medication and surgical techniques to be used. Ask your doctor whether or not you should postpone or temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens (cataract) or increased pressure in the eye (glaucoma).
Do not give this medicine to children and adolescents.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
It is especially important to inform your doctor if you are using:
Vesomni can be taken with or without food, according to your preference.
Vesomni is not indicated for use by women.
In men, abnormal ejaculation has been reported (ejaculation disorder). This means that the semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless.
Vesomni might cause dizziness, blurred vision, tiredness and, uncommonly, sleepiness. If you suffer from these side effects, do not drive or operate machinery.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The maximum daily dose is one tablet containing 6 mg of solifenacin and 0.4 mg of tamsulosin, taken by mouth. It can be taken with or without food, according to your preference. Do not crush or chew the tablet.
If you have taken more tablets than you have been told to take, or if someone else accidentally takes your tablets, contact your doctor, pharmacist or hospital immediately for advice.
In case of an overdose your doctor may treat you with activated charcoal; emergency stomach washout may be useful if performed within 1 hour of overdose. Do not induce vomiting.
Symptoms of overdose may include: dry mouth, dizziness, and blurred vision, perceiving things that are not there (hallucinations), over-excitability, seizures (convulsions), difficulty breathing, increased heart rate (tachycardia), inability to completely or partially empty the bladder or pass urine (urinary retention) and/or an unwanted decrease in blood pressure.
Take your next tablet of Vesomni as normal. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Vesomni, your original complaints may return or worsen. Always consult your doctor, if you are considering stopping the treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effect that has uncommonly (may affect up to 1 in 100 men) been observed during treatment with Vesomni in clinical studies is acute urinary retention, which is a sudden inability to pass urine. If you think you may have this, see a doctor straight away. You may need to stop taking Vesomni.
Allergic reactions could occur with Vesomni:
If you experience an allergic attack, or a severe skin reaction (e.g. blistering and peeling of the skin), you must inform your doctor immediately, and stop using Vesomni. Appropriate therapy and/or measures should be taken.
Common side effects (may affect up to 1 in 10 men)
Other uncommon side effects (may affect up to 1 in 100 men)
Rare side effects (may affect up to 1 in 1,000 men)
Very rare side effects (may affect up to 1 in 10,000 men)
Not known (frequency cannot be estimated from the available data)
If you get 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Vesomni 6 mg/0.4 mg tablets are round, red film-coated tablets, debossed with “6/0.4”.
Vesomni modified release tablets are available in aluminium 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 Authorisation Holder:
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Greece, Ireland, Luxembourg, Slovakia, Spain, United Kingdom, The 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
This leaflet was last revised in 12/2022.
Other sources of information
Detailed information on this medicine is available on the website of the Dutch Medicines Evaluation Board (http://www.cbg-meb.nl/cbg/nl).