Vesomni 6 mg/0.4 mg modified release tablets

• 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.

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

• you are allergic to solifenacin or tamsulosin or any of the other ingredients of this medicine (listed in section 6).
• you are undergoing kidney dialysis.
• you have a severe liver disease.
• you suffer from severe kidney disease AND if, at the same time, you are being treated with medicines that may decrease the removal of Vesomni from the body (for example ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will have informed you if this is the case.
• you suffer from moderate liver disease AND if, at the same time, you are being treated with medicines that may decrease the removal of Vesomni from the body (for example ketoconazole, ritonavir, nelfinavir, itraconazole). Your doctor or pharmacist will have informed you if this is the case.
• you have a severe stomach or bowel condition (including toxic megacolon, a complication associated with ulcerative colitis).
• you suffer from a muscle disease called myasthenia gravis, which can cause an extreme weakness of certain muscles.
• you suffer from increased pressure in the eyes (glaucoma), with gradual loss of eye sight.
• you suffer from fainting due to reduced blood pressure when changing posture (going to sit up or stand up); this is called orthostatic hypotension.

Tell your doctor if you think that any of these conditions apply to you.

Talk to your doctor or pharmacist before using Vesomni if:

• you have an inability to pass water (urinary retention).
• you have some obstruction of the digestive system.
• you are at risk of your digestive system slowing down (stomach and bowel movements). Your doctor will have informed you if this is the case.
• you have a stomach tear (hiatus hernia) or heartburn and/or if, at the same time, you are taking medicines that can cause or worsen oesophagitis.
• you suffer from a certain type of nervous disease (autonomic neuropathy).
• you suffer from severe kidney disease.
• you suffer from moderate liver disease.

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:

• medicines like ketoconazole, erythromycin, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, and paroxetine which decrease the rate at which Vesomni is removed from the body.
• other anticholinergic medicines, as effects and side effects of both medications can be enhanced if you are taking two medicines of the same type.
• cholinergics, as they can reduce the effect of Vesomni.
• medicines like metoclopramide and cisapride, which make the digestive system work faster. Vesomni can reduce their effect.
• other alpha-blockers, as this may cause an unwanted decrease in blood pressure.
• medicines such as bisphosphonates, that can cause or exacerbate inflammation of the gullet (oesophagitis).

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.

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 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.

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

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.

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