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VESOMNI 6 MG/0.4 MG MODIFIED RELEASE TABLETS

Active substance(s): SOLIFENACIN SUCCINATE / TAMSULOSIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

6 mg/0.4 mg

solifenacin succinate/tamsulosin hydrochloride
modified release tablets
solifenacin succinate/tamsulosin hydrochloride

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Read all of this leaflet carefully before you start using 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.
What is in this leaflet
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
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 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.
2. What you need to know before you use Vesomni
Do not use 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 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.
Warnings and precautions
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).

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- 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).
Children and adolescents
Do not give this medicine to children and adolescents.
Other medicines and Vesomni
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 with food and drink
Vesomni can be taken with or without food, according to your preference.
Pregnancy, breast-feeding and fertility
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.
Driving and using machines
Vesomni might cause dizziness, blurred vision, tiredness and, uncommonly,
sleepiness. If you suffer from these side effects, do not drive or operate
machinery.
3. How to use Vesomni
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 take more Vesomni than you should
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.

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Like all medicines, Vesomni can cause side effects, although not everybody
gets them.

Not known (frequency cannot be estimated from the available data)
- Decreased appetite
- High levels of blood potassium (hyperkalaemia) which can cause abnormal
heart rhythm
- Increased pressure in the eyes (glaucoma)
- Irregular or unusual heart beat (QT prolongation, Torsade de Pointes, atrial
fibrillation, arrhythmia)
- Faster heartbeat (tachycardia)
- Shortness of breath (dyspnoea)
- During an operation of the eye for cloudiness of the lens (cataract) or for
increased pressure in the eye (glaucoma) the pupil (the black circle in the
middle of your eye) may not increase in size as needed. Also, the iris (the
coloured part of the eye) may become floppy during surgery.
- Voice disorder
- Liver disorder
- Muscle weakness
- Renal disorder
- Impaired vision
- Nose bleeds (epistaxis)

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.

Reporting of side effects
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.

Allergic reactions could occur with Vesomni:
- Uncommon signs of allergic reactions can include skin rash (which can 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 on tamsulosin and very rarely with
solifenacin. If angioedema occurs, Vesomni should be stopped immediately
and not started again.

By reporting side effects you can help provide more information on the safety
of this medicine.

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.

This medicinal product does not require any special storage conditions.

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.
If you forget to take Vesomni
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
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.
4. Possible side effects

Common side effects (may affect up to 1 in 10 men)
- Dry mouth
- Constipation
- Indigestion (dyspepsia)
- Dizziness
- Blurred vision
- Tiredness (fatigue)
- Abnormal ejaculation (ejaculation disorder). This means that 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.
- Feeling sick (nausea)
- Abdominal pain
Other uncommon side effects (may affect up to 1 in 100 men)
- Sleepiness (somnolence)
- Itching (pruritus)
- Urinary tract infection, bladder infection (cystitis)
- Impaired sense of taste (dysgeusia)
- Dry eyes
- Dry nose
- Reflux disease (gastro-oesophageal reflux)
- Dry throat
- Dry skin
- Difficulty in passing urine
- Accumulation of fluid in the lower legs (oedema)
- Headache
- Fast or uneven heartbeat (palpitations)
- Feeling dizzy or weak especially when you stand up (orthostatic
hypotension)
- Runny or blocked nose (rhinitis)
- Diarrhoea
- Being sick (vomiting)
- Tiredness (asthenia)
Rare side effects (may affect up to 1 in 1,000 men)
- Lodging of a large amount of hardened stool in the large intestine (faecal
impaction)
- Feeling faint (syncope)
- Skin allergy that results in the swelling that occurs in the tissue just below
the surface of the skin (angioedema)
Very rare side effects (may affect up to 1 in 10,000 men)
- Hallucinations, confusion
- Allergic skin reaction (Erythema multiforme)
- Long-lasting and painful erection (usually not during sexual activity)
(priapism)
- Rash, inflammation and blistering of the skin and/or mucous membranes
of the lips, eyes, mouth, nasal passages or genitals (Stevens-Johnson
syndrome)

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 which is stated on the carton
or blister after EXP. The expiry date refers to the last day of that month.
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.
6. Contents of the pack and other information
What Vesomni contains
- 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).
What Vesomni looks like and contents of the pack
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 and Manufacturer
Marketing Authorisation Holder:
Astellas Pharma Ltd.
2000 Hillswood Drive
Chertsey
Surrey
KT16 0RS
UK.
Manufacturer:
Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
The Netherlands.
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 10/2013.
Other sources of information
Detailed information on this medicine is available on the web site of the
Dutch Medicines Evaluation Board (http://www.cbg-meb.nl/cbg/nl).

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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