PATIENT INFORMATION LEAFLET

SOLIFENACIN SUCCINATE TABLETS 5 mg (URYSOREN-5)

Read all of this leaflet carefully before you start taking this medicine
 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 any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your <doctor, health care provider><or><pharmacist>.>
Prescription only medicine
In this leaflet:
a) What Urysoren is and what it is used for
b) Before you take Urysoren
c) How to take Urysoren
d) Possible side effects
e) How to store Urysoren
f) Further information
a. What Urysoren is and what it is used for
The active substance of Urysoren belongs to the group of Anticholinergics. These medicines are used to
reduce the activity of an overactive bladder. This enables you to wait longer before having to go to the
bathroom and increases the amount of urine that can be held by your bladder.

Solifenacin tablets is used to treat the symptoms of a condition called overactive bladder. These
symptoms include: having a strong, sudden urge to urinate without prior warning, having to urinate
frequently or wetting yourself because you could not get to the bathroom in time.
b. Before you take Urysoren
Do not take Solifenacin tablets
 if you have an inability to pass water or to empty your bladder completely (urinary retention)
 if you have a severe stomach or bowel condition (including toxic megacolon, a complication
associated with ulcerative colitis)
 if you suffer from the muscle disease called myasthenia gravis, which can cause an extreme weakness
of certain muscles

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 if you suffer from increased pressure in the eyes, with gradual loss of eye sight (glaucoma)
 if you are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6)
 if you are undergoing kidney dialysis
 if you have severe liver disease
 If you suffer from severe kidney disease or moderate liver disease AND at the same time are being
treated with medicines that may decrease the removal of Solifenacin from the body (for example,
ketoconazole). Your doctor or pharmacist will have informed you if this is the case.
Inform your doctor if you have or ever had any of the above mentioned conditions before treatment with
Solifenacin tablets starts.
Warnings and precautions
Talk to your doctor or pharmacist before taking Solifenacin tablets
 if you have trouble emptying your bladder (= bladder obstruction) or have difficulty in passing urine
(e.g. a thin urine flow). Risk of accumulation of urine in the bladder (urinary retention) is much
higher.
 if you have some obstruction of the digestive system (constipation).
 if 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.
 if you suffer from severe kidney disease.
 if you have moderate liver disease.
 if you have a stomach tear (hiatus hernia) or heartburn.
 if you have a nervous disorder (autonomic neuropathy).
Children and adolescents
Solifenacin tablets is not to be used in children or adolescents under 18 years.
Inform your doctor if you have or ever had any of the above mentioned conditions before treatment with
Solifenacin tablets starts.
Before starting Solifenacin tablets, your doctor will assess whether there are other causes for your need to
pass urine frequently (for example heart failure (insufficient pumping power of the heart) or kidney
disease). If you have a urinary tract infection, your doctor will prescribe you an antibiotic (a treatment
against particular bacterial infections).
Other medicines and Solifenacin tablets
Please tell your doctor or pharmacist if you are taking or have recently taken or might take other
medicines.
It is especially important to inform your doctor if you are taking:
 other anticholinergic medicines, effects and side effects of both medications can be enhanced.
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 cholinergics as they can reduce the effect of Solifenacin tablets.
 medicines, like metoclopramide and cisapride, which make the digestive system work faster.
Solifenacin tablets can reduce their effect.
 medicines, like ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil and diltiazem, which
decrease the rate at which Solifenacin tablets is broken down by the body
 medicines like rifampicin, phenytoin and carbamazepine, as they may increase the rate at which
Solifenacin tablets is broken down by the body.
 medicines such as bisphosphonates that can cause or exacerbate inflammation of the gullet
(oesophagitis).

Solifenacin tablets with food and drink

Solifenacin tablets can be taken with or without food, depending on your preference.
Pregnancy and breast-feeding
You should not use Solifenacin tablets if you are pregnant unless clearly necessary.
Do not use Solifenacin tablets if you are breast-feeding as solifenacin may get into your breast milk.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Solifenacin tablets may cause blurred vision and sometimes sleepiness or tiredness. If you suffer from any
of these side effects, do not drive or operate machinery.
Solifenacin tablets contains lactose. If you have been told by your doctor that you have a rare hereditary
problem of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption you should
not use this medicine.
c. How to take Urysoren
Instructions for proper use
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure.
You should swallow the whole tablet with some liquid. It can be taken with or without food, according to
your preference. Do not crush the tablets.
The usual dose is 5 mg per day, unless your doctor told you to take 10 mg per day.
If you take more Solifenacin tablets than you should
If you have taken too much Solifenacin tablets or if a child has accidentally taken Solifenacin tablets,
contact your doctor or pharmacist immediately.

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Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness and blurred vision,
perceiving things that are not there (hallucinations), over- excitability, seizures (convulsions), difficulty
breathing, elevated heart rate (tachycardia), accumulation of urine in the bladder (urinary retention) and
dilated pupils (mydriasis).
If you forget to take Solifenacin tablets
If you forget to take a dose at the usual time, take it as soon as you remember, unless it is time to take
your next dose. Never take more than one dose per day. If you are in doubt, always consult your doctor or
pharmacist.
If you stop taking Solifenacin tablets
If you stop taking Solifenacin tablets, your symptoms of overactive bladder 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 product, ask your doctor or pharmacist.
d. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience an allergic attack, or a severe skin reaction (e.g. blistering and peeling of the skin), you
must inform your doctor or pharmacist immediately
Angioedema (skin allergy that results in the swelling that occurs in the tissue just below the surface of the
skin) with airway obstruction (difficulty in breathing) has been reported in some patients on solifenacin
succinate (Solifenacin tablets). If angioedema occurs, solifenacin succinate (Solifenacin tablets) should be
discontinued immediately and appropriate therapy and/or measures should be taken.
Solifenacin tablets may cause the following other side effects:
Very common (may affect more than 1 in 10 people)
 dry mouth
Common (may affect up to 1 in 10 people)
 blurred vision
 constipation, nausea, indigestion with symptoms such as abdominal fullness, abdominal pain, burping,
nausea, and heartburn (dyspepsia), stomach discomfort
Uncommon (may affect up to 1 in 100 people)
 urinary tract infection, bladder infection
 sleepiness, impaired sense of taste (dysgeusia)
 dry (irritated) eyes
 dry nasal passages
 reflux disease (gastro-oesophageal reflux), dry throat
 dry skin
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 difficulty in passing urine
 tiredness, accumulation of fluid in the lower legs
(oedema) Rare (may affect up to 1 in 1,000 people)
 Lodging of a large amount of hardened stool in the large intestine (faecal impaction)
 Build up of urine in the bladder due to inability to empty the bladder (urinary retention)
 Dizziness, headache
 Vomiting
 Itching, rash
Very rare (may affect up to 1 in 10,000 people)
 hallucinations, confusion
 allergic rash
Not known (frequency cannot be estimated from the available data)
 decreased appetite, high levels of blood potassium which can cause abnormal heart rhythm
 increased pressure in the eyes
 changes in the electrical activity of the heart (ECG), irregular heartbeat, feeling your heartbeat, faster
heart beat
 voice disorder
 liver disorder
 muscle weakness
 renal disorder
e. How to store Urysoren
Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use Solifenacin after the expiry date which is stated on the carton after EXP. The expiry date refers
to the last day of that month. There are no special precautions for storage.
f. Further information
What Urysoren contains
Active substance is: Solifenacin
The other ingredients are:
Lactose Monohydrate, Maize starch, Hydroxy Propyl cellulose, Magnesium stearate, Opadry Yellow
(030520002)
What Urysoren looks like and contents of the pack
Light yellow colored, round shaped, biconvex, film coated tablet, debossed with Every "C" on one side
and "24" on other side
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Alu/alu Blister pack of 10 tablets
Name and full physical address of Marketing Authorization Holder and Manufacturing site
Marketing Authorization Holder
MICRO LABS LIMITED
31, Race course road
Bangalore-560001
INDIA
Manufacturer
MICRO LABS LIMITED
No. 92, Sipcot Industrial Complex
Hosur -635 126 (TN)
INDIA
For any information about this medicinal product, please contact the <local representative of the>
supplier:
Country: Rwanda
M/s.Wessex
Pharmaceuticals (Rwanda) Ltd
C/o.Phillips Pharmaceuticals (Rwanda) Ltd
Shop No: Gf68, Kigali Modern City Market Commercial Street
Kigali, Rwanda
This leaflet was last approved in
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