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SOLIFENACIN SUCCINATE 5 MG FILM COATED TABLETS

Active substance(s): SOLIFENACIN SUCCINATE

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Package leaflet: Information for the patient

Solifenacin succinate 5 mg film-coated tablets
Solifenacin succinate 10 mg film-coated tablets
solifenacin succinate
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 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 Solifenacin succinate is and what it is used for
2. What you need to know before you take Solifenacin succinate
3. How to take Solifenacin succinate
4. Possible side effects
5. How to store Solifenacin succinate
6. Contents of the pack and other information

1. What Solifenacin succinate is and what it is used for
The active substance of Solifenacin succinate 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 succinate 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.

2. What you need to know before you take Solifenacin succinate
Do not take Solifenacin succinate
• if you are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6),
• 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,
• if you suffer from increased pressure in the eyes, with gradual loss of eye sight (glaucoma),
• 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 succinate 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 succinate starts.
Warnings and precautions
Talk to your doctor or pharmacist before taking Solifenacin succinate.
• 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).
Inform your doctor if you have or ever had any of the above mentioned conditions before treatment with
Solifenacin succinate starts.
Before starting Solifenacin succinate, 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).
Children and adolescents
Solifenacin succinate is not to be used in children or adolescents under 18 years.
Other medicines and Solifenacin succinate
Tell 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:
• other anticholinergic medicines, effects and side effects of both medications can be enhanced.
• cholinergics as they can reduce the effect of Solifenacin succinate.
• medicines, like metoclopramide and cisapride, which make the digestive system work faster. Solifenacin
succinate can reduce their effect.
• medicines, like ketoconazole, ritonavir, nelfinavir, intraconazole, verapamil and diltiazem, which decrease the
rate at which Solifenacin succinate is broken down by the body.
• medicines like rifampicin, phenytoin and carbamazepine, as they may increase the rate at which Solifenacin
succinate is broken down by the body.
• medicines such as bisphosphonates, that can cause or exacerbate inflammation of the gullet (oesophagitis).
Solifenacin succinate with food and drink
Solifenacin succinate can be taken with or without food, depending on your preference.
Pregnancy and breast-feeding
You should not use Solifenacin succinate if you are pregnant unless clearly necessary. Do not use Solifenacin
succinate if you are breast-feeding as solifenacin may get into your breast milk.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
Driving and using machines
Solifenacin succinate 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 succinate contains lactose monohydrate.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine product.

3. How to take Solifenacin succinate
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 recommended dose is 5 mg per day, unless your doctor told you to take 10 mg per day.
If you take more Solifenacin succinate than you should
If you have taken too much Solifenacin succinate or if a child has accidentally taken Solifenacin succinate, contact
your doctor or pharmacist immediately.
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 succinate
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 succinate
If you stop taking Solifenacin succinate, your symptoms of overactive bladder may return or worsen. Always
consult your doctor if you consider stopping treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Solifenacin succinate and seek medical help immediately if you notice any of the
following side effects:
• allergic attack, or a severe skin reaction (e.g. blistering and peeling of the skin);
• 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 succinate 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 a 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,
• 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.
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 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.

5. HOW TO STORE Solifenacin succinate
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 packaging after EXP. The expiry date refers
to the last day of that month.
This medicinal product does not require any special storage conditions.
Tablet container after first opening
Do not store above 25°C.
Shelf life after the first opening is 12 months.
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 Solifenacin succinate contains
• The active substance is solifenacin succinate.
Solifenacin succinate 5 mg film-coated tablets: Each 5 mg film-coated tablet contains 5 mg solifenacin
succinate corresponding to 3.8 mg solifenacin.
Solifenacin succinate 10 mg film-coated tablets: Each 10 mg film-coated tablet contains 10 mg solifenacin
succinate corresponding to 7.5 mg solifenacin.
• The other ingredients are:
tablet core: lactose monohydrate, povidone and magnesium stearate.
film coating: hypromellose, talc, titanium dioxide (E171), triacetin and red iron oxide (E172) (only in 10 mg tablets).
What Solifenacin succinate looks like and contents of the pack
Solifenacin succinate 5 mg film-coated tablets
White to brown white, round, slightly convex film-coated tablets with beveled edges. Tablet diameter: 7.5 mm.
Solifenacin succinate 10 mg film-coated tablets
Pinkish white, round, slightly convex film-coated tablets with beveled edges. Tablet diameter: 7.5 mm.
Boxes of 10, 30, 50, 60, 90 and 100 film-coated tablets in blisters are available.
Boxes of 250 film-coated tablets in tablet containers are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia.
Distributed by:
Consilient Health (UK) Ltd., No. 1 Church Road, Richmond upon Thames, Surrey. TW9 2QE.
This leaflet was last revised in October 2017.

P0693

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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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