Patient leaflet - Solifenacin Succinate Umedica 5 mg film-coated tablets
1. What Solifenacin succinate is and what it is used for
The active substance of Solifenacin succinate Umedica film-coated tablets 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
Ÿ if you have an inability to pass water or to
empty your bladder completely (urinary retention)
Ÿ if you have a severe stomach or bowel
condition (including toxic megacolon, a complication associated with ulcerative colitis)
Ÿ if you suffer from the muscle disease called
myasthenia gravis, which can cause an extreme weakness of certain muscles Ÿ if you suffer from increased pressure in the
eyes, with gradual loss of eye sight (glaucoma)
Ÿ if you are allergic to solifenacin or any of
the other ingredients of this medicine (listed in section 6)
Ÿ if you are undergoing kidney dialysis Ÿ if you have severe liver disease
Ÿ 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
Ÿ 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. Ÿ if you have some obstruction of the
digestive system (constipation).
Ÿ 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.
Ÿ if you suffer from severe kidney disease. Ÿ if you have moderate liver disease. Ÿ if you have a stomach tear (hiatus hernia)
or heartburn.
Ÿ if you have a nervous disorder (autonomic
neuropathy).
Children and adolescents
Solifenacin succinate 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 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).
Other medicines and Solifenacin succinate Umedica film-coated tablet
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:
Ÿ other anticholinergic medicines, effects and
side effects of both medications can be enhanced.
Ÿ cholinergics as they can reduce the effect
of Solifenacin succinate
Ÿ medicines, like metoclopramide and
cisapride, which make the digestive system work faster. Solifenacin succinate can reduce their effect.
Ÿ medicines, like ketoconazole, ritonavir,
nelfinavir, itraconazole, verapamil and diltiazem, which decrease the rate at which Solifenacin succinate is broken down by the body
Ÿ medicines like rifampicin, phenytoin and
carbamazepine, as they may increase the rate at which Solifenacin succinate is broken down by the body.
Ÿ medicines such as bisphosphonates, that can
cause or exacerbate inflammation of the gullet (oesophagitis).
Solifenacin succinate with food and drink
Solifenacin succinate Umedica film-coated tablets 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.
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. "If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal 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 tablets 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 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 Umedica film-coated tablets your symptoms of overactive bladder may return or worsen. Always consult your doctor, if you are considering stopping the treatment.
Package leaflet: Information for the user
solifenacin succinate
Solifenacin succinate Umedica 5 mg film-coated tablets Solifenacin succinate Umedica 10 mg film-coated tablets
Umedica Laboratories UK Ltd Solifenacin succinate Umedica 5 mg film-coated tablets Solifenacin succinate Umedica 10 mg film-coated tablets
(PIL Size: 135x400 MM)
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. 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 succinate). If angioedema occurs, solifenacin succinate (Solifenacin succinate) should be discontinued immediately and appropriate therapy and/or measures should be taken.
Solifenacin succinate may cause the following other side effects:
Very common (may affect more than 1 in 10 people)
Ÿ dry mouth
Common (may affect up to 1 in 10 people) Ÿ blurred vision
Ÿ 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) Ÿ urinary tract infection, bladder infection Ÿ sleepiness, impaired sense of taste
(dysgeusia)
Ÿ dry (irritated) eyes
Ÿ dry nasal passages
Ÿ reflux disease (gastro-oesophageal reflux),
dry throat
Ÿ dry skin
Ÿ difficulty in passing urine
Ÿ tiredness, accumulation of fluid in the lower
legs (oedema)
Rare (may affect up to 1 in 1,000 people) Ÿ lodging of a large amount of hardened stool
in the large intestine (faecal impaction) Ÿ build up of urine in the bladder due to
inability to empty the bladder (urinary retention)
Ÿ dizziness, headache
Ÿ vomiting
Ÿ itching, rash
Very rare (may affect up to 1 in 10,000 people) Ÿ hallucinations, confusion
Ÿ allergic rash
Not known (frequency cannot be estimated from the available data)
Ÿ decreased appetite, high levels of blood
potassium which can cause abnormal heart rhythm
Ÿ increased pressure in the eyes
Ÿ changes in the electrical activity of the heart
(ECG), irregular heartbeat, feeling your heartbeat, faster heart beat
Ÿ voice disorder
Ÿ liver disorder
Ÿ muscle weakness
Ÿ 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 Solifenacin succinate Umedica film-coated tablets after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Store below 30°C
Store in the original package in order to protect from light
6. Contents of the pack and other information
What Solifenacin succinate Umedica film-coated tablets contains
Ÿ The active substance is solifenacin succinate
5 mg or 10 mg. Each tablets contains 5 mg and 10 mg solifenacin succinate. Ÿ The other ingredients are corn starch, lactose
monohydrate, Hydroxypropyl methyl cellulose E464, magnesium stearate E572,
Hypromellose, talc, polyethylene glycol E1520 or E490 titanium dioxide E171, yellow iron oxide E172 and red iron oxide E172
What Solifenacin succinate Umedica film-coated tablets looks like and contents of the pack
Solifenacin succinate Umedica 5 mg film-coated tablets area round shaped, 7.5 mm, light-yellow tablet, debossed with “SOL” on one side and “5”on the other side
Solifenacin succinate Umedica 10 mg film-coated tablets are a round shaped, 7.5 mm, light-pink tablet, debossed with “SOL” on one side and “10”on the other side.
Solifenacin succinate Umedica film-coated tablets are supplied in blister packs of 10, 30, 50, 60, 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder: Umedica Laboratories UK Ltd
Office No. G42
The Panorama Park Street
Ashford, England
TN24 8DF
Manufacturer:
Elara Pharmaservices Limited
5 Garden Court, Lockington Hall
Main Street, Lockington
Derby, DE74 2RH
United Kingdom
This medicinal product is authorised under the following names:
Solifenacin succinate Umedica 5 mg film-coated tablets - PL 60528/0005
Solifenacin succinate Umedica 10 mg film-coated tablets - PL 60528/0006
This leaflet was last revised in 03/2026
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