Patient leaflet - Solifenacin Succinate 5 mg film-coated tablets

1. WHAT SOLIFENACIN SUCCINATE FILM-COATED TABLETS IS AND WHAT IT IS USED FOR

The active substance of Solifenacin 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 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 FILM-COATED TABLETS

Do not take Solifenacin succinate film-coated 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,

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 starts.

Warnings and precautions

Talk to your doctor or pharmacist before taking Solifenacin

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 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 starts.

Before starting Solifenacin, 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 film-coated Tablets

Tell your doctor 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,

medicines, like metoclopramide and cisapride, which make the digestive system work faster. Solifenacin can reduce their effect,

medicines, like ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil and diltiazem, which decrease the rate at which Solifenacin is broken down by the body, medicines like rifampicin, phenytoin and carbamazepine, as they may increase the rate at which Solifenacin is broken down by the body,

medicines such as bisphosphonates, that can cause or exacerbate inflammation of the gullet (oesophagitis).

Solifenacin succinate film-coated Tablets with food and drink

Solifenacin can be taken with or without food, depending on your preference. Pregnancy and breast-feeding

You should not use Solifenacin if you are pregnant unless clearly necessary. Do not use Solifenacin 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 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 film-coated Tablets 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 FILM-COATED TABLETS

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 succinate film-coated Tablets than you should

If you have taken too much Solifenacin or if a child has accidentally taken Solifenacin, 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 film-coated 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.

(Continued overleaf)

As stated in design

Package leaflet

PP001023

TW271761 (launch)

All

001023

9 pts (Reg text)

TW265767 10/08/2026 08/09/2026

Black C

Folded Size : 105 x 37.5 mm Paper : 40gsm Bible Paper If you stop taking Solifenacin succinate film-coated Tablets

If you stop taking Solifenacin, 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 medicine, 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. If angioedema occurs, Solifenacin should be discontinued immediately and appropriate therapy and/or measures should be taken.

Solifenacin 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

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 (Torsade de Pointes), 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 FILM-COATED TABLETS

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 after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Solifenacin succinate film-coated Tablets contains

The active substance is solifenacin succinate.

Solifenacin succinate 5 mg film-coated Tablets: each film-coated tablet contains 5 mg of solifenacin succinate, corresponding to 3.8 mg of solifenacin.

Solifenacin succinate 10 mg film-coated Tablets: each film-coated tablet contains 10 mg of solifenacin succinate, corresponding to 7.5 mg of solifenacin. The other ingredients are:

Tablet core: lactose monohydrate, hypromellose (E464), magnesium stearate (E572). Tablet coating: Solifenacin succinate 5 mg film-coated Tablets: Opadry yellow (hypromellose (E464), titanium dioxide (E171), triacetin (E1518), talc (E553b), iron oxide yellow (E172)).

Solifenacin succinate 10 mg film-coated Tablets: Opadry pink (hypromellose (E464), titanium dioxide (E171), triacetin (E1518), talc (E553b), iron oxide red (E172)). What Solifenacin succinate film-coated Tablets looks like and contents of the pack

Solifenacin succinate 5 mg film-coated Tablets: light yellow coloured, round shaped, biconvex film-coated tablets debossed with ‘S5’ on one side and plain on other side. Solifenacin succinate 10 mg film-coated Tablets: light pink coloured, round shaped, biconvex film-coated tablets debossed with ‘S10’ on one side and plain on other side. Tablets are packed in PVC/PVdC-Al blister in carton box.

Pack size: 10, 20, 30, 50, 60, 90, 100 and 200 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Tillomed Laboratories Limited

220 Butterfield, Great Marlings

Luton, LU2 8DL, United Kingdom

Manufacturer