Leaflet: Information for the user

Vesurol 5 mg film-coated tablets EFG

Solifenacin,succinate

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Vesurol is and what it is used for

2.What you need to know before you start taking Vesurol

3.How to take Vesurol

4.Possible side effects

5Storage of Vesurol

6.Contents of the pack and additional information

The active ingredient of Vesurol belongs to the group of anticholinergics. These medications are used to reduce the activity of an overactive bladder. This allows you to have more time before needing to go to the bathroom and increases the amount of urine that your bladder can hold.

Vesurol is used to treat the symptoms of overactive bladder syndrome. These symptoms include: having a strong and sudden need to urinate without prior warning, having to urinate frequently or experiencing urine leakage due to not making it to the bathroom on time.

Do not take Vesurol

• if you are allergic to solifenacin succinateor to any of the other ingredients ofthis medicine (listed in section 6),
• if you have difficulty urinating or emptying your bladder completely (urinary retention),
• if you have a severe stomach or intestinal disorder (including toxic megacolon, a complication associated with ulcerative colitis),
• if you have a muscle disease called myasthenia gravis, which can cause extreme weakness in certain muscles,
• if you have high pressure in the eyes, with gradual loss of vision (glaucoma),
• if you are undergoing renal dialysis,
• if you have severe liver disease,
• if you have severe kidney disease or moderate liver disease and are being treated with medications that can reduce the elimination of solifenacin from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Inform your doctor if you have or have had any of the conditions mentioned above before starting treatment with solifenacin.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

• if you have difficulty emptying your bladder (bladder obstruction) or urinating (e.g. weak urine flow). The risk of urine accumulation in the bladder (urinary retention) is much higher,

• if you have any obstruction of the digestive system (constipation),
• if you have an increased risk of decreased activity of the digestive system (gastrointestinal motility). Your doctor will inform you if this is the case,
• if you have severe kidney disease,
• if you have moderate liver disease,
• if you have hiatal hernia or heartburn,
• if you have a nervous disorder (autonomic neuropathy).

Children and adolescents

Thismedicineshould not be used in children or adolescents under 18 years.

Inform your doctor before starting treatment with this medicine, if any of the circumstances mentioned above have occurred at any time.

Before starting treatment with solifenacin, your doctor will assess whether there are other causes for your need to urinate frequently (e.g. heart failure or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (a treatment for certain bacterial infections).

Use of Vesurol with other medicines

Inform your doctor or pharmacist that you are using, have used recently or may need to use any other medicine.

It is especially important to inform your doctor if you are taking:

• other anticholinergic medicines, the activity and adverse effects of both medicines may increase,
• cholinergic medicines as they may reduce the effect of solifenacin,
• medicines such as metoclopramide or cisapride, which make the digestive system work faster. Solifenacin may reduce their effect,
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil and diltiazem, which reduce the rate of elimination of solifenacin from the body,
• medicines such as rifampicin, phenytoin and carbamazepine, as they may increase the rate of elimination of solifenacin from the body,
• medicines such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

Use of Vesurol with food, drinks and alcohol

This medicine can be taken with or without food, as you prefer.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not use solifenacin if you are pregnant unless absolutely necessary.

Do not usesolifenacin during breastfeeding as solifenacin may pass into breast milk.

Driving and operating machinery

Solifenacin may cause blurred vision and sometimes drowsiness or fatigue. If you experience any of these side effects, do not drive or operate machinery.

Warnings about excipients

Vesurol contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

InstructionsforCorrectUse

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Swallow the entire tablet with some liquid. You can take it with or without food, according to your preference. Do not crush the tablets.

The recommended dose is 5 mg per day, unless your doctor tells you to take 10 mg per day.

If you take more Vesurol than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of an overdose may include: headache, dry mouth, dizziness, drowsiness, and blurred vision, perception of things that are not there (hallucinations), pronounced excitement, convulsions, difficulty breathing, increased heart rate (tachycardia), urine accumulation in the bladder (urinary retention), and pupil dilation (mydriasis).

If you forget to take Vesurol

If you forget to take a dose at the usual time, take it as soon as you remember, unless it is time to take the next dose.Nevertakemorethanonedoseperday.If you have any doubts, consult your doctor or pharmacist always.

If you interrupt treatment with Vesurol

If you stop taking solifenacin, your overactive bladder symptoms may return or worsen. Always consult your doctor if you are thinking of interrupting treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience an allergic attack or a severe skin reaction (such as blistering and peeling of the skin), you must inform your doctor or nurse immediately.

Angioedema (allergic reaction on the skin resulting in inflammation of the tissue beneath the skin surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate.If angioedema appears, treatment with solifenacin succinate must be stopped immediately and appropriate treatment and/or measures must be taken.with solifenacin succinate and appropriate treatment and/or measures must be taken.

Solifenacin may cause the following 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 feeling of stomach heaviness, abdominal pain, belching, nausea, and stomach burning (dyspepsia), stomach discomfort.

Rare side effects (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection,
• drowsiness,
• abnormal taste perception (dysgeusia),
• dry eyes (irritated),
• nasal dryness,
• gastroesophageal reflux disease (GERD),
• dry throat,
• dry skin,
• difficulty urinating,
• fatigue,
• swelling of the lower extremities (edema).

Rare side effects (may affect up to 1 in 1,000 people)

• accumulation of hardened feces in the large intestine (fecal impaction),
• urinary retention (inability to empty the bladder),
• dizziness, headache,
• vomiting,
• itching, skin rash.

Very rare side effects (may affect up to 1 in 10,000 people)

• hallucinations, confusion,
• allergic skin rash.

Unknown frequency (frequency cannot be estimated from available data)

• decreased appetite, high levels of potassium in the blood that may cause an abnormal heart rhythm,
• increased eye pressure,
• changes in heart electrical activity (ECG), irregular heartbeats (Torsades de Pointes),
• voice disorder,
• liver disorder,
• muscle weakness,
• renal disorder.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use Website:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the packaging and unused medications if you are unsure. By doing so, you will help protect the environment.

Composition of Vesurol

• The active principle is solifenacin succinate5 mg (equivalent to 3.8 mg of solifenacin).
• The other components (excipients) are:

Tablet core: cornstarch, lactose monohydrate, hypromellose (E464) and magnesium stearate.

Coating: hypromellose (E464), macrogol, talc, titanium dioxide (E171) and yellow iron oxide (E172).

Appearance of the product and contents of the packaging

Vesurol 5 mg tablets are yellow, round, coated tablets.

Vesurol 10 mg tablets are round, pink tablets with a notch on one side. The tablet can be divided into two equal halves

Vesurol tablets are supplied in blisters of 30 tablets.

Marketing authorization holder and responsible manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet:December 2014

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/