Patient Information Leaflet

Vesacin 5 mg film-coated tablets
Vesacin 10 mg film-coated tablets
Solifenacin succinate
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Vesacin is and what it is used for
What you need to know before taking Solifenacin Sealed
How to take Solifenacin Sealed
Possible side effects
How to store Solifenacin Sealed
Contents of the pack and other information

1. What Vesacin is and what it is used for

The active substance in Vesacin belongs to a group of medicines called anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This helps delay the need to go to the toilet and increases the amount of urine that can be held in your bladder.
Vesacin is used to treat the symptoms of a condition called overactive bladder. These symptoms include: a sudden, strong urge to urinate without prior warning, frequent need to urinate, or leakage because you cannot reach the toilet in time.

2. What you need to know before taking Solifenacin Sigillata

Do not take Solifenacin Sigillata

if you are allergic to solifenacin or to any of the other ingredients of this medicine (listed in section 6)
if you have difficulty urinating or completely emptying your bladder (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 causes extreme weakness of certain muscles
if you have increased intraocular pressure 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 at the same time with medicines that may reduce the elimination of
Vesacin from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you
about this if it applies to you.
Inform your doctor if you have or have ever had any of the above conditions before starting treatment
with Solifenacin Sigillata.
Warnings and precautions
Talk to your doctor or pharmacist before taking Solifenacin Sigillata
if you have problems emptying your bladder (bladder obstruction) or have difficulty urinating (e.g., reduced urine flow). The risk of urine accumulation in the bladder (urinary retention) is very high.
if you have gastrointestinal obstructions (e.g., constipation).
if your gastrointestinal motility (stomach and intestinal movements) is at risk of slowing down. Your doctor will inform you about this possibility if it applies to you.
if you have severe kidney disease.
if you have moderate liver disease.
if you have a stomach condition (hiatal hernia) or heartburn.
if you suffer from a nervous system disorder (autonomic neuropathy).

Children and adolescents
Vesacin must not be used in children or adolescents under 18 years of age.
Inform your doctor if you have or have previously had any of the above conditions before starting treatment with Solifenacin Sigillata.
Before starting treatment with Solifenacin Sigillata, your doctor must assess whether there are other causes for your frequent need to urinate (e.g., heart failure (insufficient pumping capacity of the heart) or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (a treatment for certain bacterial infections).
Other medicines and Solifenacin Sigillata
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important to inform your doctor if you are taking:

other anticholinergic medicines, as the effectiveness and side effects of both medicines may increase.
cholinergic agents, as they may reduce the effect of Solifenacin Sigillata.
medicines such as metoclopramide and cisapride, which speed up digestive system activity, as Solifenacin Sigillata may reduce their effect.
medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the rate of elimination of Vesacin from the body.
medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the rate of elimination of Vesacin from the body.
medicines such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

Vesacin with food and drink
Vesacin can be taken with or without food, according to your preference.
Pregnancy, breastfeeding, and fertility
You must not use Vesacin if you are pregnant, unless strictly necessary. Do not use Vesacin if you are breastfeeding, as solifenacin may pass into your breast milk.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Vesacin may cause blurred vision and sometimes drowsiness or fatigue. If you experience these side effects, do not drive and do not operate machinery.
Vesacin contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Solifenacin Sigillata

Instructions for proper use
Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Swallow the tablet whole with liquid. You may take it with or without food, as preferred.
Do not crush the tablets.
The recommended dose is 5 mg once daily, unless your doctor has instructed you to take 10 mg daily.

If you take more Vesacindi than you should
If you have taken too much Vesacindo or if a child has accidentally taken Solifenacin Sigillata, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, perception of non-existent objects (hallucinations), overexcitation, epileptic seizures (convulsions), breathing difficulties, increased heart rate (tachycardia), urine retention in the bladder (urinary retention), and dilated pupils (mydriasis).

If you forget to take Solifenacin Sigillata
If you forget to take a dose at your usual time, take it as soon as you remember, unless it is already time for your next dose. Never take more than one dose per day. If in doubt, always consult your doctor or pharmacist.

If you stop taking Solifenacin Sigillata
If you stop taking Solifenacin Sigillata, your symptoms of bladder overactivity may return or worsen.
Always consult your doctor if you are considering stopping treatment.

If you have any questions about 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 everyone experiences them.
If you experience an allergic reaction or a severe skin reaction (e.g. blistering and peeling of the skin), you must inform your doctor or pharmacist immediately.
Angioedema (an allergic skin reaction characterized by swelling of the tissue just beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate. If angioedema occurs, Vesacin must be discontinued immediately and appropriate therapies and/or measures must be taken.

Vesacin may cause the following additional 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, belching, nausea and heartburn (dyspepsia), stomach discomfort.

Uncommon (may affect up to 1 in 100 people)

Urinary tract infection or bladder infection
Drowsiness, altered sense of taste (dysgeusia)
Dry (irritated) eyes
Nasal dryness
Gastroesophageal reflux disease (acid reflux), dry throat
Dry skin
Difficulty urinating
Fatigue, fluid accumulation in the lower parts of the legs (oedema).

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

Accumulation of large amounts of hardened faeces in the colon (faecal impaction)
Increased urine formation 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 available data)

Decreased appetite, elevated levels of potassium in the blood which may cause heart rhythm abnormalities
Increased pressure inside the eyes
Changes in the heart's electrical activity (ECG), irregular heartbeat (torsades de pointes), awareness of your heartbeat, faster heartbeat
Voice disorders
Liver disorders
Muscle weakness
Kidney disorders

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Solifenacin Sigillata

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Solifenacina Sigillata contains

The active substance is solifenacin succinate 5 mg or 10 mg.
The other components are:

Tablet core: microcrystalline cellulose, povidone, crospovidone, anhydrous lactose, anhydrous colloidal silica, magnesium stearate.
Tablet coating:
Vesacin 5 mg film-coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol 3350, talc (E553b), yellow iron oxide (E172).
Vesacin 10 mg film-coated tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol 3350, talc (E553b), carmine (E120), red iron oxide (E172), yellow iron oxide (E172).

Description of the appearance of Vesacine and package contents
Vesacin 5 mg film-coated tablets are film-coated, light yellow to yellow, standard convex round tablets, imprinted with "S5" on one side and smooth on the other.
Vesacin 10 mg film-coated tablets are film-coated, light pink to pink, standard convex round tablets, imprinted with "S10" on one side and smooth on the other.
Vesacin 5 mg film-coated tablets are available in aluminum-aluminum blister packs containing 30 tablets.
Vesacin 10 mg film-coated tablets are available in polymer blister packs containing 20 tablets.
Aluminum-aluminum blister packs.
Polymer blister packs.
Not all pack sizes may be marketed.

Marketing Authorization Holder
S.F. GROUP S.r.l.
Via Tiburtina, 1143
00156 Rome, Italy

Manufacturer
Teva Pharma B.V.
Swensweg 5,
2031GA Haarlem,
The Netherlands;
PLIVA Hrvatska d.o.o
Prilaz baruna Filipovica 25,
10 000 Zagreb,
Croatia

This medicinal product is authorized in the European Economic Area countries under the following names:
DK: SOLIFENACINSUCCINAT SIGILLATA
IT: VESACIN