Vesisol

Leaflet included in the packaging: Information for the user

Vesisol, 5 mg, coated tablets

Vesisol, 10 mg, coated tablets

Solifenacin succinate
You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Vesisol and what is it used for
• 2. Important information before taking Vesisol
• 3. How to take Vesisol
• 4. Possible side effects
• 5. How to store Vesisol
• 6. Contents of the pack and other information

1. What is Vesisol and what is it used for

Solifenacin succinate, the active substance of Vesisol, belongs to a group of medicines called anticholinergics. These medicines reduce the activity of an overactive bladder. This action allows for longer intervals between visits to the toilet and an increased amount of urine retained in the bladder. Vesisol is used to treat the symptoms of an overactive bladder. These symptoms include: urgency, i.e. episodes of sudden, urgent need to urinate, frequent urination, and urge incontinence, i.e. incontinence associated with a sudden need to urinate, because the patient did not have time to use the toilet.

2. Important information before taking Vesisol

When not to take Vesisol

• if you are allergic to solifenacin succinate or any of the other ingredients of this medicine (listed in section 6);
• if you have difficulty urinating or emptying your bladder (urinary retention);
• if you have severe gastrointestinal disorders (toxic megacolon, a complication associated with ulcerative colitis);
• if you have a muscle disease called myasthenia gravis, which can cause significant weakness of some muscles;
• if you have increased pressure in the eye, which can lead to a gradual loss of vision (glaucoma);
• if you are undergoing hemodialysis;
• if you have severe liver function disorders;
• if you have severe kidney disease or moderate liver disease and are taking medicines that may slow down the elimination of solifenacin from the body (e.g. ketoconazole). Your doctor or pharmacist will provide information on this.

Before starting treatment with Vesisol, you should inform your doctor if any of the above situations apply or have applied in the past.

Warnings and precautions

Before starting to take Vesisol, you should discuss this with your doctor or pharmacist.

• if you have difficulty emptying your bladder (narrowing of the urethra) or urinating (weak urine stream). In such cases, the risk of urine accumulation in the bladder (urinary retention) is much higher;
• if you have gastrointestinal motility disorders (constipation);
• if there is a risk of slowing down the movement of the gastrointestinal tract; your doctor will provide information on this;
• if you have severe kidney disease;
• if you have moderate liver disease;
• if you have severe stomach pain (hiatal hernia) or heartburn;
• if you have autonomic nervous system disorders (autonomic neuropathy).

Before starting treatment with Vesisol, you should inform your doctor if any of the above situations apply or have applied in the past.
Before starting treatment with Vesisol, your doctor will assess whether there are other causes of frequent urination (e.g. heart failure - insufficient strength of the heart muscle to pump blood - or kidney disease). If a urinary tract infection occurs, your doctor will prescribe an antibiotic (an antibacterial medicine that acts on specific bacteria).

Children and adolescents

Vesisol should not be used in children or adolescents under the age of 18.

Vesisol and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, it is important to inform your doctor if you are taking:

• other anticholinergic medicines, as taking such a medicine with Vesisol may lead to an increase in both the therapeutic effect and the side effects of both medicines;
• cholinergic receptor agonists, as they may weaken the effect of Vesisol;
• medicines that enhance gastrointestinal motility, such as metoclopramide and cisapride, as Vesisol may weaken their effect;
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they slow down the metabolism of Vesisol;
• medicines such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of Vesisol;
• medicines such as bisphosphonates, as they may exacerbate esophagitis.

Vesisol with food and drink

Vesisol can be taken with or without food, depending on the patient's preferences.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Vesisol should not be used during pregnancy, unless it is absolutely necessary.
Vesisol should not be used during breastfeeding, as solifenacin passes into breast milk.

Driving and using machines

Solifenacin may cause blurred vision, sometimes drowsiness, and a feeling of fatigue. If such side effects occur, you should not drive or operate any machinery.

Vesisol contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Vesisol

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should ask your doctor or pharmacist.
The usual dose is 5 mg, unless your doctor has recommended a dose of 10 mg.
The tablet should be swallowed whole, with a drink of water. Vesisol can be taken with or without food, depending on the patient's preferences. The tablets should not be crushed.

Taking a higher dose of Vesisol than recommended

If you have taken too many Vesisol tablets or if a child has accidentally taken Vesisol, you should immediately contact your doctor or pharmacist.
Overdose symptoms may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, seeing things that are not there (hallucinations), excessive stimulation, seizures (convulsions), difficulty breathing, rapid heartbeat (tachycardia), urine accumulation in the bladder (urinary retention), and dilated pupils.

Missing a dose of Vesisol

If you miss a dose of Vesisol, you should take the next dose as soon as possible, unless it is almost time for the next dose. You should not take the medicine more often than once a day. If you are unsure, you should ask your doctor or pharmacist.

Stopping treatment with Vesisol

If you stop taking Vesisol, the symptoms of an overactive bladder may return or worsen. If you intend to stop treatment, you should consult your doctor.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vesisol can cause side effects, although not everybody gets them.
If you experience an allergic reaction or a severe skin reaction (e.g. blistering and peeling of the skin), you should immediately inform your doctor or pharmacist.
In some patients taking solifenacin succinate, angioedema (a type of allergic skin reaction that causes swelling of the tissue under the skin) with swelling of the airways (difficulty breathing) has been reported. If you experience angioedema, you should immediately stop taking Vesisol and initiate appropriate treatment and/or take appropriate measures.
Vesisol may cause other side effects, including:

• 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 feeling of a full stomach, stomach pain, belching, nausea, and heartburn (dyspepsia), a feeling of discomfort in the abdominal cavity.

Uncommon(may affect up to 1 in 100 people):

• urinary tract infection, cystitis,
• drowsiness,
• taste disturbances,
• dry eyes,
• dry nose,
• gastroesophageal reflux (heartburn),
• dry throat,
• dry skin,
• difficulty urinating,
• fatigue,
• fluid accumulation in the lower limbs (edema).

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

• accumulation of large amounts of hard stool in the intestine (fecal impaction),
• difficulty urinating despite a full bladder (urinary retention),
• dizziness, headache,
• vomiting,
• rash.

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

• hallucinations, disorientation,
• allergic rash.

Frequency not known(frequency cannot be estimated from the available data):

• decreased appetite, increased potassium levels in the blood, which can cause heart rhythm disturbances,
• increased pressure in the eye,
• ECG changes, irregular heartbeat (Torsade de Pointes), palpitations, rapid heartbeat,
• voice disorders,
• liver function disorders,
• muscle weakness,
• kidney function disorders.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vesisol

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
Do not use this medicine after the expiry date stated on the carton/blister after EXP.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Vesisol contains

• The active substance of Vesisol is solifenacin succinate. Vesisol, 5 mg: each coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin. Vesisol, 10 mg: each coated tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg of solifenacin.
• The other ingredients are: Tablet core: lactose monohydrate, maize starch, talc, magnesium stearate.

Coating:
Vesisol, 5 mg: Opadry yellow OY 32823 [hypromellose 6cP, titanium dioxide (E 171), macrogol 400, iron oxide yellow (E 172), iron oxide red (E 172)].
Vesisol, 10 mg: Opadry white 03B28796 [hypromellose 6cP, titanium dioxide (E 171), macrogol 400], Opadry brown 02F23883 [hypromellose 5cP, titanium dioxide (E 171), macrogol 6000, iron oxide yellow (E 172), iron oxide red (E 172)].

What Vesisol looks like and contents of the pack

Vesisol, 5 mg: yellow, round, biconvex coated tablet with a diameter of 6 mm.
Vesisol, 10 mg: pink, round, biconvex coated tablet with a diameter of 7 mm.
Pack sizes: 30, 50, 60, 90, and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria.

Manufacturer

G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria, PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic.

For more information and information on the names of the medicinal product in other EU member states, please contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o., Al. Jana Pawła II 61/313, 01-031 Warsaw, Poland, Tel: 022/ 636 52 23; 636 53 02, biuro@gl-pharma.pl.

Date of last revision of the leaflet: