Vesisol

Package leaflet: Information for the user

Vesisol, 5 mg, coated tablets
Vesisol, 10 mg, coated tablets
Solifenacini succinas
Please read carefully the entire leaflet before using the medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, you should inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Vesisol is and what it is 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 Vesisol is and what it is used for

The active substance, solifenacin succinate, belongs to a group of medicines called anticholinergics. These medicines reduce the activity of an overactive bladder. This action allows longer intervals between toilet visits and increases the amount of urine the bladder can hold.
Vesisol is used in the treatment of symptoms of overactive bladder. These include urgency, which are sudden, compelling urges to pass urine, frequency, and urge incontinence—leakage of urine due to inability to reach the toilet in time.

2. Important information before using Vesisol

When not to use Vesisol

• if the patient is allergic to solifenacin succinate or any of the other ingredients of this medicine (listed in section 6);
• if the patient is unable to pass urine or empty the bladder (urinary retention);
• if the patient has severe stomach or bowel problems (toxic megacolon, a complication associated with ulcerative colitis);
• in patients suffering from a muscle disorder called myasthenia gravis, which may cause significant weakness of certain muscles;
• if the patient has increased pressure of fluid in the eye leading to gradual loss of vision (glaucoma);
• if the patient is undergoing hemodialysis;
• in patients with severe liver function disorders;
• in patients with severe kidney disease or moderate liver disease who are also taking medicines that may delay 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 occurred in the past.

Warnings and precautions

Before starting treatment with Vesisol, discuss this with your doctor or pharmacist.

• if the patient has difficulty emptying the bladder (obstruction of urinary outflow from the bladder) or difficulty passing urine (weak urinary stream). In such cases, the risk of urine accumulation in the bladder (urinary retention) is significantly increased;
• if the patient suffers from gastrointestinal motility disorders (constipation);
• if there is a risk of slowed gastrointestinal tract function (stomach and intestinal movements); your doctor will provide information on this;
• if the patient has severe kidney disease;
• if the patient has moderate liver disease;
• if the patient suffers from severe stomach pain (hiatal hernia) or heartburn;
• if the patient has nervous system disorders (autonomic neuropathy).

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

Before starting treatment with Vesisol, your doctor will assess whether there are other possible causes of frequent urination (e.g. heart failure – insufficient cardiac muscle strength to pump blood adequately – or kidney disease). If a urinary tract infection occurs, your doctor will prescribe an antibiotic (an antibacterial agent effective against the specific bacteria).

Children and adolescents

Vesisol must not be used in children or adolescents under 18 years of age.

Vesisol and other medicines

Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

It is especially important to inform your doctor if the patient is taking:

• other anticholinergic medicines, as using such a medicine together with Vesisol may enhance both the therapeutic effects and adverse reactions of both medicines;
• medicines belonging to the group of cholinergic receptor agonists, as they may reduce the effectiveness of Vesisol;
• medicines that enhance gastrointestinal motility, such as metoclopramide and cisapride, as Vesisol may reduce their effectiveness;
• 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 worsen esophagitis.

Vesisol with food and drink

Vesisol may be taken during meals or independently of food, according to patient preference.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Vesisol must not be used during pregnancy unless absolutely necessary.

Vesisol must not be used during breastfeeding, as solifenacin passes into breast milk.

Driving and operating machinery

Solifenacin may cause blurred vision, drowsiness, and fatigue. If these adverse effects occur, the patient should not drive or operate machinery.

Vesisol contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Vesisol

This medicine should always be taken as instructed by the doctor. If in doubt, consult
your doctor or pharmacist.
The usual dose is 5 mg unless the doctor recommends using a 10 mg dose.
The tablet should be swallowed whole with liquid. The medicine may be taken during meals or
independently of meals, depending on patient preference. Tablets must not be crushed.
Use of a higher than recommended dose of Vesisol
If too many Vesisol tablets have been taken, or if a child accidentally swallows Vesisol,
immediately contact a doctor or pharmacist.
Symptoms of overdose may include: headache, dry mouth, dizziness,
drowsiness and visual disturbances, seeing non-existent objects (hallucinations), excessive excitation,
seizures (convulsions), breathing difficulties, rapid heartbeat (tachycardia),
urinary retention, and dilated pupils.
Missed dose of Vesisol
If a dose is missed, take the next dose as soon as possible, unless it is almost time for the next dose.
Do not take the medicine more often than once a day. If in doubt, consult your doctor or pharmacist.
Stopping treatment with Vesisol
If treatment with Vesisol is discontinued, symptoms of overactive bladder may return
or worsen. If the patient intends to stop treatment, medical advice should be sought.
If you have any further questions regarding the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicinal product may cause adverse reactions, although not everyone experiences them.
If the patient develops an allergic attack or a severe skin reaction (e.g. blistering and peeling of the skin), the doctor or pharmacist should be informed immediately.
In some patients taking solifenacin succinate, angioedema (a type of allergic skin reaction causing swelling of the tissue just beneath the skin surface) with swelling of the airways (difficulty breathing) has been reported. If angioedema occurs, treatment with Vesisol should be stopped immediately and appropriate treatment and/or emergency measures should be initiated.

Vesisol may cause other adverse reactions listed below:

Very common (may occur in more than 1 in 10 people):

• dry mouth.

Common (may occur in up to 1 in 10 people):

• blurred vision,
• constipation, nausea, dyspepsia with symptoms such as feeling of fullness in the stomach, abdominal pain, belching, nausea and heartburn (dyspepsia), discomfort in the abdominal cavity.

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

• urinary tract infection, cystitis,
• somnolence,
• taste disturbances,
• dry (irritated) eyes,
• nasal dryness,
• gastroesophageal reflux (heartburn),
• dry throat,
• dry skin,
• difficulty in urination,
• fatigue,
• fluid accumulation in the lower limbs (oedema).

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

• accumulation of large amounts of hard stool in the colon (faecal impaction),
• difficulty passing urine despite a full bladder (urinary retention),
• dizziness, headache,
• vomiting,
• itching, rash.

Very rare (may occur in 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 blood potassium levels which may cause cardiac arrhythmias,
• increased intraocular pressure,
• changes in ECG, irregular heartbeat (torsade de pointes), palpitations, tachycardia,
• voice disorders,
• liver function abnormalities,
• muscle weakness,
• kidney function disorders.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting of adverse reactions enables further accumulation of information on the safety of the medicine.

5. How to store Vesisol

Keep Vesisol out of the sight and reach of children.
No special storage instructions apply to this medicinal product.
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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Vesisol contains

• The active substance 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.
• Other ingredients are:
  Tablet core: Lactose monohydrate, maize starch, talc, magnesium stearate.
  Tablet coating:
  Vesisol 5 mg: Opadry yellow OY 32823 [hypromellose 6cP, titanium dioxide (E 171), polyethylene glycol 400, iron oxide yellow (E 172), iron oxide red (E 172)].
  Vesisol 10 mg: Opadry white 03B28796 [hypromellose 6cP, titanium dioxide (E 171), polyethylene glycol 400], Opadry brown 02F23883 [hypromellose 5cP, titanium dioxide (E 171), polyethylene glycol 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 Authorisation 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

This medicinal product is authorised in the European Economic Area under the following names:
Austria: Vesisol 5/10 mg-Filmtabletten
Czech Republic: Solifenacin G.L.Pharma, 5/10 mg potahované tablety
Poland: Vesisol
Bulgaria: Vesisol 5/10 mg film-coated tablets
Slovakia: Urokur 5/10 mg filmom obalená tablety

For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
Tel: 022/ 636 52 23; 636 53 02
[email protected]