Zevesin

Leaflet attached to the packaging: Information for the user

Zevesin, 5 mg, film-coated tablets

Zevesin, 10 mg, film-coated tablets

Solifenacin succinate

You should carefully read the contents of the leaflet before using 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 doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Zevesin and what is it used for
• 2. Important information before using Zevesin
• 3. How to use Zevesin
• 4. Possible side effects
• 5. How to store Zevesin
• 6. Contents of the packaging and other information

1. What is Zevesin and what is it used for

The active substance of Zevesin belongs to the group of anticholinergic medicines. These medicines reduce the activity of an overactive bladder. This action allows for longer intervals between using the toilet and increases the amount of urine held in the bladder. Zevesin is used to treat symptoms of an overactive bladder. These include: urgent urination, i.e., episodes of sudden, urgent need to urinate, frequent urination, and urinary incontinence, related to the fact that the patient did not have time to use the toilet.

2. Important information before using Zevesin

When not to use Zevesin:

• in a patient with an allergy (hypersensitivity) to solifenacin or any of the other ingredients of this medicine (listed in section 6).
• if the patient cannot urinate or cannot empty their bladder (urinary retention).
• if the patient has severe stomach or intestinal disorders (toxic megacolon, a complication associated with ulcerative colitis).
• in a patient with a muscle disease called myasthenia, which can cause significant weakness of some muscles.
• if the patient has increased fluid pressure in the eyeball, which can lead to gradual vision loss (narrow-angle glaucoma).
• if the patient is undergoing hemodialysis procedures.
• in a patient with severe liver function disorders.
• if the patient has severe kidney disease or moderate liver disease and is taking medicines that may delay the elimination of Zevesin from the body (e.g., ketoconazole). The doctor or pharmacist will provide information on this.

Warnings and precautions

Before starting to use Zevesin, you should discuss it with your doctor or pharmacist:

• if the patient has difficulty emptying their bladder (narrowing of the urine outflow tract) or urinating (weak urine stream). In such a case, the risk of urine accumulation in the bladder (urinary retention) is much higher.
• if the patient has gastrointestinal motility disorders (constipation).
• if there is a risk of slowed gastrointestinal motility (peristalsis). The doctor will provide information on this.
• if the patient has severe kidney function disorders.
• if the patient has moderate liver function disorders.
• if the patient has a tearing stomach pain (hiatus hernia) or heartburn.
• if the patient has autonomic nervous system disorders (autonomic neuropathy).

Before starting treatment with Zevesin, you should inform your doctor if any of the above situations occur or have occurred in the past. Before starting treatment with Zevesin, the 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, the doctor will prescribe an antibiotic (an antibacterial medicine that acts on specific bacteria).

Children and adolescents

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

Zevesin and other medicines

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

• other anticholinergic medicines, as concomitant use of both medicines may lead to increased therapeutic effects and side effects.
• cholinergic receptor agonist medicines, as they may weaken the effect of Zevesin.
• medicines that enhance gastrointestinal motility, such as metoclopramide and cisapride, as Zevesin may weaken their effect.
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they slow down the metabolism of Zevesin.
• medicines such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of Zevesin.
• medicines such as bisphosphonates, as they may cause or exacerbate esophagitis.

Zevesin with food, drink, and alcohol

Zevesin can be taken with or without food.

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 using this medicine. You should not use Zevesin during pregnancy, unless it is absolutely necessary. You should not use Zevesin during breastfeeding, as solifenacin passes into breast milk.

Driving and using machines

Zevesin may cause blurred vision, and less often, drowsiness and fatigue. If such side effects occur, you should not drive or operate any machinery.

Zevesin contains lactose monohydrate

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

3. How to use Zevesin

Zevesin should always be used in accordance with the doctor's recommendations. If you have any doubts, you should consult your doctor or pharmacist. The usual dose is 5 mg per day, unless the doctor recommends a dose of 10 mg per day. Zevesin should be taken at the same time every day. The tablet should be swallowed whole, with a drink of water. The medicine can be taken with or without food, according to your preferences. The tablets should not be crushed. You should consult your doctor if the effect of the medicine is too strong or too weak.

Using a higher dose of Zevesin than recommended

If you have taken too many Zevesin tablets or if a child has accidentally swallowed Zevesin, you should immediately consult your doctor or pharmacist. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, hallucinations, excessive stimulation, seizures (convulsions), breathing difficulties, rapid heartbeat (tachycardia), urinary retention, and dilated pupils.

Missing a dose of Zevesin

If you miss a dose of Zevesin, 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 than once a day. If you have any doubts, you should consult your doctor or pharmacist.

Stopping the use of Zevesin

If you stop using Zevesin, the symptoms of an overactive bladder may return or worsen. Stopping the use of Zevesin should always be consulted with your doctor. If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zevesin 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. Some patients taking solifenacin succinate have reported angioedema (a form of allergic skin reaction that causes swelling of the tissue just below the skin surface) with swelling of the airways (difficulty breathing). If you experience angioedema, you should immediately stop using Zevesin and start appropriate treatment and/or take appropriate measures. Zevesin 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, dyspepsia with symptoms such as: feeling of a full stomach, abdominal pain, belching, nausea, heartburn, discomfort in the abdominal cavity.

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

• urinary tract infection, cystitis (inflammation of the bladder),
• drowsiness, taste disturbances,
• dry eye syndrome,
• dryness in the nasal cavity,
• gastroesophageal reflux disease (gastroesophageal reflux), dryness in the throat,
• dry skin,
• difficulty urinating,
• fatigue, swelling of the lower limbs.

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

• dizziness, headaches,
• accumulation of hard stool in the colon; obstruction (blockage) of the colon,
• vomiting,
• itching, rash,
• difficulty urinating despite a full bladder (urinary retention).

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

• hallucinations, confusion,
• 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 disorders,
• delirium
• increased eye pressure,
• ECG changes, irregular heartbeat, palpitations, rapid heartbeat,
• voice disorders,
• intestinal obstruction (blockage), discomfort in the abdominal cavity
• liver function disorders, abnormal liver test results
• redness and peeling of the skin (exfoliative dermatitis)
• muscle weakness,
• kidney function disorders,
• anaphylactic reaction.

Reporting side effects

If you experience any side effects, including any side effects not listed in the 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, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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 or its representative in Poland. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Zevesin

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton/blister after: Expiry Date (EXP)/EXP. The expiry date refers to the last day of the given month. There are no special precautions for storage. Store in the original packaging to protect from light. 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 packaging and other information

What Zevesin contains

• The active substance of Zevesin is solifenacin succinate in a quantity of 5 mg or 10 mg.
• The other ingredients are corn starch, lactose monohydrate, microcrystalline cellulose, hypromellose 2910/5, magnesium stearate, macrogol 6000, titanium dioxide (E 171), yellow iron oxide (E 172) - Zevesin 5 mg, red iron oxide (E 172) - Zevesin 10 mg, talc.

What Zevesin looks like and contents of the pack

Zevesin 5 mg is a white to yellowish, lens-shaped, film-coated tablet with a diameter of 8.0-8.2 mm. Zevesin 10 mg is a pink, lens-shaped, film-coated tablet with a diameter of 10.0-10.2 mm. Zevesin is packaged in blisters containing 10, 30, 50, 90, or 100 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Zentiva k.s., U kabelovny 130, Dolni Mĕcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

Saneca Pharmaceuticals a.s., Nitrianska 100, Hlohovec, 920 27, Slovakia. For more detailed information, you should contact the representative of the marketing authorization holder: Zentiva Polska Sp. z o.o., ul. Bonifraterska 17, 00-203 Warsaw, tel: +48 22 375 92 00. Date of last revision of the leaflet: June 2024