ZEVESIN 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Zevesin, 5 mg, film-coated tablets
3. Zevesin, 10 mg, film-coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
4. What is Zevesin and what is it used for
5. Important information before taking Zevesin
   1. When not to take Zevesin:
   2. Warnings and precautions
   3. Children and adolescents
   4. Zevesin and other medicines
   5. Zevesin with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Zevesin contains lactose monohydrate
6. How to take Zevesin
   1. Taking a higher dose of Zevesin than recommended
   2. Missing a dose of Zevesin
   3. Stopping treatment with Zevesin
7. Possible side effects
   1. Reporting side effects
8. How to store Zevesin
9. Contents of the pack and other information
   1. What Zevesin contains
   2. What Zevesin looks like and contents of the pack
   3. Marketing authorization holder and manufacturer:
   4. Marketing authorization holder
   5. Manufacturer

Package Leaflet: Information for the User

Zevesin, 5 mg, film-coated tablets

Zevesin, 10 mg, film-coated tablets

Solifenacin succinate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, 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, please inform your 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 taking Zevesin
• 3. How to take Zevesin
• 4. Possible side effects
• 5. How to store Zevesin
• 6. Contents of the pack and other information

1. What is Zevesin and what is it used for

The active substance of Zevesin belongs to a group of cholinergic antagonists. These drugs reduce the activity of an overactive urinary bladder. This action allows for longer intervals between visits to 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 taking Zevesin

When not to take Zevesin:

• in patients with hypersensitivity (allergy) to solifenacin or any of the other ingredients of this medicine (listed in section 6).
• if the patient cannot urinate or cannot empty the urinary bladder (urinary retention).
• if the patient has severe stomach or intestinal disorders (toxic megacolon, a complication associated with ulcerative colitis).
• in patients with a muscle disease called myasthenia gravis, which can cause significant weakness of some muscles.
• if the patient has increased fluid pressure in the eyeball, which progresses with gradual vision loss (narrow-angle glaucoma).
• if the patient is undergoing hemodialysis procedures.
• in patients with severe liver function disorders.
• if the patient has severe kidney disease or moderate liver disease and is taking medications 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 take Zevesin, you should discuss it with your doctor or pharmacist:

• if the patient has difficulty emptying the urinary bladder (narrowing of the urine outflow tract) or urinating (weak urine stream). In such cases, 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 slowing down the movement of the digestive tract (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 severe stomach pain (hiatal 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 drug that acts on specific bacteria).

Children and adolescents

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

Zevesin and other medicines

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

• other cholinergic antagonists, as concomitant use of both medicines may lead to increased therapeutic and adverse effects.
• cholinergic receptor agonists, as they may weaken the effect of Zevesin.
• gastrointestinal motility enhancers, such as metoclopramide and cisapride, as Zevesin may weaken their effect.
• drugs such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they slow down the metabolism of Zevesin.
• drugs such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of Zevesin.
• drugs 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, ask your doctor or pharmacist for advice before taking this medicine. You should not take Zevesin during pregnancy, unless it is absolutely necessary. You should not take 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 been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Zevesin

Zevesin should always be taken as directed by your doctor. If you are unsure, you should contact your doctor or pharmacist. The usual dose is 5 mg once daily, unless your doctor recommends taking a dose of 10 mg once daily. 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 contact your doctor if the effect of the medicine is too strong or too weak.

Taking 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 contact your doctor or pharmacist immediately. 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 are unsure, you should contact your doctor or pharmacist.

Stopping treatment with Zevesin

If you stop taking Zevesin, the symptoms of an overactive bladder may return or worsen. Stopping treatment with Zevesin should always be discussed with your doctor. If you have any further questions about taking this medicine, you should contact 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 inform your doctor or pharmacist immediately. Some patients taking solifenacin succinate have reported angioedema (a form of allergic skin reaction that causes swelling of the tissue just below the surface of the skin) with swelling of the airways (difficulty breathing). If you experience angioedema, you should stop taking Zevesin and seek medical attention. 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, indigestion with symptoms such as: feeling of fullness in the 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 nose,
• gastroesophageal reflux disease (gastroesophageal reflux), dry 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 may cause heart rhythm disturbances,
• delirium
• increased eye pressure,
• ECG changes, irregular heartbeat, palpitations, rapid heartbeat,
• voice disorders,
• intestinal obstruction (blockage), abdominal discomfort
• 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 those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of 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: [email protected]. 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 this 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 EXP. The expiry date refers to the last day of that month. There are no special precautions for storage. Store in the original package to protect from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Zevesin contains

• The active substance of Zevesin is solifenacin succinate in a dose of 5 mg or 10 mg.
• The other ingredients are maize 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, please 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