Zevesin

Package leaflet: Information for the user

Zevesin, 5 mg, coated tablets
Zevesin, 10 mg, coated tablets
Solifenacin succinate
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, 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 another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Leaflet contents:

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

The active substance in Zevesin belongs to the group of cholinolytic medicines. These medicines reduce the activity of an overactive bladder. This effect allows longer intervals between toilet visits and increases the amount of urine the bladder can hold.
Zevesin is used to treat symptoms of overactive bladder. These include urgency, which is a sudden, compelling need to pass urine, frequent urination, and urinary incontinence resulting from the inability to reach the toilet in time.

2. Important information before using Zevesin

When not to use Zevesin:

• in patients with hypersensitivity (allergy) to solifenacin or any of the other ingredients of this medicine (listed in section 6).
• in patients unable to pass urine or empty the bladder (urinary retention).
• in patients with severe gastrointestinal disorders (toxic megacolon, a complication associated with ulcerative colitis).
• in patients suffering from a muscle disease called myasthenia gravis, which may cause significant weakness of certain muscles.
• in patients with increased intraocular pressure leading to progressive loss of vision (narrow-angle glaucoma).
• in patients undergoing hemodialysis procedures.
• in patients with severe liver function impairment.
• in patients with severe kidney disease or moderate liver disease who are also taking medicines that may delay the elimination of Zevesin from the body (e.g. ketoconazole). Your doctor or pharmacist will provide information on this.

Warnings and precautions
Before starting treatment with Zevesin, discuss the following 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 higher.
• if the patient suffers from gastrointestinal motility disorders (constipation).
• if there is a risk of slowed gastrointestinal motility (peristalsis). Your doctor will provide further information on this.
• if the patient has severe kidney function impairment.
• if the patient has moderate liver function impairment.
• if the patient suffers from severe stomach pain (hiatal hernia) or heartburn (gastroesophageal reflux).
• if the patient has disorders of the nervous system (autonomic neuropathy).

Before starting treatment with Zevesin, inform your doctor if any of the above conditions are currently present or have occurred in the past.
Before initiating treatment with Zevesin, your doctor will assess whether there are other possible causes of frequent urination (e.g. heart failure – insufficient cardiac muscle strength to pump blood effectively – or kidney disease). If a urinary tract infection occurs, your doctor will prescribe an antibiotic (an antibacterial agent effective against the specific bacteria involved).

Children and adolescents
Zevesin must not be used in children or adolescents under 18 years of age.

Zevesin and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use.

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

• other anticholinergic medicines, as concomitant use may enhance both therapeutic effects and adverse reactions.
• cholinergic receptor agonists, as they may reduce the effectiveness of Zevesin.
• drugs that enhance gastrointestinal motility, such as metoclopramide and cisapride, as Zevesin may reduce their effectiveness.
• drugs such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, which may slow down the metabolism of Zevesin.
• drugs such as rifampicin, phenytoin, carbamazepine, which may accelerate the metabolism of Zevesin.
• drugs such as bisphosphonates, which may cause or worsen esophagitis.

Zevesin with food, drink, and alcohol
Zevesin may be taken during or independent of meals.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Zevesin must not be used during pregnancy unless absolutely necessary.
Zevesin must not be used during breastfeeding, as solifenacin passes into breast milk.

Driving and operating machinery
Zevesin may cause blurred vision, and less frequently drowsiness and fatigue. If these adverse effects occur, patients should not drive or operate any machinery.

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

3. How to take Zevesin

Zevesin should always be taken as directed by your doctor. If you have any doubts, you should
contact your doctor or pharmacist.
The usual dose is 5 mg once daily, unless your doctor recommends a dose of 10 mg once daily.
Zevesin should be taken at the same time each day.
The tablet should be swallowed whole with liquid. The medicine can be taken with or without food,
according to your preference. Do not crush the tablets.
If the effect of the medicine is too strong or too weak, contact your doctor.

Taking more Zevesin than recommended
If you have taken too many Zevesin tablets, or if a child accidentally swallows Zevesin,
contact your doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, visual disturbances,
hallucinations, excessive agitation, seizures (convulsions), breathing difficulties, rapid heartbeat
(tachycardia), urine retention (urinary retention), and dilated pupils.

If you miss a dose of Zevesin
If you miss a dose, take the next dose as soon as possible, unless it is almost time for your next scheduled dose.
Do not take the medicine more than once a day. If you are unsure, consult your doctor or pharmacist.

Stopping Zevesin treatment
If you stop taking Zevesin, symptoms of overactive bladder may return or worsen. Stopping treatment should always be discussed with your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences an allergic attack or a severe skin reaction (e.g. blistering and peeling of the skin),
the doctor or pharmacist should be informed immediately.
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 in some patients taking solifenacin succinate. If angioedema occurs in the patient, treatment with Zevesin should be stopped immediately and appropriate treatment and/or corrective measures should be initiated.

Zevesin may cause other adverse reactions listed below:

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

• dry mouth sensation.

Common (may occur in less than 1 in 10 people):

• blurred vision,
• constipation, nausea, dyspepsia with symptoms such as: feeling of full stomach, abdominal pain, belching, nausea, heartburn, feeling of discomfort in the abdominal cavity.

Uncommon (may occur in less than 1 in 100 people):

• urinary tract infection, bladder infection (cystitis),
• somnolence, taste disturbances,
• dry eye syndrome,
• nasal dryness,
• gastroesophageal reflux disease (GERD), throat dryness,
• skin dryness,
• difficulty passing urine,
• fatigue, peripheral edema.

Rare (may occur in less than 1 in 1000 people):

• dizziness, headache,
• accumulation of hard stool in the colon; colon obstruction (ileus),
• vomiting,
• itching, rash,
• difficulty passing urine despite a full bladder (urinary retention).

Very rare (may occur in less than 1 in 10,000 people):

• hallucinations, confusion,
• allergic rash.

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

• decreased appetite, increased blood potassium levels which may cause cardiac arrhythmia,
• delirium,
• increased intraocular pressure,
• ECG changes, irregular heartbeat, palpitations, tachycardia,
• voice disturbances,
• intestinal obstruction (ileus), abdominal discomfort,
• liver function disorders, abnormal liver function tests,
• skin redness and peeling (exfoliative skin inflammatory condition),
• muscle weakness,
• kidney function disorders,
• anaphylactic reaction.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration 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].
Adverse reactions can also be reported to the marketing authorization holder or its representative in Poland.
Reporting adverse reactions allows gathering further information on the safety of the medicine.

5. How to store Zevesin medicine

Keep this medicine 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 specified month.
No special storage instructions apply.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This practice helps protect the environment.

6. Contents of the pack and other information

What Zevesin contains

• The active substance is solifenacin succinate, 5 mg or 10 mg
• The other ingredients are pregelatinized starch, monohydrate lactose, 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 white to yellowish, biconvex coated tablets with a diameter of 8.0–8.2 mm.
Zevesin 10 mg is pinkish, biconvex coated tablets with a diameter of 10.0–10.2 mm.
Zevesin is packed in blisters containing: 10, 30, 50, 90 or 100 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation 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 further information, please contact the representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw, Poland
tel: + 48 22 375 92 00