Solifenacin Sanexcel

Leaflet attached to the packaging: patient information

Solifenacin SaneXcel, 5 mg, film-coated tablets

Solifenacin SaneXcel, 10 mg, film-coated tablets

Solifenacin succinate

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• 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 you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Solifenacin SaneXcel and what is it used for

The active substance of Solifenacin SaneXcel belongs to a group of medicines called anticholinergics. These medicines reduce the activity of an overactive urinary bladder. This action allows for longer intervals between trips to the toilet and increases the amount of urine held in the bladder. Solifenacin SaneXcel is used to treat symptoms of an overactive bladder. These include: urgent urination, frequent urination, and involuntary loss of urine, as the patient may not be able to get to the toilet in time.

2. Important information before taking Solifenacin SaneXcel

When not to take Solifenacin SaneXcel:

• if the patient is unable to urinate or empty their bladder (urinary retention)
• if the patient has severe stomach or intestinal diseases (toxic megacolon, a complication of ulcerative colitis)
• if the patient has a muscle disease called myasthenia gravis, which can cause significant weakness of some muscles
• if the patient has increased pressure in the eyeball, which can lead to gradual vision loss (glaucoma)
• if the patient is allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6)
• if the patient is undergoing kidney dialysis
• if the patient has severe liver function disorders
• if the patient has severe kidney function disorders or moderate liver function disorders and is taking medicines that may delay the elimination of solifenacin from the body (e.g., ketoconazole). The doctor or pharmacist will provide information on this.

Before starting treatment with Solifenacin SaneXcel, inform your doctor if any of the above situations are currently present or have occurred in the past.

Warnings and precautions

Before starting treatment with Solifenacin SaneXcel, discuss it with your doctor, pharmacist, or nurse:

• if the patient has difficulty emptying their 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 the patient has gastrointestinal motility disorders (constipation).
• if there is a risk of slowed gastrointestinal motility (gastrointestinal movement). 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 burning stomach pain (hiatal hernia) or heartburn.
• if the patient has autonomic nervous system disorders (autonomic neuropathy).

Children and adolescents

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

Before starting treatment with Solifenacin SaneXcel, inform your doctor if any of the above situations are currently present or have occurred in the past. Before starting treatment with Solifenacin SaneXcel, the doctor will assess whether there are other causes of frequent urination (e.g., heart failure - insufficient heart muscle strength to pump blood or kidney disease). If a urinary tract infection occurs, the doctor will prescribe an antibiotic (an antibacterial medicine).

Solifenacin SaneXcel and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. It is especially important to inform your doctor if you are taking:

• other anticholinergic medicines, as the effects and side effects of both medicines may be enhanced.
• cholinergic medicines, as they may weaken the effect of solifenacin.
• medicines such as metoclopramide and cisapride, which accelerate gastrointestinal motility. Solifenacin may weaken their effect.
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, as they slow down the metabolism of Solifenacin SaneXcel in the body.
• medicines such as rifampicin, phenytoin, and carbamazepine, as they may accelerate the metabolism of Solifenacin SaneXcel in the body.
• medicines such as bisphosphonates, as they may cause esophageal inflammation or worsen it.

Solifenacin SaneXcel with food and drink

Solifenacin SaneXcel can be taken with or without food, depending on the patient's preference.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Pregnancy Do not take Solifenacin SaneXcel during pregnancy, unless it is absolutely necessary. Breastfeeding Do not take Solifenacin SaneXcel during breastfeeding, as solifenacin passes into human milk.

Driving and using machines

Solifenacin may cause blurred vision and sometimes drowsiness or fatigue. If such side effects occur, do not drive or operate machinery.

Solifenacin SaneXcel contains lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Solifenacin SaneXcel

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist. Swallow the tablet whole with a drink of water. You can take Solifenacin SaneXcel with or without food. Do not crush the tablets. The usual dose is 5 mg once daily, unless your doctor advises you to take a dose of 10 mg once daily.

Taking more than the recommended dose of Solifenacin SaneXcel

If you take more Solifenacin SaneXcel than you should or if a child accidentally swallows some, contact your doctor or pharmacist immediately. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, seeing things that are not there (hallucinations), excessive excitement, seizures (convulsions), breathing difficulties, rapid heartbeat (tachycardia), and urinary retention.

Missing a dose of Solifenacin SaneXcel

If you miss a dose, take the next dose as soon as possible, unless it is almost time for the next dose. Do not take more than one dose in 24 hours. If you are unsure, consult your doctor or pharmacist.

Stopping treatment with Solifenacin SaneXcel

If you stop taking Solifenacin SaneXcel, the symptoms of an overactive bladder may return or worsen. Always consult your doctor if you are considering stopping treatment. If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Solifenacin SaneXcel can cause side effects, although not everybody gets them. If you experience an allergic reaction or severe skin reaction (e.g., blistering and peeling of the skin), tell your doctor or pharmacist immediately. Some patients taking solifenacin 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, stop taking Solifenacin SaneXcel and seek medical attention. Solifenacin SaneXcel 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 bloating, abdominal pain, belching, and heartburn (indigestion), abdominal discomfort

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

• urinary tract infection, bladder infection
• drowsiness
• taste disturbances
• dry eye syndrome
• dry nose
• gastroesophageal reflux disease (GERD), dry throat
• dry skin
• difficulty urinating
• fatigue, swelling of the lower limbs (edema)

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

• intestinal obstruction (hard stool accumulation in the intestine)
• difficulty urinating despite a full bladder (urinary retention)
• dizziness, headache
• vomiting
• itching, 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, high potassium levels in the blood, which can cause heart rhythm disturbances
• increased eye pressure
• changes in heart electrical activity (ECG), irregular heartbeat, 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, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring, 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, website: https://smz.ezdrowie.gov.pl You can also report side effects 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 Solifenacin SaneXcel

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. There are no special precautions for storage. 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 Solifenacin SaneXcel contains

• The active substance is solifenacin succinate. Each 5 mg film-coated tablet contains 5 mg of solifenacin succinate, which corresponds to 3.8 mg of solifenacin.

Each 10 mg film-coated tablet contains 10 mg of solifenacin succinate, which corresponds to 7.5 mg of solifenacin.

• The other ingredients are: 5 mg tablets: Core: corn starch, lactose monohydrate, hypromellose, and magnesium stearate Coating: hypromellose, talc, titanium dioxide (E 171), macrogol, and yellow iron oxide (E 172).

10 mg tablets: Core: corn starch, lactose monohydrate, hypromellose, and magnesium stearate Coating: hypromellose, talc, titanium dioxide (E 171), macrogol, and red iron oxide (E 172).

What Solifenacin SaneXcel looks like and contents of the pack

5 mg: Yellow, round, and convex film-coated tablets. 10 mg: Light pink, round, and convex film-coated tablets. Solifenacin SaneXcel film-coated tablets are available in blisters containing 30 or 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder J.J. Bishop Health a.s. Rybná 682/14, Staré Město 110 00 Prague 1 Czech Republic e-mail: pharmacovigilance@jjbishop.eu Manufacturer Atlantic Pharma – Produções Farmacêuticas, S.A. Rua de Tapada Grande 2, Abrunheira 2710-228 Sintra Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic: Solifenacin SaneXcel Poland: Solifenacin SaneXcel Portugal: Solifenacina JJ Bishop Slovakia: Solifenacin SaneXcel

Date of last revision of the leaflet: