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

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging 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 cholinolytic 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. Solifenacin SaneXcel 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 Solifenacin SaneXcel

When not to take Solifenacin SaneXcel:

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

Warnings and precautions

Before starting to take Solifenacin SaneXcel, the patient should discuss it with their doctor, pharmacist, or nurse:

Children and adolescents

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

Before starting treatment with Solifenacin SaneXcel, the patient should inform their doctor if any of the above situations are currently present or have occurred in the past. Before starting to take Solifenacin SaneXcel, 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, effective against specific bacterial infections).

Solifenacin SaneXcel and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. It is especially important to inform the doctor if the patient is taking:

• other cholinolytic 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 the digestive tract. 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 exacerbate 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Pregnancy Solifenacin SaneXcel should not be used during pregnancy, unless it is absolutely necessary. Breastfeeding Solifenacin SaneXcel should not be used 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, the patient should not drive or operate machines.

Solifenacin SaneXcel contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Solifenacin SaneXcel

This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist. The tablet should be swallowed whole, with a drink of liquid. The medicine can be taken with or without food, depending on the patient's preference. The tablets should not be crushed. The usual dose is 5 mg per day, unless the doctor recommends taking a dose of 10 mg per day.

Taking a higher dose of Solifenacin SaneXcel than recommended

In case of taking too high a dose of Solifenacin SaneXcel or if a child accidentally swallows the medicine, the patient should immediately contact their doctor or pharmacist. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, perceiving things that are not there (hallucinations), excessive excitement, seizures (convulsions), breathing difficulties, rapid heartbeat (tachycardia), urinary retention, and pupil dilation.

Missing a dose of Solifenacin SaneXcel

In case of missing a dose, the patient should take the next dose as soon as possible, unless it is almost time for the next dose. The medicine should not be taken more than once a day. If the patient has any doubts, they should consult their doctor or pharmacist.

Stopping Solifenacin SaneXcel

In case of stopping Solifenacin SaneXcel, the symptoms of an overactive bladder may return or worsen. The patient should always consult their doctor if they are considering stopping treatment. If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Solifenacin SaneXcel can cause side effects, although not everybody gets them. If the patient experiences an allergic reaction or a severe skin reaction (e.g., blistering and peeling of the skin), they should immediately inform their doctor or pharmacist. Some patients taking solifenacin succinate have reported angioedema (a form of skin allergy that causes swelling of the tissue just below the skin surface) with swelling of the airways (difficulty breathing). If the patient experiences angioedema, they should immediately stop taking Solifenacin SaneXcel and initiate appropriate treatment and/or take appropriate measures. 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 a feeling of fullness in the stomach, stomach pain, belching, and heartburn (indigestion), discomfort in the stomach

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 (gastroesophageal reflux), dry throat
• dry skin
• difficulty urinating
• fatigue, fluid accumulation in the lower limbs (edema)

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

• accumulation of a large amount of hard stool in the colon (obstruction)
• difficulty urinating despite a full bladder (urinary retention)
• dizziness, headache
• nausea and 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 the electrical activity of the heart (ECG), irregular heartbeat, palpitations, rapid heartbeat
• voice disorders
• liver dysfunction
• muscle weakness
• kidney dysfunction

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Solifenacin SaneXcel

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 and blister after EXP. The expiry date refers to the last day of the month. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Solifenacin SaneXcel contains

• The active substance of Solifenacin SaneXcel 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: cornstarch, lactose monohydrate, hypromellose, and magnesium stearate The coating of the tablet: hypromellose, talc, titanium dioxide (E 171), macrogol, and yellow iron oxide (E 172).

10 mg tablets: Core of the tablet: cornstarch, lactose monohydrate, hypromellose, and magnesium stearate The coating of the tablet: 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: