VELOXSOL 5 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. VELOXSOL, 5 mg, orally disintegrating tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is VELOXSOL and what is it used for
4. Important information before taking VELOXSOL
   1. When not to take VELOXSOL
   2. Warnings and precautions
   3. Children and adolescents
   4. This medicine should not be used in children and adolescents under 18 years of age.
   5. VELOXSOL and other medicines
   6. VELOXSOL with food and drink
   7. Pregnancy and breastfeeding
   8. Driving and operating machines
   9. VELOXSOL contains lactose
5. How to take VELOXSOL
   1. Instructions for proper use
   2. Taking a higher dose of VELOXSOL than recommended
   3. Missing a dose of VELOXSOL
   4. Stopping treatment with VELOXSOL
6. Possible side effects
   1. Reporting side effects
7. How to store VELOXSOL
8. Contents of the packaging and other information
   1. What VELOXSOL contains
   2. What VELOXSOL looks like and contents of the packaging
   3. Marketing authorization holder
   4. Intas Third Party Sales 2005 S.L.
   5. Manufacturer
   6. Idifarma Desarrollo Farmacéutico, S.L.
   7. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   8. Date of last revision of the leaflet:

Leaflet accompanying the packaging: information for the user

VELOXSOL, 5 mg, orally disintegrating 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 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is VELOXSOL and what is it used for

The active substance of VELOXSOL belongs to a group of anticholinergic medicines. These medicines are used to reduce the activity of an overactive bladder. This allows for a longer period of time between visits to the bathroom and increases the amount of urine that the patient can hold in the bladder.

VELOXSOL is used to treat the symptoms of a condition called overactive bladder.

These symptoms include: a sudden, urgent need to urinate without prior pressure on the urinary bladder; frequent urination, incontinence due to the fact that the patient did not have time to use the toilet.

2. Important information before taking VELOXSOL

When not to take VELOXSOL

• if the patient is unable to urinate or empty the urinary bladder (urinary retention)
• if the patient has severe stomach or intestinal disease (including toxic megacolon, a complication associated with 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 eye pressure with 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 dialysis
• if the patient has severe liver disease
• if the patient has severe kidney disease or moderate liver disease AND is being treated with medicines that may delay the elimination of VELOXSOL from the body (e.g. ketoconazole). The doctor or pharmacist will inform the patient if this applies to them.

Before starting to take VELOXSOL, the patient should tell their doctor if they have or have had any of the above situations.

Warnings and precautions

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

• if the patient has difficulty emptying the bladder (bladder obstruction) or has difficulty urinating (e.g. weak urine stream). The risk of urine accumulation in the urinary bladder (urinary retention) is then much higher.
• if the patient has intestinal obstruction (constipation).
• if the patient is at risk of slowed gastrointestinal motility (slowing of stomach and intestinal movements) - the doctor will provide information on this.
• if the patient has severe kidney disease.
• if the patient has moderate liver disease.
• if the patient has a tearing stomach pain (hiatus hernia) or heartburn.
• if the patient has nervous system disorders (autonomic nervous system neuropathy).

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age.

Before starting to take this medicine, the patient should tell their doctor if they have or have had any of the above situations.

Before starting treatment with this medicine, 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). In case of a urinary tract infection, the doctor will prescribe an antibiotic (a medicine that acts against certain bacterial infections).

VELOXSOL and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.

• other anticholinergic medicines, as the therapeutic effect and side effects of both medicines may be enhanced.
• cholinergic medicines, as they may weaken the effect of this medicine.
• medicines such as metoclopramide and cisapride, which speed up gastrointestinal motility. This medicine may weaken their effect.
• medicines such as ketoconazole, itraconazole (medicines used to treat fungal infections), ritonavir, nelfinavir (medicines used to treat HIV infections), verapamil and diltiazem (medicines used to treat high blood pressure and heart disease), as they slow down the metabolism of this medicine by the body
• medicines such as rifampicin, phenytoin and carbamazepine, as they may speed up the metabolism of VELOXSOL.
• medicines such as bisphosphonates, which may cause or exacerbate esophageal inflammation (esophagitis).

VELOXSOL with food and drink

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

Pregnancy and breastfeeding

If the doctor has not explicitly recommended the use of this medicine, it should not be used during pregnancy.

This medicine should not be used during breastfeeding, as solifenacin may pass into human milk. Before taking this medicine, the patient should consult their doctor or pharmacist.

Driving and operating machines

VELOXSOL may cause blurred vision, and sometimes drowsiness or fatigue.

If the patient experiences such side effects, they should not drive or operate machines.

VELOXSOL contains lactose

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

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take VELOXSOL

Instructions for proper use

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.

The tablets should be taken orally. The tablet should be sucked until it is completely dissolved.

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

The recommended dose is 5 mg per day, unless the doctor has recommended a dose of 10 mg per day.

perforation.

• 1. Separate a single blister from the others by tearing it along

• 2. Remove the foil from the blister, starting from the corner with the printed arrow, tearing the foil in the direction of the arrow.
• 3. Completely remove the foil from the blister to access the tablet. Carefully remove the tablet from the blister. Place the tablet in the mouth and suck until it is completely dissolved.

Taking a higher dose of VELOXSOL than recommended

In case of taking too many VELOXSOL tablets or accidental ingestion of VELOXSOL by a child, the patient should immediately contact their doctor or pharmacist.

Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, hallucinations, excessive excitement, convulsions, breathing difficulties, rapid heartbeat, urinary retention, and dilated pupils.

Missing a dose of VELOXSOL

If the patient forgets to take the medicine at the usual time, they should take the tablet as soon as they remember, unless it is close to the time for the next dose. Never take more than one dose of the medicine per day. In case of doubts, the patient should consult their doctor or pharmacist.

Stopping treatment with VELOXSOL

If the patient stops taking VELOXSOL, the symptoms of overactive bladder may return or worsen. The patient should always consult their doctor if they plan to stop treatment.

In case of any further doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, VELOXSOL can cause side effects, although not everybody gets them.

If an allergic reaction or severe skin reaction (e.g. blisters and peeling of the skin) occurs, the patient should immediately inform their doctor or pharmacist.

Angioedema (an allergic skin reaction causing swelling in the tissue just below the skin surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate (VELOXSOL). If the patient experiences angioedema, they should immediately stop treatment with solifenacin succinate (VELOXSOL) and initiate appropriate treatment and/or take appropriate precautions.

VELOXSOL may cause the following side effects:

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 full in the stomach, stomach pain, belching, nausea, and heartburn (dyspepsia), feeling of discomfort in the stomach.

Uncommon (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection,
• drowsiness, taste disturbances (taste disorders),
• eye dryness (irritation of the eyes),
• nasal dryness,
• 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)

• impaction of a large amount of hardened stool in the large intestine (fecal impaction),
• urinary retention due to inability to empty the bladder,
• 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 irregular heartbeat,
• increased eye pressure,
• changes in the electrical activity of the heart (ECG), irregular heartbeat, palpitations, rapid heartbeat,
• voice disorders,
• liver function disorders,
• muscle weakness,
• kidney function disorders.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store VELOXSOL

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month stated.

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.

Store in a temperature below 25°C.

6. Contents of the packaging and other information

What VELOXSOL contains

• The active substance of VELOXSOL is solifenacin succinate 5 mg.
• The other ingredients are polacrilin potassium, hypromellose, mannitol, sucralose, peppermint flavor, lactose monohydrate, croscarmellose sodium, menthol flavor, sodium stearylfumarate

What VELOXSOL looks like and contents of the packaging

VELOXSOL, 5 mg, orally disintegrating tablets are white, round, biconvex tablets with the inscription "5" on one side.

VELOXSOL, 5 mg, orally disintegrating tablets are available in blisters containing 3, 5, 10, 20, 30, 50, 60, 90, 100, or 200 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Intas Third Party Sales 2005 S.L.

Edificio World Trade Center

Calle Moll de Barcelona S/N

08039 Barcelona

Spain

Manufacturer

Idifarma Desarrollo Farmacéutico, S.L.

Pol. Mocholi C/ Noáin, 1

3110 Noáin (Navarra)

Spain

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

Spain: VELOXSOL

France: VELOXSOL

Germany: VELOXSOL

Poland: VELOXSOL

Sweden: Veloxsol

Italy: Orodax

Czech Republic: Solifenacin Edest

Austria: Solifenacin Edest

Netherlands: VELOXSOL

Date of last revision of the leaflet: