Veloxsol

Package Leaflet:

Information for the user

VELOXSOL, 10 mg, orally disintegrating 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the package 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 pack and other information

1. What is VELOXSOL and what is it used for

The active substance of VELOXSOL belongs to a group of medicines called anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This allows the patient to extend the time between visits to the bathroom and increase the amount of urine that can be held in the bladder.

VELOXSOL is used to treat the symptoms of a condition called overactive bladder. These symptoms include: a sudden, intense 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, tell your doctor if you have or have had any of the above situations.

Warnings and precautions

Before starting to take VELOXSOL, discuss it with your 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 has a risk of slowing down the digestive system (slowing down 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 severe stomach pain (hiatal 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, tell your doctor if you have or have had any of the above situations.

VELOXSOL and other medicines

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.

• 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 the digestive system. 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 food or between meals, depending on the patient's preference.

Pregnancy and breastfeeding

If your doctor has not explicitly recommended taking this medicine, do not take it during pregnancy.

Do not take this medicine while breastfeeding, as solifenacin may pass into breast milk. Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

If you experience such side effects, do not drive or operate machinery.

VELOXSOL contains lactose

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

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Take the tablets orally. Suck the tablet until it is completely dissolved.

This medicine can be taken with food or between meals, depending on the patient's preference.

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

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

• 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 your mouth and suck until it is completely dissolved

Overdose of VELOXSOL

If you have taken too many VELOXSOL tablets or if a child has accidentally swallowed VELOXSOL, contact your doctor or pharmacist immediately.

Overdose symptoms may include: headache, dry mouth, dizziness, drowsiness, blurred vision, hallucinations, excessive excitement, seizures (convulsions), breathing difficulties, rapid heartbeat (tachycardia), urinary retention, and dilated pupils.

Missing a dose of VELOXSOL

If you forget to take your medicine at the usual time, take the tablet as soon as you remember, unless it is almost time for your next dose. Never take more than one dose of VELOXSOL per day. If you are unsure, consult your doctor or pharmacist.

Stopping treatment with VELOXSOL

If you stop taking VELOXSOL, your overactive bladder symptoms may return or worsen. Always consult your doctor if you plan to stop treatment.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience an allergic reaction or severe skin reaction (e.g. blisters and peeling skin), tell your doctor or pharmacist immediately.

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 you experience angioedema, stop taking solifenacin succinate (VELOXSOL) immediately and take appropriate treatment and/or 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, indigestion with symptoms such as bloating, abdominal pain, belching, nausea, and heartburn (indigestion), discomfort in the abdomen.

Uncommon (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection,
• drowsiness, taste disorders (taste disturbances),
• dry eyes,
• 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)

• 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 you experience any side effects, including any not listed in this leaflet, please tell 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.: 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 this medicine.

5. How to store VELOXSOL

Keep this medicine out of the sight and reach of children.

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

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.

Store in a temperature below 25°C.

6. Contents of the pack and other information

What VELOXSOL contains

• The active substance is solifenacin succinate 10 mg.
• The other ingredients are polacrilin potassium, hypromellose, mannitol, sucralose, peppermint flavor, lactose monohydrate, croscarmellose sodium, menthol flavor, sodium stearyl fumarate.

What VELOXSOL looks like and contents of the pack

VELOXSOL, 10 mg, orally disintegrating tablets are white, round, biconvex tablets.

VELOXSOL, 10 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

31110 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: