Veloxsol

Poland
Brand name Veloxsol
Form tablets, dispersible in the oral cavity
Active substance / Dosage
solifenacin succinate · 10 mg
Prescription type Prescription only
ATC code
G04BD08
Registration number 100420584
Manufacturer Laboratori Fundació Dau

Table of Contents

Package leaflet:

information for the user
VELOXSOL, 10 mg, orodispersible tablets
solifenacin succinate
Please read all of this leaflet carefully before taking this medicine because it contains
important information for the patient.

  • Keep this leaflet so that you can read it again if necessary.
  • If you have any further questions, please ask your doctor or pharmacist.
  • This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
  • If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:

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

The active substance in VELOXSOL belongs to a group of medicines called anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This allows for a longer time between trips to the toilet and increases the amount of urine the patient can hold in the bladder.
VELOXSOL is used in the treatment of symptoms of a condition called overactive bladder.
These symptoms include: a sudden, strong need to urinate without prior bladder pressure; frequent urination; urinary incontinence due to the inability to reach the toilet in time.

2. Important information before using VELOXSOL

When not to use VELOXSOL

  • if the patient is unable to pass urine or empty the bladder (urinary retention)
  • if the patient has a severe stomach or intestinal disorder (including toxic megacolon, a complication associated with ulcerative colitis)
  • if the patient has a muscle disorder called myasthenia, which may cause significant weakness of certain muscles
  • if the patient has increased pressure in the eye with progressive loss of vision (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 impairment AND is also being treated with medicines that may delay elimination of VELOXSOL from the body (e.g. ketoconazole). The doctor or pharmacist will inform the patient if this applies.

Before starting treatment with VELOXSOL, tell the doctor if the patient
has or has ever had any of the conditions listed above.
Warnings and precautions
Before taking VELOXSOL, discuss this with the doctor or pharmacist

  • if the patient has difficulty emptying the bladder (bladder outlet obstruction) or has problems passing urine (e.g. weak urine stream). The risk of urine accumulating in the bladder (urinary retention) is then significantly increased.
  • if the patient has gastrointestinal obstruction (constipation).
  • if the patient is at risk of slowed gastrointestinal motility (slowed stomach and intestinal movements) – the doctor will provide information on this.
  • if the patient has serious kidney disease.
  • if the patient has moderate liver impairment.
  • if the patient has severe stomach pain (hiatal hernia) or heartburn.
  • if the patient has nervous system disorders (autonomic neuropathy). Children and adolescents VELOXSOL must not be used in children and adolescents under 18 years of age. Before starting treatment with this medicine, tell the doctor if the patient has or has ever had any of the conditions listed above.

Before starting treatment with this medicine, the doctor will assess whether there are other causes of frequent urination (e.g. circulatory failure – insufficient heart muscle strength to pump blood, or kidney disease). In case of urinary tract infection, the doctor will prescribe an antibiotic (a medicine effective against specific bacterial infections).
VELOXSOL and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
It is especially important to inform the doctor if the patient is taking:

  • other anticholinergic medicines, as the therapeutic effect and side effects of both medicines may be intensified.
  • cholinergic medicines, as they may reduce the effect of this medicine.
  • medicines such as metoclopramide and cisapride, which accelerate gastrointestinal motility. This medicine may reduce their effect.
  • medicines such as ketoconazole, itraconazole (used to treat fungal infections), ritonavir, nelfinavir (used to treat HIV infections), verapamil and diltiazem (used to treat high blood pressure and heart conditions), as they slow down the metabolism of this medicine in the body.
  • medicines such as rifampicin, phenytoin and carbamazepine, as they may accelerate the metabolism of VELOXSOL.
  • medicines such as bisphosphonates, which may cause or worsen inflammation of the oesophagus (oesophagitis). VELOXSOL with food and drink This medicine can be taken with food or between meals, depending on patient preference.

Pregnancy and breastfeeding
This medicine must not be used during pregnancy unless clearly prescribed by the doctor.
This medicine must not be used during breastfeeding, as solifenacin may pass into human milk. Consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
VELOXSOL may cause blurred vision and, occasionally, drowsiness or fatigue. If such side effects occur, the patient should not drive or operate machinery.
VELOXSOL contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take VELOXSOL

Instructions for proper use
This medicine should always be taken as directed by the physician. If in doubt, consult the
physician or pharmacist.
The tablets should be taken orally. The tablet should be sucked until completely dissolved.
This medicine may be taken with food or between meals, according to patient preference.
The recommended dose is 5 mg once daily, unless the physician has advised taking a dose of 10 mg once daily.

Three-step instructional diagram showing square fields with circles, an arrow pointing to a field, and an arrow moving an element downward
  1. Separate a single blister from the rest by tearing along the perforation
  2. Remove the foil from the blister, starting at the corner with the printed arrow, peeling 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 completely dissolved

Use of a higher than recommended dose of VELOXSOL
If too many VELOXSOL tablets have been taken, or if a child has accidentally swallowed the medicine,
contact a physician or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision,
seeing things that are not there (hallucinations), excessive excitement, seizures (convulsions),
difficulty breathing, rapid heartbeat (tachycardia), urine retention (urinary retention), and dilated pupils.

Missed 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 almost time for the next dose. Never take more than one dose of the medicine per day.
If in doubt, consult the physician or pharmacist.

Stopping treatment with VELOXSOL
If the patient stops taking VELOXSOL, symptoms of overactive bladder may return or worsen.
Always consult the physician if the patient plans to discontinue treatment.
For any further questions regarding the use of this medicine, consult the physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
If an allergic attack or a severe skin reaction (e.g. blistering and peeling of the skin) occurs, inform your doctor or pharmacist immediately.
Angioedema (a skin allergy causing swelling in the tissue just beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate (VELOXSOL). If a patient develops angioedema, treatment with solifenacin succinate (VELOXSOL) must be stopped immediately and appropriate treatment and/or precautionary measures should be initiated.
The VELOXSOL medicine may cause the following adverse 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 bloating, abdominal pain, belching, nausea and heartburn (dyspepsia), feeling of abdominal discomfort.

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

  • urinary tract infection, bladder infection,
  • somnolence, taste disturbances (dysgeusia),
  • dryness (irritation) of the eyes,
  • dryness of the nose,
  • gastroesophageal reflux disease (acid reflux), dryness of the throat,
  • dry skin,
  • difficulty in urination,
  • fatigue, fluid accumulation in the lower limbs (peripheral edema).

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

  • accumulation of hardened stool in the colon (fecal impaction),
  • urinary retention (urine retention in the bladder 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 (cannot be estimated from the available data):

  • decreased appetite, high levels of potassium in the blood which may cause irregular heart rhythm,
  • increased intraocular pressure,
  • changes in heart electrical activity (ECG), irregular heartbeat, palpitations, rapid heartbeat,
  • voice disorders,
  • liver function abnormalities,
  • muscle weakness,
  • kidney function disorders.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring 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, website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the 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 stated on the packaging after: "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
Store below 25°C.

6. Contents of the package and other information

What VELOXSOL contains

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

What VELOXSOL looks like and contents of the pack
VELOXSOL 10 mg orodispersible tablets are white, round, biconvex tablets.
VELOXSOL 10 mg orodispersible tablets are available in blister packs containing 3, 5, 10, 20, 30, 50, 60, 90, 100 or 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the European Economic Area countries 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