Veloxsol

Poland
Brand name Veloxsol
Form tablets, dispersible in the oral cavity
Active substance / Dosage
solifenacin succinate · 5 mg
Prescription type Prescription only
ATC code
G04BD08
Registration number 100420578
Manufacturer Laboratori Fundació Dau

Table of Contents

Package leaflet: Information for the user

VELOXSOL, 5 mg, orodispersible tablets
succinate solifenacin
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

  • Keep this leaflet as you may need to read it again.
  • 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. It may harm other people, even if their symptoms are the same as yours.
  • If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

  1. What VELOXSOL is and what it is used for
  2. What you need to know before you take 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 bathroom visits 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 pass urine without prior bladder pressure; frequent urination; and 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 disease (including toxic megacolon, a complication associated with ulcerative colitis)
  • if the patient has a muscle disorder called myasthenia gravis, 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 moderately severe liver disease AND is also being treated with medicines that may slow down elimination of VELOXSOL from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this applies to you.

Before starting treatment with VELOXSOL, tell your doctor if the patient
has or has ever had any of the conditions listed above.
Warnings and precautions
Before starting treatment with VELOXSOL, discuss with your 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 movement of the stomach and intestines) – your doctor will provide further information on this.
  • if the patient has serious kidney disease.
  • if the patient has moderately severe liver disease.
  • 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 your doctor if the patient has or has ever had any of the conditions listed above.

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

  • other anticholinergic medicines, as the therapeutic effect and side effects of both medicines may be increased.
  • cholinergic medicines, as they may reduce the effect of this medicine.
  • medicines such as metoclopramide and cisapride, which increase 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 diseases), as they may slow down the metabolism of this medicine in the body.
  • medicines such as rifampicin, phenytoin and carbamazepine, as they may increase 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
Unless specifically advised by a doctor, this medicine should not be used during pregnancy.
This medicine should not be used during breastfeeding, as solifenacin may pass into human milk. Consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
VELOXSOL may cause blurred vision and, occasionally, drowsiness or fatigue.
If the patient experiences such side effects, driving vehicles or operating machinery should be avoided.
VELOXSOL contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use VELOXSOL

Instructions for proper use
This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor 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, depending on patient preference.
The recommended dose is 5 mg once daily, unless the physician has advised a dose of 10 mg once daily.

Three-step instruction diagram showing four squares with circles, one square with a circle and an arrow, and one square with a circle and a downward-pointing arrow
  1. Separate a single blister from the others 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 VELOXSOL has been accidentally swallowed
by a child, contact your doctor 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 in the bladder (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.
In case of doubt, consult your doctor or pharmacist.

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

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.
If an allergic attack or severe skin reaction (e.g. blistering and peeling of the skin) occurs, the doctor or pharmacist should be informed immediately.
Angioedema (an allergic skin reaction causing swelling of 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 discontinued immediately and appropriate treatment and/or precautionary measures initiated.
The VELOXSOL medicine may cause the following adverse reactions:

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 discomfort in the abdomen.

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

  • urinary tract infection, bladder infection,
  • somnolence, disturbances in taste sensation (dysgeusia),
  • dry (irritated) eyes,
  • dryness of the nasal cavity,
  • gastroesophageal reflux disease (gastroesophageal reflux), dry throat,
  • dry skin,
  • difficulty in urination,
  • fatigue, fluid accumulation in the lower limbs (oedema).

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

  • faecal impaction (accumulation of hardened stool in the colon),
  • urinary retention (accumulation of urine 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 (frequency 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 disorders,
  • muscle weakness,
  • kidney function disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions 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.: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps 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 in use. Proper disposal helps protect the environment.
Store below 25°C.

6. Contents of the packaging and other information

What Veloxsol contains

  • The active substance is solifenacin succinate 5 mg.
  • The other ingredients are potassium polycrylate, hypromellose, mannitol, sucralose, peppermint flavour, lactose monohydrate, sodium croscarmellose, menthol flavour, sodium stearyl fumarate.

What Veloxsol looks like and contents of the pack
Veloxsol 5 mg orodispersible tablets are white, round, biconvex tablets with the inscription "5" embossed on one side.
Veloxsol 5 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
3110 Noáin (Navarra)
Spain

This medicinal product is authorised for marketing in 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