Veloxsol 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Veloxsol 5 mg orodispersible tablets EFG

solifenacin, succinate

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Veloxsol is and what it is used for
2. What you need to know before taking Veloxol
3. How to take Veloxol
4. Possible adverse effects
5. Storage of Veloxol
6. Package contents and additional information

1. What Veloxsol is and what it is used for

The active substance in this medicine belongs to the anticholinergic group. These medicines are used to reduce the activity of the overactive bladder. This allows you to have more time before needing to go to the toilet and increases the amount of urine your bladder can hold.

Solifenacin is used to treat the symptoms of overactive bladder syndrome. These symptoms include a sudden, strong urge to urinate with no warning, needing to urinate frequently, or leaking urine due to not reaching the toilet in time.

2. What you need to know before starting to take Veloxsol

Do not take Veloxsol:

• if you have difficulty urinating or emptying your bladder completely (urinary retention).
• if you have a serious stomach or intestinal disorder (including toxic megacolon, a complication associated with ulcerative colitis).
• if you have a muscle disease called myasthenia gravis, which can cause extreme weakness of certain muscles.
• if you have high pressure in the eyes with gradual loss of vision (glaucoma).
• if you are allergic to solifenacin or to any of the other ingredients of this medicine (listed in section 6).
• if you are undergoing renal dialysis.
• if you have severe liver disease.
• if you have severe renal disease or moderate liver disease and are simultaneously being treated with medicines that may reduce the elimination of solifenacin from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you if this applies to you.

Before starting treatment with solifenacin, inform your doctor if you have or have had any of the conditions listed above.

Warnings and precautions

Consult your doctor or pharmacist before starting to take solifenacin

• if you have difficulty emptying your bladder (bladder obstruction) or difficulty urinating (e.g., weak urine stream). The risk of urine accumulation in the bladder (urinary retention) is much higher.
• if you have any obstruction of the digestive system (constipation).
• if you are at increased risk of reduced digestive system activity (stomach and intestinal movements). Your doctor will inform you if this applies to you.
• if you have severe renal disease.
• if you have moderate liver disease.
• if you have a hiatal hernia or heartburn.
• if you have a nervous system disorder (autonomic neuropathy).

Children and adolescents

This medicine must not be used in children or adolescents under 18 years of age.

Inform your doctor before starting treatment with solifenacin if any of the above-mentioned conditions have ever occurred in you.

Before starting treatment with solifenacin, your doctor will assess whether there are other causes for your frequent need to urinate (e.g., heart failure: insufficient pumping capacity of the heart; or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (a treatment for certain bacterial infections).

Taking Veloxsol with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is especially important that you inform your doctor if you are taking:

• other anticholinergic medicines, as the activity and adverse effects of both medicines could increase.
• cholinergic agents, as they may reduce the effect of solifenacin.
• medicines such as metoclopramide or cisapride, which increase digestive system motility. Solifenacin may reduce their effect.
• medicines such as ketoconazole, itraconazole, ritonavir, nelfinavir, verapamil, and diltiazem, which decrease the rate of elimination of this medicine from the body.
• medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the rate of elimination of solifenacin from the body.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

Taking Veloxsol with food and drinks

This medicine can be taken with or without food, according to your preference.

Pregnancy and breastfeeding

You must not use this medicine during pregnancy unless absolutely necessary.

Do not use this medicine while breastfeeding, as solifenacin may pass into breast milk. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

Solifenacin may cause blurred vision and, occasionally, somnolence or fatigue. If you experience any of these side effects, do not drive or operate machinery.

Velosxol contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

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

This medicine contains 0.30 mg of sorbitol in each dosage unit, equivalent to 0.03 mg/g.

3. How to take Veloxsol

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

This medicine is to be taken orally. You must suck the tablet until it dissolves completely. It can be taken with or without food, according to your preference.

The recommended dose is 5 mg daily, unless your doctor instructs you to take 10 mg daily.

1. Remove a blister from the strip by tearing along the perforations.

2. Peel off the foil from the blister starting at the corner where the arrow is printed, pulling the foil in the direction of the arrow.

3. Completely remove the foil from the blister so that the tablet is exposed. Carefully remove the tablet from the blister. Place the tablet in your mouth and suck it until it dissolves completely.

If you take more Veloxsol than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 915 620 420, stating the name of the medicine and the amount ingested.

Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, perception of things that are not present (hallucinations), pronounced excitation, seizures, breathing difficulties, increased heart rate (tachycardia), accumulation of urine in the bladder (urinary retention), and dilation of the pupils (mydriasis).

If you forget to take Veloxsol

If you forget to take a dose at the usual time, take it as soon as you remember, unless it is almost time for your next dose. Never take more than one dose per day. If you have any doubts, always consult your doctor or pharmacist.

If you stop taking Veloxsol

If you stop taking solifenacin, your overactive bladder symptoms may return or worsen. Always consult your doctor if you are considering stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience an allergic reaction or a severe skin reaction (for example, blistering and peeling of the skin), you must inform your doctor or nurse immediately.

Angioedema (a skin allergy resulting in swelling of the tissue beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate. If angioedema occurs, treatment with solifenacin succinate must be stopped immediately and appropriate treatment and/or measures should be taken.

Solifenacin 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, indigestion (accompanied by symptoms such as abdominal fullness, abdominal pain, belching, nausea, heartburn (dyspepsia), and stomach discomfort.

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

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

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

• accumulation of hardened feces in the large intestine (fecal impaction)
• urine retention in the bladder due to inability to empty it (urinary retention)
• dizziness, headache
• vomiting
• itching, rash

Very rare adverse effects (may affect up to 1 in 10,000 people):

• hallucinations, confusion
• allergic rash

Frequency not known (frequency cannot be estimated from the available data):

• decreased appetite, elevated blood potassium levels, which may cause abnormal heart rhythm
• increased eye pressure
• changes in the heart's electrical activity (ECG), irregular heartbeat, awareness of heartbeat, rapid heartbeat
• voice disorders
• liver disorders
• muscle weakness
• kidney disorder

.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist. This includes any adverse reaction not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of 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 EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy or any other medicine waste collection system. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

Do not store above 25 °C.

6. Contents of the pack and other information

Composition of Veloxsol

• The active substance is solifenacin succinate 5 mg.
• The other components are polacrilin resin, hypromellose E15 (E-464), mannitol (E-421), acesulfame potassium (E950), peppermint flavour (contains sorbitol), lactose monohydrate, sodium croscarmellose (E-468), menthol flavour, and stearic fumarate and sodium.

Appearance of the product and contents of the pack

Veloxsol 5 mg orodispersible tablets are round, white to off-white, biconvex tablets with bevelled edges, marked with the inscription on one side and smooth on the other.

VELOXSOL orodispersible tablets are available in blister packs containing 3, 5, 10, 20, 30, 50, 60, 90, 100 or 200 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Theramex Ireland Limited
3rd Floor, Kilmore House,
Park Lane, Spencer Dock,
Dublin 1
D01 YE64
Ireland

Manufacturer

Laboratori Fundació DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
Barcelona 08040
Spain

Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy

Local representative of the Marketing Authorization Holder:

Theramex Healthcare Spain, S.L.
Calle Martínez Villergas 52,
Edificio C, planta 2ª izquierda
28027 Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Veloxsol 5 mg orodispersible tablets EFG
Poland: VELOXSOL, 5 mg, tabletki ulegajace rozpadowi w jamie ustnej
Sweden: Veloxsol 5 mg munsönderfallande tablett
Italy: Orodax
Czech Republic: Brisol
Austria: Solifenacin Edest 5 mg Schmelztabletten
Netherlands: VELOXSOL 5 mg orodispergeerbare tabletten

Date of the most recent revision of this leaflet: 03/2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.