VELOXSOL 5 mg ORALLY DISINTEGRATING TABLETS

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

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

Contents of the Package Leaflet

1. What is Veloxsol and what is it used for
2. What you need to know before taking Veloxol
3. How to take Veloxol
4. Possible side effects
5. Storage of Veloxol
6. Package Contents and Additional Information

1. What is Veloxsol and what is it used for

The active ingredient of this medication belongs to the group of anticholinergics. These medications are used to reduce the activity of the overactive bladder. This allows you to have more time before needing to go to the bathroom and increases the amount of urine your bladder can hold.

Solifenacin is used to treat the symptoms of overactive bladder syndrome. These symptoms include: having a strong and sudden need to urinate without warning, needing to urinate frequently, or having urine leaks due to not reaching the bathroom in time.

2. What you need to know before taking Veloxsol

Do not take Veloxsol:

• if you have difficulty urinating or emptying your bladder completely (urinary retention).
• if you have a severe 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 any of the other components of this medication (listed in section 6).
• if you are undergoing renal dialysis.
• if you have severe liver disease.
• if you have severe kidney disease or moderate liver disease and are being treated with medications that may decrease the elimination of solifenacin from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Before starting treatment with solifenacin, inform your doctor if you have or have had any of the above-mentioned diseases.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take solifenacin

• if you have a problem emptying your bladder (obstruction of the bladder) or urinating (e.g., a weak urine flow). 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 have an increased risk of decreased activity of the digestive system (movements of the stomach and intestine). Your doctor will inform you if this is the case.
• if you have severe kidney disease.
• if you have moderate liver disease.
• if you have a hiatal hernia or heartburn.
• if you have an autonomic nervous disorder (autonomic neuropathy).

Children and Adolescents

This medication should 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 circumstances have occurred to you.

Before starting treatment with solifenacin, your doctor will assess if 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 (treatment against certain bacterial infections).

Taking Veloxol with Other Medications

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

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

• other anticholinergic medications, as the activity and side effects of both medications may increase.
• cholinergics, as they may reduce the effect of solifenacin.
• medications such as metoclopramide or cisapride, which make the digestive system work faster. Solifenacin may reduce their effect.
• medications such as ketoconazole, itraconazole (medications used to treat fungal infections), ritonavir, nelfinavir (medications used to treat HIV infections), verapamil, and diltiazem (used to treat high blood pressure and heart disease), which decrease the rate of breakdown of this medication in the body.
• medications such as rifampicin, phenytoin, and carbamazepine, as they may increase the rate of elimination of solifenacin from the body.
• medications such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

Taking Veloxsol with Food and Drinks

This medication can be taken with or without food, as you prefer.

Pregnancy and Breastfeeding

Do not use this medication if you are pregnant, unless it is absolutely necessary.

Do not use this medication during 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 medication.

Driving and Using Machines

Solifenacin may cause blurred vision and, sometimes, drowsiness or fatigue. If you experience any of these side effects, do not drive or use machines.

Veloxol Contains Lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Veloxol Contains Sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to Take Veloxsol

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

This medication should be taken orally. You should suck the tablet until it is completely dissolved. It can be taken with or without food, as you prefer.

The recommended dose is 5 mg per day, unless your doctor indicates that you should take 10 mg per day.

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

1. Remove the foil from the blister, starting from the corner where the arrow is printed, pulling the foil in the direction of the arrow.

1. Completely remove the foil from the blister, so that the tablet is released. Carefully remove the tablet from the blister. Place the tablet in your mouth and suck it until it is completely dissolved.

If You Take More Veloxsol Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

The symptoms in case of overdose may include: headache, dry mouth, dizziness, drowsiness, and blurred vision, perception of things that are not there (hallucinations), pronounced excitement, convulsions, difficulty breathing, 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 time to take the 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 symptoms of overactive bladder may return or worsen. Always consult your doctor if you are thinking of stopping treatment.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you suffer an allergic attack or a severe skin reaction (e.g., blistering and peeling of the skin), you should inform your doctor or nurse immediately.

Angioedema (allergy in the skin that results in inflammation that occurs in the tissue under the skin surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate. If angioedema occurs, treatment with solifenacin succinate should be discontinued immediately and appropriate treatment and/or measures should be taken.

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

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

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

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

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

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

• hallucinations, confusion
• allergic rash

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

• decreased appetite, elevated potassium levels in the blood, which can cause an abnormal heart rhythm
• increased eye pressure
• variations in the electrical activity of the heart (ECG), irregular heartbeat, perception of heartbeats, rapid heartbeat
• voice disorders
• liver disorders
• muscle weakness
• kidney disorder

.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Veloxsol

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy or any other Medication Waste Collection System. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Do not store above 25°C

6. Package Contents and Additional Information

Composition of Veloxsol

• The active ingredient is solifenacin, succinate 5 mg.
• The other ingredients are polyacrylate resin, hypromellose E15 (E-464), mannitol (E-421), potassium acesulfame, peppermint flavor, lactose monohydrate, sodium croscarmellose (E-468), peppermint flavor, and sodium stearyl fumarate.

Appearance of the Product and Package Contents

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

VELOXSOL orodispersible tablets are available in blisters of 3, 5, 10, 20, 30, 50, 60, 90, 100, or 200 tablets.

Not all 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

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

Spain: VELOXSOL 5mg orodispersible tablets EFG

France VELOXSOL

Germany VELOXSOL

Poland VELOXSOL

Sweden Veloxsol

Italy Orodax

Czech Republic Brisol

Austria Solifenacin Edest

Netherlands VELOXSOL

Date of the Last Revision of this Package Leaflet:July 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.