SOLIFENACIN VIVANTA 10 mg FILM-COATED TABLETS

2. What you need to know before taking Solifenacin Vivanta

Do not take Solifenacin Vivanta

• 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 muscular disease called myasthenia gravis, which can cause extreme weakness of certain muscles
• if you have high pressure in the eyes, with gradual vision loss (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.

If you have or have had any of the above-mentioned diseases, inform your doctor before starting treatment with Solifenacin Vivanta.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Solifenacin Vivanta

• if you have a problem emptying your bladder (= bladder obstruction) 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 (stomach and intestinal movements). 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

Solifenacin Vivanta should not be used in children or adolescents under 18 years of age.

Inform your doctor before starting treatment with Solifenacin Vivanta if any of the above circumstances have ever occurred to you.

Before starting treatment with Solifenacin Vivanta, your doctor will assess if there are other causes for your frequent need to urinate (e.g., heart failure or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (treatment against certain bacterial infections).

Use of Solifenacin Vivanta with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

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

• other anticholinergic medications, as the activity and side effects of both medications may increase.
• cholinergic medications, 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, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the elimination of solifenacin from the body.
• medications such as rifampicin, phenytoin, and carbamazepine, as they may increase the elimination of solifenacin from the body.
• medications such as bisphosphonates, which may cause or worsen esophageal inflammation (esophagitis).

Taking Solifenacin Vivanta with food and drinks

Solifenacin Vivanta can be taken with or without food, as you prefer.

Pregnancy and Breastfeeding

Do not use Solifenacin Vivanta if you are pregnant unless it is absolutely necessary.

Do not use Solifenacin Vivanta 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.

Solifenacin Vivanta 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.

3. How to take Solifenacin Vivanta

Instructions for correct use

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Swallow the tablet whole with some liquid. It can be taken with or without food, as you prefer. Do not crush the tablets.

The normal dose is 5 mg per day, unless your doctor tells you to take 10 mg per day.

If you take more Solifenacin Vivanta than you should

If you have taken too much Solifenacin Vivanta or if a child has accidentally taken Solifenacin Vivanta, contact your doctor or pharmacist immediately, or call the Toxicology Information Service (Tel. 91 562 04 20).

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), urine accumulation in the bladder (urinary retention), and dilation of the pupils (mydriasis).

If you forget to take Solifenacin Vivanta

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

If you stop taking Solifenacin Vivanta

If you stop taking Solifenacin Vivanta, your overactive bladder symptoms may return or worsen. Always consult your doctor if you are thinking of stopping treatment.

If you have any other questions about using 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 reaction or a severe skin reaction (e.g., blistering and peeling of the skin), inform your doctor or pharmacist immediately.

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

Solifenacin Vivanta 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 a feeling of stomach heaviness, abdominal pain, belching, nausea, and heartburn (dyspepsia), stomach discomfort

Uncommon(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 passages
• 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)

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

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

• hallucinations, confusion

• allergic skin rash.

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

• decreased appetite, high potassium levels in the blood that can cause an abnormal heart rhythm.
• increased pressure in the eyes

• changes in the electrical activity of the heart (ECG), irregular heartbeats (Torsades de Pointes), palpitations, rapid heartbeat.
• voice disorder
• liver disorder
• 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 Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Solifenacin Vivanta

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the package after EXP.

The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Solifenacin Vivanta

• The active ingredient is solifenacin succinate.

Each tablet contains 10 mg of solifenacin succinate, which corresponds to 7.5 mg of solifenacin.

• The other ingredients are:

Core of the tablet: lactose monohydrate, hypromellose (E464), magnesium stearate (E572).

Tablet coating:

Opadry pink (hypromellose (E464), titanium dioxide (E171), triacetin (E1518), talc (E553b), iron oxide red (E172)).

Appearance of the product and package contents

Film-coated tablet, light pink, round (7.40 ± 0.1 mm in diameter), biconvex (3.40 ± 0.15 mm in thickness), and engraved with the inscription "S10" on one side and smooth on the other.

The tablets are packaged in PVC/PVdC/Al blisters in a cardboard box.

Package size: 10, 20, 30, 50, 60, 90, 100, and 200 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Prague 9

Czech Republic

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA3000

Malta

You can request more information about this medication from the local representative of the Marketing Authorization Holder:

Local Representative:

Mabo-Farma S.A.

Calle Vía de los Poblados 3, Edificio 6

28033 Madrid

Spain

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

Netherlands Solifenacine succinaat Vivanta 10 mg film-coated tablets

Germany Solifenacin Vivanta 10 mg film-coated tablets

Spain Solifenacina Vivanta 10 mg film-coated tablets EFG

Ireland Solifenacin succinate Vivanta 10 mg film-coated tablet

Date of last revision of this package leaflet: November 2019

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/