Prospect: information for the patient

Solifenacina Viatris 5 mg film-coated tablets EFG

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you must not give it to other people even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist,even if they do not appear in this prospect. See section 4.

1.What Solifenacina Viatris is and for what it is used

2.What you need to know before starting to take Solifenacina Viatris

3.How to take Solifenacina Viatris

4.Possible adverse effects

1. Storage of Solifenacina Viatris

6.Contents of the package and additional information

The active ingredient of Solifenacina Viatris is solifenacina, which belongs to the group of anticholinergics. These medications are used to reduce the activity of an overactive bladder. This allows you to wait longer before needing to go to the bathroom and increases the amount of urine that your bladder can hold.

Solifenacina Viatris is used to treat the symptoms of a condition called overactive bladder syndrome. These symptoms include: a sudden and urgent need to urinate without prior warning, the need to urinate frequently or urine loss due to not reaching the bathroom in time.

Do not take Solifenacina Viatris:

• If you are allergic to solifenacin or any of the other components of this medication (listed in section 6).
• If you have difficulty urinating or emptying your bladder completely (urinary retention).
• If you have a severe stomach or intestinal disorder (such as toxic megacolon, a complication associated with ulcerative colitis).
• If you have a muscle disease called myasthenia gravis, which can cause extreme weakness in certain muscles.
• If you have high blood pressure in the eyes, or are at risk of developing it, with gradual loss of vision (glaucoma).
• If you are undergoing renal dialysis.
• If you have severe liver disease.
• If you have a severe kidney disease or moderate liver disease and are also taking medications that can reduce the elimination of solifenacin from the body (for example, ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• If you have difficulty emptying your bladder (bladder obstruction) or urinating (e.g., 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 (e.g., constipation).
• If you are at risk of decreased activity of the digestive system (gastrointestinal motility). Your doctor will inform you if this is the case.
• If you have severe kidney disease.
• If you have moderate liver disease.
• If you are taking certain medications called CYP3A4 inhibitors (such as ketoconazole), which can increase the amount of solifenacin in the blood.
• If you have a hiatal hernia, stomach acid, and/or are taking certain medications (such as bisphosphonates) that can cause or worsen esophageal inflammation.
• If you have a nervous system disorder (autonomic neuropathy).
• If you have heart rhythm disturbances (observed on ECG) or low potassium levels in the blood.

Inform your doctor or pharmacist if you have had any of the previous conditions before starting treatment with solifenacin succinate.

Before initiating solifenacin administration, your doctor will evaluate whether there are other causes for frequent urination (e.g., heart failure [insufficient heart pumping force] or kidney disease). If you have a bacterial urinary tract infection, your doctor will prescribe an antibiotic (treatment for specific bacterial infections).

Children and adolescents

Solifenacina should not be used in children and adolescents under 18 years old.

Use of Solifenacina Viatris with other medications

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

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

• Other anticholinergic medications (such as atropine, oxybutynin, hydroxyzine, bupropion, dextromethorphan), as they can increase the effects and adverse effects of both medications.
• Cholinergic medications (such as carbacol and pilocarpine), as they can reduce the effect of solifenacin.
• Medications such as metoclopramide or cisapride, which make the digestive system work faster.

Solifenacina may reduce its effect.

• Medications such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the rate of elimination of solifenacin from the body.
• Medications such as rifampicin, phenytoin, and carbamazepine, as they can increase the rate of degradation of solifenacin from the body.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not use solifenacina if you are pregnant unless it is clearly necessary.

Lactation

Do not use this medication if you are breastfeeding, as solifenacina may pass into breast milk.

Driving and operating machinery

Solifenacina may cause blurred vision and sometimes drowsiness or fatigue. If you experience any of these adverse effects, do not drive or operate machinery.

Solifenacina Viatris contains lactose

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

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

Swallow the entire tablet with some liquid. It can be taken with or without food, according to your preference. Do not crush the tablet.

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

Patients with liver or kidney problems

If you have severe kidney problems or moderate liver problems, do not take more than 5 mg per day.

If you take more Solifenacina Viatris than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of an overdose may include: headache, dry mouth, dizziness, drowsiness, and blurred vision, perception of things that are not there (hallucinations), overexcitement, convulsions, difficulty breathing, increased heart rate (tachycardia), urine accumulation in the bladder (urinary retention), and pupil dilation (mydriasis).

If you forget to take Solifenacina Viatris

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. Do not take a double dose to make up for the missed dose. Never take more than one dose per day. If you have any doubts, consult your doctor or pharmacist.

If you interrupt treatment with Solifenacina Viatris

If you stop taking solifenacina, your overactive bladder symptoms may return or worsen. Consult your doctor at all times if you are thinking of interrupting treatment.

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

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

If you experience any of the following side effects, stop taking this medication and contact your doctor or visit the nearest hospital emergency service immediately:

Very rare(may affect fewer than 1 in 10,000 patients)

• Angioedema (allergic reaction on the skin resulting in inflammation beneath the skin surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate.

Frequency unknown(cannot be estimated from available data)

• Severe allergic reaction or skin rash (e.g., blistering and skin peeling).

Solifenacin Viatris may cause the following side effects::

Very common(may affect more than 1 in 10 patients)

• Dry mouth.

Common(may affect between 1 and 10 in 100 patients)

• Blurred vision.
• Constipation, nausea, indigestion with symptoms such as feeling of stomach heaviness, abdominal pain, belching, nausea, and heartburn (dyspepsia).

Uncommonside effects(may affect between 1 and 10 in 1,000 patients)

• Urinary tract or bladder infection with symptoms such as painful or burning urination, back pain, cloudy urine, or blood in the urine. Consult your doctor if you experience these symptoms.
• Drowsiness, abnormal taste perception (dysgeusia).
• Dry eyes (irritated eyes).
• Nasal dryness.
• Gastroesophageal reflux disease (GERD) with symptoms such as heartburn, difficulty swallowing, sour or unpleasant taste in the upper throat or back of the mouth.
• Dry throat.
• Dry skin.
• Difficulty urinating.
• Fatigue, edema (fluid accumulation in the lower extremities).

Rare(may affect between 1 and 10 in 10,000 patients)

• Impaction of a large amount of hardened feces in the large intestine (fecal retention).
• Intestinal obstruction.
• Urinary retention due to inability to empty the bladder.
• Dizziness, headache.
• Vomiting.
• Itching, skin rash.

Very rare(may affect fewer than 1 in 10,000 patients)

• Hallucinations, confusion.
• Urticaria.
• Round, measles-like skin rash.

Frequency unknown(cannot be estimated from available data)

• Decreased appetite, high potassium levels in the blood that may cause abnormal heart rhythm.
• Increased eye pressure.
• Changes in heart activity (ECG), irregular heartbeats.
• Total intestinal obstruction (ileus).
• Severe confusion that may be associated with increased or decreased activity, sleep pattern disturbances, or hallucinations (perception of images or sounds that do not exist).
• Voice disorder.
• Liver disorder or changes in its function that may be observed in a blood test.
• Muscle weakness.
• Renal disorder.
• Stomach discomfort.
• Redness and peeling of the skin (dermatitis exfoliativa).
• Perception of heartbeats, increased heart rate.

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use, www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Only for the bottle:Once opened, use within a period of 100days.

Do not use this medication after the expiration date that appears on the carton box, blister pack, or bottle, after CAD. 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 drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Solifenacina Viatris

• The active ingredient is solifenacin succinate.

Each film-coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin.

• The other components are:

Core tablet:

Lactose monohydrate, maize starch, hypromellose (E464), talc, magnesium stearate (E572)

Film coating:

Hypromellose, titanium dioxide (E171), propylene glycol, yellow iron oxide (E172)

Appearance of Solifenacina Viatris and packaging contents

Yellow film-coated, round, biconvex tablet, marked with “M” on one face and “SF” over “5” on the other.

Packaging sizes:

Continuous blisters containing 3, 5, 10, 20, 30, 50, 60, 90, 100, and 200 tablets.

Single-dose perforated blister containing 30 tablets.

Bottles containing 30, 50, 90, 100, 200, 250, and 500 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Mylan Hungary Kft,

H-2900 Komárom, Mylan utca 1, Hungary.

McDermott Laboratories Limited trading as Gerard Laboratories,

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1

Bad Homburg v. d. Hoehe

Hessen, 61352,

Germany

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the European Economic Area with the following names:

Germany: Solifenacinsuccinat Mylan 5 mg Filmtabletten

Austria: Solfenacinsuccinat Mylan 5 mg Filmtabletten

Belgium: Solifenacine Mylan 5 mg filmomhulde tabletten

Croatia: Solven 5 mg filmom obložene tablete

Cyprus: Solifenacin / Mylan

Denmark: Solifenacin Mylan

Slovakia: Solifenacin Mylan 5 mg, filmom obalené tablety

Spain: Solifenacina Viatris 5 mg comprimidos recubiertos con película

Finland: Solifenacin Mylan

France: SOLIFENACINE MYLAN 5 mg, comprimé pelliculé

Greece: Solifenacin / Mylan

Ireland: Solifenacin succinate 5 mg Film-coated tablets

Iceland: Solifenacin Mylan

Italy: Solifenacina Mylan

Luxembourg: Solifenacine Mylan 5 mg comprimés pelliculés

Norway: Solifenacin Mylan

Netherlands: Solifenacinesuccinaat Mylan 5 mg, filmomhulde tabletten

Portugal: Solifenacina Mylan

United Kingdom(Northern Ireland): Solifenacin succinate 5 mg Film-coated tablets

Czech Republic: Solifenacin Mylan 5 mg, potahované tablety

Sweden: Solifenacin Mylan

Last review date of this leaflet:September 2015.

For detailed and up-to-date information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/