SOLIFENACIN VIATRIS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Solifenacin Viatris 5 mg Film-Coated Tablets EFG

Read the package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Solifenacin Viatris and what is it used for
2. What you need to know before you take Solifenacin Viatris
3. How to take Solifenacin Viatris
4. Possible side effects
   1. Storage of Solifenacin Viatris

1. Package Contents and Additional Information

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

The active substance of Solifenacin Viatris is solifenacin, which belongs to the group of anticholinergics. These medicines are used to reduce the activity of the overactive bladder. This allows you to wait longer before having to go to the bathroom and increases the amount of urine your bladder can hold.

Solifenacin Viatris is used to treat the symptoms of a condition called overactive bladder syndrome. These symptoms include: a sudden, urgent need to urinate without prior warning, the need to urinate frequently, or involuntary loss of urine.

2. What you need to know before you take Solifenacin Viatris

Do not take Solifenacin Viatris:

• If you are allergic to solifenacin or any of the other ingredients of this medicine (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 disorder called myasthenia gravis, which can cause extreme weakness of certain muscles.
• If you have high pressure in the eyes, or risk of having it, with gradual loss of vision (glaucoma).
• If you are undergoing kidney dialysis.
• If you have severe liver disease.
• If you have severe kidney disease or moderate liver disease and are also taking medicines that may decrease the elimination of solifenacin from the body (such as 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 medicine:

• If you have problems 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 (e.g., constipation).
• If you are at risk of suffering a decrease in digestive system activity (stomach and intestine 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 are taking certain medicines called CYP3A4 inhibitors (such as ketoconazole), which can increase the amount of solifenacin in the blood.
• If you have a stomach tear (hiatal hernia), heartburn, and/or are taking certain medicines (such as bisphosphonates) that can cause or worsen esophageal inflammation.
• If you have a nervous disorder (autonomic neuropathy).
• If you have heart rhythm disorders (observed in the ECG) or low potassium levels in the blood.

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

Before starting solifenacin, your doctor will assess if there are other causes for your frequent need to urinate (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

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

Taking Solifenacin Viatris with Other Medicines

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

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

• Other anticholinergic medicines (such as atropine, oxybutynin, hydroxyzine, bupropion, dextromethorphan), as they may increase the effects and side effects of both medicines.
• Cholinergics (medicines such as carbachol and pilocarpine), as they may reduce the effect of solifenacin.
• Medicines such as metoclopramide or cisapride, which make the digestive system work faster.

Solifenacin may reduce their effect.

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

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

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 Viatris Contains Lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to Take Solifenacin Viatris

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

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

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

Patients with Liver or Kidney Problems

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

If You Take More Solifenacin 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 medicine and the amount taken.

Symptoms in case of 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 dilation of the pupils (mydriasis).

If You Forget to Take Solifenacin 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 forgotten doses. Never take more than one dose in a day. If you have any doubts, always consult your doctor or pharmacist.

If You Stop Taking Solifenacin Viatris

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

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking this medicine and contact your doctor or go to the nearest hospital emergency department immediately:

Very Rare(may affect less than 1 in 10,000 patients)

• 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.

Frequency Not Known(cannot be estimated from the available data)

• Allergic reaction or severe skin reaction (e.g., blistering and peeling of the skin).

Solifenacin Viatris can cause the following other side effects:

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

• Dry mouth.

Common(may affect up to 1 in 10 patients)

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

Uncommon(may affect up to 1 in 100 patients)

• Urinary tract infection or bladder infection with signs such as painful or burning sensation when urinating, back pain, cloudy or bloody urine. Talk to your doctor if you experience these signs.

• Drowsiness, abnormal taste perception (dysgeusia).
• Dry eyes (irritated).
• Dryness of the nasal passages.
• Reflux disease (gastroesophageal reflux, with symptoms such as heartburn, difficulty swallowing, sour or unpleasant taste in the upper throat or the back of the mouth).
• Dry throat.
• Dry skin.
• Difficulty urinating.
• Tiredness, accumulation of fluid in the lower limbs (edema).

Rare(may affect up to 1 in 1,000 patients)

• Accumulation of a large amount of hardened feces in the large intestine (fecal impaction).
• Obstruction in the large intestine (colon).
• Accumulation of urine in the bladder due to inability to empty it (urinary retention).
• Dizziness, headache.
• Vomiting.
• Itching, skin rash.

Very Rare(may affect less than 1 in 10,000 patients)

• Hallucinations, confusion.
• Hives.
• Severe skin rash with round, measles-like patches.

Frequency Not Known(cannot be estimated from the 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.
• Complete intestinal obstruction (ileus).
• Severe confusion that can be associated with increased or decreased activity, sleep pattern problems, or hallucinations.
• Voice disorder.
• Liver disorder or changes in liver function that can be observed in a blood test.
• Muscle weakness.
• Kidney disorder.
• Stomach upset.
• Redness and peeling of the skin (exfoliative dermatitis).
• Perception of heartbeats, increased heart rate.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Health Products Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Solifenacin Viatris

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

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

Do not use this medicine after the expiry date which is stated on the carton, blister, or bottle, after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition of Solifenacin Viatris

• The active substance is solifenacin succinate.

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

• The other ingredients are:

Tablet core:

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

Tablet coating:

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

Appearance of Solifenacin Viatris and Package Contents

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

Package sizes:

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

Perforated unit-dose blister containing 30 tablets.

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

Not all package sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

You can obtain further information on this medicine by contacting the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

You can obtain further information on this medicine by contacting the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under 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

Date of Last Revision of this Leaflet:September 2015.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/