SOLIFENACIN VIATRIS 10 mg FILM-COATED TABLETS

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 taking medicines 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.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine:

• If you have problems 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 (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 whether 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 elimination rate of solifenacin from the body.
• Medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the degradation rate 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 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.

Patient 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 per 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 may 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 feeling of stomach heaviness, 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.
• Gastroesophageal reflux disease (with symptoms such as heartburn, difficulty swallowing, sour and unpleasant taste in the upper throat or the back of the mouth).
• Dry throat.
• Dry skin.
• Difficulty urinating.
• Fatigue, fluid accumulation 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 heart electrical activity (ECG), irregular heartbeats.
• Complete intestinal obstruction (ileus).
• Severe confusion that may 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 via the Spanish Medicines and Healthcare Products Agency (AEMPS) website, 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 further information

Composition of Solifenacin Viatris

• The active substance is solifenacin succinate.

Each film-coated tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg of solifenacin.

• The other ingredients are:

Core of the tablet:

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

Coating of the tablet:

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

Appearance of Solifenacin Viatris and package contents

Film-coated tablet of pink color, round, biconvex, marked with "M" on one side and "SF" over "10" 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 pack 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

You can ask for more information about this medicine from 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 Member States of the European Economic Area under the following names:

Germany: Solifenacinsuccinat Mylan 10 mg Filmtabletten

Belgium: Solifenacine Mylan 10 mg filmomhulde tabletten

Cyprus: Solifenacin / Mylan

Denmark: Solifenacin Mylan

Slovakia: Solifenacin Mylan 10 mg, filmom obalené tablety

Spain: Solifenacina Viatris 10 mg comprimidos recubiertos con película

France: SOLIFENACINE MYLAN 10 mg, comprimé pelliculé

Greece: Solifenacin / Mylan

Ireland: Solifenacin succinate 10 mg Film-coated tablets

Iceland: Solifenacin Mylan

Italy: Solifenacina Mylan

Luxembourg: Solifenacine Mylan 10 mg comprimés pelliculés

Norway: Solifenacin Mylan

Netherlands: Solifenacinesuccinaat Mylan 10 mg, filmomhulde tabletten

Portugal: Solifenacina Mylan

United Kingdom: Solifenacin succinate 10 mg Film-coated tablets

Czech Republic: Solifenacin Mylan 10 mg, potahované tablety

Sweden: Solifenacin Mylan

Date of last revision of this leaflet:September 2015.

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