Solifenacin ViatriS 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Solifenacin Viatris 5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Solifenacin Viatris is and what it is used for
2. What you need to know before taking Solifenacin Viatris
3. How to take Solifenacin Viatris
4. Possible side effects
5. How to store Solifenacin Viatris
6. Contents of the pack and other information

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

The active substance in Solifenacina Viatris is solifenacin, which belongs to a group of medicines called anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This allows you to wait longer before needing to go to the toilet and increases the amount of urine your bladder can hold.

Solifenacina Viatris is used to treat the symptoms of a condition called overactive bladder syndrome. These symptoms include a sudden, strong need to urinate without warning, needing to urinate frequently, or leaking urine because you cannot reach the toilet in time.

2. What you need to know before taking Solifenacin Viatris

Do not take Solifenacin Viatris:

• If you are allergic to solifenacin or to any of the other ingredients of this medicine (listed in section 6).
• If you have difficulty passing urine 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 of certain muscles.
• If you have high 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 severe kidney disease or moderate liver disease AND are also taking medicines that may reduce the elimination of solifenacin from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you if this applies to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• If you have problems emptying your bladder (bladder obstruction) or difficulty passing urine (e.g., weak urine stream). 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 reduced activity of the digestive system (stomach and intestinal movements). Your doctor will inform you if this applies to you.
• 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 may 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 may cause or worsen inflammation of the oesophagus.
• If you have a nervous system disorder (autonomic neuropathy).
• If you have heart rhythm disorders (seen on ECG) or low blood potassium levels.

Inform your doctor 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 needing to pass urine frequently (e.g., heart failure [insufficient pumping strength of the heart] or kidney disease). If you have a bacterial urinary tract infection, your doctor will prescribe an antibiotic (treatment to fight specific bacterial infections).

Children and adolescents

Solifenacin must 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 need to take any other medicines.

It is especially important that you inform 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.
• Cholinergic agents (medicines such as carbachol and pilocarpine), as they may reduce the effect of solifenacin.
• Medicines such as metoclopramide or cisapride, which increase the activity of the digestive system.

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 breakdown of solifenacin in the body.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should not use solifenacin during pregnancy unless clearly necessary.

Breastfeeding

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

Driving and use of machines

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

Solifenacin Viatris contains lactose

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

3. How to take Solifenacin Viatris

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You must swallow the tablet whole with liquid. It can be taken with or without food, according to your preference. Do not crush the tablet.

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

Patients with liver or kidney problems

If you have severe kidney problems or moderate liver problems, you must not take more than 5 mg 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 Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, perception of things that are not present (hallucinations), overexcitation, seizures, breathing difficulty, increased heart rate (tachycardia), urine accumulation in the bladder (urinary retention), and pupil dilation (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 almost time for your 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 considering stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

• Angioedema (a skin allergy causing swelling in the tissue beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate.

Frequency not known (cannot be estimated from available data)

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

Solifenacina Viatris may cause the following other adverse 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, feeling sick (nausea), indigestion with symptoms such as stomach heaviness, abdominal pain, belching, nausea, and heartburn (dyspepsia).

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

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

• Drowsiness, altered taste perception (dysgeusia).

• Dry, irritated eyes.

• Dry nasal passages.

• Reflux disease (gastroesophageal reflux, with symptoms such as heartburn, difficulty swallowing, sour and unpleasant taste in the upper throat or back of the mouth).

• Dry throat.

• Dry skin.

• Difficulty urinating.

• Fatigue, fluid accumulation in the lower limbs (edema).

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

• Accumulation of hardened feces in the large intestine (fecal retention).
• Obstruction in the large intestine (colon).
• Urine retention 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.
• Urticaria (hives).
• Skin rash with round, measles-like patches.

Frequency not known (cannot be estimated from available data)

• Decreased appetite, elevated blood potassium levels that may cause abnormal heart rhythm.
• Increased pressure in the eyes.
• Changes in the heart's electrical activity (ECG), irregular heartbeat.
• Complete intestinal obstruction (ileus).
• Severe confusion which may be associated with increased or decreased activity, disturbances in sleep patterns, or hallucinations (perception of images or sounds that are not real).
• Voice disorder.
• Liver disorder or changes in liver function that may be detected in a blood test.
• Muscle weakness.
• Kidney disorder.
• Stomach discomfort.
• Redness and peeling of the skin (exfoliative dermatitis).
• Awareness of heartbeat, increased heart rate.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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.

For the bottle only: Once opened, use within 100 days.

Do not use this medicine after the expiry date stated on the cardboard box, blister pack, or bottle, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other 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 components are:

Tablet core:

Monohydrate lactose, 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 contents of the pack

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

Pack sizes:

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

Perforated single-dose blister containing 30 tablets.

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

Only certain 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized 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 the most recent review of this leaflet: September 2015.

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