SOLIFENACIN NOVALIE 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Solifenacin Novalie 10 mg film-coated tablets EFG

Solifenacin, succinate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Solifenacin Novalie and what is it used for
2. What you need to know before taking Solifenacin Novalie
3. How to take Solifenacin Novalie
4. Possible side effects
5. Storage of Solifenacin Novalie
6. Package contents and additional information

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

The active substance in Solifenacin Novalie belongs to the group of anticholinergics. These medications are used to reduce the activity of the overactive bladder. This allows you to have more time before needing to go to the bathroom and increases the amount of urine that your bladder can hold.

Solifenacin Novalie is used to treat the symptoms of overactive bladder syndrome. These symptoms include: having a strong and sudden need to urinate without warning, needing to urinate frequently, or having urine leaks because you cannot get to the bathroom in time.

2. What you need to know before taking Solifenacin Novalie

Do not take Solifenacin Novalie

• if you are allergic to solifenacin succinate or any of the other ingredients 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 (including 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, 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 being treated with medications that can decrease the elimination of solifenacin from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Before starting treatment with solifenacin, inform your doctor if you have or have had any of the above-mentioned diseases.

Warnings and precautions

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

• if you have difficulty 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 (constipation),
• if you have an increased risk of decreased digestive system activity (movements of the stomach and intestine). 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 a nervous disorder (autonomic neuropathy).

Children and adolescents

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

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

Before starting treatment with solifenacin, 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).

Using Solifenacin Novalie with other medications

Tell your doctor or pharmacist that 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 rate of solifenacin from the body,
• medications such as rifampicin, phenytoin, and carbamazepine, as they may increase the elimination rate of solifenacin from the body,
• medications such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

Using Solifenacin Novalie with food, drinks, and alcohol

This medication can be taken with or without food, as preferred.

Pregnancy, breastfeeding, and fertility

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.

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

Do not use solifenacin during 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 Novalie 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 Novalie

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 preferred. Do not crush the tablets.

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

If you take more Solifenacin Novalie than you should

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

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 Novalie

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. Never take more than one dose per day. If you are unsure, consult your doctor or pharmacist.

If you stop taking Solifenacin Novalie

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 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 nurse immediately.

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

Solifenacin 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 side effects (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 (GERD),
• dry throat,
• dry skin,
• difficulty urinating,
• fatigue,
• fluid accumulation in the lower limbs (edema).

Rare side effects (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 side effects (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 eye pressure,
• changes in heart electrical activity (ECG), irregular heartbeats, 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 and Healthcare Products Agency's website: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Solifenacin Novalie

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

This medication does not require special storage conditions.

Do not use Solifenacin Novalie after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. If you are unsure, consult your pharmacist on 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 Novalie

• The active substance is solifenacin succinate. Each tablet contains 10 mg of solifenacin succinate (equivalent to 7.5 mg of solifenacin).

• The other ingredients are lactose monohydrate, cornstarch, hypromellose (E464), anhydrous colloidal silica, magnesium stearate, talc, macrogol, titanium dioxide (E171), and red iron oxide (E172).

Appearance of the product and package contents

Solifenacin Novalie 10 mg is presented in the form of film-coated tablets, round, pink, and with the inscription "E3" on one side.

Solifenacin Novalie 10 mg film-coated tablets are available in packages of 30 tablets.

Marketing authorization holder

Novalie Pharma, S.L.U.

Calle Jorge Ruiz de Santallana, 51

05005 Avila, Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí (Barcelona), Spain

This medication is authorized in:

Netherlands Solifenacinesuccinaat Lesvi 10 mg film-coated tablets

Poland Soreca

Spain Solifenacina Novalie 10 mg film-coated tablets

Date of the last revision of this package leaflet: June 2017

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