SOLIFENACIN NOVALIE 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Solifenacin Novalie 5 mg film-coated tablets EFG

Solifenacin, succinate

Read the package leaflet carefully before starting to take this medicine because it contains important information for you.

• Keep this package leaflet, as 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects 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. Contents of the pack and further 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 medicines are used to reduce the activity of the overactive bladder. This allows you to have more time before you need to urinate 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 prior warning, having to urinate frequently or having urine leaks because you cannot get to the toilet 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 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 (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 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.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take 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 (constipation),
• if you have an increased risk of decreased activity of the digestive system (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 hiatus hernia or heartburn,
• if you have a nervous disorder (autonomic neuropathy).

Children and adolescents

This medicine must not be used in children and adolescents under 18 years.

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

Before starting treatment with solifenacin, your doctor will assess whether 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 medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. It is especially important to inform your doctor if you are taking:

• other anticholinergic medicines, as the activity and side effects of both medicines may increase,
• cholinergic medicines, 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 elimination rate of solifenacin from the body,
• medicines such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

Using Solifenacin Novalie with food, drinks, and alcohol

This medicine can be taken with or without food, as you prefer.

Pregnancy, breastfeeding, and fertility

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.

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 medicine 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 Novalie

Instructions for correct use

Follow exactly the administration instructions of this medicine given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Swallow the tablet whole with some liquid. It can be taken with or without food, as you prefer. 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 medicine and the amount taken.

The 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), accumulation of urine 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 in doubt, 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 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 suffer an allergic attack or a severe skin reaction (e.g. blistering and peeling of the skin), you should inform your doctor or nurse immediately.

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. If angioedema appears, 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 (gastroesophageal reflux),
• 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),
• accumulation of urine 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 the available data)

• decreased appetite, high levels of potassium 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, palpitations, rapid heartbeat,
• voice disorder,
• liver disorder,
• muscle weakness,
• kidney disorder.

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 package leaflet. You can also report side effects directly through the Spanish Medicines Vigilance System for Human Use. Website: www.notificaRAM.es.

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

5. Storage of Solifenacin Novalie

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

This medicine does not require any special storage conditions.

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

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. Contents of the pack and further information

Composition of Solifenacin Novalie

• The active substance is solifenacin succinate. Each tablet contains 5 mg of solifenacin succinate (equivalent to 3.8 mg of solifenacin).

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

Appearance of the product and pack contents

Solifenacin Novalie 5 mg is presented in the form of film-coated tablets, round, yellow, and with the inscription "E2" on one side.

Solifenacin Novalie 5 mg film-coated tablets are available in packs of 30 tablets.

Marketing authorisation holder

Novalie Pharma, S.L.U.

Calle Jorge Ruiz de Santallana, 51

05005 Ávila, España

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí (Barcelona), España

This medicine is authorised in the following countries:

Netherlands Solifenacinesuccinaat Lesvi 5 mg filmomhulde tabletten

Poland Soreca

Spain Solifenacina Novalie 5 mg comprimidos recubiertos con película

Date of last revision of this package leaflet: June 2017

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/