Solifenacin Novalie 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Solifenacin Novalie 5 mg film-coated tablets EFG

Solifenacin succinate

Read the entire leaflet carefully before you start taking this medicine, because 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Solifenacin Novalie is and what it is 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 needing to go to the toilet 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 a sudden, strong urge 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 starting Solifenacin Novalie

Do not take Solifenacin Novalie

• if you are allergic to solifenacin succinate 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 (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 renal disease or moderate liver disease and are also being treated with 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.

Before starting treatment with solifenacin, inform your doctor if you have or have had any of the conditions listed above.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

• if you have difficulty emptying your bladder (bladder obstruction) or 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 gastrointestinal tract (constipation),
• if you are at increased risk of reduced gastrointestinal motility (stomach and intestinal movements). Your doctor will inform you if this applies,
• 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 system disorder (autonomic neuropathy).

Children and adolescents

This medicine must not be used in children or adolescents under 18 years of age.

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

Before starting treatment with solifenacin, your doctor will assess whether there are other causes for your frequent need to urinate (for example, heart failure (inadequate pumping capacity of the heart) or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (a treatment for certain bacterial infections).

Taking Solifenacin Novalie 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, as the activity and adverse effects of both medicines may increase,
• cholinergic agents, as they may reduce the effect of solifenacin,
• medicines such as metoclopramide or cisapride, which increase gastrointestinal motility. 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 elimination of solifenacin from the body,
• medicines such as bisphosphonates, which may cause or worsen inflammation of the oesophagus (oesophagitis).

Taking Solifenacin Novalie with food, drinks and alcohol

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

Pregnancy, breast-feeding and fertility

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

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

Do not use solifenacin during breast-feeding, 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 operate machinery.

Solifenacin Novalie contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Solifenacin Novalie

Instructions for proper use

Follow exactly the instructions for use provided by your doctor. 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 tablets.

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

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 at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, perception of things that are not present (hallucinations), marked excitement, seizures, breathing difficulties, 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 almost time for your next dose. Never take more than one dose per day. If you have any doubts, always 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 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 experiences them.

If you suffer an allergic attack or a severe skin reaction (for example, blistering and peeling of the skin), you must inform your doctor or nurse immediately.

Angioedema (skin allergy resulting in swelling of the tissue beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate. If angioedema occurs, treatment with solifenacin succinate must be stopped immediately, and appropriate treatment and/or measures must be taken.

Solifenacin may cause the following adverse 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 stomach heaviness, abdominal pain, belching, nausea and heartburn (dyspepsia), stomach discomfort.

Uncommon adverse effects (may affect up to 1 in 100 people)

• urinary tract infection, bladder infection,
• somnolence,
• abnormal taste perception (dysgeusia),
• dry (irritated) eyes,
• 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 adverse effects (may affect up to 1 in 1,000 people)

• accumulation of a large amount of hardened feces in the colon (fecal impaction),
• urine retention in the bladder due to inability to empty the bladder (urinary retention),
• dizziness, headache,
• vomiting,
• itching, skin rash.

Very rare adverse 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 levels of potassium in the blood which may cause an abnormal heart rhythm,
• increased pressure in the eyes,
• changes in the heart's electrical activity (ECG), irregular heartbeat, palpitations, rapid heartbeat,
• voice disorder,
• liver disorder,
• muscle weakness,
• kidney disorder.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaRAM.es.

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

5. Storage of Solifenacin Novalie

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use Solifenacin Novalie after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, 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 Solifenacina Novalie

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

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

Nature of the product and contents of the container

Solifenacina Novalie 5 mg is presented as film-coated tablets, round, yellow in colour, with the imprint "E2" on one side.

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

Marketing Authorization Holder

Novalie Pharma, S.L.U.

Calle Jorge Ruiz de Santallana, 51

05005 Ávila, Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí (Barcelona), Spain

This medicinal product is authorized in:

Netherlands Solifenacinesuccinaat Lesvi 5 mg filmomhulde tabletten
Poland Soreca
Spain Solifenacina Novalie 5 mg comprimidos recubiertos con película

Date of the most recent revision of this leaflet: June 2017

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/