SOLIFENACIN Aurovitas 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Solifenacin Aurovitas 5 mg film-coated tablets EFG

Solifenacin succinate

Read the entire package leaflet carefully before starting to use 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, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

The active substance in Solifenacin Aurovitas belongs to the group of anticholinergics. These medications are used to reduce the activity of an overactive bladder. This allows you to have more time before needing to urinate and increases the amount of urine your bladder can hold. Solifenacin is used to treat the symptoms of overactive bladder syndrome. These symptoms include: having a strong and sudden need to urinate without prior warning, needing to urinate frequently, or experiencing urine leakage due to not reaching the toilet in time.

2. What you need to know before taking Solifenacin Aurovitas

Do not takeSolifenacin Aurovitas

• If you are allergic to solifenacin or any of the other components 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 muscular disease called myasthenia gravis, which can cause extreme weakness of certain muscles.
• If you have high pressure in the eyes, with gradual vision loss (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 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 this medication, inform your doctor if you have or have had any of the aforementioned diseases.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Solifenacin Aurovitas.

• If you have a problem emptying your bladder (= bladder obstruction) 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 a risk of decreased activity of the digestive system (stomach and intestinal 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 have a hiatal hernia or heartburn.
• If you have an autonomic nervous disorder (autonomic neuropathy).

Children and adolescents

Solifenacin should not be used in children or adolescents under 18 years of age.

Inform your doctor before starting treatment with solifenacin if any of the aforementioned circumstances have 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).

Taking Solifenacin Aurovitas with other medications

Inform your doctor if you are taking, have recently taken, or may need to take 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.
• Cholinergics, 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 esophageal inflammation (esophagitis).

Taking Solifenacin Aurovitas with food, drinks, and alcohol

Solifenacin can be taken with or without food, as preferred.

Pregnancy, breastfeeding, and fertility

You should 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.

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.

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 Aurovitas 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 Aurovitas

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You should 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 indicates that you should take 10 mg per day.

If you take more Solifenacin Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and package leaflet of the medication to the healthcare professional. 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), urine accumulation in the bladder (urinary retention), and dilation of the pupils (mydriasis).

If you forget to take Solifenacin Aurovitas

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. If in doubt, consult your doctor or pharmacist.

If you stop taking Solifenacin Aurobindo

If you stop taking this medication, 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 the use of 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), you should inform your doctor or pharmacist immediately.

Angioedema (allergy in the skin that results in inflammation under the skin's surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate (Solifenacin Aurovitas). If angioedema occurs, treatment with solifenacin succinate (Solifenacin Aurovitas) should be discontinued immediately, and 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(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(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(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 pressure in the eyes.
• 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 Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Solifenacin Aurovitas

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Solifenacin Aurovitas

• The active substance is solifenacin succinate. Each film-coated tablet contains 5 mg of solifenacin succinate.
• The other components are:

Tablet core:lactose monohydrate, cornstarch, hypromellose (5 cp), colloidal anhydrous silica, magnesium stearate.

Tablet coating:hypromellose (6 cp), macrogol (PEG 4000), titanium dioxide (E171), talc, yellow iron oxide (E172).

Appearance of the product and package contents

Film-coated tablets, round (7.6 mm in diameter), light yellow in color, biconvex, with the mark "CC" on one side and "31" on the other.

Solifenacin Aurovitas film-coated tablets are available in PVC transparent-Aluminum blister packs of 30 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medication is authorized in EEA member states under the following names:

Date of the last revision of this package leaflet: February 2016

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