Prospect: Information for the User

Solifenacina Aurovitas 10 mg Film-Coated Tablets

Solifenacin Succinate

Read this prospect carefully before starting to use this medication, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Solifenacina Aurovitas

3.How to take Solifenacina Aurovitas

4.Possible adverse effects

5.Storage of Solifenacina Aurovitas

6.Contents of the package and additional information

The active ingredient of SolifenacinaAurovitasbelongs 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 go to the bathroom and increases the amount of urine that your bladder can hold. Solifenacina 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 do not arrive on time to the bathroom.

Do not takeSolifenacina Aurovitas

-If you are allergic tosolifenacinaor to 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 in certain muscles.

-If you have high eye pressure, 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 reduce the elimination ofsolifenacinafrom the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Inform your doctor before starting treatment with this medication if you have or have had any of the above-mentioned conditions.

Warnings and precautions

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

-If you have difficulty emptying your bladder (= bladder obstruction) or urinating (e.g. weak urine flow). The risk of urine accumulation in the bladder (urinary retention) is much higher.

-If you have any gastrointestinal obstruction (constipation).

-If you have a risk of decreased gastrointestinal activity (gastrointestinal motility). 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 hiatal hernia or heartburn.

-If you have a nervous disorder (autonomic neuropathy).

Children and adolescents

Solifenacina should not be used in children or adolescents under 18 years old.

Inform your doctor before starting treatment with solifenacina if any of the above-mentioned circumstances have occurred at any time.

Before starting treatment with solifenacina, your doctor will evaluate whether there are other causes for your need to urinate frequently (e.g. heart failure or kidney disease). If you have a urinary tract infection, your doctor will prescribe an antibiotic (a treatment for certain bacterial infections).

TakingSolifenacinaAurovitaswith other medications

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

It is especially important to inform your doctor if you are taking:

-Other anticholinergic medications, the activity and adverse effects of both medications may increase.

-Cholinergic medications, as they may reduce the effect of solifenacina.

-Medications such as metoclopramide or cisapride, which make the digestive system work faster. Solifenacina may reduce their effect.

-Medications such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which reduce the rate of elimination of solifenacina from the body.

-Medications such as rifampicin, phenytoin, and carbamazepine, as they may increase the rate of elimination of solifenacina from the body.

-Medications such as bisphosphonates, which may cause or worsen esophagitis.

TakingSolifenacinaAurovitaswith food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

You should not use solifenacina if you are pregnant unless it is absolutely necessary. Do not use solifenacina during breastfeeding as solifenacina may pass into breast milk.

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

Driving and operating machinery

Solifenacina may cause blurred vision and, occasionally, drowsiness or fatigue. If you experience any of these adverse effects, do not drive or operate machinery.

Solifenacina Aurovitascontains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

Swallow the entire tablet with some liquid. It can be taken with or without food, according to your preference. 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 moreSolifenacinaAurovitasthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional. Symptoms 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 useSolifenacinaAurovitas

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 compensate for the missed doses. If you have any doubts, consult your doctor or pharmacist always.

If you interrupt treatment with Solifenacina Aurobindo

If you stop taking this medication, your overactive bladder symptoms may return or worsen. Consult your doctor always if you are thinking of interrupting treatment.

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

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

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

Angioedema (allergy on the skin that results in inflammation that occurs in the tissue beneath the surface of the skin) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate (Solifenacina Aurovitas). If angioedema appears, treatment with solifenacin succinate (Solifenacina Aurovitas) must be stopped immediately and appropriate treatment and/or measures must be taken.

Solifenacina can 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 stomach burning (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).

-nasal dryness.

-gastroesophageal reflux disease (GERD), dry throat.

-dry skin.

-difficulty urinating.

-fatigue.

-lower extremity edema (swelling).

Rare(may affect up to 1 in 1,000 people)

-fecal impaction (accumulation of a large amount of hardened feces in the large intestine).

-urinary retention (accumulation of urine in the bladder due to inability to empty the bladder).

-dizziness, headache.

-vomiting.

-itching, skin rash.

Very rare(may affect up to 1 in 10,000 people)

-hallucinations, confusion.

-allergic skin eruption.

Frequency not known(the frequency cannot be estimated from the available data)

-decreased appetite, high levels of potassium in the blood that may 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.

-renal disorder.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the carton 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 drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist if you are unsure how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofSolifenacina Aurovitas

-The active ingredient is solifenacin succinate. Each film-coated tablet contains 10 mg of solifenacin succinate.

-The other components are:

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

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

Appearance of the product and content of the container

Film-coated tablets, round (7.6 mm in diameter), light pink in color, biconvex, with the mark “CC” on one face and “32” on the other.

Solifenacina Aurovitas film-coated tabletsis available in PVC transparent-Aluminum blister packs containing 30 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Last review date of this leaflet: February 2016

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