SOLIFENACIN Aurovitas 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Solifenacin Aurovitas 10 mg film-coated tablets EFG

Solifenacin succinate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

The active substance of Solifenacin Aurovitas belongs to the group of anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This allows you to have more time before you need 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, having to urinate frequently, or having urine leaks because you cannot get to the toilet in time.

2. What you need to know before you take Solifenacin Aurovitas

Do not takeSolifenacin Aurovitas

• If you are allergic to solifenacin 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 this medicine, tell 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 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 (movements of the stomach and intestines). 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.

Tell your doctor before starting treatment with solifenacin if any of the above 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).

TakingSolifenacinAurovitaswith other medicines

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

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

• Other anticholinergic medicines, the activity and side effects of both medicines may increase.
• Cholinergics, 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).

TakingSolifenacinAurovitaswith food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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.

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.

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 Aurovitascontains 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 Aurovitas

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

You should 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 moreSolifenacinAurovitasthan 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 medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine 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), accumulation of urine in the bladder (urinary retention), and dilation of the pupils (mydriasis).

If you forget to takeSolifenacinAurovitas

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 you have any doubts, always consult your doctor or pharmacist.

If you stop taking Solifenacin Aurobindo

If you stop taking this medicine, your overactive bladder symptoms may return or worsen. Always consult your doctor if you are thinking of stopping treatment.

If you have any other questions about 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 pharmacist 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 (Solifenacin Aurovitas). If angioedema appears, 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.
• 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 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Solifenacin Aurovitas

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

No special storage conditions are required.

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 other information

Composition ofSolifenacin Aurovitas

• The active substance is solifenacin succinate. Each film-coated tablet contains 10 mg of solifenacin succinate.
• The other ingredients are:

Core of the tablet:lactose monohydrate, corn starch, hypromellose (5 cp), colloidal anhydrous silica, magnesium stearate.

Coating of the tablet:hypromellose (6 cp), macrogol (PEG 4000), titanium dioxide (E171), talc, red iron oxide (E172).

Appearance of the product and contents of the pack

Film-coated tablets, round (7.6 mm in diameter), light pink, biconvex, with the mark "CC" on one side and "32" 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 medicine is authorized in the EEA member states under the following names:

Date of the last revision of this leaflet: February 2016

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