Package Leaflet: Information for the User

Solifenacina Stada 10mg Film-Coated Tablets

Solifenacina, succinate

Read this leaflet carefully before you start taking this medicinebecause 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 prescribedonlyfor you. Do not pass it on to others even if their symptoms are the same as yours, as it may harm them.
• Ifyou experienceany side effects, consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before taking Solifenacina Stada

3.How to take Solifenacina Stada

4.Possible side effects

5Storage of Solifenacina Stada

6.Contents of the pack and additional information

The active ingredient of Solifenacina Stada 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 go to the bathroom and increases the amount of urine that your bladder can hold.

Solifenacina Stada 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 leakage because you did not make it to the bathroom in time.

Do not take Solifenacina Stada

• 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 allergic to solifenacina or any of the other components of this medication (listed in section 6)
• 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 of solifenacina from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Inform your doctor before starting treatment with solifenacina if you have or have had any of the diseases mentioned above.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Solifenacina Stada

• 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 obstruction of the digestive system (constipation).
• if you have an increased risk of decreased digestive system 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 system disorder known as autonomic neuropathy.

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

Before starting treatment with Solifenacina Stada, 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).

Children and adolescents

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

Other medications and Solifenacina Stada

Inform your doctor or pharmacist that you are using, have used recently, or may need to use 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. Consult your doctor if your medication belongs to this group.
• cholinergic medications, which may reduce the effect of Solifenacina Stada. Consult your doctor if your medication belongs to this group.
• medications such as metoclopramide or cisapride, which make the digestive system work faster. Solifenacina Stada may reduce their effect.
• medications such as ketoconazole, itraconazole (medications used to treat fungal infections), ritonavir, nelfinavir (medications used to treat HIV infections) and verapamil, diltiazem (medications used to treat hypertension and heart disease). These medications reduce the rate of elimination of solifenacina from the body.
• medications such as rifampicin (medication used to treat tuberculosis and other bacterial infections) and phenytoin, carbamazepine (medications used to treat epilepsy). These may increase the rate of elimination of solifenacina from the body.
• medications such as bisphosphonates, which may cause or worsen esophagitis. Consult your doctor if your medication belongs to this group.

Taking Solifenacina Stada with food and drinks

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

Pregnancy, breastfeeding, and fertility

Do not use solifenacina if you are pregnant unless absolutely necessary. Do not use this medication during breastfeeding as solifenacina may pass into breast milk.

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

Driving and operating machinery

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

Solifenacina Stada contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Instructions for Correct Use

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

Dose

The recommended dose is 5 mg per day, unless your doctor tells you to take 10 mg per day.

Administration Form

You must swallow the tablet whole with some liquid, for example, a glass of water. You can take it with or without food, as you prefer. Do not crush the tablets.

Use in Children and Adolescents

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

If You Take More Solifenacina Stada Than You Should

If you have taken too much Solifenacina Stada or if a child has taken this medication by accident, contact your doctor or pharmacist immediately, or call the Toxicological Information Service (Tel. 91 562 04 20).

The symptoms of an 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 pupil dilation (mydriasis).

If You Forget to Take Solifenacina Stada

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 have any doubts, consult your doctor or pharmacist.

If You Interrupt Treatment with Solifenacina Stada

If you stop taking this medication, your overactive bladder symptoms may return or worsen. Consult your doctor at all times 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 medications, this medication may cause side effects, although not everyone will experience them.

Stop taking Solifenacina Stada and seek medical attention immediately if you notice any of the following side effects

• if you experience an allergic attack or severe skin reaction (such as blistering and skin peeling)
• angioedema (allergic reaction under the skin's surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacina succinate

Solifenacina 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 feeling of stomach heaviness, abdominal pain, belching, nausea, and stomach burning (dyspepsia), stomach discomfort

Rare (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 (fluid accumulation)

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

• fecal impaction (accumulation of hardened feces in the large intestine)
• urinary retention (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.

Unknown frequency (frequency cannot be estimated from available data)

• decreased appetite, high potassium levels in the blood that may cause abnormal heart rhythm
• increased eye pressure
• changes in heart electrical activity (ECG), irregular heartbeat, 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 not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

This medication does not require any special temperature for conservation. Store in the original packaging to protect it from moisture.

Keepthis medicationout of the sight and reach of children.

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

Do not use this medication if the packaging is damaged or shows signs of alteration.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at theSIGREcollection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

Composition of Solifenacina Stada

• The active ingredient is solifenacin succinate

Each film-coated tablet contains 10 mg of solifenacin succinate equivalent to 7.5 mg of solifenacin.

• The other components are:

Core of the tablet

Lactose, maize starch, hypromellose, magnesium stearate

Film coating

Hypromellose, titanium dioxide (E171), macrogol 8000, talc, and iron oxide red (E172).

Appearance of the product and contents of the package

Solifenacina Stada 10 mg tablets are round, biconvex, film-coated tablets, light pink in color.

Solifenacina Stada tablets are supplied inblister packs of 10, 20, 30, 40, 50, 60, 80, 90, 100, 105, 120, 150, 180, and 200 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel, Co. Tipperary

Ireland

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

or

IBS-Experts International, d.o.o

Ruševje 15

10290 Zaprešic,

Croatia

Last review date of this leaflet:June 2017

This medicinal product is authorized in the member states of the European Economic Area with the following names:

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/