Package Insert: Information for the Patient

Solifenacina Teva 5 mg Film-Coated Tablets EFG

Solifenacin Succinate

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Solifenacina Teva and how is it used

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

3. How to take Solifenacina Teva

4. Possible adverse effects

5. Storage of Solifenacina Teva

6. Contents of the package and additional information

The active ingredient of Solifenacina Teva 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 Teva 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 make it to the bathroom in time.

Do not take Solifenacina Teva

• 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 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 of Solifenacina Teva from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this is the case.

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

Warnings and precautions

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

• 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 (autonomic neuropathy).

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

Before starting treatment with Solifenacina Teva, your doctor will evaluate whether there are other causes for your frequent urination (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 Teva should not be used in children or adolescents under 18 years old.

Taking Solifenacina Teva with other medications

Inform your doctor or pharmacist if you are taking, have taken, or may 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 Teva.
• Medications such as metoclopramide or cisapride, which make the digestive system work faster. Solifenacina Teva may reduce their effect.
• Medications such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which reduce the elimination of Solifenacina Teva from the body.
• Medications such as rifampicin, phenytoin, and carbamazepine, which may increase the elimination of Solifenacina Teva from the body.
• Medications such as bisphosphonates, which may cause or worsen esophagitis.

Taking Solifenacina Teva with food

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

Pregnancy and lactation

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

Do not use Solifenacina Teva if you are pregnant, unless absolutely necessary. Do not use Solifenacina Teva during breastfeeding, as solifenacin may pass into breast milk.

Driving and operating machinery

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

Solifenacina Teva contains lactose

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

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

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

Swallow the tablet whole with some liquid. You can take it with or without food, according to your preference. Do not crush the tablets.

If you take moreSolifenacina Tevathan you should

If you have taken too much Solifenacina Teva or if a child has taken Solifenacina Teva accidentally, contact your doctor or pharmacist immediately, or call the Toxicological Information Service (Tel. 91 562 04 20). It is recommended to bring the packaging and the leaflet to the healthcare professional.

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), urinary retention, and dilation of the pupils (mydriasis).

If you forget to takeSolifenacina Teva

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 always.

If you interrupt treatment with Solifenacina Teva

If you stop taking Solifenacina Teva, 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 may 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 nurse immediately.

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

Solifenacin Teva 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

Uncommon (may affect up to 1 in 100 people)

• Urinary tract infection, bladder infection
• Drowsiness
• Abnormal taste perception (dysgeusia)
• Dry eyes (irritated)
• Runny nose dryness
• Gastroesophageal reflux disease (GERD)
• Dry throat
• Dry skin
• Difficulty urinating
• Fatigue
• Swelling of the lower extremities (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)
• 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.

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 pressure in the eyes
• Changes in heart electrical activity (ECG), irregular heartbeats (Torsades de Pointes), 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 prospectus. You can also report them directly through the Spanish System for 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.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe boxafter CAD. The expiration date is the last day of the month indicated.

Blister Packs

This medication does not require special storage conditions.

Bottles

This medication does not require special temperature conditions. Keep the bottle perfectly closed to protect it from moisture.

Medications should not be disposed of through drains or trash. Deposit containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacisthow to disposeofcontainers and medicationsyou no longerneed. This will help protect the environment.

Composition of Solifenacina Teva 5 mg

• The active ingredient is solifenacin succinate.

Each film-coated tablet contains 5 mg of solifenacin succinate, which corresponds to 3.8 mg of solifenacin. The exact amount is shown on the packaging.

• The other excipients are:

Core tablet: microcrystalline cellulose, povidone, crospovidone, anhydrous lactose, anhydrous colloidal silica, magnesium stearate.

Coating: polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol 3350, talc (E553b), yellow iron oxide (E172).

Appearance of the product and contents of the packaging

Solifenacina Teva 5 mg is a yellowish, round, convex film-coated tablet with a diameter of 8 mm, marked with “S5” on one side and flat on the other side.

The packaging may be presented in:

• Aluminum-aluminum blisters
• Polymer blisters
• HDPE bottles with child-resistant caps

Solifenacina Teva 5 mg film-coated tablets are available in blister packs of 3, 5, 10, 20, 30, 50, 60, 90, 100, or 200 tablets, and in bottles of 30 or 100 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

Alcobendas, 28108 Madrid

Spain

Responsible manufacturer

TEVA Pharmaceutical Works Private Limited Company

Debrecen, Pallagi út 13, H-4042

Hungary

or

Teva Czech Industries s.r.o.

Ostravská 29, c.p. 305

Opava-Komárov 747 70

Czech Republic

or

Merckle GmbH

Ludwig-Merckle-Straße 3, Blaubeuren 89143

Germany

or

Merckle GmbH

Graf-Arco-Str. 3, Ulm 89079

Germany

or

Teva Pharma B.V.

Swensweg 5, 2031 GA

Netherlands

or

Teva Operations Poland Sp. z.o.o.

ul. Mogilska 80, Kraków

31-546

Poland

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25, Zagreb

10000 Croatia

or

Balkanpharma - Dupnitsa AD

3 Samokovsko Shoose Str.

2600 Dupnitsa

Bulgaria

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

Germany: Solifenacin AbZ 5 mg Filmtabletten

Belgium: Solifenacine Teva 5 mg filmomhulde tabletten

Croatia: Solifenacin Pliva 5 mg filmom obložene tablete

Denmark: Solifenacinsuccinat “Teva” 5 mg

Spain: Solifenacina Teva 5 mg comprimidos recubiertos con película EFG

Finland: Solifenacin ratiopharm 5 mg tabletti, kalvopäällysteinen

France: Solifénacine Teva 5 mg, comprimé pelliculé

Ireland: Solifenacin Teva

Italy: Solifenacina Teva

Netherlands: Solifenacinesuccinaat Teva 5 mg, filmomhulde tabletten

Poland: Solifenacin Teva

United Kingdom (Northern Ireland): Solifenacin Succinate 5 mg Film-coated Tablets

Czech Republic: Solifenacin Teva 5mg

Sweden: Solifenacin Teva

Last review date of thisleaflet:October 2018

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

You can access detailed and updated information on this medicine by scanning the QR code on the packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/81959/P_81959.html

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