SOLIFENACIN TEVA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Solifenacin Teva 5 mg Film-Coated Tablets EFG

Solifenacin Succinate

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

Package Leaflet Contents

1. What is Solifenacin Teva and what is it used for
2. What you need to know before taking Solifenacin Teva
3. How to take Solifenacin Teva
4. Possible side effects
5. Storage of Solifenacin Teva
6. Package Contents and Additional Information

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

The active substance in Solifenacin 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 urinate and increases the amount of urine your bladder can hold.

Solifenacin 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, needing to urinate frequently, or experiencing involuntary leakage of urine.

2. What you need to know before taking Solifenacin Teva

Do not take Solifenacin 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 muscular disorder 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 medications that may decrease the elimination of Solifenacin Teva from the body (e.g., ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Before starting treatment with Solifenacin Teva, 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 Teva.

• If you have problems 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 an increased risk of decreased digestive system activity (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).

Inform your doctor before starting treatment with Solifenacin Teva if any of the aforementioned circumstances have occurred to you.

Before starting treatment with Solifenacin Teva, your doctor will assess whether 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 for certain bacterial infections).

Children and Adolescents

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

Taking Solifenacin Teva with Other Medications

Inform your doctor or pharmacist 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.
• cholinergic medications, as they may reduce the effect of Solifenacin Teva.
• medications such as metoclopramide or cisapride, which make the digestive system work faster. Solifenacin Teva may reduce their effect.
• medications such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the elimination of Solifenacin Teva from the body.
• medications such as rifampicin, phenytoin, and carbamazepine, as they may increase the elimination of Solifenacin Teva from the body.
• medications such as bisphosphonates, which may cause or worsen esophageal inflammation (esophagitis).

Taking Solifenacin Teva with Food

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

Pregnancy and Breastfeeding

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.

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

Driving and Using Machines

Solifenacin Teva may cause blurred vision and sometimes drowsiness or fatigue. If you experience any of these side effects, do not drive or use machines.

Solifenacin Teva 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 Teva

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

The recommended dose is 5 mg per day, unless your doctor indicates that you should take 10 mg per day.

Swallow the tablet whole with some liquid. It can be taken with or without food, as you prefer. Do not crush the tablets.

If You Take More Solifenacin Teva Than You Should

If you have taken too much Solifenacin Teva or if a child has accidentally taken Solifenacin Teva, contact your doctor or pharmacist immediately, or call the Toxicology Information Service (Tel. 91 562 04 20). It is recommended to bring the package and package leaflet 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 Take Solifenacin 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, always consult your doctor or pharmacist.

If You Stop Taking Solifenacin Teva

If you stop taking Solifenacin Teva, 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 nurse immediately.

Angioedema (allergy in the skin that results in inflammation under the skin surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate. If angioedema occurs, treatment with solifenacin succinate should be discontinued immediately, and appropriate treatment and/or measures should 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 a feeling of heaviness in the stomach, 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
• dry throat
• dry skin
• difficulty urinating
• fatigue
• accumulation of fluid 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)
• accumulation of urine 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 reaction.

Frequency Not Known (frequency cannot be estimated from 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 (Torsades de Pointes), 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 Medicines 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 Teva

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

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

Blisters

This medication does not require special storage conditions.

Bottles

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

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 your pharmacy. 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 Teva 5 mg

• The active substance 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 Package Contents

Solifenacin Teva 5 mg is a film-coated tablet, light yellow to yellow in color, round, convex, with a diameter of 8 mm, marked with "S5" on one side of the tablet and flat on the other side.

The packaging may be presented in:

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

Solifenacin Teva 5 mg film-coated tablets EFG 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.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura Street, 11 Edificio Albatros B, 1st Floor

Alcobendas, 28108 Madrid

Spain

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 medication is authorized in the Member States of the European Economic Area under 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

Date of the Last Revision of this Package Leaflet:October 2018

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

You can access detailed and updated information about this medication by scanning the QR code included in 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

QR Code + URL