Solifenacin Teva 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Solifenacin Teva 5 mg film-coated tablets EFG

Solifenacin succinate

Read the entire leaflet carefully before you start taking this medicine, because 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 prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

The active substance in Solifenacin Teva 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 needing to go to the toilet 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 a sudden and strong urge to urinate without prior warning, needing to urinate frequently, or leaking urine because you cannot reach the toilet in time.

2. What you need to know before taking Solifenacin Teva

Do not take Solifenacin Teva

• If you are allergic to solifenacin or to 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 renal disease or moderate liver disease and are also being treated with medicines that may reduce 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 conditions mentioned above.

Warnings and precautions

Consult your doctor or pharmacist before starting Solifenacin Teva.

• if you have difficulty emptying your bladder (= bladder obstruction) or difficulty 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 are at increased risk of reduced activity of the digestive system (stomach and intestinal movements). Your doctor will inform you if this applies.
• if you have severe kidney disease.
• if you have moderate liver disease.
• if you have a hiatal hernia or heartburn.
• if you have a nervous system disorder (autonomic neuropathy).

Inform your doctor before starting treatment with Solifenacin Teva if any of the above conditions have ever occurred to you.

Before starting treatment with Solifenacin Teva, your doctor will assess whether there are other causes for your need to urinate frequently (for example, heart failure (inadequate pumping capacity of the heart) 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

Solifenacin Teva must not be used in children or adolescents under 18 years of age.

Taking Solifenacin Teva with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines.

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

• other anticholinergic medicines, as the activity and adverse effects of both medicines could increase.
• cholinergics, as they may reduce the effect of Solifenacin Teva.
• medicines such as metoclopramide or cisapride, which speed up the digestive system. Solifenacin Teva may reduce their effect.
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil and diltiazem, which decrease the rate of elimination of Solifenacin Teva from the body.
• medicines such as rifampicin, phenytoin and carbamazepine, as they may increase the rate of elimination of Solifenacin Teva from the body.
• medicines such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

Taking Solifenacin Teva with food

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

Pregnancy and breastfeeding

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

You must not use Solifenacin Teva during pregnancy unless 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 operate machinery.

Solifenacin Teva contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Solifenacin Teva

Always follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

You must swallow the tablet whole with liquid. It can be taken with or without food, according to your preference. 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 take the package and 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), marked excitement, seizures, breathing difficulty, increased heart rate (tachycardia), urine retention 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 almost time for your 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

If you suffer 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 (a skin allergy resulting in swelling of the tissue beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate. If angioedema occurs, treatment with solifenacin succinate must be stopped immediately and appropriate treatment and/or measures must be taken.

Solifenacina Teva may cause the following adverse 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 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
• somnolence
• abnormal taste perception (dysgeusia)
• dry (irritated) eyes
• 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 large amounts of hardened feces in the colon (fecal impaction)
• urine retention 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 which may cause an abnormal heart rhythm
• increased pressure in the eyes
• changes in the heart's electrical activity (ECG), irregular heartbeats (Torsades de Pointes), palpitations, rapid heartbeat
• voice disorder
• liver disorder
• muscle weakness
• kidney disorder

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Solifenacin Teva

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

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of the month indicated.

Blisters

This medicine does not require any special storage conditions.

Vials

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Solifenacin Teva 5 mg

• The active substance is solifenacin succinate.

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

• The other excipients are:

Tablet core: microcrystalline cellulose, povidone, crospovidone, anhydrous lactose, colloidal anhydrous 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 pack

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

Packs may be presented as:

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Holder

Teva Pharma, S.L.U.
C/Anabel Segura, 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 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 authorised in the European Economic Area (EEA) member states 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 latest revision of the summary of product characteristics: February 2026

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) (http://www.aemps.gob.es/)

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. 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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