Package Leaflet: Information for the User

Solifenacina Zentiva 5 mg Film-Coated Tablets EFG

Solifenacin Succinate

Read this 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. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Solifenacina Zentiva

3. How to take Solifenacina Zentiva

4. Possible side effects

5. Storage of Solifenacina Zentiva

6. Contents of the pack and additional information

The active ingredient of Solifenacina Zentiva 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 Zentiva 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 experiencing urine leakage due to not reaching the bathroom in time.

Do not takeSolifenacina Zentiva

• if you are allergic to solifenacina or any of the other ingredients 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 from the body (e.g. ketoconazole). Your doctor or pharmacist will inform you if this is the case.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• if you have problems 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 activity of the digestive system (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 are being treated with medications that can reduce the elimination of solifenacina from the body (e.g. ketoconazole).
• if you have hiatal hernia or heartburn.
• if you have a nervous system disorder (autonomic neuropathy).

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

Before starting treatment with this medication, your doctor will evaluate whether there are other causes for your need to urinate frequently (e.g. heart failure (insufficient heart pumping capacity) 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 should not be used in children and adolescents under 18 years old.

Taking Solifenacina Zentiva with other medications

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

Taking Solifenacina Zentiva with food and drinks

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

Pregnancy, breastfeeding, and fertility

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.

You should not use this medication if you are pregnant, unless it is absolutely necessary.

You should not use this medication during breastfeeding, as solifenacina may pass into breast milk.

Driving and operating machinery

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

Solifenacina Zentiva contains lactose monohydrate

If your doctor has told you that you have intolerance to some sugars, consult your doctor before taking this medication.

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

The usual dose is 5 mg per day, unless your doctor tells you to take 10 mg per day. Try to take Solifenacina Zentiva every day at the same time.

This medication should be swallowed whole with some liquid. It can be taken with or without food, as you prefer. Do not crush the tablets.

Inform your doctor or pharmacist if you feel that the effect of solifenacina is too strong or too weak.

If you take more Solifenacina Zentiva than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

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), urine accumulation in the bladder (urinary retention), and pupil dilation (mydriasis).

If you forgot to take Solifenacina Zentiva

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 interrupt treatment with Solifenacina Zentiva

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

If you have any other doubts 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 (such as blistering and peeling of the skin), you must inform your doctor or pharmacist immediately.

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

Solifenacin Zentiva 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, and stomach burning (dyspepsia), stomach discomfort.

Uncommon(may affect up to 1 in 100 people):

• Urinary tract infection; inflammation of the bladder (cystitis).
• Drowsiness; abnormal taste perception (dysgeusia).
• Dry eyes (irritated).
• Nasal dryness.
• Reflex disease (gastroesophageal reflux); dry throat.
• Dry skin.
• Difficulty urinating.
• Fatigue, accumulation of fluid in the lower extremities (edema).

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

• Dizziness, headache.
• Intestinal obstruction; accumulation of a large amount of hardened feces in the large intestine (fecal impaction).
• Vomiting.
• Itching, skin rash.
• Urinary retention due to inability to empty the bladder.

Very rare(may affect up to 1 in 10,000 people):

• Hallucinations; confusion.
• Allergic skin rash.

Frequency not known(the frequency cannot be estimated from the available data):

• Loss of appetite; high levels of potassium in the blood that may cause an abnormal heart rhythm (hyperkalemia).
• Delirium.
• Increased pressure in the eyes (glaucoma).
• Irregular heartbeats (Torsade de Pointes);changes in heart electrical activity (ECG), palpitations, rapid heartbeat.
• Voice disorder (dysphonia).
• Intestinal blockage (ileus); abdominal discomfort.
• Liver disorder; abnormal liver tests.
• Erythema and skin peeling (dermatitis exfoliativa)
• Muscle weakness.
• Renal disorder
• Anaphylactic reaction

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 on the blister pack and onthe box after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofSolifenacina Zentiva

• The active ingredientissuccinato de solifenacina.

Solifenacina Zentiva5 mg:Each tablet contains 5 mg of succinato de solifenacina corresponding to 3.8 mg of solifenacina.

• The other ingredients are:

Nucleus of the tablet:Maize pregelatinized starch; lactose monohydrate; microcrystalline cellulose; hypromellose; magnesium stearate.

Coating: Macrogol 6000; talc; hypromellose; titanium dioxide (E171); iron oxide yellow (E172).

Appearance of the product and contents of the package

Solifenacina Zentiva 5 mg are film-coated tablets, white to yellowish, biconvex, with a diameter of 8.0-8.2 mm.

Solifenacina Zentiva is supplied in blisters of10, 30, 50, 90 and 100 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Zentiva, k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Manufacturers responsible

Saneca

Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovak Republic

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

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

Last review date of thisleaflet: December 2018

Other sources of information

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