Leaflet: Information for the user

Solifenacina Krka 5 mg film-coated tablets EFG

Solifenacina Krka 10 mg film-coated tablets EFG

succinate of solifenacin

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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

The active ingredient of Solifenacina Krkabelongs 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 Krka 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 due to not making it to the bathroom on time.

Do not takeSolifenacina Krka

-If you are allergic tosolifenacinaor 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 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 medicines that can reduce the elimination ofsolifenacinafrom the body (e.g. ketoconazole). Your doctor or pharmacist will have informed you if this is the case.

Before starting treatment with Solifenacina Krka, inform your doctor 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 Krka.

-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 a risk of decreased activity of the digestive system (gastrointestinal motility). Your doctor will have informed 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 disorder (autonomic neuropathy).

Before starting treatment with Solifenacina Krka, inform your doctor if you have or have had any of the diseases mentioned above.

Before starting treatment with Solifenacina Krka, your doctor will assess 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 Krka should not be used in children or adolescents under 18 years.

Other medicines andSolifenacina Krka

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

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

-Other anticholinergic medicines, the activity and adverse effects of both medicines may increase.

-Cholinergic medicines, as they may reduce the effect of solifenacina.

-Medicines such as metoclopramide or cisapride, which make the digestive system work faster. Solifenacina may reduce their effect.

-Medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which reduce the rate of elimination of solifenacina from the body.

-Medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the rate of elimination of solifenacina from the body.

-Medicines such as bisphosphonates, which may cause or worsen inflammation of the esophagus (esophagitis).

Administration ofSolifenacina Krkawith food and drinks

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

Pregnancy and lactation

You should not use Solifenacina Krka if you are pregnant unless absolutely necessary. Do not use Solifenacina Krka during lactation as solifenacina may pass into breast milk.

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

Driving and operating machines

Solifenacina may cause blurred vision and, occasionally, drowsiness or fatigue. If you experience any of these adverse effects, do not drive or operate machines.

Solifenacina Krkacontains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

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.

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

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

If You Take MoreSolifenacinaKrkaThan You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication 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), pronounced excitement, convulsions, difficulty breathing, increased heart rate (tachycardia), urine accumulation in the bladder (urinary retention), and pupil dilation (mydriasis).

If You Forget to UseSolifenacinaKrka

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.

Do not take a double dose to compensate for the missed doses. If you have any doubts, consult your doctor or pharmacist always.

If You Stop Taking Solifenacina Krka

If you stop taking this medication, your overactive bladder symptoms may return or worsen. Consult your doctor always if you are thinking of stopping treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

Stop taking Solifenacina krka 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 peeling of the skin);

- angioedema (allergic reaction on the skin resulting in inflammation under the skin surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate.

Solifenacina Krka 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).

-nasal dryness.

-gastroesophageal reflux disease (GERD), dry throat.

-dry skin.

-difficulty urinating.

-fatigue, accumulation of fluid in the lower extremities (edema).

Rare(may affect up to 1 in 1000 people):

-impaction of a large amount of hardened feces in the large intestine.

-urinary retention due to 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 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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the 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 medicine.

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

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

This medication does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition ofSolifenacina Krka

-The active ingredient is solifenacin succinate.

Solifenacina Krka 5 mg film-coated tablets:Each film-coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin.

Solifenacina Krka 10 mg film-coated tablets:Each film-coated tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg of solifenacin.

-The other components are:

Core tablet:lactose monohydrate,pellucid and magnesium stearate.

Tablet coating:hypromellose, talc, titanium dioxide (E171), triacetin and iron oxide red (E172) (only for the 10 mg dose)

See section 2 “Solifenacina Krka contains lactose”

Appearance of the product and contents of the pack

Solifenacina Krka 5 mg film-coated tablets

Film-coated tablets, white to off-white, round, slightly convex with beveled edges. Tablet diameter: 7.5 mm.

Solifenacina Krka 10 mg film-coated tablets

Film-coated tablets, white to pinkish, round, slightly convex with beveled edges. Tablet diameter: 7.5 mm.

It is available in boxes with blisters of 10, 20 and 30 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

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

Last revision date of this leaflet: July 2023

Further detailed 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/).