SOLIFENACIN KRKA 5 mg FILM-COATED TABLETS

Introduction

Leaflet: Information for the user

Solifenacin Krka 5 mg film-coated tablets EFG

Solifenacin Krka 10 mg film-coated tablets EFG

solifenacin succinate

Read the entire leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, 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, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Solifenacin Krka and what is it used for
2. What you need to know before taking Solifenacin Krka
3. How to take Solifenacin Krka
4. Possible side effects
5. Storage of Solifenacin Krka
6. Package contents and additional information

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

The active ingredient of Solifenacin Krka belongs to the group of anticholinergics. These medications are used to reduce the activity of the 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.

Solifenacin Krka is used to treat the symptoms of overactive bladder syndrome. These symptoms include: having a strong and sudden need to urinate without warning, needing to urinate frequently, or having urine leaks due to not reaching the bathroom in time.

2. What you need to know before taking Solifenacin Krka

Do not takeSolifenacin Krka

• 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 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 can decrease the elimination of solifenacin from the body (e.g., ketoconazole). Your doctor or pharmacist will have informed you if this is the case.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Solifenacin Krka.

• 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 a risk of decreased activity of the digestive system (stomach and intestinal movements). 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 a hiatal hernia or heartburn.
• If you have an autonomic nervous disorder (autonomic neuropathy).

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

Before starting treatment with Solifenacin Krka, your doctor will assess if 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 against certain bacterial infections).

Children and adolescents

Solifenacin Krka should not be used in children or adolescents under 18 years of age.

Other medications andSolifenacinKrka

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

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

• Other anticholinergic medications, as the activity and side effects of both medications may increase.
• Cholinergics, as they may reduce the effect of solifenacin.
• Medications such as metoclopramide or cisapride, which make the digestive system work faster. Solifenacin may reduce their effect.
• Medications such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the elimination of solifenacin from the body.
• Medications such as rifampicin, phenytoin, and carbamazepine, as they may increase the elimination of solifenacin from the body.
• Medications such as bisphosphonates, which may cause or worsen esophageal inflammation (esophagitis).

TakingSolifenacinKrkawith food and drinks

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

Pregnancy and breastfeeding

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

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.

Driving and using machines

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

Solifenacin Krkacontains lactose

This medication 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 Krka

Instructions for correct use

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor or pharmacist again.

Swallow the tablet whole with some liquid. It can be taken with or without food, as you prefer. 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 moreSolifenacinKrkathan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the leaflet of the medication 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), urine accumulation in the bladder (urinary retention), and dilation of the pupils (mydriasis).

If you forget to useSolifenacinKrka

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 make up for forgotten doses. If in doubt, always consult your doctor or pharmacist.

If you stop taking Solifenacin Krka

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

If you have any other doubts 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 experiences them.

Stop taking Solifenacin Krka and seek medical attention immediately if you notice any of the following side effects:

• angioedema (allergy in the skin that results in inflammation that occurs in the tissue under the skin surface) with respiratory tract obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate.

Solifenacin 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 a feeling of 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.
• drowsiness.
• abnormal taste perception (dysgeusia).
• dry eyes (irritated).
• dryness of the nasal passages.
• gastroesophageal 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 a large amount of hardened feces in the large intestine (fecal impaction).
• urine accumulation 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 available data):

• decreased appetite, high potassium levels in the blood that can cause an abnormal heart rhythm.
• increased pressure in the eyes.
• changes in heart electrical activity (ECG), irregular heartbeat, 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 leaflet. You can also report them directly through the Spanish Medicines Monitoring System (www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Solifenacin Krka

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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. If in doubt, 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 ofSolifenacin Krka

• The active ingredient is solifenacin succinate.

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

Solifenacin 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 ingredients are:

Core of the tablet: lactose monohydrate, povidone, and magnesium stearate.

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

See section 2 "Solifenacin Krka contains lactose"

Appearance of the product and package contents

Solifenacin Krka 5 mg film-coated tablets

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

Solifenacin Krka 10 mg film-coated tablets

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

Available in boxes with blisters of 10, 20, and 30 film-coated tablets.

Not all 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

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

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

Date of the last revision of this leaflet: July 2023

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