Solifenacin Krka 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package 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 you start using this medicine, as 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, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

The active substance in Solifenacina Krka belongs to the group of anticholinergics. These medicines are used to reduce the activity of the 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.

Solifenacina Krka is used to treat the symptoms of overactive bladder syndrome. These symptoms include a sudden and strong urge to urinate without warning, needing to urinate frequently, or experiencing urine leakage because you cannot reach the toilet in time.

2. What you need to know before starting to take Solifenacin Krka

Do not take Solifenacin Krka

• 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 kidney disease or moderate liver disease and are also being treated with medicines that may reduce the elimination of solifenacin from the body (e.g. ketoconazole). Your doctor or pharmacist will have informed you if this applies.

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

Warnings and precautions

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

• If you have difficulty emptying your bladder (= bladder obstruction) or difficulty urinating (e.g. weak urine stream). 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 risk of reduced activity of the digestive system (stomach and intestinal movements). Your doctor will have informed 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).

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

Before starting treatment with Solifenacin Krka, your doctor will assess whether there are other causes for your need to urinate frequently (for example, heart failure (reduced 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 Krka must not be used in children or adolescents under 18 years of age.

Other medicines and Solifenacin Krka

Tell 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.
• Medicines such as metoclopramide or cisapride, which increase digestive system activity. Solifenacin may reduce their effect.
• Medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which decrease the rate of elimination of solifenacin from the body.
• Medicines such as rifampicin, phenytoin, and carbamazepine, as they may increase the rate of elimination of solifenacin from the body.
• Medicines such as bisphosphonates, which may cause or worsen inflammation of the oesophagus (oesophagitis).

Taking Solifenacin Krka with food and drink

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

Pregnancy and breastfeeding

You must not use Solifenacin Krka during pregnancy unless 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 medicine.

Driving and using machines

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

Solifenacin Krka contains lactose

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

3. How to take Solifenacin Krka

Instructions for correct use

Follow exactly the instructions for use of this medicine given by your doctor. If you are unsure, please consult your doctor or pharmacist again.

You should swallow the tablet whole with some liquid. It can be taken with or without food, according to your preference. Do not crush the tablets.

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

If you take more Solifenacin Krka than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision, perception of things that are not present (hallucinations), pronounced excitement, seizures, breathing difficulty, increased heart rate (tachycardia), urine accumulation in the bladder (urinary retention), and dilation of the pupils (mydriasis).

If you forget to take Solifenacin Krka

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.

Do not take a double dose to make up for forgotten doses. If you have any doubts, always consult your doctor or pharmacist.

If you stop taking Solifenacin Krka

If you stop taking this medicine, 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 experiences them.

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

• if you have an allergic attack or a severe skin reaction (for example, blistering and peeling of the skin);
• angioedema (a skin allergy resulting in swelling beneath the skin surface) with airway obstruction (difficulty breathing) has been reported in some patients treated with solifenacin succinate.

Solifenacin Krka 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 (drowsiness).
• 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 hardened feces in the large intestine (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 available data):

• decreased appetite, high levels of potassium in the blood which may cause an abnormal heart rhythm.
• increased eye pressure.
• changes in the heart's electrical activity (ECG), irregular heartbeat, palpitations, rapid heartbeat.
• voice disorder.
• liver disorder.
• muscle weakness.
• kidney disorder.

Reporting of adverse effects

If you experience any 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 Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Solifenacin Krka

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Solifenacin Krka

• The active substance 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 components are:

Tablet core: lactose monohydrate, povidone, 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 “Solifenacin Krka contains lactose”.

Appearance of the product and contents of the pack

Solifenacin Krka 5 mg film-coated tablets

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

Solifenacin Krka 10 mg film-coated tablets

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

Available in cardboard packs containing 10, 20, and 30 film-coated tablets in blisters.

Only certain 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

For more information about this medicine, contact the local representative of the Marketing Authorization Holder:

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

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last review of this leaflet: July 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).