Soreca

Leaflet accompanying the packaging: information for the user

Soreca, 10 mg, coated tablets

Solifenacin succinate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Soreca and what is it used for
• 2. Important information before taking Soreca
• 3. How to take Soreca
• 4. Possible side effects
• 5. How to store Soreca
• 6. Contents of the pack and other information

1. What is Soreca and what is it used for

The active substance of Soreca belongs to a group of anticholinergic medicines. These medicines are used to reduce the activity of an overactive bladder. This allows the patient to extend the time between visits to the toilet and increase the amount of urine that the patient can hold in the bladder.

Soreca is used to treat the symptoms of a condition called overactive bladder. These symptoms include: sudden, urgent need to urinate without prior warning, frequent urination or incontinence, because the patient is unable to reach the toilet in time.

2. Important information before taking Soreca

When not to take Soreca

• If you are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6)
• if you have difficulty emptying your bladder or cannot empty your bladder completely (urinary retention)
• if you have a severe stomach or intestinal disease (including toxic megacolon, a complication of ulcerative colitis)
• if you have a muscle disease called myasthenia gravis, which can cause severe weakness of some muscles
• if you have increased pressure in the eyes, with gradual loss of vision (glaucoma)
• if you are on dialysis
• if you have severe liver disease
• if you have severe kidney disease or moderate liver disease, and you are taking medicines that may reduce the elimination of solifenacin from the body (such as ketoconazole). Your doctor or pharmacist will inform you if any of these cases apply to you.

Before starting treatment with solifenacin, you should tell your doctor if you have ever had any of the above conditions.

Warnings and precautions

Before taking this medicine, you should tell your doctor or pharmacist

• if you have difficulty emptying your bladder (obstruction of the bladder) or have trouble urinating (e.g. weak stream of urine). The risk of urine accumulation in the bladder (urinary retention) is much higher.
• if you have intestinal obstruction (constipation).
• if you are at risk of slowing down the digestive system (gastric and bowel movements). Your doctor will inform you if any of these cases apply to you.
• if you have severe kidney disease.
• if you have moderate liver disease.
• if you have a hiatal hernia or heartburn.
• if you have autonomic nervous system disorders (autonomic neuropathy).

Children and adolescents

This medicine should not be given to children and adolescents under 18 years of age.

Before starting treatment with Soreca, you should tell your doctor if you have ever had any of the above conditions.

Before starting treatment with Soreca, your doctor will assess whether there are other causes of frequent urination (e.g. heart failure or kidney disease). In case of urinary tract infection, your doctor will prescribe an antibiotic (treatment aimed at specific bacterial strains causing the infection).

Soreca and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take. It is especially important to inform your doctor if you are taking:

• other anticholinergic medicines, as the effects and side effects of both medicines may be enhanced.
• cholinergic medicines, as they may reduce the effect of solifenacin.
• medicines such as metoclopramide and cisapride, which speed up the digestive system. Solifenacin may limit their effect.
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which slow down the breakdown of solifenacin by the body.
• medicines such as rifampicin, phenytoin, and carbamazepine, as they may speed up the breakdown of solifenacin by the body.
• medicines such as bisphosphonates, which may cause or worsen esophageal inflammation (esophagitis).

Taking Soreca with food, drink, and alcohol

This medicine can be taken with or without food, depending on the patient's preference.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.

Unless it is absolutely necessary, solifenacin should not be used during pregnancy.

Solifenacin should not be used during breastfeeding, as solifenacin may pass into breast milk.

Driving and using machines

Solifenacin may cause blurred vision, and sometimes drowsiness or fatigue. You should not drive or operate machinery if you experience such side effects.

Soreca contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Soreca

Instructions for proper intake of the medicine

This medicine should always be taken as directed by your doctor. If you are unsure, ask your doctor or pharmacist.

The tablet should be swallowed whole with a sufficient amount of liquid. This medicine can be taken with or without food, depending on the patient's preference. Do not crush the tablets.

The recommended dose is 5 mg per day, unless your doctor has advised you to take a dose of 10 mg per day.

Using a higher dose of Soreca than recommended

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, stating the name of the medicine and the amount taken.

Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and blurred vision, seeing things that are not there (hallucinations), agitation, seizures, difficulty breathing, rapid heartbeat (tachycardia), accumulation of urine in the bladder (urinary retention), and dilated pupils.

Missing a dose of Soreca

If you miss a dose, take it as soon as possible, unless it is almost time for the next dose. Never take more than one dose per day. If you are unsure, ask your doctor or pharmacist.

Stopping treatment with Soreca

If you stop taking Soreca, the symptoms of overactive bladder may return.

Always consult your doctor if you plan to stop treatment.

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

4. Possible side effects

Like all medicines, Soreca can cause side effects, although not everybody gets them.

If you experience an allergic reaction or severe skin reaction (e.g. blisters and peeling skin), tell your doctor or pharmacist immediately.

In some patients treated with solifenacin succinate, angioedema (an allergic skin reaction causing swelling in the tissue just below the surface of the skin) with airway obstruction (difficulty breathing) has been reported.

If you experience angioedema, stop taking solifenacin succinate immediatelyand initiate appropriate treatment and/or precautions.

Solifenacin may cause the following side effects:

Very common side effects (may affect more than 1 in 10 people):

• dry mouth.

Common side effects (may affect up to 1 in 10 people):

• blurred vision, constipation, nausea, indigestion with symptoms such as feeling full in the stomach, stomach pain, belching, nausea, and heartburn (indigestion), discomfort in the stomach.

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

• urinary tract infection, bladder infection,
• drowsiness,
• taste disorders (taste disturbances),
• dry eye syndrome (irritation),
• dry nose,
• gastroesophageal reflux disease (gastroesophageal reflux),
• dry throat,
• dry skin,
• difficulty urinating,
• fatigue,
• fluid accumulation in the lower limbs (edema).

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

• accumulation of large amounts of hardened stool in the large intestine (fecal impaction),
• urine accumulation in the bladder due to inability to empty the bladder (urinary retention),
• dizziness, headache,
• vomiting,
• itching, rash.

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

• hallucinations, confusion,
• allergic rash.

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

• decreased appetite, high potassium levels in the blood, which can cause irregular heartbeat,
• increased eye pressure,
• changes in the electrical activity of the heart (ECG), irregular heartbeat, palpitations, rapid heartbeat,
• voice disorders,
• liver function disorders,
• muscle weakness,
• kidney function disorders.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

PL-02 222 Warsaw

Tel.: + 48 22 49 21 301

Fax: + 48 22 49 21 309

website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Soreca

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

There are no special precautions for storage.

Do not use Soreca after the expiry date stated on the carton after "EXP".

The expiry date refers to the last day of the month stated.

The batch number is stated after the abbreviation "Lot".

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

This will help protect the environment.

6. Contents of the pack and other information

What Soreca contains

The active substance is solifenacin succinate. Each tablet contains 10 mg of solifenacin succinate (which corresponds to 7.5 mg of solifenacin).

The other ingredients are: lactose monohydrate, maize starch, hypromellose (4-6 mPas), colloidal anhydrous silica, magnesium stearate, hypromellose (6mPs), talc, macrogol, titanium dioxide (E171), and red iron oxide (E172).

What Soreca looks like and contents of the pack

Soreca 10 mg is a pink, round tablet with "E3" engraved on one side.

Soreca 10 mg coated tablets are supplied in a cardboard box containing 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Recordati Polska sp. z o.o.

al. Armii Ludowej 26

00-609 Warsaw

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí (Barcelona)

Spain

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

Netherlands

Solifenacinesuccinaat Neuraxpharm 5/10 mg filmomhulde tabletten

Spain

Solifenacina Novalie 10 mg comprimidos recubiertos con película

Poland

Soreca

Date of last revision of the leaflet: 09/2023