Soreca

Package Leaflet: Information for the User

Soreca, 5 mg, coated tablets

Solifenacin succinate

Read the package 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 for you only. 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 medicines called anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This allows the patient to extend the time between visits to the bathroom 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 cannot reach the bathroom 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)

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:

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 the case of a urinary tract infection, your doctor will prescribe an antibiotic for you.

Soreca and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as 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 increased.
• cholinergic medicines, as they may reduce the effect of solifenacin.
• medicines such as metoclopramide and cisapride, which speed up the movement of food through the digestive system. Solifenacin may reduce 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 inflammation of the esophagus (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 are planning to have a baby, 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 these side effects.

Soreca contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Soreca

Instructions for proper intake of the medicine

This medicine should always be taken exactly as your doctor has told you. If you are not sure, 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 once daily, unless your doctor has told you to take a dose of 10 mg once daily.

Overdose of Soreca

If you have taken more than you should, or if someone else has taken your medicine, 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), restlessness, convulsions, difficulty breathing, rapid heartbeat (tachycardia), accumulation of urine in the bladder (urinary retention), and dilated pupils.

Missed dose of Soreca

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

Stopping treatment with Soreca

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

Always consult your doctor before stopping treatment.

If you have any further questions on the use of this product, 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), you should contact your doctor or pharmacist immediately.

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

If you experience angioedema, you should stop taking solifenacin succinate immediatelyand receive appropriate treatment and/or take 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 disturbances (taste disorders),
• 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),
• accumulation of urine 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 storage instructions for this medicine.

Do not use Soreca after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

The batch number is stated after “Lot”.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 5 mg of solifenacin succinate (which corresponds to 3.8 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 yellow iron oxide (E172).

What Soreca looks like and contents of the pack

Soreca 5 mg is a yellow, round, film-coated tablet with “E2” engraved on one side.

Soreca 5 mg film-coated tablets are available 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 5 mg comprimidos recubiertos con película

Poland

Soreca

Date of last revision of the leaflet: 09/2023