Package leaflet: Information for the user

Soreca, 5 mg, coated tablets
Solifenacin succinate
Please read all of this leaflet carefully before 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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Soreca is and what it is used for
What you need to know before taking Soreca
How to take Soreca
Possible side effects
How to store Soreca
Contents of the pack and other information

1. What Soreca is and what it is used for

The active substance in Soreca belongs to a group of medicines called anticholinergics. These medicines are used to reduce the activity of an overactive bladder. This allows for a longer time between bathroom visits and increases the amount of urine the patient can hold in the bladder.
Soreca is used to treat the symptoms of a condition called overactive bladder. These symptoms include: a strong, sudden need to urinate without prior warning, frequent urination, or urinary incontinence because the patient cannot reach the toilet in time.

2. Important information before using Soreca

When not to use Soreca

If the patient is allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6)
if the patient is unable to pass urine or completely empty the bladder (urinary retention)
if the patient has severe stomach or intestinal disease (including toxic megacolon, a complication associated with ulcerative colitis)
if the patient has a muscle disorder called myasthenia gravis, which may cause severe weakening of certain muscles
if the patient has increased pressure in the eye with progressive loss of vision (glaucoma)
if the patient is undergoing dialysis
if the patient has severe liver disease
if the patient has severe kidney disease or moderate liver disease and is also being treated with medicines that may reduce the elimination of solifenacin from the body (for example, ketoconazole). The doctor or pharmacist will inform the patient if any of these situations apply.

Before starting treatment with solifenacin, the patient should inform the doctor if they have ever had any of the conditions listed above.
Warnings and precautions
Before starting to take this medicine, consult a doctor or pharmacist:

if the patient has difficulty emptying the bladder (bladder outlet obstruction) or has trouble passing urine (e.g. weak urine stream). The risk of urine accumulating in the bladder (urinary retention) is significantly increased.
if the patient has gastrointestinal obstruction (constipation).
if the patient is at risk of slowed gastrointestinal motility (slowed stomach and bowel function). The doctor will inform the patient if any of these conditions apply.
if the patient has severe kidney disease.
if the patient has moderate liver disease.
if the patient has a hiatal hernia or gastroesophageal reflux disease (heartburn).
if the patient has neurological disorders (autonomic neuropathy).

Children and adolescents
This medicine must not be given to children and adolescents under 18 years of age.
Before starting treatment with Soreca, the patient should inform the doctor if any of the above-mentioned conditions have ever occurred.
Before starting treatment with Soreca, the doctor will assess whether there are other causes of frequent urination (e.g. heart failure (inadequate pumping of blood by the heart) or kidney disease). In case of a urinary tract infection, the doctor will prescribe an antibiotic for the patient (treatment directed against specific strains of bacteria causing the infection).
Soreca and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. It is especially important to inform the doctor if the patient is 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 increase gastrointestinal motility. Solifenacin may reduce their effectiveness.
medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, and diltiazem, which slow down the breakdown of solifenacin in the body.
medicines such as rifampicin, phenytoin, and carbamazepine, as they may speed up the breakdown of solifenacin in the body.
medicines such as bisphosphonates, which may cause or worsen inflammation of the oesophagus (oesophagitis).

Taking Soreca with food, drink and alcohol
This medicine can be taken with food or separately, depending on the patient's preference.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Solifenacin must not be used during pregnancy unless absolutely necessary.
Do not use solifenacin during breastfeeding, as solifenacin may pass into breast milk.
Driving and operating machinery
Solifenacin may cause blurred vision and sometimes drowsiness or fatigue. The patient should not drive or operate machinery if these side effects occur.
Soreca contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

3. How to take Soreca

Instructions for correct use of the medicine
This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
The tablet should be swallowed whole with an adequate amount of liquid. This medicine may be taken
with food or on an empty stomach, according to patient preference. Do not crush the tablets.
The recommended dose is 5 mg once daily, unless the doctor has prescribed a dose of 10 mg once daily.
Taking more Soreca than prescribed
In case of overdose or accidental ingestion, contact a doctor or pharmacist immediately, providing
the name of the medicine and the amount taken.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, blurred vision,
perception of things that are not present (hallucinations), hyperexcitability, seizures, breathing difficulties,
increased heart rate (tachycardia), urine retention in the bladder (urinary retention), and dilated pupils.
If you miss a dose of Soreca
If a dose is missed and the next scheduled dose is not approaching, take the missed dose immediately.
Never take more than one dose of the medicine per day. In case of doubt, consult your doctor or pharmacist.
Stopping Soreca
If the patient stops taking Soreca, symptoms of overactive bladder may return. Always consult your doctor
before stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
If an allergic attack or severe skin reaction (e.g. blistering and peeling of the skin) occurs, a doctor or pharmacist should be informed immediately.
In some patients treated with solifenacin succinate, angioedema (an allergic skin reaction causing swelling of the tissue just beneath the skin surface) with airway obstruction (difficulty breathing) has been reported. If angioedema occurs in a patient, treatment with solifenacin succinate must be discontinued immediately and appropriate treatment and/or precautionary measures initiated.

Solifenacine may cause the following adverse effects:

Very common adverse effects (may occur in more than 1 in 10 patients):

dry mouth.

Common adverse effects (may occur in up to 1 in 10 patients):

blurred vision, constipation, nausea, dyspepsia with symptoms such as feeling of fullness in the abdomen, abdominal pain, belching, nausea and heartburn (dyspepsia), feeling of discomfort in the abdomen.

Uncommon adverse effects (may occur in up to 1 in 100 patients):

urinary tract infection, bladder infection,
somnolence,
disturbances in taste sensation (taste disorders),
dry eye syndrome (irritation),
dry nose,
gastroesophageal reflux disease (gastroesophageal reflux),
dry throat,
dry skin,
difficulty in passing urine,
fatigue,
fluid accumulation in the lower limbs (oedema).

Rare adverse effects (may occur in up to 1 in 1,000 patients):

accumulation of hardened faeces in the colon (faecal impaction),
urine retention in the bladder due to inability to empty the bladder (urinary retention),
dizziness, headache,
vomiting,
itching, rash.

Very rare adverse effects (may occur in up to 1 in 10,000 patients):

hallucinations, confusion,
allergic rash.

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

decreased appetite, high levels of potassium in the blood which may cause irregular heart rhythm,
increased intraocular pressure,
changes in electrical activity of the heart (ECG), irregular heartbeat, palpitations, increased heart rate,
voice disorders,
liver function abnormalities,
muscle weakness,
kidney function disorders.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Soreca

Keep this medicine out of sight and reach of children.
There are no special requirements for the storage of this medicine.
Do not use Soreca after the expiry date stated on the outer packaging after "EXP".
The expiry date refers to the last day of the month indicated. The batch number follows the abbreviation "Lot".
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 (equivalent to 3.8 mg of solifenacin).
The other ingredients are: monohydrate lactose, corn starch, hypromellose (4-6 mPas), colloidal anhydrous silica, magnesium stearate, hypromellose (6 mPs), talc, macrogol, titanium dioxide (E171), and yellow iron oxide (E172).

What Soreca looks like and contents of the pack
Soreca 5 mg is yellow, round tablets with the inscription "E2" on one side.
Soreca 5 mg film-coated tablets are supplied in a cardboard box containing 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Recordati Polska sp. z o.o.
al. Armii Ludowej 26
00-609 Warsaw
Poland

Manufacturer
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona 69
08970 Sant Joan Despí (Barcelona)
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands Solifenacinesuccinaat Neuraxpharm 5/10 mg filmomhulde tabletten
Spain Solifenacina Novalie 5 mg comprimidos recubiertos con película
Poland Soreca