Soreca

Patient Information Leaflet

Soreca, 10 mg, film-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. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Soreca is and what it is used for
2. What you need to know before you take 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 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 bladder can hold.
Soreca is used to treat the symptoms of a condition called overactive bladder. These symptoms include: a strong, sudden need to pass urine 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 a severe stomach or bowel condition (including toxic megacolon, a complication associated with ulcerative colitis)
• if the patient has a muscle disorder called myasthenia gravis, which may cause severe weakness 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 (e.g. 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 above-mentioned conditions.

Warnings and precautions

Before starting to take this medicine, consult a doctor or pharmacist:

• if the patient has difficulty emptying the bladder (bladder 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 (e.g. intestinal blockage).
• if the patient is at risk of slowed gastrointestinal motility (slowed stomach or bowel function). The doctor will inform the patient if any of these situations 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 targeted against specific bacterial strains causing the infection).

Soreca with other medicines

Tell your 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 speed up 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 may be taken with or without food, depending on patient 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 a doctor or pharmacist before using this medicine.

Solifenacin should not be used during pregnancy unless absolutely necessary.

Do not use solifenacin while breastfeeding, as solifenacin may pass into breast milk.

Driving and operating machinery

Solifenacin may cause blurred vision and, occasionally, 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, they should contact their doctor before taking this medicine.

3. How to use Soreca

Instructions for correct use of the medicine
This medicine should always be taken as directed by the physician. In case of doubt, consult a
doctor or pharmacist.
The tablet should be swallowed whole with an adequate amount of liquid. This medicine may be
taken with food or separately, according to patient preference. Do not crush the tablets.
The recommended dose is 5 mg once daily, unless the physician has advised a dose of 10 mg
once daily.

Use of a higher than recommended dose of Soreca
In case of overdose or accidental ingestion, contact a doctor or pharmacist immediately, providing
the name of the medicine and the amount ingested.
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.

Missed dose of Soreca
If a dose is missed, and the next scheduled dose is not approaching, take the missed dose as
soon as possible. Never take more than one dose of this medicine per day. In case of doubt, consult
a doctor or pharmacist.

Stopping treatment with Soreca
If the patient discontinues treatment with Soreca, symptoms of overactive bladder may return.
Always consult a doctor before stopping treatment.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If an allergic attack or severe skin reaction (e.g. blisters 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 should be discontinued immediately, and appropriate treatment and/or precautionary measures should be initiated.

Solifenacin may cause the following adverse reactions:

Very common adverse reactions (may occur in more than 1 in 10 people):

• dry mouth.

Common adverse reactions (may occur in up to 1 in 10 people):

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

Uncommon adverse reactions (may occur in up to 1 in 100 people):

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

Rare adverse reactions (may occur in up to 1 in 1,000 people):

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

Very rare adverse reactions (may occur in 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 levels of potassium in the blood which may cause irregular heart rhythm,
• increased pressure in the eye,
• changes in the heart's electrical activity (ECG), irregular heartbeat, palpitations, rapid heartbeat,
• voice disorders,
• liver function disturbances,
• muscle weakness,
• kidney function disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions
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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to 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.
No special storage instructions apply to this medicine.
Do not use Soreca after the expiry date stated on the carton following "EXP".
The expiry date refers to the last day of the stated month. The batch number is indicated after "Lot".
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such 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 10 mg of solifenacin succinate (equivalent to 7.5 mg of solifenacin).
The other ingredients are: monohydrate lactose, corn starch, hypromellose (4-6 mPas), anhydrous colloidal silicon dioxide, magnesium stearate, hypromellose (6 mPs), talc, macrogol, titanium dioxide (E171) and red iron oxide (E172).

What Soreca looks like and contents of the pack
Soreca 10 mg is pink, round, film-coated tablets marked with "E3" on one side.
Soreca 10 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 10 mg comprimidos recubiertos con película
Poland: Soreca