Solinco

Leaflet accompanying the packaging: information for the user

SOLINCO, 5 mg, film-coated tablets

SOLINCO, 10 mg, film-coated tablets

Solifenacin succinate

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is SOLINCO and what is it used for

The active substance of SOLINCO belongs to a group of cholinolytic medicines. These medicines reduce the activity of an overactive urinary bladder. This action allows for longer intervals between using the toilet and increases the amount of urine held in the bladder. SOLINCO is used to treat symptoms of an overactive bladder. These include: urgent urination, i.e., episodes of sudden, urgent need to urinate, frequent urination, and urinary incontinence, related to the fact that the patient did not have time to use the toilet.

2. Important information before taking SOLINCO

When not to take SOLINCO

• if the patient cannot urinate or cannot empty the urinary bladder (urinary retention)
• if the patient has severe stomach or intestinal disorders (toxic megacolon, a complication associated with ulcerative colitis)
• in patients with a muscle disease called myasthenia, which can cause significant weakness of some muscles
• if the patient has increased fluid pressure in the eyeball, which can lead to gradual vision loss (narrow-angle glaucoma)
• if the patient is allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6)
• if the patient is undergoing kidney dialysis
• in patients with severe liver function disorders
• if the patient has severe kidney disease or moderate liver disease and is taking medicines that may delay the elimination of SOLINCO from the body (e.g., ketoconazole). The doctor or pharmacist will provide information on this.

Before starting to take SOLINCO, the patient should inform their doctor if any of the above situations apply or have occurred in the past.

Warnings and precautions

Before starting to take SOLINCO, the patient should discuss it with their doctor or pharmacist:

• if the patient has difficulty emptying the urinary bladder (narrowing of the urethra) or urinating (weak urine stream). In such cases, the risk of urine accumulation in the bladder (urinary retention) is much higher.
• if the patient has gastrointestinal motility disorders (constipation)
• if there is a risk of slowing down the movement of the digestive tract (peristalsis). The doctor will provide information on this.
• if the patient has severe kidney function disorders
• if the patient has moderate liver function disorders
• if the patient has a burning stomach pain (hiatal hernia) or heartburn
• if the patient has nervous system disorders (autonomic nervous system neuropathy).

Before starting to take SOLINCO, the patient should inform their doctor if any of the above situations apply or have occurred in the past. Before starting SOLINCO treatment, the doctor will assess whether there are other causes of frequent urination, such as heart failure (insufficient heart muscle strength to pump blood) or kidney disease. If a urinary tract infection occurs, the doctor will prescribe an antibiotic (an antibacterial medicine that acts on specific bacteria).

Children and adolescents

SOLINCO is not intended for use in children and adolescents under 18 years of age.

SOLINCO and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take. It is especially important to inform the doctor if the patient is taking:

• other cholinolytic medicines, as taking such a medicine with SOLINCO may lead to an increase in both the therapeutic effect and the side effects of both medicines
• medicines from the group of cholinergic receptor agonists, as they may weaken the effect of SOLINCO
• medicines that accelerate the movement of the digestive tract, such as metoclopramide and cisapride, as SOLINCO may weaken their effect
• medicines such as ketoconazole, itraconazole (medicines used to treat fungal infections), ritonavir, nelfinavir (medicines used to treat HIV infection), and verapamil, diltiazem (medicines used to treat high blood pressure and heart disease), as they slow down the metabolism of SOLINCO
• medicines such as rifampicin (medicines used to treat tuberculosis or other bacterial infections) and phenytoin, carbamazepine (medicines used to treat epilepsy), as they may accelerate the metabolism of SOLINCO
• medicines such as bisphosphonates, as they may cause or exacerbate esophageal inflammation (esophagitis). The patient should ask their doctor if the medicine belongs to this group.

SOLINCO with food and alcohol

The medicine can be taken during meals or independently of meals.

Pregnancy and breastfeeding

SOLINCO should not be taken during pregnancy, unless it is absolutely necessary. SOLINCO should not be taken during breastfeeding, as solifenacin passes into human milk. If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

SOLINCO may cause blurred vision, and less often, drowsiness and fatigue. If such side effects occur, the patient should not drive or operate any machinery.

SOLINCO contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take SOLINCO

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist. The tablet should be swallowed whole, with a liquid, e.g., a glass of water. The medicine can be taken during meals or independently of meals, depending on the patient's preferences. The tablets should not be crushed. The usual dose is 5 mg per day, unless the doctor recommends taking a dose of 10 mg per day.

Use in children and adolescents

SOLINCO is not intended for use in children and adolescents under 18 years of age.

Taking a higher dose of SOLINCO than recommended

In case of taking too many SOLINCO tablets or if a child accidentally swallows SOLINCO, the patient should immediately contact their doctor or pharmacist. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disorders, hallucinations, excessive stimulation, seizures (convulsions), breathing difficulties, rapid heartbeat (tachycardia), urine accumulation in the bladder (urinary retention), and dilated pupils.

Missing a dose of SOLINCO

In case of missing a dose, the patient should take the next dose as soon as possible, unless it is almost time for the next dose. The medicine should not be taken more than once a day. In case of doubts, the patient should consult their doctor or pharmacist. The patient should not take a double dose to make up for the missed dose.

Stopping SOLINCO treatment

If the patient stops taking SOLINCO, the symptoms of an overactive bladder may return or worsen. Stopping the treatment should always be consulted with the doctor. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, SOLINCO can cause side effects, although not everybody gets them. If the patient experiences an allergic reaction or a severe skin reaction (e.g., blistering and peeling of the skin), they should immediately inform their doctor or pharmacist. Some patients taking solifenacin succinate (SOLINCO) have reported angioedema (a form of skin allergy that causes swelling of the tissue just beneath the skin surface) with swelling of the airways (difficulty breathing). If the patient experiences angioedema, they should immediately stop taking solifenacin succinate (SOLINCO) and receive appropriate treatment and/or take appropriate measures. SOLINCO may cause other side effects, including:

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

• dry mouth

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

• blurred vision
• constipation, nausea, indigestion with symptoms such as: feeling of a full stomach, abdominal pain, belching, nausea, heartburn, feeling of discomfort in the abdominal cavity

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

• urinary tract infection, bladder infection (cystitis)
• drowsiness
• taste disorders
• dry (irritated) eyes
• dryness in the nasal cavity
• gastroesophageal reflux disease (gastroesophageal reflux)
• dryness in the throat
• dry skin
• difficulty urinating
• fatigue
• fluid accumulation in the lower limbs (edema)

Rare side effects (which may affect up to 1 in 1000 patients):

• accumulation of a large amount of hard stool in the colon (fecal impaction)
• difficulty urinating despite a full bladder (urinary retention)
• dizziness, headaches
• vomiting
• itching, rash

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

• hallucinations, disorientation
• allergic rash

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

• decreased appetite, increased potassium levels in the blood, which may cause heart rhythm disorders
• increased eye pressure
• changes in ECG, irregular heartbeat (Torsade de Pointes), palpitations, rapid heartbeat
• voice disorders
• liver function disorders
• muscle weakness
• kidney function disorders

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store SOLINCO

There are no special precautions for storing the medicine. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated. Do not use this medicine if the packaging is damaged or shows signs of opening. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What SOLINCO contains

• The active substance of SOLINCO is solifenacin succinate.
• Each film-coated tablet contains 5 mg or 10 mg of solifenacin succinate.
• The other ingredients are: lactose monohydrate, cornstarch, hypromellose 6cP, magnesium stearate. Tablet coating: hypromellose, Macrogol 8000, talc, titanium dioxide (E 171), yellow iron oxide (E 172) (SOLINCO, 5 mg, film-coated tablets), red iron oxide (E 172) (SOLINCO, 10 mg, film-coated tablets)

What SOLINCO looks like and contents of the pack

SOLINCO, 5 mg, film-coated tablets: yellow, round tablets with the marking "390" on one side. SOLINCO, 10 mg, film-coated tablets: pink, round tablets with the marking "391" on one side. SOLINCO is available in cartons containing 30, 60, 90, 120 tablets.

Marketing authorization holder

+pharma arzneimittel gmbh, Hafnerstrasse 211, 8054 Graz, Austria

Manufacturer

S.C. Zentiva S.A., B-dul Theodor Pallady nr 50, sector 3, 032266 Bucharest, Romania

Genericon Pharma Gesellschaft m.b.H.

Hafnerstrasse 211, 8054 Graz, Austria To obtain information on the names of this medicine, under which it has been authorized in the Member States of the European Economic Area, or to obtain more detailed information, the patient should contact the representative of the marketing authorization holder: +pharma Polska sp. z o.o., ul. Podgórska 34, 31-536 Kraków, Poland, tel: +48 12 262 32 36, e-mail: [email protected]

Date of last revision of the leaflet: