Solinco

Package Leaflet: Information for the User

SOLINCO, 5 mg, film-coated tablets

SOLINCO, 10 mg, film-coated tablets

Solifenacin succinate

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

• Keep this package 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 package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 medicines called antimuscarinics. These medicines reduce the activity of an overactive urinary bladder. This allows for longer intervals between visits to the toilet and increases the amount of urine that can be held in the bladder. SOLINCO is used to treat the symptoms of an overactive bladder. These symptoms include: sudden, urgent need to urinate, frequent urination, and involuntary loss of urine, because the patient cannot get to the toilet in time.

2. Important information before taking SOLINCO

When not to take SOLINCO

• if the patient has difficulty urinating or emptying the bladder (urinary retention)
• if the patient has severe gastrointestinal disorders (toxic megacolon, a complication of ulcerative colitis)
• in patients with a muscle disorder called myasthenia gravis, which can cause significant weakness of some muscles
• if the patient has increased pressure in the eye, which can lead to gradual loss of vision (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 impairment
• 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, inform your doctor if any of the above situations apply or have applied in the past.

Warnings and precautions

Before starting to take SOLINCO, discuss with your doctor or pharmacist:

• if the patient has difficulty emptying the bladder (narrowing of the urethra) or urinating (weak urine stream). In this case, the risk of urine accumulation in the bladder (urinary retention) is much higher.
• if the patient has gastrointestinal 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 impairment
• if the patient has moderate liver impairment
• if the patient has a burning stomach pain (hiatus hernia) or heartburn
• if the patient has nervous system disorders (autonomic nervous system neuropathy).

Before starting to take SOLINCO, inform your doctor if any of the above situations apply or have applied in the past. Before starting treatment with SOLINCO, 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).

Children and adolescents

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

SOLINCO and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. It is especially important to inform your doctor if you are taking:

• other antimuscarinic medicines, as taking such a medicine with SOLINCO may lead to increased therapeutic and adverse effects of both medicines
• medicines that stimulate the cholinergic receptor, as they may weaken the effect of SOLINCO
• medicines that speed up 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 worsen inflammation of the esophagus (esophagitis). You should ask your doctor if the medicine belongs to this group.

SOLINCO with food and alcohol

The medicine can be taken with or without food.

Pregnancy and breastfeeding

Do not take SOLINCO during pregnancy, unless it is absolutely necessary. Do not take SOLINCO during breastfeeding, as solifenacin passes into human milk. 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.

Driving and using machines

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

SOLINCO contains lactose monohydrate

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

3. How to take SOLINCO

Always take this medicine 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 glass of water. The medicine can be taken with or without food, as preferred. Do not crush the tablets. The usual dose is 5 mg once daily, unless your doctor advises you to take a dose of 10 mg once daily.

Use in children and adolescents

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

Overdose of SOLINCO

If you have taken too many SOLINCO tablets or if a child has accidentally taken SOLINCO, contact your doctor or pharmacist immediately. Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, and vision disturbances, hallucinations, excessive stimulation, seizures (convulsions), difficulty breathing, rapid heartbeat (tachycardia), urine accumulation in the bladder (urinary retention), and dilated pupils.

Missed dose of SOLINCO

If you miss a dose, take the next dose as soon as possible, unless it is almost time for the next dose. Do not take more than one dose in 24 hours. If you are unsure, ask your doctor or pharmacist. Do not take a double dose to make up for a missed dose.

Stopping treatment with SOLINCO

If you stop taking SOLINCO, the symptoms of an overactive bladder may return or worsen. Stopping treatment with SOLINCO should always be discussed with your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

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 of fullness, abdominal pain, belching, nausea, heartburn, discomfort in the abdomen

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

• urinary tract infection, bladder infection (cystitis)
• drowsiness
• taste disturbances
• dry eyes
• 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 hard stool in the colon (fecal impaction)
• difficulty urinating despite a full bladder (urinary retention)
• dizziness, headaches
• vomiting
• itching, rash

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

• 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 disturbances
• increased pressure in the eye
• 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 you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, 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: ndl@urpl.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 SOLINCO

There are no special storage instructions for this medicine. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering. 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 SOLINCO contains

• The active substance is solifenacin succinate.
• Each film-coated tablet contains 5 mg or 10 mg of solifenacin succinate.
• The other ingredients are: lactose monohydrate, corn starch, 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, or 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 other European Economic Area countries, or for more detailed information, please 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: krakow@pluspharma.eu

Date of last revision of the package leaflet: