Solifurin

Leaflet attached to the packaging: patient information

Solifurin, 5 mg, coated tablets

Solifurin, 10 mg, 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 Solifurin and what is it used for
• 2. Important information before taking Solifurin
• 3. How to take Solifurin
• 4. Possible side effects
• 5. How to store Solifurin
• 6. Package contents and other information

1. What is Solifurin and what is it used for

The active substance of Solifurin belongs to the group of anticholinergic medicines. These medicines reduce the activity of an overactive urinary bladder. This action allows for longer intervals between trips to the toilet and increases the amount of urine held in the bladder. Solifurin is used to treat symptoms of an overactive bladder. These include: urgent urination, 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 Solifurin

When not to take Solifurin:

Before starting treatment with Solifurin, the patient should inform their doctor if any of the above situations occur or have occurred in the past.

Warnings and precautions

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

Children and adolescents

Solifurin should not be used in children and adolescents under 18 years of age.

Before starting treatment with Solifurin, the doctor will assess whether there are other causes of frequent urination (e.g., heart failure - insufficient strength of the heart muscle 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).

Solifurin and other medicines

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

• other anticholinergic medicines, as taking such a medicine with Solifurin 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 Solifurin;
• medicines that increase the movement of the digestive tract, such as metoclopramide and cisapride, as Solifurin may weaken their effect;
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they slow down the metabolism of Solifurin;
• medicines such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of Solifurin;
• medicines such as bisphosphonates, as they may cause or exacerbate esophagitis.

Taking Solifurin with food and drink

Solifurin can be taken during meals or independently of meals.

Pregnancy and breastfeeding

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

Driving and operating machines

Solifurin may cause blurred vision, and less often, drowsiness and fatigue. If such side effects occur, the patient should not drive or operate any mechanical devices. Solifurin contains lactose.If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Solifurin

This medicine should always be taken as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist.

Recommended dose

Usually, a dose of 5 mg per day is used, unless the doctor recommends a dose of 10 mg per day. The tablet should be swallowed whole, with a drink. The medicine can be taken during meals or independently of meals, depending on the patient's preferences. The tablets should not be crushed.

Taking a higher dose of Solifurin than recommended

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

Missing a dose of Solifurin

The patient should not take a double dose to make up for a missed tablet. If a dose is missed, 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. If in doubt, the patient should consult their doctor or pharmacist.

Stopping Solifurin treatment

If the patient stops taking Solifurin, the symptoms of an overactive bladder may return or worsen. The patient should always consult their doctor if they are considering stopping treatment. 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, Solifurin can cause side effects, although not everybody gets them.

The patient should immediately inform their doctor or go to the nearest hospital if they experience:

• an allergic reaction or severe skin reaction (e.g., blistering and peeling of the skin).

In some patients taking solifenacin succinate, angioedema (a form of skin allergy that causes swelling of the tissue just beneath the skin's surface) with swelling of the airways (difficulty breathing) has been reported. If the patient experiences angioedema, they should immediately stop taking Solifurin and receive appropriate treatment and/or take measures. Solifurin may cause other side effects, including:

• very common (occurring in more than 1 in 10 people): dry mouth.

common (occurring in 1 to 10 people in 100):

• 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 (occurring in 1 to 10 people in 1,000):

• urinary tract infection, cystitis;
• drowsiness;
• taste disturbances;
• dry eye syndrome;
• dry nose;
• gastroesophageal reflux disease (heartburn);
• dry throat;
• dry skin;
• difficulty urinating;
• fatigue;
• swelling of the lower limbs.

rare (occurring in 1 to 10 people in 10,000):

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

very rare (occurring in less than 1 in 10,000 people):

• hallucinations, confusion;
• hives.

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

• decreased appetite, increased potassium levels in the blood, which can 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 Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products of the 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, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Solifurin

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month. The blister is marked with: Lot: batch number. EXP: expiry date. There are no special precautions for storage. Do not use this medicine if you notice a change in color or visible signs of deterioration. 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. Package contents and other information

What Solifurin contains

• The active substance of Solifurin is solifenacin succinate. Solifurin 5 mg: each coated tablet contains 5 mg of solifenacin succinate, which corresponds to 3.8 mg of solifenacin. Solifurin 10 mg: each coated tablet contains 10 mg of solifenacin succinate, which corresponds to 7.5 mg of solifenacin.
• Other ingredients are:

Tablet core: lactose monohydrate, corn starch, corn starch paste, magnesium stearate. Solifurin 5 mg coating Opadry Yellow 02F220022: hypromellose 5cP, titanium dioxide (E171), macrogol 8000, talc, yellow iron oxide (E172). Solifurin 10 mg coating Opadry Pink 02F240016: hypromellose 5cP, titanium dioxide (E171), macrogol 8000, talc, red iron oxide (E172), yellow iron oxide (E172).

What Solifurin looks like and what the package contains

Solifurin 5 mg: light yellow, round, biconvex coated tablet with a diameter of 5.8 mm. Solifurin 10 mg: light pink, round, biconvex coated tablet with a diameter of 7.9 mm with a dividing line on one side. The tablet can be divided into equal doses. The tablets are packaged in blisters and a cardboard box. The package contains 30 tablets.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o., ul. Partyzancka 133/151, 95-200 Pabianice, tel. (42) 22-53-100.

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o., ul. Partyzancka 133/151, 95-200 Pabianice, tel. (42) 22-53-100, Genepharm S.A., 18 km Marathons Avenue, 153 51 Pallini Attiki, Greece. Date of last revision of the leaflet:24.08.2022