Solifurin

Leaflet attached to the packaging: patient information

Solifurin, 5 mg, film-coated tablets

Solifurin, 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 you experience any side effects, including those not listed in this leaflet, tell your 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 bladder. This action allows for longer intervals between visits 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, 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 Solifurin

When not to take Solifurin:

• if the patient is allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6);
• if the patient cannot urinate or cannot empty the 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 glaucoma with a narrow angle of filtration (increased pressure of the fluid in the eyeball, which can lead to gradual vision loss);
• if the patient is undergoing hemodialysis;
• 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 Solifurin from the body (e.g., ketoconazole). The doctor or pharmacist will provide information on this.

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

Warnings and precautions

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

• if the patient has difficulty emptying the bladder (narrowing of the urethra) or urinating (weak urine stream). In such a case, 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).

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

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 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Do not take Solifurin during pregnancy, unless it is absolutely necessary. Do not take Solifurin during breastfeeding, as solifenacin passes into breast milk. Before taking any medicine, consult your doctor or pharmacist.

Driving and operating machines

Solifurin may cause blurred vision, and less often, drowsiness and fatigue. If such side effects occur, do not drive or operate any machinery. Solifurin contains lactose.If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Solifurin

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

Recommended dose

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

Taking a higher dose of Solifurin than recommended

If you have taken too many Solifurin tablets or if a child has accidentally swallowed Solifurin, consult your doctor or pharmacist immediately. 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 Solifurin

Do not take a double dose to make up for a missed tablet. If you miss a dose of Solifurin, take the next dose as soon as possible, unless it is almost time for the next dose. Do not take the medicine more than once a day. If you have any doubts, consult your doctor or pharmacist.

Stopping Solifurin treatment

If you stop taking Solifurin, the symptoms of an overactive bladder may return or worsen. Always consult your doctor if you are considering stopping treatment. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Solifurin can cause side effects, although not everybody gets them.

Seek medical help immediately if you 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 under the skin surface) with swelling of the airways (difficulty breathing) has been reported. If you experience angioedema, stop taking Solifurin immediately and start 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 a feeling of a full stomach, abdominal pain, belching, nausea, heartburn, and discomfort in the abdominal cavity.

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

• urinary tract infection, cystitis;
• drowsiness;
• taste disorders;
• dry eye syndrome;
• dry nose;
• gastroesophageal reflux (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 you experience any side effects, including those not listed in the leaflet, tell your 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, you can help provide more information on the safety of this medicine.

5. How to store Solifurin

Keep the medicine 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. Markings on the blister: 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. Ask your 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 film-coated tablet contains 5 mg of solifenacin succinate, which corresponds to 3.8 mg of solifenacin. Solifurin 10 mg: each film-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, pregelatinized corn starch, 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 film-coated tablet, 5.8 mm in diameter. Solifurin 10 mg: light pink, round, biconvex film-coated tablet, 7.9 mm in diameter, 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