Solifurin

Poland
Brand name Solifurin
Form tablets, film-coated
Active substance / Dosage
solifenacin succinate · 5 mg
Prescription type Prescription only
ATC code
G04BD08
Registration number 100328000
Manufacturer Aflofarm Farmacja Polska Sp. z o.o. Genepharm S.A.

Table of Contents

Patient Information Leaflet

Solifurin, 5 mg, film-coated tablets
Solifurin, 10 mg, film-coated tablets
Solifenacini succinas
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

  • Keep this leaflet, as 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 pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
  • If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Solifurin is and what it is used for

The active substance in Solifurin belongs to a group of medicines called anticholinergics. These medicines reduce the activity of an overactive bladder. This effect allows longer intervals between urinations and increases the amount of urine the bladder can hold.
Solifurin is used to treat the symptoms of an overactive bladder. These symptoms include urgency, which is a sudden, compelling need to pass urine, urinary frequency, and urge incontinence, where the patient is unable to reach the toilet in time.

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 is unable to pass urine or empty the bladder (urinary retention);
  • if the patient has severe stomach or intestinal disorders (toxic megacolon, a complication associated with ulcerative colitis);
  • in patients suffering from a muscle disease called myasthenia gravis, which may cause significant weakness of certain muscles;
  • if the patient has narrow-angle glaucoma (increased fluid pressure in the eye leading to gradual loss of vision);
  • 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 simultaneously taking medicines that may delay elimination of Solifurin from the body (e.g. ketoconazole). Your doctor or pharmacist will provide information on this.

Before starting treatment with Solifurin, inform your doctor if any of the above conditions are present or have occurred in the past.
Warnings and precautions
Before starting Solifurin, discuss the following with your doctor or pharmacist:

  • if the patient has difficulty emptying the bladder (obstruction of urinary outflow from the bladder) or difficulty passing urine (weak urine stream). In such cases, the risk of urine retention in the bladder (urinary retention) is much higher;
  • if the patient suffers from gastrointestinal obstruction (constipation);
  • if there is a risk of slowed gastrointestinal motility (peristalsis). Your doctor will provide further information;
  • if there are severe kidney function disorders;
  • if there are moderate liver function disorders;
  • if the patient suffers from severe stomach pain (hiatal hernia) or heartburn;
  • if the patient has nervous system disorders (autonomic neuropathy).

Children and adolescents
Solifurin must 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 possible causes of frequent urination (e.g. heart failure – insufficient cardiac muscle strength to pump blood adequately – or kidney disease). If a urinary tract infection occurs, the doctor will prescribe an antibiotic (an antibacterial agent effective against the specific bacteria).
Solifurin and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
It is especially important to inform your doctor if the patient is taking:

  • other anticholinergic medicines, as using such drugs together with Solifurin may increase both the therapeutic effects and adverse reactions of both medicines;
  • medicines belonging to the group of cholinergic receptor agonists, as they may reduce the effectiveness of Solifurin;
  • medicines enhancing gastrointestinal motility, such as metoclopramide and cisapride, as Solifurin may reduce their effectiveness;
  • medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, which slow down the metabolism of Solifurin;
  • medicines such as rifampicin, phenytoin, carbamazepine, which may accelerate the metabolism of Solifurin;
  • medicines such as bisphosphonates, which may cause or worsen esophagitis.

Taking Solifurin with food and drink
Solifurin may be taken during meals or independently of food.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not take Solifurin during pregnancy unless 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 machinery
Solifurin may cause blurred vision, and less frequently drowsiness and fatigue. If these adverse effects occur, do not drive or operate any mechanical equipment.
Solifurin contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to take Solifurin

This medicine should always be taken as directed by the physician. In case of doubt, consult a doctor or pharmacist.
Recommended dose
The usual dose is 5 mg once daily, unless the doctor recommends a dose of 10 mg once daily.
The tablet should be swallowed whole with liquid.
Solifurin may be taken with food or independently of meals, according to patient preference.
The tablets must not be crushed.
If you take more Solifurin than recommended
If too many Solifurin tablets have been taken or if a child accidentally swallows Solifurin, contact a doctor or pharmacist immediately.
Symptoms of overdose may include: headache, dry mouth, dizziness, drowsiness, visual disturbances, hallucinations, excessive excitation, seizures (convulsions), difficulty breathing, rapid heartbeat (tachycardia), urine retention (urinary retention), and dilated pupils.
If you miss a dose of Solifurin
Do not take a double dose to make up for the missed tablet.
If a dose has been missed, take the next dose as soon as possible, unless it is almost time for the next scheduled dose. Do not take the medicine more often than once daily. In case of doubt, consult a doctor or pharmacist.
Stopping Solifurin treatment
If treatment with Solifurin is discontinued, symptoms of overactive bladder may return or worsen. 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.
You should immediately inform your doctor or go to the nearest hospital if you experience:

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

Angioedema (a type of allergic skin reaction causing swelling of the tissue just beneath the skin surface), including swelling of the airways (difficulty breathing), has been reported in some patients treated with solifenacin succinate. If angioedema occurs, treatment with Solifurin should be stopped immediately and appropriate treatment and/or countermeasures should be initiated.
Solifurin may cause other adverse reactions listed below:

Very common (affects more than 1 in 10 people):

  • dry mouth.

Common (affects 1 to 10 in 100 people):

  • blurred vision, constipation, nausea, dyspepsia with symptoms such as: feeling of fullness in the stomach, abdominal pain, belching, nausea, heartburn, discomfort in the abdominal cavity.

Uncommon (affects 1 to 10 in 1,000 people):

  • urinary tract infection, cystitis;
  • somnolence;
  • taste disturbances;
  • dry eye syndrome;
  • dryness of the nasal cavity;
  • gastroesophageal reflux (heartburn);
  • dry throat;
  • dry skin;
  • difficulty in urination;
  • fatigue;
  • peripheral edema.

Rare (affects 1 to 10 in 10,000 people):

  • accumulation of hard stool in the colon, colon obstruction (impaction);
  • difficulty passing urine despite a full bladder (urinary retention);
  • dizziness, headache;
  • vomiting;
  • itching, rash.

Very rare (affects fewer than 1 in 10,000 people):

  • hallucinations, confusion;
  • urticaria.

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

  • decreased appetite, increased blood potassium levels which may cause cardiac arrhythmias;
  • increased intraocular pressure;
  • changes in ECG, irregular heartbeat ( Torsade de Pointes ), palpitations, tachycardia;
  • voice disorders;
  • liver function abnormalities;
  • muscle weakness;
  • kidney function disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, please inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Solifurin

Keep the medicine out of the 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 stated month.
Markings on the blister:
Lot: batch number.
EXP: expiry date.
No special storage instructions apply.
Do not use this medicine if you notice any change in colour or visible signs of deterioration.
Medicines must 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 Solifurin contains

  • The active substance is solifenacin succinate.
    Solifurin 5 mg: Each coated tablet contains 5 mg of solifenacin succinate, equivalent to 3.8 mg of solifenacin.
    Solifurin 10 mg: Each coated tablet contains 10 mg of solifenacin succinate, equivalent to 7.5 mg of solifenacin.
  • The 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)
Polyethylene glycol 8000
Talc
Iron oxide yellow (E172)

Solifurin 10 mg
Coating Opadry Pink 02F240016:
Hypromellose 5cP
Titanium dioxide (E171)
Polyethylene glycol 8000
Talc
Iron oxide red (E172)
Iron oxide yellow (E172)

What Solifurin looks like and contents of the pack
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 division line on one side. The tablet can be divided into equal doses.
The tablets are packed in blisters and placed in a cardboard box.
Pack size: 30 tablets

Marketing Authorisation 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