Nifelox

Package Leaflet: Information for the User

Nifelox, 5 mg, film-coated tablets

Nifelox, 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 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 leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Nifelox and what is it used for

The active substance of Nifelox belongs to a group of cholinergic antagonists. These drugs reduce the activity of an overactive urinary bladder. This allows for less frequent use of the toilet and increases the amount of urine held in the bladder. Nifelox 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 Nifelox

When not to take Nifelox:

• 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 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 glaucoma with a narrow angle of filtration (increased fluid pressure in the eyeball, which can lead to gradual vision loss),
• if the patient is undergoing hemodialysis procedures,
• in patients with severe liver function disorders,
• if the patient has severe kidney disease or moderate liver disease and is taking medications that may delay the elimination of Nifelox from the body (e.g., ketoconazole). The doctor or pharmacist will provide information on this.

Before starting treatment with Nifelox, inform your doctor if any of the above situations occur or have occurred in the past.

Warnings and precautions

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

• if the patient has difficulty emptying the urinary bladder (narrowing of the urine outflow tract from the urinary bladder) 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 gastrointestinal 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 treatment with Nifelox, inform your doctor if any of the above situations occur or have occurred in the past.

Before starting treatment with Nifelox, 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). In case of a urinary tract infection, the doctor will prescribe an antibiotic (an antibacterial drug that acts on specific bacteria).

Children and adolescents

Nifelox should not be used in children or adolescents under 18 years of age.

Nifelox 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 cholinergic antagonists, as taking such a medicine with Nifelox may lead to an increase in both the therapeutic effect and the side effects of both medicines.
• drugs from the group of cholinergic receptor agonists, as they may weaken the effect of Nifelox.
• drugs that enhance gastrointestinal motility, such as metoclopramide and cisapride, as Nifelox may weaken their effect.
• drugs such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they slow down the metabolism of Nifelox.
• drugs such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of Nifelox.
• drugs such as bisphosphonates, as they may cause or exacerbate esophagitis.

Taking Nifelox with food and drink

Nifelox 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. PregnancyNifelox should not be taken during pregnancy, unless it is absolutely necessary. BreastfeedingNifelox should not be taken during breastfeeding, as solifenacin passes into breast milk. Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

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

Nifelox contains lactose

The medicine should not be taken by patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type), or glucose-galactose malabsorption syndrome.

3. How to take Nifelox

Instructions for proper use

This medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

Dosage

Adults, including the elderly

Usually, a dose of 5 mg per day is used, unless the doctor recommends a dose of 10 mg per day.

Children and adolescents

Nifelox should not be taken by children and adolescents under 18 years of age.
Method of administration The tablet should be swallowed whole, with a liquid. The medicine can be taken during meals or independently of meals, depending on the patient's preference. The tablets should not be crushed.

Taking a higher dose of Nifelox than recommended

In case of taking too many Nifelox tablets or if Nifelox is accidentally swallowed by a child, contact your doctor or pharmacist immediately. 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)
• dilated pupils.

Missing a dose of Nifelox

In case of missing a dose, take the next dose as soon as possible, unless it is close to the time of taking the next dose. Do not take the medicine more often than once a day. If you are unsure, consult your doctor or pharmacist.

Stopping treatment with Nifelox

If treatment with Nifelox is stopped, the symptoms of an overactive bladder may return or worsen. Stopping treatment should always be consulted with a doctor. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nifelox can cause side effects, although not everybody gets them. If you experience an allergic reaction or a severe skin reaction (e.g., blistering and peeling of the skin), inform your doctor or nurse immediately. In some patients taking solifenacin succinate, angioedema (a form of skin allergy that causes swelling of the tissue just below the skin surface) with swelling of the respiratory tract (difficulty breathing) has been reported. If you experience angioedema, stop taking solifenacin succinate and initiate appropriate treatment and/or take appropriate measures. Nifelox may cause other side effects, including:

• Very common(may affect more than 1 in 10 people):
• dry mouth.

Common(may affect up to 1 in 10 people):

• 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(may affect up to 1 in 100 people):

• 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(may affect up to 1 in 1,000 people):

• 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(may affect up to 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,
• ECG changes, irregular heartbeat, 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 leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department for 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: ndl@urpl.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Nifelox

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 after the abbreviation: EXP. The expiry date refers to the last day of the month stated. The batch number is stated after the abbreviation: Lot. There are no special precautions for storing the medicine. 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. Contents of the pack and other information

What Nifelox contains

• The active substance of Nifelox is solifenacin succinate (Solifenacini succinas) in a quantity of 5 mg or 10 mg.
• The other excipients are: Nifelox, 5 mg: lactose monohydrate, corn starch, hypromellose 6 mPa˖s, magnesium stearate. Tablet coating: hypromellose, macrogol 8000, talc, titanium dioxide (E171), yellow iron oxide (E172).

Nifelox, 10 mg: lactose monohydrate, corn starch, hypromellose 6mPa˖s, magnesium stearate. Tablet coating: hypromellose, macrogol 8000, talc, titanium dioxide (E171), red iron oxide (E172).

What Nifelox looks like and contents of the pack

Nifelox, 5 mg: round, biconvex, film-coated tablets in light yellow, with a diameter of about 7.5 mm, with the inscription "390" on one side and smooth on the other side. Nifelox, 10 mg: round, biconvex, film-coated tablets in light pink, with a diameter of about 7.5 mm, with the inscription "391" on one side and smooth on the other side. The tablets are packaged in blisters containing: 30 or 90 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Synoptis Pharma Sp. z o.o. ul. Krakowiaków 65 02-255 Warsaw

Manufacturer

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

Date of last revision of the leaflet: