Nifelox

Package leaflet: Information for the user

Nifelox, 5 mg, coated tablets
Nifelox, 10 mg, coated tablets
Solifenacin succinate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as 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 personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Nifelox is and what it is used for
2. What you need to know 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 Nifelox is and what it is used for

The active substance in Nifelox belongs to a group of medicines called anticholinergics. These medicines reduce the activity of an overactive bladder. This allows less frequent trips to the toilet and increases the amount of urine the bladder can hold.
Nifelox is used to treat the symptoms of an overactive bladder. These include urgency, which are sudden, strong urges to pass urine, frequent urination, and urinary incontinence, occurring because the person is unable to reach the toilet in time.

2. Important information before using Nifelox

When not to use Nifelox:

• 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 eyeball leading to gradual loss of vision),
• if the patient is undergoing haemodialysis,
• in patients with severe liver function disorders,
• if the patient has severe kidney disease or moderate liver disease and is also taking medicines that may delay elimination of Nifelox from the body (e.g. ketoconazole). Your doctor or pharmacist will provide information on this.

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

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

Before starting treatment with Nifelox, inform your doctor if any of the
above-mentioned conditions are present or have occurred in the past.
Before starting treatment with Nifelox, your 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, your doctor will prescribe an antibiotic (an antibacterial agent effective against the specific bacteria).

Children and adolescents
Nifelox must not be used in children or adolescents under 18 years of age.

Nifelox with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
It is especially important to inform your doctor if the patient is taking:

• other anticholinergic medicines, as concomitant use with Nifelox may enhance both the therapeutic effects and adverse reactions of both medicines.
• cholinergic receptor agonists, as they may reduce the effectiveness of Nifelox.
• medicines that enhance gastrointestinal motility, such as metoclopramide and cisapride, as Nifelox may reduce their effectiveness.
• medicines such as ketoconazole, ritonavir, nelfinavir, itraconazole, verapamil, diltiazem, as they slow down the metabolism of Nifelox.
• medicines such as rifampicin, phenytoin, carbamazepine, as they may accelerate the metabolism of Nifelox.
• medicines such as bisphosphonates, as they may cause or worsen oesophagitis.

Taking Nifelox with food and drink
Nifelox may be taken with food or independently of meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Nifelox should not be used during pregnancy unless absolutely necessary.
Breastfeeding
Nifelox should not be used during breastfeeding, as solifenacin passes into breast milk.

Before taking any medicine, consult your doctor or pharmacist.

Driving and operating machinery
Nifelox may cause blurred vision, and less frequently drowsiness and fatigue. If these adverse effects occur, the patient should not drive or operate any machinery.

Nifelox contains lactose
This medicine should not be used in patients with rare hereditary galactose intolerance, Lapp-type lactase deficiency, or glucose-galactose malabsorption syndrome.

3. How to use Nifelox

Instructions for proper use
This medicine should always be used as directed by the physician.
If in doubt, consult your doctor or pharmacist.
Dosage
Adults, including elderly patients
The usual dose is 5 mg once daily, unless the doctor recommends a dose of 10 mg once daily.
Children and adolescents
Nifelox must not be used in children and adolescents under 18 years of age.
Method of administration
The tablet should be swallowed whole with liquid.
Nifelox may be taken with or without food, according to patient preference.
Do not crush the tablets.
Overdose of Nifelox
If too many Nifelox tablets have been taken, or if a child accidentally swallows the medicine,
contact a doctor or pharmacist immediately.
Symptoms of overdose may include:

• headache,
• dry mouth,
• dizziness,
• drowsiness and visual disturbances,
• hallucinations,
• excessive excitation,
• seizures,
• breathing difficulties,
• rapid heartbeat (tachycardia),
• urinary retention,
• dilated pupils.

Missed dose of Nifelox
If a dose is 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 than once daily. If in doubt, consult your doctor or pharmacist.
Discontinuation of Nifelox
If treatment with Nifelox is stopped, symptoms of overactive bladder may return or worsen. Discontinuation should always be discussed with the doctor.
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 experiences them.
If the patient experiences an allergic attack or a severe skin reaction (e.g. blistering and peeling of the
outer layer of skin), the doctor or nurse should be informed immediately.
In some patients taking solifenacin succinate, angioedema (a type of allergic skin reaction causing
swelling of the tissue just beneath the skin surface) with swelling of the airways (difficulty breathing)
has been reported. If angioedema occurs in the patient, treatment with solifenacin succinate must be
stopped immediately and appropriate treatment and/or corrective measures should be initiated.
Nifelox may cause other adverse reactions listed below:
Very common (may occur in more than 1 in 10 people):

• dry mouth.

Common (may occur in less than 1 in 10 people):

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

Uncommon (may occur in less than 1 in 100 people):

• urinary tract infection, cystitis,
• somnolence,
• disturbances in taste sensation,
• dry eye syndrome,
• nasal dryness,
• gastroesophageal reflux (heartburn),
• throat dryness,
• skin dryness,
• difficulty passing urine,
• fatigue,
• peripheral edema.

Rare (may occur in less than 1 in 1000 people):

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

Very rare (may occur in less than 1 in 10,000 people):

• hallucinations, confusion,
• urticaria.

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

• decreased appetite, increased blood potassium levels which may cause heart rhythm disturbances,
• increased intraocular pressure,
• changes in ECG, irregular heartbeat, palpitations, rapid heartbeat,
• voice disorders,
• liver function abnormalities,
• muscle weakness,
• kidney function disorders.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. 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, e-mail: [email protected].
Reporting adverse reactions allows collection of further information on the safety of the medicine.
Adverse reactions can also be reported to the responsible entity.

5. How to store Nifelox

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 following the abbreviation:
EXP. The expiry date refers to the last day of the stated month. The batch number is indicated after the abbreviation:
Lot.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Nifelox contains

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

Nifelox 10 mg: monohydrate lactose, corn starch, hypromellose 6 mPa·s, magnesium stearate.
Tablet coating: hypromellose, polyethylene glycol 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 colour, approximately 7.5 mm in diameter, with the imprint "390" on one side and smooth on the other.
Nifelox 10 mg: round, biconvex, film-coated tablets in light pink colour, approximately 7.5 mm in diameter, with the imprint "391" on one side and smooth on the other.
Tablets are packed in blisters containing: 30 or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Poland

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