Tolzurin

Package Leaflet: Information for the Patient

Tolzurin, 2 mg, Prolonged-Release Hard Capsules

Tolzurin, 4 mg, Prolonged-Release Hard Capsules

Tolterodine tartrate

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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Tolzurin and what is it used for

The active substance in Tolzurin is tolterodine. Tolterodine belongs to a group of medicines called antimuscarinic agents.
Tolzurin is used to treat the symptoms of overactive bladder. When overactive bladder occurs, patients may experience:

• inability to control urination,
• sudden need to urinate quickly without prior sensation and/or frequent urination.

2. Important information before taking Tolzurin

When not to take Tolzurin

• if the patient is allergic to tolterodine or any of the other ingredients of this medicine;
• if the patient is unable to urinate (urinary retention);
• if the patient has uncontrolled high pressure in the eye with loss of vision, which is not adequately treated (narrow-angle glaucoma);
• if the patient has significant muscle weakness (myasthenia gravis);
• if the patient has ulcerative colitis (ulcerative colitis);
• if the patient has acute enlargement of the colon (toxic megacolon).

Warnings and precautions

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

• if the patient has difficulty urinating and/or urinates with a weak stream;
• if the patient has gastrointestinal diseases that affect the passage and/or digestion of food;
• if the patient has kidney problems (renal insufficiency);
• if the patient has liver disease;
• if the patient has neurological disorders that affect blood pressure, intestines, or sexual functions (any autonomic neuropathy);
• if the patient has a hiatal hernia (a protrusion of an organ through its normal cavity);
• if the patient has decreased intestinal motility or severe constipation (decreased gastrointestinal motility);
• if the patient has any of the following heart diseases:
• abnormal heart rhythm (ECG),
• slow heart rate (bradycardia),
• significant, previously diagnosed heart diseases such as:
• heart muscle weakness (cardiomyopathy),
• decreased blood flow through the heart (myocardial ischemia),
• irregular heartbeat (arrhythmia)
• and heart failure;
• if the patient has low levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia) in the blood.

Tolzurin and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Tolterodine, the active substance in Tolzurin, may interact with other medicines.
It is not recommended to take Tolzurin with:

• certain antibiotics (e.g., erythromycin, clarithromycin);
• medicines used to treat fungal infections (e.g., ketoconazole, itraconazole);
• medicines used to treat HIV.

Care should be taken when taking Tolzurin with:

• medicines that affect the passage of food (e.g., metoclopramide and cisapride);
• medicines used to treat irregular heartbeat (e.g., amiodarone, sotalol, quinidine, procainamide);
• and other medicines that work in a similar way to Tolzurin (antimuscarinic properties) or medicines that work in the opposite way to Tolzurin (cholinergic properties). In case of any doubts, consult a doctor.

Tolzurin with food and drink

Tolzurin can be taken before, after, or during a meal.

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.
Pregnancy
Tolzurin should not be taken during pregnancy.
Breastfeeding
It is not known whether tolterodine, the active substance in Tolzurin, is excreted in breast milk. Tolzurin should not be taken during breastfeeding.

Driving and using machines

Tolzurin may cause dizziness, fatigue, and affect vision, which may impair the ability to drive vehicles and operate machinery.

Tolzurin contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Tolzurin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

3. How to take Tolzurin

Dosage

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.

Prolonged-release hard capsules are for oral use and should be swallowed whole.

Do not chew the capsules.
Adults
The recommended dose is one 4 mg prolonged-release hard capsule per day.
Patient with liver or kidney disease or troublesome side effects:
The doctor may reduce the dose of Tolzurin to one 2 mg capsule per day.
Use in children
Tolzurin should not be used in children.

Taking more than the recommended dose of Tolzurin

In case of taking too many capsules, the patient should immediately consult a doctor or pharmacist

Missing a dose of Tolzurin

In case of missing a dose, the patient should take the missed dose as soon as possible, unless it is close to the time for the next dose. In this case, the patient should skip the missed dose and continue taking the medicine as usual.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Tolzurin

The doctor should inform the patient how long the treatment with Tolzurin will last. The patient should not stop the treatment early due to the lack of immediate effect. Time is needed for the bladder to adjust. The patient should finish taking the capsules as directed by the doctor. If no effect is seen by then, the patient should consult their doctor.
The effects of treatment should be evaluated after 2-3 months. The patient should always consult their doctor if they consider stopping the treatment.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Tolzurin can cause side effects, although not everybody gets them.
The patient should consult a doctor or report to the emergency room if they experience symptoms of an allergic reaction, such as:

• swelling of the face, tongue, or throat;
• difficulty swallowing;
• hives and difficulty breathing.

This reaction occurs uncommonly (in less than 1 in 100 patients).
The patient should consult a doctor or report to the emergency room if they experience:

• chest pain, difficulty breathing, easy fatigue (even at rest), difficulty breathing at night, swelling of the legs. These may be symptoms of heart failure. This occurs uncommonly (in less than 1 in 100 patients).

The following side effects have been observed during treatment with tolterodine with the following frequency:

Very common(may affect more than 1 in 10 people):

• dry mouth.

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

• sinusitis;
• dizziness, drowsiness, headache;
• dry eyes, blurred vision;
• difficulty digesting food (dyspepsia), constipation, abdominal pain, excessive air or gas in the stomach or intestines;
• painful or difficult urination;
• fatigue;
• excess fluid in the body causing swelling (e.g., in the ankles);
• diarrhea.

Uncommon(may affect up to 1 in 100 people):

• allergic reactions;
• nervousness;
• tingling sensation in the fingers and toes;
• feeling of spinning;
• palpitations, heart failure, irregular heartbeat;
• inability to empty the bladder;
• chest pain;
• memory disorders.

Additional reported reactions include severe allergic reactions, confusion, hallucinations, rapid heart rate, skin redness, heartburn, vomiting, severe swelling of the skin, especially around the mouth, eyes, genitals, hands, or feet (angioedema), dry skin, and disorientation. There have also been reports of worsening symptoms of dementia in patients being treated for it.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Tolzurin

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
Do not store above 25°C.
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. Contents of the pack and other information

What Tolzurin contains

The active substance in Tolzurin, 2 mg, prolonged-release hard capsules is 2 mg of tolterodine tartrate, which corresponds to 1.37 mg of tolterodine.
The active substance in Tolzurin, 4 mg, prolonged-release hard capsules is 4 mg of tolterodine tartrate, which corresponds to 2.74 mg of tolterodine.
The other ingredients are:
Lactose monohydrate, microcrystalline cellulose, polyvinyl acetate, povidone, colloidal silica, anhydrous, sodium lauryl sulfate, sodium docusate, magnesium stearate, hypromellose.
Capsule shell: indigo carmine (E 132), quinoline yellow (only in 2 mg capsules) (E 104), titanium dioxide (E 171), gelatin.
Inner tablet coating: ethylcellulose, triethyl citrate, methacrylic acid, and ethyl acrylate copolymer, dispersion 30%, propylene glycol.

What Tolzurin looks like and contents of the pack

Tolzurin is available in the form of prolonged-release hard capsules for once-daily use.
Tolzurin, 2 mg, prolonged-release hard capsules are green, size 1, hard gelatin capsules containing two white, round, biconvex, film-coated tablets.
Tolzurin, 4 mg, prolonged-release hard capsules are light blue, size 1, hard gelatin capsules containing four white, round, biconvex, film-coated tablets.
Tolzurin, 2 mg, prolonged-release hard capsules are available in the following pack sizes:
PVC/PE/PVDC/Aluminum blisters containing: 28, 56, 84 prolonged-release hard capsules.
Tolzurin, 4 mg, prolonged-release hard capsules are available in the following pack sizes:
PVC/PE/PVDC/Aluminum blisters containing: 28, 56, 84, 98 prolonged-release hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Recordati Polska sp. z o.o.
al. Armii Ludowej 26
00-609 Warsaw
Manufacturer/Importer
Pharmathen S.A
6, Dervenakion St., 15351 Pallini, Attiki, Greece
Pharmathen International S.A.
Industrial Park Sapes
Rodopi Prefecture, Block 5, 69300 Rodopi, Greece

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

United Kingdom
Neditol XL 2 mg, 4 mg prolonged release capsules
(Northern Ireland)
Cyprus
Tolterana 2 mg, 4 mg prolonged release capsules
Germany
Tolterodin PUREN 4 mg Hartkapseln, retardiert
Spain
Tolterodina Neo Edigen 4 mg cápsulas duras de liberación prolongada EFG
Poland
Tolzurin
Greece
Toldesor 2 mg, 4 mg prolonged release capsules

Date of last revision of the leaflet: 07/2023