TOLZURIN 2 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Tolzurin, 2 mg, Prolonged-Release Hard Capsules
3. Tolzurin, 4 mg, Prolonged-Release Hard Capsules
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
4. What is Tolzurin and what is it used for
5. Important information before taking Tolzurin
   1. When not to take Tolzurin
   2. Warnings and precautions
   3. Tolzurin and other medicines
   4. Tolzurin with food and drink
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Tolzurin contains lactose
   8. Tolzurin contains sodium
6. How to take Tolzurin
   1. Dosage
   2. Prolonged-release hard capsules are for oral use and should be swallowed whole.
   3. If you take more Tolzurin than you should
   4. If you forget to take Tolzurin
   5. Stopping Tolzurin treatment
7. Possible side effects
   1. Reporting side effects
8. How to store Tolzurin
9. Contents of the pack and other information
   1. What Tolzurin contains
   2. What Tolzurin looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. 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:
   5. Date of last revision of the package leaflet: 07/2023

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 package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor, 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 package leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 syndrome. When overactive bladder syndrome 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 you are allergic to tolterodine or any of the other ingredients of this medicine;
• if you are unable to urinate (urinary retention);
• if you have uncontrolled narrow-angle glaucoma (increased pressure in the eye with loss of vision);
• if you have significant muscle weakness (myasthenia gravis);
• if you have ulcerative colitis (inflammation of the colon);
• if you have toxic megacolon (a serious condition of the colon).

Warnings and precautions

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

• if you have difficulty urinating and/or urinate with a weak stream;
• if you have gastrointestinal diseases that affect the passage and/or digestion of food;
• if you have kidney problems (renal insufficiency);
• if you have liver disease;
• if you have neurological disorders that affect blood pressure, intestines, or sexual function (any autonomic nervous system neuropathy);
• if you have a hiatal hernia (a condition where part of the stomach bulges up into the chest through an opening in the diaphragm);
• if you have decreased intestinal movement or severe constipation (decreased gastrointestinal motility);
• if you have any heart disease, including:
• abnormal heart rhythm (ECG),
• slow heart rate (bradycardia),
• significant, previously diagnosed heart diseases such as:
• heart muscle weakness (cardiomyopathy),
• reduced blood flow through the heart (myocardial ischemia),
• irregular heartbeat (arrhythmia)
• and heart failure;
• if you have low levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia) in the blood.

Tolzurin and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Tolterodine, the active substance in Tolzurin, may interact with other medicines.

Do not take Tolzurin with:

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

Be cautious 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). If in doubt, consult your doctor.

Tolzurin with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Tolzurin during pregnancy.

Breastfeeding

It is not known whether tolterodine, the active substance in Tolzurin, is excreted in breast milk. Do not take Tolzurin while breastfeeding.

Driving and using machines

Tolzurin may cause dizziness, tiredness, and affect vision, which may impair your ability to drive or operate machinery.

Tolzurin contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Tolzurin contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is considered to be essentially sodium-free.

3. How to take Tolzurin

Dosage

Always take this medicine exactly as your doctor has told you.

In case of doubt, consult your 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:

Your doctor may reduce the dose of Tolzurin to one 2 mg capsule per day.

Use in children

Tolzurin is not recommended for use in children.

If you take more Tolzurin than you should

If you have taken too many capsules, contact your doctor or pharmacist immediately.

If you forget to take Tolzurin

If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In this case, skip the missed dose and continue with your normal schedule.

Do not take a double dose to make up for a forgotten dose.

Stopping Tolzurin treatment

Your doctor will tell you how long to take Tolzurin.

Do not stop treatment early, as it may take time for your bladder to adapt.

Complete the treatment with the capsules as prescribed by your doctor.

Contact your doctor if you have not seen any effect after this time.

The effect of the treatment should be evaluated after 2-3 months.

Always consult your doctor if you are considering stopping treatment.

In case of any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Contact your doctor or go to the emergency room if you 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).

Contact your doctor or go to the emergency room if you 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).

During treatment with tolterodine, the following side effects have been observed 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;
• vertigo;
• palpitations, heart failure, irregular heartbeat;
• inability to empty the bladder;
• chest pain;
• memory disorders.

Additional reported reactions include severe allergic reactions, confusion, hallucinations, rapid heartbeat, 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 this condition.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety 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 this medicine.

5. How to store Tolzurin

Keep this medicine out of the 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.

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 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 silicon dioxide, 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 oral administration.

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 package leaflet: 07/2023