Tolzurin

Package leaflet: Information for the patient

Tolzurin, 2 mg, prolonged-release capsules, hard
Tolzurin, 4 mg, prolonged-release capsules, hard
tolterodine tartrate
Please read 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 a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Tolzurin is and what it is 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 Tolzurin is and what it is used for

The active substance in Tolzurin is tolterodine. Tolterodine belongs to a group of medicines called
antimuscarinic drugs.
Tolzurin is used to treat the symptoms of overactive bladder syndrome. In patients with overactive bladder syndrome, the following may occur:

• inability to control urination,
• sudden need to rush to the toilet without prior warning and/or frequent need to urinate.

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 pass urine (urinary retention);
• if the patient has untreated narrow-angle glaucoma with vision loss (narrow-angle glaucoma not properly treated);
• if the patient has significant muscle weakness (myasthenia gravis);
• if the patient has ulcerative colitis (acute ulcerative colitis);
• if the patient has acute colonic dilation (toxic megacolon).

Warnings and precautions
Before starting Tolzurin, discuss with your doctor or pharmacist if:

• the patient has difficulty passing urine and/or passes urine with a weak stream;
• the patient has gastrointestinal disorders affecting food passage and/or digestion;
• the patient has kidney problems (renal impairment);
• the patient has liver disease;
• the patient has neurological disorders affecting blood pressure, intestines, or sexual function (any autonomic neuropathy);
• the patient has a hiatal hernia (herniation of an abdominal organ into the chest);
• the patient has decreased intestinal motility or severe constipation (reduced gastrointestinal motility);
• the patient has any of the following heart conditions:
  • abnormal electrocardiogram (ECG),
  • slow heart rate (bradycardia),
  • significant, previously diagnosed heart diseases such as:
  • weakened heart muscle (cardiomyopathy),
  • reduced blood flow through the heart (myocardial ischemia),
  • irregular heartbeat (arrhythmia),
  • and heart failure;
• the patient has abnormally low blood levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia).

Tolzurin and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan to take.
Tolterodine – the active substance in Tolzurin – may interact with other medicines.
Concomitant use of Tolzurin is not recommended with:

• certain antibiotics (containing, for example, erythromycin, clarithromycin);
• medicines used to treat fungal infections (containing, for example, ketoconazole, itraconazole);
• medicines used in the treatment of HIV.

Use Tolzurin with caution when taken together with:

• medicines affecting gastrointestinal motility (containing, for example, metoclopramide, cisapride);
• medicines used to treat irregular heartbeat (containing, for example, amiodarone, sotalol, quinidine, procainamide);
• and other medicines with similar antimuscarinic effects as Tolzurin or medicines with opposing cholinergic effects. If in doubt, consult your doctor.

Tolzurin with food and drink
Tolzurin may be taken before, after, or during meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Tolzurin should not be used during pregnancy.
Breastfeeding
It is unknown whether tolterodine, the active substance in Tolzurin, is excreted in breast milk. Tolzurin is not recommended during breastfeeding.

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

Tolzurin contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Tolzurin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to take Tolzurin

Dosage
This medicine should always be taken as prescribed by the doctor. If in doubt, consult the
doctor or pharmacist.
Extended-release hard capsules are intended for oral use and must be swallowed whole.
Do not chew the capsules.
Adults
The recommended dose is one 4 mg extended-release hard capsule once daily.
Patients with liver or kidney disease or troublesome side effects:
The doctor may reduce the dose of Tolzurin to one 2 mg capsule once daily.
Use in children
Tolzurin is not recommended for use in children.
Taking more Tolzurin than recommended
If too many extended-release capsules have been taken, contact a doctor or pharmacist immediately.
Missed dose of Tolzurin
If a dose is missed at the usual time, take it as soon as possible, unless it is almost time for the next dose. In that case, skip the missed dose and continue with the regular dosing schedule.
Do not take a double dose to make up for a missed dose.
Stopping Tolzurin treatment
The doctor should inform the patient how long Tolzurin treatment should continue. Do not stop treatment early due to lack of immediate effect. Time is needed for the bladder to adapt. Continue taking the extended-release capsules as directed by the doctor. Contact the doctor if no improvement has occurred by then.
Treatment effects should be evaluated after 2–3 months. Always consult the doctor if the patient is considering stopping treatment.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Seek medical advice or go to the emergency room if symptoms of an allergic reaction occur, such as:

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

This reaction occurs uncommonly (in less than 1 in 100 patients).
Seek medical advice or go to the emergency room if any of the following occur:

• 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 adverse reactions have been observed during treatment with tolterodine, with the frequencies listed below:
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;
• digestive difficulties (dyspepsia), constipation, abdominal pain, excessive gas in the stomach or intestines;
• painful or difficult urination;
• fatigue;
• fluid retention causing swelling (e.g. in the ankles);
• diarrhoea.

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

• allergic reactions;
• nervousness;
• tingling sensation in hands and feet;
• sensation of spinning (vertigo);
• palpitations, heart failure, irregular heartbeat;
• inability to empty the bladder;
• chest pain;
• memory disturbances.

Additional reported reactions include severe allergic reactions, confusion, hallucinations, rapid heartbeat, skin redness, heartburn, vomiting, severe swelling of the subcutaneous tissue, especially around the mouth, eyes, genital organs, hands, feet or tongue (angioedema), dry skin and disorientation. Worsening of dementia symptoms has also been reported in patients being treated for this condition.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 provide more information on the safety of the 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 cardboard packaging and
blister after "EXP". The expiry date refers to the last day of the stated month.
Do not store above 25°C.
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 Tolzurin contains
The active substance in Tolzurin 2 mg, prolonged release hard capsules, is 2 mg of tolterodine tartrate, corresponding to 1.37 mg of tolterodine.
The active substance in Tolzurin 4 mg, prolonged release hard capsules, is 4 mg of tolterodine tartrate, corresponding to 2.74 mg of tolterodine.
The other ingredients are:
Monohydrate lactose, microcrystalline cellulose, polyvinyl acetate, povidone, colloidal silicon dioxide, anhydrous, sodium lauryl sulfate, sodium docusate, magnesium stearate, hydroxypropylmethylcellulose.
Capsule shell composition: indigo carmine (E 132), quinoline yellow (only in 2 mg capsules) (E 104), titanium dioxide (E 171), gelatin.
Composition of the tablet's inner coating: ethylcellulose, triethyl citrate, methacrylic acid-ethyl acrylate copolymer dispersion 30%, propylene glycol.

What Tolzurin looks like and contents of the pack
Tolzurin is available as prolonged release hard capsules for once-daily administration.
Tolzurin 2 mg, prolonged release hard capsules are opaque – green, size 1, hard gelatin capsules containing two white, round, biconvex coated tablets.
Tolzurin 4 mg, prolonged release hard capsules are opaque – light blue, size 1, hard gelatin capsules containing four white, round, biconvex coated tablets.
Tolzurin 2 mg, prolonged release hard capsules are available in the following pack sizes:
PVC/PE/PVDC/Aluminium 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/Aluminium blisters containing: 28, 56, 84, 98 prolonged release hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the European Economic Area countries 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