TITLODINE 4 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Titlodine, 2 mg, prolonged-release hard capsules
3. Titlodine, 4 mg, prolonged-release hard capsules
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Package Leaflet Contents:
4. What Titlodine is and what it is used for
5. Important information before taking Titlodine
   1. When not to take Titlodine:
   2. Warnings and precautions
   3. Caution should be exercised:
   4. Titolodine and other medicines
   5. Titolodine with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Titolodine contains lactose monohydrate
   9. Titolodine contains sodium
6. How to take Titlodine
   1. Dosage
   2. The prolonged-release hard capsules are for oral use and should be swallowed whole.
   3. If you take more Titlodine than you should
   4. If you forget to take Titlodine
   5. Stopping treatment with Titlodine
7. Possible side effects
   1. Reporting side effects
8. How to store Titlodine
9. Contents of the pack and other information
   1. What Titlodine contains
   2. What Titlodine looks like and contents of the pack
   3. Marketing authorization holder and manufacturer:
   4. Farmak International Sp. z o.o.
   5. Pharmathen S.A.
   6. Pharmathen International S.A.
   7. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

Titlodine, 2 mg, prolonged-release hard capsules

Titlodine, 4 mg, prolonged-release hard capsules

Tolterodine tartrate

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package 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 package leaflet, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents:

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

1. What Titlodine is and what it is used for

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

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

2. Important information before taking Titlodine

When not to take Titlodine:

• if you are allergic to tolterodine or any of the other ingredients of this medicine (listed in section 6);
• if you are unable to urinate (urinary retention);
• if you have uncontrolled narrow-angle glaucoma (high pressure in the eyes with vision loss, not being treated);
• if you have myasthenia gravis (severe muscle weakness);
• if you have acute ulcerative colitis (ulceration and inflammation of the colon);
• if you have toxic megacolon (acute dilation of the colon).

Warnings and precautions

Caution should be exercised:

• if you have difficulty urinating and (or) urinate with a weak stream;

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• if you have gastrointestinal disorders 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 neuropathy);
• if you have a hiatal hernia (a protrusion of an organ through its normal cavity);
• if you have reduced intestinal motility 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 cardiomyopathy (heart muscle weakness), myocardial ischemia (reduced blood flow to the heart), arrhythmia (irregular heartbeat), heart failure;
• if you have low levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia) in your blood.

Before starting treatment with Titlodine, discuss with your doctor or pharmacist if any of these conditions apply to you.

Titolodine and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, including those you plan to take.
Tolterodine, the active substance in Titlodine, may interact with other medicines.
It is not recommended to take Titlodine with:

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

Caution should be exercised when taking Titlodine with:

• medicines that affect gastrointestinal passage (containing e.g., metoclopramide and cisapride);
• medicines used to treat irregular heartbeat (containing e.g., amiodarone, sotalol, quinidine, procainamide);
• other medicines that work similarly to Titlodine (antimuscarinic properties) or medicines that work in the opposite way to Titlodine (cholinergic properties). If in doubt, consult your doctor.

Titolodine with food and drink

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

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.
Pregnancy
Do not take Titlodine during pregnancy.
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Breastfeeding
It is not known whether tolterodine, the active substance in Titlodine, is excreted in breast milk. Do not take Titlodine during breastfeeding.

Driving and using machines

Titolodine may cause dizziness, fatigue, or affect your vision or ability to drive or operate machinery.

Titolodine contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

Titolodine contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release hard capsule, which means it is essentially sodium-free.

3. How to take Titlodine

Dosage

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

The 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 troubling side effects
Your doctor may reduce the dose of Titlodine to 2 mg per day.
Use in children
Titolodine is not recommended for use in children.

If you take more Titlodine than you should

If you have taken too many capsules, contact your doctor or pharmacist immediately. Symptoms of overdose include: hallucinations, severe excitement, rapid heartbeat, dilated pupils, difficulty urinating, and breathing difficulties.

If you forget to take Titlodine

If you miss a dose, take it as soon as possible, 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 treatment with Titlodine

Your doctor will tell you how long to take Titlodine. Do not stop treatment early due to the lack of immediate effect. Time is needed for the bladder to adapt. Finish taking the capsules as prescribed by your doctor. If no effect is seen by then, consult your doctor.
The effect of treatment should be evaluated after 2-3 months. Always consult your doctor if you are considering stopping treatment.
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If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Titlodine can cause side effects, although not everybody gets them.
Consult your doctor or go to the emergency room if you experience symptoms of angioedema, such as:

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

Consult your doctor if you experience an allergic reaction (e.g., rash, itching, hives, difficulty breathing). This reaction occurs uncommonly (in less than 1 in 100 patients).

• 100).

Consult 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 frequencies:
Very common side effects(occurring in more than 1 in 10 patients):

• dry mouth.

Common side effects(occurring in less than 1 in 10 patients):

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

Uncommon side effects(occurring in less than 1 in 100 patients):

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

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• memory disorders.

Additional reported reactions include severe allergic reactions, confusion, hallucinations, rapid heartbeat, flushing, heartburn, vomiting, angioedema, dry skin, and disorientation. Worsening of dementia symptoms has also been reported in patients treated for this condition.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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, 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 Titlodine

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging, blister, and bottle after: EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
HDPE bottle: the shelf life after first opening is 200 days.
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 Titlodine contains

The active substance in Titlodine, 2 mg, prolonged-release hard capsules is 2 mg of tolterodine tartrate, which corresponds to 1.37 mg of tolterodine.
The active substance in Titlodine, 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 anhydrous silica, sodium lauryl sulfate, sodium docusate, magnesium stearate, hypromellose.
Capsule shell: indigo carmine (E132), quinoline yellow (only in 2 mg capsules) (E104), titanium dioxide (E171), gelatin.
Inner tablet coating: ethylcellulose, triethyl citrate, methacrylic acid, and ethyl acrylate copolymer, propylene glycol.

What Titlodine looks like and contents of the pack

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Titolodine is available as prolonged-release hard capsules for once-daily oral administration.
Titolodine, 2 mg, prolonged-release hard capsules are green - green, non-transparent, hard gelatin capsules (size 1) containing two white, round, biconvex, film-coated tablets.
Titolodine, 4 mg, prolonged-release hard capsules are light blue - light blue, non-transparent, hard gelatin capsules (size 1) containing four white, round, biconvex, film-coated tablets.
Titolodine, 2 mg, prolonged-release hard capsules are available in the following pack sizes:
Blister packs containing: 14, 28, 30, 50, 84, 100 prolonged-release hard capsules.
HDPE bottle containing: 30, 100, and 200 prolonged-release hard capsules.
Titolodine, 4 mg, prolonged-release hard capsules are available in the following pack sizes:
Blister packs containing: 7, 14, 28, 49, 84, 98 prolonged-release hard capsules.
HDPE bottle containing: 30, 100, and 200 prolonged-release hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Farmak International Sp. z o.o.

ul. Koszykowa 65
00-667 Warsaw
Manufacturer/Importer

Pharmathen S.A.

6, Dervenakion St., 15351 Pallini Attiki, Greece

Pharmathen International S.A.

Sapes Industrial Park
Block 5, 69300 Rodopi, Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

PL:
Titlodine
Date of last revision of the package leaflet:April 2025
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