TITLODINE 2 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. Contents of the package leaflet:
4. What Titlodine is and what it is used for
5. Before you take Titlodine
   1. When not to take Titlodine:
   2. Warnings and precautions
   3. Be cautious:
   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. If you stop taking Titlodine
7. Possible side effects
   1. Reporting of 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 Authorisation Holder and Manufacturer:
   4. Farmak International Sp. z o.o.
   5. Pharmathen S.A.
   6. Pharmathen International S.A.
   7. This medicinal product is authorised 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.

• You should keep this 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

• 1. What Titlodine is and what it is used for
• 2. Before you take 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 of Titlodine is tolterodine. Tolterodine belongs to a group of medicines called antimuscarinic agents.
Titolodine is used to treat the symptoms of overactive bladder. When you have overactive bladder, you may:

• not be able to control urination;
• need to rush to the toilet to urinate, with little or no warning, or need to urinate frequently.

2. Before you take 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 have difficulty passing urine (urinary retention);
• if you have an untreated narrow-angle glaucoma (high pressure in the eyes with loss of vision, which is not being treated);
• if you have myasthenia gravis (a severe muscle weakness);
• if you have an acute ulcerative colitis (ulceration and inflammation of the colon);
• if you have toxic megacolon (a life-threatening condition where the colon becomes very inflated).

Warnings and precautions

Be cautious:

• if you have difficulty passing urine and/or pass urine 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 functions (any autonomic neuropathy);
• if you have a hiatal hernia (a condition where part of the stomach bulges up into the chest through an opening);
• if you have decreased movement of the intestines or severe constipation (decreased gastrointestinal motility);
• if you have any heart condition, including:
• abnormal heart rhythm (ECG);
• slow heart rate (bradycardia);
• previously diagnosed heart conditions 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 taking Titlodine, you should discuss this 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 have bought without a prescription.
Tolterodine, the active substance of Titlodine, may interact with other medicines.
It is not recommended to take Titlodine with:

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

Be cautious when taking Titlodine with:

• medicines that affect the movement of food through the digestive system (such as metoclopramide and cisapride);
• medicines used to treat irregular heartbeat (such as amiodarone, sotalol, quinidine, procainamide);
• other medicines that work in a similar way to Titlodine (antimuscarinic properties) or medicines that work in the opposite way to Titlodine (cholinergic properties). If you are unsure, 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 are planning to have a baby, ask your doctor or pharmacist for advice 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 of Titlodine, passes into breast milk. Do not take Titlodine while breastfeeding.

Driving and using machines

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

Titolodine contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact 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, ask 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 troublesome side effects
Your doctor may reduce your 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.

If you forget to take Titlodine

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.

If you stop taking Titlodine

Your doctor will tell you how long to take Titlodine. Do not stop taking Titlodine without talking to your doctor first, even if you feel better. It may take some time for your bladder to adapt. You should finish the course of capsules as prescribed by your doctor. If you have not noticed any effect by then, talk to your doctor.
The effect of treatment should be evaluated after 2-3 months. Always talk to your doctor if you are thinking of stopping treatment.
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If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Titlodine can cause side effects, although not everybody gets them.
See a doctor or go to a hospital if you experience symptoms of angioedema, such as:

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

See a doctor if you experience an allergic reaction (such as rash, itching, hives, difficulty breathing). This reaction is not very common (affects less than 1 in 100 people).

• This occurs in less than 1 in 100 people.

See a doctor or go to a hospital if you experience:

• chest pain, difficulty breathing, easy fatigue (even when resting), difficulty breathing at night, swelling of the feet. These may be symptoms of heart failure. This occurs in less than 1 in 100 people.

During treatment with tolterodine, the following side effects have been observed with the following frequencies:

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

• dry mouth.

Common side effects(affect less than 1 in 10 people):

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

Uncommon side effects(affect less than 1 in 100 people):

• allergic reactions;
• nervousness;
• rapid heartbeat;
• inability to empty the bladder;
• feeling of spinning;
• heart failure;
• irregular heartbeat;
• chest pain;
• tingling sensation in the 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 symptoms of dementia has also been reported in patients being treated for this condition.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects, you can help provide 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 which is stated on the outer packaging, blister, and bottle after EXP. The expiry date refers to the last day of that 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Titlodine contains

The active substance of Titlodine, 2 mg, prolonged-release hard capsules is 2 mg of tolterodine tartrate, which corresponds to 1.37 mg of tolterodine.
The active substance of 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 (E104) (only in 2 mg capsules), titanium dioxide (E171), gelatin.
Inner tablet coating: ethylcellulose, triethyl citrate, methacrylic acid-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 oral use once daily.
Titolodine, 2 mg, prolonged-release hard capsules are green-green, opaque-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, opaque-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:
Blisters 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:
Blisters 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 Authorisation Holder and Manufacturer:

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names:

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