Defur

Package Leaflet: Information for the Patient

Defur, 4 mg, Prolonged-Release Hard Capsules

Tolterodine Tartrate

Read the Package Leaflet Carefully Before Taking the Medication, 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 Medication has been Prescribed Specifically for You. Do Not Pass it on to Others. The Medication may Harm them, even if their Symptoms are the Same as Yours.
• If the Patient Experiences any Undesirable Effects, Including those not Mentioned in this Package Leaflet, they Should Inform their Doctor or Pharmacist. See Section 4.

Package Leaflet Contents:

• 1. What is Defur and What is it Used for
• 2. Important Information Before Taking Defur
• 3. How to Take Defur
• 4. Possible Undesirable Effects
• 5. How to Store Defur
• 6. Package Contents and Other Information

1. What is Defur and What is it Used for

The Active Substance of Defur is Tolterodine. Tolterodine Belongs to a Group of Medications Called Antimuscarinic Agents.
Defur is Used to Treat Symptoms of Overactive Bladder, such as:

• Urge Incontinence
• Sudden and/or Frequent Urination.

2. Important Information Before Taking Defur

When Not to Take Defur

• If the Patient is Allergic to Tolterodine or any of the Other Ingredients of this Medication (listed in Section 6).
• If the Patient has Reduced Ability to Empty the Bladder (Urinary Retention)
• If the Patient has Uncontrolled Narrow-Angle Glaucoma (Increased Pressure in the Eyes with Vision Loss, not Responsive to Treatment)
• If the Patient has Myasthenia Gravis (Excessive Muscle Weakness)
• If the Patient has Severe Ulcerative Colitis (Ulcers and Inflammation of the Colon).
• If the Patient has Toxic Megacolon (Sudden Expansion of the Colon).

Warnings and Precautions

Before Starting to Take the Medication, the Patient Should Discuss the Following with their Doctor or Pharmacist:

• If the Patient has Difficulty Urinating and/or Urinates Small Amounts.
• If the Patient has a Gastrointestinal Disorder that Affects the Movement of Food and/or its Digestion.
• If the Patient has Kidney Problems (Kidney Failure).
• If the Patient has Liver Disease.
• If the Patient has Neurological Disorders that Affect Blood Pressure, Intestinal Function, and Sexual Function (any Autonomic Neuropathy).
• If the Patient has a Hiatus Hernia (Displacement of the Stomach into the Chest Cavity).
• If the Patient has Experienced Slowdown of Intestinal Movements or Severe Constipation (Decreased Motility of the Gastrointestinal Tract).
• If the Patient has Heart Problems, such as:
• Abnormal ECG
• Slow Heart Rate (Bradycardia)
• Pre-Existing Heart Conditions, such as Cardiomyopathy (Heart Muscle Weakness), Myocardial Ischemia (Reduced Blood Flow to the Heart), Arrhythmias (Irregular Heartbeat), and Heart Failure
• If the Patient has Low Levels of Potassium (Hypokalemia), Calcium (Hypocalcemia), or Magnesium (Hypomagnesemia) in the Blood.

Defur and Other Medications

The Patient Should Inform their Doctor or Pharmacist about all Medications they are Currently Taking or have Recently Taken, as well as any Medications they Plan to Take.
Tolterodine, the Active Substance of Defur, may Interact with Other Medications.
It is not Recommended to Take Tolterodine in Combination with:

• Certain Antibiotics (containing, among others, Erythromycin, Clarithromycin)
• Medications Used to Treat Fungal Infections (containing, among others, Ketoconazole, Itraconazole)
• Medications Used to Treat HIV Infections.

The Patient Should be Cautious when Taking Defur with the Following Medications:

• Medications that Affect the Movement of Food (containing, among others, Metoclopramide and Cisapride)
• Medications Used to Treat Arrhythmias (containing, among others, Amiodarone, Sotalol, Quinidine, Procainamide)
• Other Medications with Similar Effects to Defur (Antimuscarinic Properties) or Medications with Opposite Effects to Defur (Cholinergic Properties). The Slowdown of Intestinal Movements caused by Antimuscarinic Medications may Affect the Absorption of Other Medications.

Defur with Food

Defur can be Taken with or without Food.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, or Thinks they may be Pregnant or are Planning to have a Child, they Should Consult their Doctor or Pharmacist before Taking this Medication.
Pregnancy
Defur should not be Taken during Pregnancy.
Breastfeeding
It is not Known if Tolterodine, the Active Substance of Defur, Passes into Breast Milk. Breastfeeding is not Recommended while Taking Defur.
Before Taking any Medication, the Patient Should Consult their Doctor or Pharmacist.

Driving and Operating Machinery

Defur may Cause Dizziness, Fatigue, or Vision Disturbances. If any of these Symptoms Occur, the Patient Should not Drive or Operate Machinery.

Defur Contains Lactose and Sodium

If the Patient has been Diagnosed with Intolerance to some Sugars, they Should Consult their Doctor before Taking the Medication.
This Medication Contains Less than 1 mmol (23 mg) of Sodium per Prolonged-Release Capsule, which means the Medication is Considered "Sodium-Free".

3. How to Take Defur

This Medication Should Always be Taken as Directed by the Doctor. If the Patient has any Doubts, they Should Consult their Doctor or Pharmacist.
Adults
The Recommended Dose is one 4 mg Prolonged-Release Hard Capsule per Day.
Patient with Kidney or Liver Problems
The Doctor may Reduce the Dose to 2 mg of Defur per Day in Patients with Kidney or Liver Problems.
Use in Children
Defur is not Recommended for Use in Children.
Method of Administration
The Prolonged-Release Hard Capsules are for Oral Use and Should be Swallowed Whole.
The Capsules Should not be Chewed.
Duration of Treatment
The Doctor will Inform the Patient about the Duration of Treatment with Defur. The Patient Should not Stop Taking the Medication if they do not Notice an Immediate Improvement. The Bladder will Adapt Over Time. The Patient Should Complete the Course of Treatment as Prescribed by the Doctor. If the Patient does not Notice any Improvement after this Time, they Should Consult their Doctor.
After 2 or 3 Months, the Efficacy of the Treatment Should be Reassessed.

Overdose of Defur

In Case of Overdose, the Patient Should Immediately Consult their Doctor or Pharmacist. Symptoms of Overdose include: Hallucinations, Agitation, Rapid Heart Rate, Dilated Pupils, and Difficulty Urinating and Breathing.

Missed Dose of Defur

If the Patient Forgets to Take a Dose at the Usual Time, they Should Take it as Soon as they Remember, unless it is Almost Time for the Next Dose. In this Case, the Patient Should Omit the Missed Dose and Continue with the Prescribed Treatment Schedule. The Patient Should not Take a Double Dose to Make up for the Missed Dose.

Stopping Treatment with Defur

Before Stopping Treatment, the Patient Should Always Consult their Doctor.
If the Patient has any Further Doubts about Taking this Medication, they Should Consult their Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, Defur can Cause Undesirable Effects, although not Everybody gets them.
The Patient Should Immediately Consult their Doctor or Go to the Hospital if they Experience Symptoms of Angioedema, such as:

• Swelling of the Face, Tongue, or Throat
• Rash and Difficulty Breathing.

The Patient Should also Seek Medical Attention if they Experience an Allergic Reaction (such as Itching, Rash, Urticaria, Difficulty Breathing). These Reactions are not Very Common (affecting no more than 1 in 100 People).
If the Patient Notices any of the Following Symptoms, they Should Consult their Doctor or Go to the Hospital:

• Chest Pain, Difficulty Breathing, or Rapid Fatigue (even at Rest), Difficulty Breathing at Night, Swelling of the Legs. These may be Symptoms of Heart Failure, which are not Very Common (affecting no more than 1 in 100 People).

The Following Undesirable Effects were Observed in Patients Taking Defur with the Following Frequencies:
Very Common Undesirable Effects(affecting more than 1 in 10 People):

• Dry Mouth

Common Undesirable Effects(affecting no more than 1 in 10 People):

• Sinusitis
• Dizziness, Drowsiness, Headache
• Dry Eyes, Blurred Vision
• Indigestion (Dyspepsia), Constipation, Abdominal Pain, Accumulation of Excess Gas in the Stomach or Intestines
• Painful or Difficult Urination
• Diarrhea
• Excess Fluid in the Body causing Swelling (e.g., of the Ankles)
• Fatigue

Uncommon Undesirable Effects(affecting no more than 1 in 100 People):

• Allergic Reactions
• Palpitations
• Nervousness
• Arrhythmias, Heart Failure
• Chest Pain
• Urinary Retention
• Numbness or Tingling in the Fingers and Toes
• Vertigo of Vestibular Origin
• Memory Impairment

Additionally, the Following Undesirable Effects have been Reported: Severe Allergic Reactions, Confusion, Hallucinations, Rapid Heart Rate, Sudden Redness of the Skin, Heartburn, Vomiting, Angioedema, Dry Skin, and Disorientation. There have also been Reports of Worsening of Dementia Symptoms in Patients with Dementia.

Reporting Undesirable Effects

If the Patient Experiences any Undesirable Effects, including those not Mentioned in the Package Leaflet, they Should Inform their Doctor, Pharmacist, or Nurse. Undesirable Effects can be Reported Directly to the Department of Pharmacovigilance, 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
Undesirable Effects can also be Reported to the Marketing Authorization Holder.
Reporting Undesirable Effects will Help to Gather more Information on the Safety of the Medication.

5. How to Store Defur

The Medication Should be Stored out of Sight and Reach of Children.
Do not Use this Medication after the Expiration Date Stated on the Label, Box, or Blister after EXP.
The Expiration Date refers to the Last Day of the Given Month.
Store in a Temperature below 25°C.
Medications Should not be Disposed of via Wastewater or Household Waste. The Patient Should Ask their Pharmacist how to Dispose of Medications they no Longer Use. This will Help Protect the Environment.

6. Package Contents and Other Information

What Defur Contains

The Active Substance is Tolterodine Tartrate. Each Prolonged-Release Hard Capsule contains 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,
Hydroxypropyl Methylcellulose.
Capsule Shell: Indigo Carmine (E132), Titanium Dioxide (E171), Gelatin
Inner Tablet Coating: Ethylcellulose, Triethyl Citrate, Methacrylic Acid and Ethyl Acrylate Copolymer (1:1) Dispersion 30%, Propylene Glycol.

What Defur Looks Like and Contents of the Package

Defur is a Prolonged-Release Hard Capsule, Intended for Once-Daily Use, with a Light Blue Opaque Cap and a Light Blue Opaque Body.

Defur is Available in the Following Package Sizes:

Blisters Containing 14, 28, 90 Prolonged-Release Hard Capsules.
Not all Package Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Phone: (22) 345 93 00

Manufacturer:

Pharmathen S.A., 6, Dervenakion Str. 153 51 Pallini Attiki, Greece
Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków
Pharmathen International S.A., Sapes Industrial Park, Block 5, 69300 Rodopi, Greece
Pharmadox Healthcare Ltd, KW20A Kordin Industrial Park, Paola, PLA 3000, Malta
Pharmacare Premium Ltd, HHF 003, Hal Far Industrial Estate Birzebbugia BBG3000, Malta
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen Hungary
Pharmachemie B.V, Swensweg 5, 2031 GA Haarlem, Netherlands
Merckle GmbH, Ludwig-Merckle Straße 3, 89143 Blaubeuren, Germany
Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

This Medicinal Product is Authorized in the Member States of the European Economic Area under the Following Names:

Belgium: Tolterodine Teva Retard 4 mg capsules met verlengde afgifte, hard
Denmark: Tolterodintartrat Teva
Finland: Tolterodine ratiopharm
Greece: Tolterodine Teva 4 mg καψάκια παρατεταμένης αποδέσμευσης, σκληρά
Spain: Tolterodina Teva 4 mg cápsulas duras de liberación prolongada EFG
Netherlands: Tolterodinetartraat retard 4 mg Teva, capsules met verlengde afgifte
Ireland: Trusitev 4 mg Prolonged-release Capsules, hard
Luxembourg: Tolterodin-ratiopharm 4 mg Retardkapseln
Germany: Tolterodin-ratiopharm 4 mg Retardkapseln
Norway: Tolterodine Teva
Poland: Defur
Slovakia: Tolterodin Teva 4 mg
Slovenia: Tolterodin Teva 4 mg trde kapsule s podaljšanim sproščanjem
Sweden: Tolterodine Teva
United Kingdom: SASPRED 4 mg Prolonged-release Capsules, hard

Date of Last Revision of the Package Leaflet: February 2023