URIMPER 2 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Urimper, 2 mg, Prolonged-Release Hard Capsules
3. Urimper, 4 mg, Prolonged-Release Hard Capsules
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Package Leaflet Contents
4. What is Urimper and What is it Used for
5. Important Information Before Taking Urimper
   1. When Not to Take Urimper
   2. Warnings and Precautions
   3. Urimper and Other Medications
   4. Urimper with Food and Drink
   5. Pregnancy and Breastfeeding
   6. Driving and Operating Machines
   7. Urimper Contains Lactose and Sodium
6. How to Take Urimper
   1. Dosage
   2. Overdose of Urimper
   3. Missed Dose of Urimper
   4. Stopping Treatment with Urimper
7. Possible Undesirable Effects
   1. Reporting Undesirable Effects
8. How to Store Urimper
9. Package Contents and Other Information
   1. What Urimper Contains
   2. What Urimper Looks Like and Contents of the Package
   3. Marketing Authorization Holder
   4. Manufacturer
   5. For Further Information about this Medication, the Patient Should Contact the Marketing Authorization Holder.
   6. This Medicinal Product is Authorized in the Member States of the European Economic Area under the Following Names:
   7. Date of Last Revision of the Package Leaflet:

Package Leaflet: Information for the Patient

Urimper, 2 mg, Prolonged-Release Hard Capsules

Urimper, 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 Listed in this Package Leaflet, they Should Inform their Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

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

1. What is Urimper and What is it Used for

The Active Substance in Urimper is Tolterodine. Tolterodine Belongs to a Group of Medications Called Antimuscarinic Agents.
Urimper is Used to Treat Symptoms of an Overactive Urinary Bladder. Overactive Bladder Syndrome may be Characterized by:

• The Patient is Unable to Control Urination
• The Patient Feels a Sudden Need to Urinate and (or) Urinates Frequently.

2. Important Information Before Taking Urimper

When Not to Take Urimper

˗
If the Patient is Allergic to Tolterodine or any of the Other Ingredients of this Medication (Listed in Section 6).
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If the Patient is Unable to Urinate (Urinary Retention).
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If the Patient has Uncontrolled Narrow-Angle Glaucoma (High Pressure in the Eye with Vision Loss that is not Properly Treated).
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If the Patient has been Diagnosed with Myasthenia Gravis (Excessive Muscle Fatigue).
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If the Patient has been Diagnosed with Ulcerative Colitis (Ulcers and Inflammation of the Colon).
˗
If the Patient has been Diagnosed with Toxic Megacolon (Sudden Enlargement of the Colon).

Warnings and Precautions

Before Starting to Take Urimper, the Patient Should Discuss it with their Doctor or Pharmacist.
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If the Patient has Difficulty Urinating and (or) has a Weak Urine Stream.
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If the Patient has a Gastrointestinal Disorder that Causes Abnormal Movement and (or) Digestion of Food.
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If the Patient has Kidney Function Disorders (Kidney Failure).
˗
If the Patient has Liver Disease.
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If the Patient has been Diagnosed with Neurological Disorders that Affect Blood Pressure, Intestinal Movement, and Sexual Function (Any Autonomic Neuropathy).
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If the Patient has a Hiatus Hernia (A Condition where Part of the Stomach Pokes up into the Chest).
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If the Patient has Experienced Slowed Movement of the Intestines or Severe Constipation (Reduced Stomach and Intestinal Motility).
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If the Patient has Heart Function Disorders, such as:
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Abnormal ECG Readings
˗
Slow Heart Rate (Bradycardia)
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Pre-existing Heart Conditions, such as Cardiomyopathy (Heart Muscle Weakness), Myocardial Ischemia (Reduced Blood Flow to the Heart), Arrhythmia (Irregular Heartbeat), and Heart Failure.
˗
If the Patient has Low Levels of Potassium (Hypokalemia), Calcium (Hypocalcemia), or Magnesium (Hypomagnesemia) in their Blood.

Urimper 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 in Urimper, may Interact with Other Medications.
It is not Recommended to Take Urimper in Combination with:
˗
Certain Antibiotics (Containing e.g. Erythromycin, Clarithromycin)
˗
Medications Used to Treat Fungal Infections (Containing e.g. Ketoconazole, Itraconazole)
˗
Medications Used to Treat HIV Infections.
Caution Should be Exercised when Taking Urimper in Combination with:
˗
Medications that Affect the Movement of Food (Containing e.g. Metoclopramide and Cisapride)
˗
Medications Used to Treat Irregular Heart Rhythms (Containing e.g. Amiodarone, Sotalol, Quinidine, Procainamide)
˗
Other Medications with a Similar Mechanism of Action to Urimper (Antimuscarinic Properties) or Medications with Antagonistic Effects to Tolterodine (Cholinergic Properties). Reduced Intestinal Motility Caused by Antimuscarinic Agents may Affect the Absorption of Other Medications. In Case of Doubts, the Patient Should Consult their Doctor.

Urimper with Food and Drink

Urimper can be Taken Before, After, or During Meals.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant or are Planning to have a Child, they Should Consult their Doctor or Pharmacist before Taking this Medication.
Pregnancy
Urimper should not be Used During Pregnancy..
Breastfeeding
It is not Known if Tolterodine, the Active Substance in Urimper, is Excreted in Human Milk.
Breastfeeding is not Recommended during Treatment with Urimper.

Driving and Operating Machines

While Taking Urimper, the Patient may Experience Dizziness, Fatigue, or Vision Disturbances. If the Patient Experiences any of these Effects, they Should not Drive or Operate Machines.

Urimper Contains Lactose and Sodium

If the Patient has been Diagnosed with an Intolerance to some Sugars, they Should Consult their Doctor before Taking Urimper.
The Medication Contains less than 1 mmol (23 mg) of Sodium per Tablet, which means it is Considered "Sodium-Free".

3. How to Take Urimper

This Medication Should Always be Taken as Directed by the Doctor or Pharmacist. In Case of Doubts, the Patient Should Consult their Doctor or Pharmacist.

Dosage

Prolonged-Release Hard Capsules are for Oral Use and Should be Swallowed Whole.
The Capsules Should not be Chewed.
Adults
The Recommended Dose is one 4 mg Prolonged-Release Hard Capsule per Day.
Patient with Kidney or Liver Function Disorders
In Patient with Kidney or Liver Function Disorders, the Doctor may Reduce the Dose to 2 mg of Urimper per Day.
Children and Adolescents
Urimper is not Recommended for Use in Children.

Overdose of Urimper

If the Patient or Anyone Else has Taken too many Prolonged-Release Hard Capsules, they Should Contact a Doctor or Pharmacist. Symptoms of Overdose include Hallucinations, Excitement, Rapid Heartbeat, Dilated Pupils, Difficulty Urinating, or Breathing Difficulties.

Missed Dose of Urimper

If the Patient Forgets to Take a Dose at the Usual Time, they Should Take it as Soon as Possible, unless it is Almost Time for the Next Dose. In this Case, the Patient Should not Take the Missed Dose, but Continue with the Next Scheduled Dose.
The Patient Should not Take a Double Dose to Make up for the Missed Dose.

Stopping Treatment with Urimper

The Doctor will Inform the Patient how Long the Treatment with Urimper Should Last. The Patient Should not Stop the Treatment Early due to the Lack of Immediate Effect. The Urinary Bladder Needs Time to Adapt. The Patient Should Take all the Prolonged-Release Hard Capsules Prescribed by the Doctor. If there are no Visible Effects after Finishing the Treatment, the Patient Should Consult their Doctor.
The Effectiveness of the Treatment Should be Evaluated after 2-3 Months. The Patient Should Consult their Doctor if they are Considering Stopping the Treatment.
In Case of any Further Doubts about the Use of this Medication, the Patient Should Consult their Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, Urimper can Cause Undesirable Effects, although not Everybody gets them.
The Patient Should Immediately Contact their Doctor or the Hospital Emergency Department if they Experience any of the Following Symptoms of Angioedema:
˗
Swelling of the Face, Tongue, or Throat
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Difficulty Swallowing
˗
Hives and Difficulty Breathing.
The Patient Should also Seek Medical Attention if they Experience any Signs of an Allergic Reaction (e.g. Itching, Rash, Hives, Difficulty Breathing). These Symptoms are not Very Common (affecting less than 1 in 100 Patients).
The Patient Should Contact their Doctor or the Hospital Emergency Department if they Experience any of the Following Symptoms:
˗
Chest Pain, Difficulty Breathing, or Rapid Fatigue (even at Rest), Difficulty Breathing at Night, Swelling of the Legs.
These Symptoms may Indicate Heart Failure. This is an Undesirable Effect that is not Very Common (affecting less than 1 in 100 Patients).
The Following Undesirable Effects have been Observed with Urimper and are Classified according to their Frequency:

• Very Common Undesirable Effects(may affect more than 1 in 10 Patients):

Dry Mouth.

• Common Undesirable Effects(may affect up to 1 in 10 Patients):

Sinusitis, Dizziness, Drowsiness, Headache, Dry Eyes, Vision Disturbances, Digestive Disorders (Dyspepsia), Constipation, Abdominal Pain, Gas in the Stomach or Intestines, Painful or Difficult Urination, Diarrhea, Fluid Retention causing Swelling (e.g. around the Ankles), Fatigue.

• Uncommon Undesirable Effects(may affect up to 1 in 100 Patients):

Allergic Reactions, Heart Failure, Nervousness, Irregular Heartbeat, Palpitations, Chest Pain, Difficulty Emptying the Urinary Bladder, Tingling in the Fingers and Toes, Dizziness of Inner Ear Origin, Memory Disorders.

Additionally, the Following Undesirable Effects have been Reported: Severe Allergic Reactions, Confusion, Hallucinations, Rapid Heartbeat, Redness of the Skin, Heartburn, Vomiting, Angioedema, Dry Skin, and Disorientation. Furthermore, there have been Reports of Worsening Symptoms of Dementia in Patients Treated for Dementia.

Reporting Undesirable Effects

If the Patient Experiences any Undesirable Effects, including those not Listed in this Package Leaflet, they Should Inform their Doctor or Nurse.
Undesirable Effects can be Reported Directly to the Department of Adverse Reaction 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.
Undesirable Effects can also be Reported to the Marketing Authorization Holder. By Reporting Undesirable Effects, more Information can be Collected on the Safety of the Medication.

5. How to Store Urimper

The Medication Should be Stored out of Sight and Reach of Children.
Do not Use this Medication after the Expiration Date Stated on the Packaging. The Expiration Date refers to the Last Day of the Specified Month.
Do not Store above 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 Urimper Contains

• The Active Substance of Urimper 2 mg is Tolterodine Tartrate 2 mg, which corresponds to 1.37 mg of Tolterodine. The Active Substance of Urimper 4 mg is Tolterodine Tartrate 4 mg, which corresponds to 2.74 mg of Tolterodine. ˗ The Other Ingredients are: Lactose Monohydrate, Microcrystalline Cellulose, Polyvinyl Acetate, Povidone, Sodium Lauryl Sulfate, Colloidal Anhydrous Silica, Hypromellose, Sodium Docusate, Magnesium Stearate. Capsule Shell: Indigo Carmine (E132), Quinoline Yellow (only for 2 mg) (E104), Titanium Dioxide (E171), Gelatin. The Coating of the Inner Tablet in the Capsule Contains: Ethylcellulose, Triethyl Citrate, Methacrylic Acid and Ethyl Acrylate Copolymer (1:1) Dispersion 30%, Propylene Glycol.

What Urimper Looks Like and Contents of the Package

Urimper Prolonged-Release Hard Capsules are Designed for Once-Daily Dosing.
Urimper 2 mg Prolonged-Release Hard Capsules are Green- Green, Opaque.
Urimper 4 mg Prolonged-Release Hard Capsules are Light Blue- Light Blue, Opaque.
Urimper 2 mg Prolonged-Release Hard Capsules are Available in the Following Packages:
Blisters Containing: 14, 28, 30, 56, 60, 84, 98, 100 Prolonged-Release Hard Capsules.
Urimper 4 mg Prolonged-Release Hard Capsules are Available in the Following Packages:
Blisters Containing: 7, 14, 28, 30, 49, 56, 60, 84, 98, 100 Prolonged-Release Hard Capsules.
Not all Pack Sizes may be Marketed.

Marketing Authorization Holder

Holsten Pharma GmbH
Hahnstraße 31-35
60528 Frankfurt am Main
Germany
E-mail: [email protected]

Manufacturer

Pharmathen S.A.
6, Dervenakion Str.
153 51 Pallini Attiki
Greece
Pharmathen International S.A.
Sapes Industrial Park
Block 5, 69300 Rodopi
Greece

For Further Information about this Medication, the Patient Should Contact the Marketing Authorization Holder.

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

Sweden: Tolterodin Rivopharm
Finland: Tolterodin SanoSwiss
Denmark: Tolterodin Rivopharm

Date of Last Revision of the Package Leaflet: