Urimper

Package leaflet: Information for the patient

Urimper, 2 mg, prolonged-release capsules, hard
Urimper, 4 mg, prolonged-release capsules, hard
Tolterodini tartras
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Urimper is and what it is used for

The active substance in Urimper is tolterodine. Tolterodine belongs to a group of medicines called antimuscarinic agents.
Urimper is used to treat the symptoms of overactive bladder. The overactive bladder syndrome may be characterized by:

• inability to control urination
• sudden urge to urinate and/or frequent need to urinate.

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 medicine
  (listed in section 6).
• if the patient is unable to pass urine (urinary retention).
• if the patient has uncontrolled narrow-angle glaucoma (high intraocular pressure with vision loss that is not adequately treated).
• if the patient has been diagnosed with myasthenia gravis (excessive muscle fatigue).
• if the patient has been diagnosed with ulcerative colitis (ulceration and inflammation of the large intestine).
• if the patient has been diagnosed with toxic megacolon (acute dilation of the large intestine).

Warnings and precautions
Before starting Urimper, discuss this with your doctor or pharmacist.

• if the patient has difficulty passing urine and/or passes urine with a weak stream.
• if the patient has a gastrointestinal disorder that causes impaired movement and/or digestion of food.
• if the patient has kidney function disorders (renal failure).
• if the patient has liver disease.
• if the patient has been diagnosed with neurological disorders affecting blood pressure, intestinal function, and sexual function (any autonomic neuropathy).
• if the patient has a hiatal hernia (herniation of an organ within the abdominal cavity).
• if the patient has ever experienced slowed intestinal motility or severe constipation (reduced gastric and intestinal motility).
• if the patient has heart function disorders, such as:
  • abnormal ECG findings
  • slow heart rate (bradycardia)
  • pre-existing heart conditions, such as: cardiomyopathy (weakened heart muscle), 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 the blood.

Urimper and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Tolterodine, the active substance in Urimper, may interact with other medicines.
Concomitant use of Urimper is not recommended with:

• certain antibiotics (containing e.g. erythromycin, clarithromycin)
• antifungal medications (containing e.g. ketoconazole, itraconazole)
• medicines used to treat HIV infection.

Use Urimper with caution when taken together with:

• medicines affecting gastrointestinal motility (containing e.g. metoclopramide, cisapride)
• medicines used to treat irregular heart rhythm (containing e.g. amiodarone, sotalol, quinidine, procainamide)
• other medicines with a similar mechanism of action to Urimper (antimuscarinic properties) or medicines with cholinergic effects antagonistic to tolterodine. Reduced gastrointestinal motility caused by antimuscarinic drugs may affect the absorption of other medicines. In case of doubt, consult your doctor.

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Urimper should not be used during pregnancy.
Breastfeeding
It is not known whether tolterodine, the active substance in Urimper, is excreted in human milk. Breastfeeding is not recommended during treatment with Urimper.

Driving and operating machinery
While taking Urimper, the patient may experience dizziness, fatigue, or visual disturbances. If the patient experiences any of these symptoms, they should not drive or operate machinery.

Urimper contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking Urimper.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to take Urimper

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Dosage
Prolonged-release hard capsules are intended for oral administration and should be swallowed whole.
Do not chew the capsules.
Adults
The recommended dose is one 4 mg prolonged-release hard capsule once daily.
Patients with liver or kidney function disorders
In patients with impaired liver or kidney function, the doctor may reduce the dose to 2 mg of Urimper per day.
Children and adolescents
Urimper is not recommended for use in children.
Taking more Urimper than recommended
If the patient or anyone else takes too many prolonged-release capsules, contact a doctor or pharmacist immediately. Symptoms of overdose may include hallucinations, agitation, faster than normal heartbeat, dilated pupils, inability to urinate, or breathing difficulties.
If you miss a dose of Urimper
If the patient forgets to take a dose at the usual time, it should be taken as soon as possible, unless it is almost time for the next dose. In that case, the missed dose should not be taken; continue treatment as prescribed.
Do not take a double dose to make up for a missed dose.
Stopping the treatment
Your doctor will inform you how long treatment with Urimper should last. Do not stop treatment earlier because of lack of immediate effect. The bladder needs time to adapt. All prescribed prolonged-release capsules should be taken. If no improvement is observed after completing the treatment, contact your doctor.
Treatment effectiveness should be evaluated after 2–3 months. Consult your doctor if considering stopping the treatment.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Seek immediate medical attention from a doctor or hospital emergency department if any of the following symptoms of angioedema occur:

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

Also seek medical help if symptoms of hypersensitivity occur (e.g. itching, rash, urticaria, breathing difficulties). These symptoms occur uncommonly (in fewer than 1 in 100 patients).

Contact your doctor or hospital emergency department if any of the following symptoms occur:

• chest pain, shortness of breath or rapid fatigue (even at rest), nocturnal breathing difficulties, leg swelling.

These symptoms may indicate heart failure. This is an adverse reaction occurring uncommonly (in fewer than 1 in 100 patients).

The following adverse reactions have been observed during the use of Urimper and are classified according to the frequency of occurrence below:

Very common adverse reactions (may affect more than 1 in 10 patients):

• Dry mouth.

Common adverse reactions (may affect up to 1 in 10 patients):

• Sinusitis
• Dizziness, drowsiness, headache
• Dry eyes, visual disturbances
• Gastrointestinal disturbances (dyspepsia), constipation, abdominal pain, excessive gas accumulation in the stomach or intestines
• Painful or difficult urination
• Diarrhea
• Fluid retention causing swelling (e.g. around the ankles)
• Fatigue

Uncommon adverse reactions (may affect up to 1 in 100 patients):

• Allergic reactions
• Heart failure
• Nervousness
• Irregular heartbeat, palpitations
• Chest pain
• Inability to empty the bladder
• Tingling sensation in fingers and toes
• Vertigo
• Memory disturbances

In addition, the following adverse reactions have been reported: severe allergic reactions, confusion, hallucinations, rapid heartbeat, skin redness, heartburn, vomiting, angioedema, dry skin and disorientation. There have also been reports of worsening of dementia symptoms in patients treated for dementia.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of 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 to provide more information on the safety of this medicine.

5. How to store Urimper

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. 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 packaging and other information

What Urimper contains

• The active substance in Urimper 2 mg is tolterodine tartrate in the amount of 2 mg, corresponding to 1.37 mg of tolterodine. The active substance in Urimper 4 mg is tolterodine tartrate in the amount of 4 mg, corresponding to 2.74 mg of tolterodine.
  - Other ingredients: monohydrate lactose, microcrystalline cellulose, polyvinyl acetate, povidone, sodium lauryl sulfate, anhydrous colloidal silicon dioxide, hydroxypropylmethylcellulose, sodium docucinate, magnesium stearate. Capsule shell: indigo carmine (E132), quinoline yellow (for 2 mg only) (E104), titanium dioxide (E171), gelatin. Coating of the inner tablet contained in the capsule: ethylcellulose, triethyl citrate, copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion, propylene glycol.

What Urimper looks like and contents of the pack
Urimper is an extended-release hard capsule intended for once-daily dosing.
Urimper 2 mg, extended-release hard capsule, is opaque green – opaque green.
Urimper 4 mg, extended-release hard capsule, is opaque light blue – opaque light blue.
Urimper 2 mg, extended-release hard capsules, are available in the following pack sizes:
Blister packs containing: 14, 28, 30, 56, 60, 84, 98, 100 extended-release hard capsules.
Urimper 4 mg, extended-release hard capsules, are available in the following pack sizes:
Blister packs containing: 7, 14, 28, 30, 49, 56, 60, 84, 98, 100 extended-release hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product, contact the Marketing Authorisation Holder.

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Sweden: Tolterodin Rivopharm
Finland: Tolterodin SanoSwiss
Denmark: Tolterodin Rivopharm