Urotrol 2 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Urotrol 2 mg film-coated tablets

tolterodine tartrate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Urotrol is and what it is used for

The active substance in Urotrol is tolterodine. Tolterodine is a medicine that belongs to a group of medicines called antimuscarinics.

Urotrol is used to treat the symptoms of overactive bladder syndrome. If you have overactive bladder syndrome, you may notice that:

• you are unable to voluntarily control your urine
• you feel a sudden and urgent need to pass urine without warning and/or you need to pass urine more frequently than usual.

2. What you need to know before taking Urotrol

Do not take Urotrol if

• you are allergic (hypersensitive) to tolterodine or to any of the other ingredients of this medicine (listed in section 6).
• you are unable to empty urine from the bladder (urinary retention).
• you have uncontrolled narrow-angle glaucoma (increased intraocular pressure with loss of visual field that is not being adequately treated).
• you have myasthenia gravis (excessive muscle weakness).
• you suffer from severe ulcerative colitis (ulceration and inflammation in the colon).
• you have toxic megacolon (acute dilation of the colon).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Urotrol if you think any of the following situations may apply to you.

• If you have difficulty passing urine and/or have a weak or slow urinary stream.

• If you have a gastrointestinal disorder affecting the passage and digestion of food.

• If you have kidney problems (renal failure).

• If you have liver disease.

• If you suffer from neurological disorders affecting your blood pressure, intestinal or sexual function (any autonomic neuropathy).

• If you have a hiatal hernia (herniation of an abdominal organ).

• If you ever experience reduced intestinal movements or suffer from severe constipation (decreased gastrointestinal motility).

• If you have a relevant heart condition such as:

• abnormal heart rhythm (ECG)

• slow heart rate (bradycardia)

• pre-existing heart diseases such as:

  • cardiomyopathy (weakness of the heart muscle)
  • myocardial ischemia (reduced blood flow to the heart)
  • arrhythmia (irregular heart rhythm)
  • heart failure

• If you have abnormally low levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia) in your blood.

Other medicines and Urotrol

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Tolterodine, the active substance in Urotrol, may interact with other medicines.

The use of tolterodine is not recommended in combination with:

• certain antibiotics (containing e.g.: erythromycin and clarithromycin).
• medicines used to treat fungal infections (containing e.g.: ketoconazole and itraconazole).
• medicines for the treatment of HIV.

Urotrol should be used with caution when administered in combination with:

• certain medicines affecting food transit (containing e.g.: metoclopramide and cisapride).
• medicines for the treatment of irregular heart rhythm (containing e.g.: amiodarone, sotalol, quinidine, and procainamide).
• other medicines with a similar mode of action to Urotrol (antimuscarinic properties), or medicines with an opposite mode of action to Urotrol (cholinergic properties). Consult your doctor if you are unsure.

Taking Urotrol with food and drink

Urotrol may be taken before, during, or after a meal.

Pregnancy and Breast-feeding

Pregnancy

You should not use Urotrol if you are pregnant. Inform your doctor immediately if you are pregnant, think you might be pregnant, or are planning to become pregnant.

Breast-feeding

It is unknown whether tolterodine, the active ingredient of Urotrol, is excreted in breast milk. The use of Urotrol during breast-feeding is not recommended.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Urotrol may cause dizziness, tiredness, or affect your vision; your ability to drive or operate machinery may be impaired.

Urotrol contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.

3. How to take Urotrol

Dosage

Follow exactly the administration instructions for Urotrol given by your doctor. Consult your doctor or pharmacist if you have any doubts.

The recommended dose is one 2 mg tablet twice daily, except in patients with hepatic or renal disease, or who experience bothersome side effects, in which case your doctor may reduce your dose to one 1 mg tablet twice daily.

Use of Urotrol is not recommended in children.

Urotrol is taken orally. The tablets must be swallowed whole.

Duration of treatment

Your doctor will determine how long you should take Urotrol. Do not stop treatment prematurely if you do not observe an immediate effect, as your bladder needs time to adapt to it. Complete the course of tablets as prescribed by your doctor. If by then you have noticed no improvement, consult your doctor.

The benefit of treatment should be re-evaluated after 2–3 months of use.

Always consult your doctor if you are considering stopping treatment.

If you take more Urotrol than you should

If you or anyone else takes too many tablets, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, go to the nearest hospital or contact the Toxicology Information Service, Tel. 91 562 04 20.

If you forget to take Urotrol

If you forget to take a dose at the usual time, take it as soon as you remember, unless it is almost time for the next dose. In that case, skip the missed dose and continue with your regular dosing schedule as directed by your doctor.

Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

The following adverse effects have been observed during treatment with Urotrol, with the following frequencies:

Very common (may affect at least 1 in 10 people):

• dry mouth
• headache

Common (may affect at least 1 in 100 people):

• bronchitis
• dizziness, drowsiness, tingling sensation in the fingers and toes
• dry eyes, blurred vision
• vertigo
• palpitations
• difficulty digesting (dyspepsia), constipation, abdominal pain, excessive gas in the stomach or intestines, vomiting
• dry skin
• pain or difficulty urinating, inability to empty the bladder
• fatigue, chest pain, swelling due to fluid retention (e.g., in the ankles)
• weight gain
• diarrhoea

Uncommon (may affect at least 1 in 1,000 people):

• allergic reactions
• nervousness
• increased heart rate, heart failure which may present with symptoms such as: chest pain, shortness of breath or fatigue (even at rest), difficulty breathing at night, leg swelling, and irregular heartbeat
• heartburn
• memory disturbance

Additional reported reactions include severe allergic reactions, confusion, hallucinations, red skin rash, angioedema (swelling of the face, tongue or throat, difficulty swallowing, urticaria and breathing difficulty), and disorientation. Cases of worsening dementia symptoms have been reported in patients receiving treatment for dementia.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Urotrol Storage

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Urotrol

The active substance in Urotrol 2 mg film-coated tablets is tolterodine. Each tablet contains 2 mg of tolterodine tartrate, equivalent to 1.37 mg of tolterodine.

The other components are:

Core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium starch glycolate (type B) (see section 2, “Urotrol contains sodium”), magnesium stearate, and colloidal anhydrous silica.

Coating: hypromellose, microcrystalline cellulose, stearic acid, and titanium dioxide (E171).

Appearance of the product and contents of the pack

Urotrol 2 mg tablets are white, round, biconvex, with arcs above and below the letters “DT”.

Urotrol is available in packages containing 56 film-coated tablets (4 blisters of 14 tablets each).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Almirall, S.A.

General Mitre, 151

08022 - Barcelona, Spain

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca – Barcelona (Spain)

or

Pfizer Italia, S.r.L.

Località Marino del Tronto

63100 Ascoli Piceno

Italy

Date of latest revision of the package leaflet: December 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/