UROTROL 2 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Urotrol 2 mg film-coated tablets

Tolterodine tartrate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the package leaflet:

1. What is Urotrol and what is it used for
2. What you need to know before taking Urotrol
3. How to take Urotrol
4. Possible side effects
5. Storage of Urotrol
6. Package contents and additional information

1. What is Urotrol and what is it used for

The active ingredient of Urotrol is tolterodine. Tolterodine is a medication that belongs to the group of medications known as 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 control urination voluntarily
• you feel a sudden and urgent need to urinate without prior warning and/or need to urinate 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 any of the other ingredients of this medication (listed in section 6).
• you are unable to empty your bladder (urinary retention).
• you have uncontrolled narrow-angle glaucoma (high intraocular pressure with loss of vision, which is not being treated properly).
• you have myasthenia gravis (excessive muscle weakness).
• you have 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 these situations may apply to you.

• If you have difficulty urinating and/or urinate with a weak or slow stream.
• If you have a gastrointestinal disorder that affects the passage and digestion of food.
• If you have kidney problems (renal insufficiency).
• If you have liver disease.
• If you have neuronal disorders that affect your blood pressure, intestinal function, or sexual function (any autonomic nervous system neuropathy).
• If you have a hiatal hernia (hernia in an abdominal organ).
• If you have ever noticed a decrease in bowel movements or have severe constipation (decreased gastrointestinal motility).
• If you have any relevant heart conditions, such as:
• abnormal heart rhythm (ECG)
• slow heart rate (bradycardia)
• pre-existing heart conditions, such as:
• • cardiomyopathy (weakness in the heart muscle)
  • myocardial ischemia (decreased blood flow to the heart)
  • arrhythmia (abnormal heart rhythm)
  • heart failure

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

Other medications and Urotrol

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication.

Tolterodine, the active ingredient of Urotrol, may interact with other medications.

It is not recommended to use tolterodine in combination with:

• certain antibiotics (e.g., erythromycin and clarithromycin).
• medications used to treat fungal infections (e.g., ketoconazole and itraconazole).
• HIV medications.

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

• certain medications that affect food passage (e.g., metoclopramide and cisapride).
• medications for treating irregular heart rhythm (e.g., amiodarone, sotalol, quinidine, and procainamide).
• other medications that have a similar mechanism of action to Urotrol (antimuscarinic properties) or medications that have an opposite mechanism of action to Urotrol (cholinergic properties). Consult your doctor if you are unsure.

Taking Urotrol with food and drinks.

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

Pregnancy and Breastfeeding

Pregnancy

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

Breastfeeding

It is unknown whether tolterodine, the active ingredient of Urotrol, is excreted in breast milk. Urotrol is not recommended during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

Urotrol may make you feel dizzy, tired, or affect your vision; your ability to drive or operate machinery may be impaired.

Urotrol contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per dose; it is essentially "sodium-free".

3. How to take Urotrol

Dose

Follow your doctor's instructions for taking Urotrol exactly. Consult your doctor or pharmacist if you have any questions.

The recommended dose is one 2 mg tablet twice a day, except in patients with liver or kidney disease, or bothersome side effects, in which case your doctor may reduce your dose to one 1 mg tablet twice a day.

Urotrol is not recommended for use in children.

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

Duration of treatment

Your doctor will indicate the duration of your treatment with Urotrol. Do not stop treatment before if you do not see an immediate effect, as your bladder needs time to adapt to it. Finish the treatment with the prescribed tablets. If, by then, you do not notice any effect, consult your doctor.

The benefit of treatment should be reevaluated after 2-3 months of use.

Always consult your doctor if you are thinking of stopping treatment.

If you take more Urotrol than you should

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

In case of overdose or accidental ingestion, go to the nearest hospital or consult the Toxicology Information Service, phone 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 follow the normal dosing schedule, as indicated by your doctor.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

The following side 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 intestine, vomiting
• dry skin
• difficulty urinating, inability to empty the bladder
• fatigue, chest pain, swelling due to fluid accumulation (e.g., in the ankles)
• weight gain
• diarrhea

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

• allergic reactions
• nervousness
• increased heart rate, heart failure, which can manifest with symptoms such as: chest pain, difficulty breathing, or fatigue (even at rest), difficulty breathing at night, swelling of the legs, and irregular heartbeat
• heartburn
• memory impairment

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Urotrol

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

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Urotrol

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

The other ingredients are:

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

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

Appearance of the product and package contents

Urotrol 2 mg tablets are white, round, biconvex, and have 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

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 the last revision of this package leaflet: December 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/