Label: information for the user

Urotrol 2 mg film-coated tablets

tolterodine tartrate

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

The active ingredient of Urotrol is tolterodine. Tolterodine is a drug that belongs to the group of medications known as antimuscarinics.

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

• You are unable to control your urine voluntarily.
• You feel a sudden and urgent need to urinate without prior warning and/or have to urinate more frequently than usual.

Do not take Urotrol if

• You are allergic (hypersensitive) to tolterodina or to any of the other components of this medication (listed in section 6).
• You are unable to urinate from the bladder (urinary retention).
• You have uncontrolled narrow-angle glaucoma (high intraocular pressure with vision loss, not being adequately treated).
• You have myasthenia gravis (excessive muscle weakness).
• You have severe ulcerative colitis (colon ulceration and inflammation).
• 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 or have a weak or slow urine 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 neurological disorders that affect your blood pressure, intestinal function, or sex (any autonomic nervous system neuropathy).
• If you have hiatal hernia (hernia in an abdominal organ).
• If you ever notice a decrease in intestinal movement or have severe constipation (gastrointestinal motility decrease).
• If you have a relevant heart disease such as:
• Abnormal heart rhythm (ECG)
• Slowed heart rate (bradycardia)
• Pre-existing heart diseases such as:
• • Cardiomyopathy (heart muscle weakness)
  • Myocardial ischemia (decreased blood flow to the heart)
  • Arrhythmia (alteration of heart rhythm)
  • Heart failure

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

Other medications and Urotrol

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

Tolterodina, the active ingredient in Urotrol, may interact with other medications.

Urotrol should not be used in combination with:

• Some antibiotics (containing, e.g., erythromycin and clarithromycin).
• Medications used to treat fungal infections (containing, e.g., ketoconazole and itraconazole).
• Medications for HIV treatment.

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

• Some medications that affect food transit (containing, e.g., metoclopramide and cisapride).
• Medications for irregular heart rhythm (containing, e.g., amiodarone, sotalol, quinidine, and procainamide).
• Other medications with a similar mode of action to Urotrol (antimuscarinic properties), medications with an opposite mode of action to Urotrol (cholinergic properties). Consult your doctor if 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 or think you may be pregnant or if you are planning to become pregnant.

Breastfeeding

The excretion of tolterodina, the active ingredient in Urotrol, in breast milk is unknown. Urotrol is not recommended during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Urotrol contains sodium

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

Dosage

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

The recommended dose is one 2 mg tablet twice a day, except in patients with liver or kidney disease, or in cases of 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.

Treatment Duration

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 tablets prescribed by your doctor. If, by then, you do not notice any effect, consult with 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 Toxicological Information Service, Tel. 91 562 04 20.

If you forgot 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 your next dose. In that case, omit the missed dose and follow the normal dosing schedule as indicated by your doctor.

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

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

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

• Dry mouth
• Headache

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

• Bronchitis
• Dizziness, drowsiness, sensation of tingling in the fingers of the hands and feet
• Dry eyes, blurred vision
• Dizziness
• Palpitations
• Difficulty digesting food (dyspepsia), constipation, abdominal pain, excessive amount of air or 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 accumulation (e.g., in the ankles)
• Weight gain
• Diarrhea

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

• Allergic reactions
• Nervousness
• Increased heart rate, heart failure that may manifest with symptoms such as: chest pain, difficulty breathing or fatigue (even at rest), difficulty breathing at night, leg inflammation, and irregular heartbeat
• Stomach burning
• Memory alteration

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

Reporting 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears 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 drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Urotrol

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

The other components are:

Core: microcrystalline cellulose, dihydrate calcium hydrogen phosphate, sodium glycolate starch (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 contents of the packaging

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

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Almirall, S.A.

General Mitre, 151

08022 - Barcelona

Responsible for manufacturing

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

Last review date of this leaflet: December 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/