DETRUSITOL 2 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Detrusitol 2 mg Film-Coated Tablets

(Tolterodine Tartrate)

Read the entire package leaflet carefully before starting to take the medicine

• Keep this package leaflet, as 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. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What Detrusitol is and what it is used for

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

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

• you are not able to control your urine voluntarily.
• you feel a sudden and urgent need to urinate without prior warning and/or that you urinate more frequently during the day.

2. What you need to know before taking Detrusitol

Do not take Detrusitol if:

• You are allergic (hypersensitive) to tolterodine or any of the other ingredients of Detrusitol (listed in section 6).
• You are not able to empty your bladder (urinary retention).
• You have uncontrolled narrow-angle glaucoma (high intraocular pressure with loss of visual field, which is not being treated properly).
• You have myasthenia gravis (excessive weakness in the muscles).
• 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 Detrusitol 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/or 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 ever notice 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 (irregular heartbeat)
• heart failure

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

Other medicines and Detrusitol:

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

Tolterodine, the active substance of Detrusitol, may interact with other medicines.

It is not recommended to use tolterodine in combination with:

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

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

• certain medicines that affect food transit (e.g., metoclopramide and cisapride).
• medicines for the treatment of irregular heartbeat (e.g., amiodarone, sotalol, quinidine, and procainamide).
• other medicines that have a similar mode of action to Detrusitol (antimuscarinic properties) or medicines that have an opposite mode of action to Detrusitol (cholinergic properties). Consult your doctor if you are unsure.

Taking Detrusitol with food and drinks.

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

Pregnancy and Breastfeeding

Pregnancy

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

Breastfeeding

It is not known if tolterodine is excreted in breast milk. The use of Detrusitol is not recommended during breastfeeding. Consult your doctor or pharmacist before using any medicine.

Driving and using machines:

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

Detrusitol contains sodium

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

3. How to take DETRUSITOL

Dose:

Follow your doctor's instructions for taking Detrusitol exactly.

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 bothersome side effects, in which case your doctor may reduce your dose to one 1 mg tablet twice a day.

The use of Detrusitol is not recommended in children.

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

Duration of treatment:

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

If you forget to take a dose, take it as soon as you can. However, if it is almost time for your next dose, wait for the next dose and take it at the usual time. In this case, continue taking the tablets as your doctor has indicated.

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should consult your doctor immediately if you notice symptoms of angioedema, such as:

• Swelling of the face, tongue, or pharynx.
• Difficulty swallowing.
• Hives and difficulty breathing.

In addition, you should seek medical attention if you experience a hypersensitivity reaction (e.g., itching, rash, hives, and difficulty breathing). This occurs rarely (in at least 1 in 1,000 patients).

Tell your doctor or go to the emergency department if you experience:

• Chest pain, difficulty breathing, or tiredness (even at rest), difficulty breathing at night, swelling of the legs.

These may be symptoms of heart failure. This occurs rarely (in at least 1 in 1,000 patients).

The following side effects have been observed during treatment with Detrusitol with the following frequencies.

Very common(may affect more than 1 in 10 people):

• Dry mouth
• Headache

Common(may affect up to 1 in 10 people):

• Bronchitis
• Dizziness, drowsiness, finger cramps, or toe cramps
• Dry eyes, blurred vision
• Vertigo
• Palpitations
• Difficulty digesting (dyspepsia), constipation, abdominal pain, excessive air or gas in the stomach or intestine, vomiting
• Dry skin
• Difficulty urinating, inability to empty the bladder.
• Tiredness, chest pain, swelling due to fluid accumulation (e.g., in the ankles)
• Weight gain
• Diarrhea

Uncommon(may affect up to 1 in 100 people):

• Allergic reactions
• Nervousness
• Increased heart rate, heart failure, irregular heartbeat.
• Heartburn
• Memory impairment

Additional reactions reported include severe allergic reactions, confusion, hallucinations, red skin, and angioedema, and disorientation. Cases of worsening dementia symptoms have been reported in patients being treated for dementia.

If you think any of the side effects you are experiencing is serious or if you notice any side effects not listed in this package leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

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5. Storage of DETRUSITOL

Keep Detrusitol out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton. The expiry date is the last day of the month stated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Further information

Composition of Detrusitol

The active substance in Detrusitol 2 mg tablets is tolterodine.

Each tablet contains 2 mg of tolterodine tartrate, which corresponds to 1.37 mg of tolterodine.

The excipients are:

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

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

Appearance of the product and pack contents

Detrusitol 2 mg tablets are white, round, biconvex, and have arcs above and below the letters "DT".

The pack sizes in which Detrusitol is available are:

Blister packs:

20 tablets (2 strips of 10)

30 tablets (3 strips of 10)

50 tablets (5 strips of 10)

100 tablets (10 strips of 10)

14 tablets (1 strip of 14)

28 tablets (2 strips of 14)

56 tablets (4 strips of 14)

280 tablets

560 tablets

Bottles: containing 60 or 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Farmasierra Laboratorios, S.L.

Carretera de Inún, km. 26,200

28700 San Sebastian de los Reyes (Madrid)

Manufacturer:

Pfizer Italia, S.r.l.

63100 Marino del Tronto.

Ascoli Piceno. Italy

This medicine is authorized with the name Detrusitol in the member states of the European Economic Area:Austria, Belgium and Luxembourg, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom.

Date of the last revision of this package leaflet: February 2021

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