Package Insert: Information for the Patient

Detrusitol 2 mg Film-Coated Tablets

(Tolterodine Tartrate)

Read this package insert carefully before starting to take the medication

− Keep this package insert, 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 and should not be given to others, even if they have the same symptoms, as it may harm them.

− If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Detrusitol and what it is used for.

2. What you need to know before taking Detrusitol.

3. How to take Detrusitol.

4. Possible adverse effects.

5. Storage of Detrusitol.

6. Contents of the package and additional information

The active ingredient of Detrusitol is tolterodina. Tolterodina is a drug that belongs to the group of medications known as antimuscarinics.

Detrusitol is used for the treatment of 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 you increase the number of times you urinate during the day.

Do not take Detrusitol if:

• You are allergic (hypersensitive) to tolterodina or to any of the other components of Detrusitol (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, not being adequately treated).
• 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 Detrusitol if you think any of these situations may apply to you:

• If you have difficulty urinating and/or weak or slow urine flow.
• 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 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 (decreased gastrointestinal motility).
• 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 levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia) in your blood.

Other medicines and Detrusitol:

Inform your doctor if you are taking or have taken recently or may have to take any other medicine.

Tolterodina, the active ingredient in Detrusitol, may interact with other medicines.

Tolterodina should not be used in combination with:

• Some antibiotics (containing, for example, erythromycin and clarithromycin).
• Medicines used to treat fungal infections (containing, for example, ketoconazole and itraconazole).
• Medicines for the treatment of HIV.

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

• Some medicines that affect food transit (containing, for example, metoclopramide and cisapride).
• Medicines for the treatment of irregular heart rhythm (containing, for example, amiodarone, sotalol, quinidine, and procainamide).
• Other medicines that have a similar mode of action to Detrusitol Neo (antimuscarinic properties) or medicines that have an opposite mode of action to Detrusitol Neo (cholinergic properties). Consult your doctor if you are unsure.

Take 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 if you are planning to become pregnant.

Breastfeeding

The excretion of tolterodina in breast milk is unknown. Detrusitol is not recommended during breastfeeding. Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery:

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

Detrusitol contains sodium

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

Dose:

Follow exactly the administration instructions for Detrusitol 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 bothersome side effects, in which case your doctor may reduce your dose to one 1 mg tablet twice a day.

Detrusitol is not recommended for use in children.

Detrusitol is taken orally. Tablets should be swallowed whole.

Treatment Duration:

Your doctor will indicate the duration of your treatment with Detrusitol. Do not stop treatment unless you observe an immediate effect, as your bladder needs time to adapt. Complete 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 Toxicological Information Service, Tel. 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 until the next scheduled dose and take it at the usual time. In this case, continue taking the tablets as directed by your doctor.

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

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

Like all medicines, this medicine may also have side effects, although not everyone will experience them.

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

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

You should also seek medical attention if you experience an allergic reaction (for example: itching, rash, urticaria, and difficulty breathing). This occurs infrequently (less than 1 in 1,000 patients).

Inform your doctor or go to the emergency service if you experience:

• Chest pain, difficulty breathing, or fatigue (even at rest), difficulty breathing at night, leg inflammation.

These may be symptoms of heart failure. This occurs infrequently (less than 1 in 1,000 patients).

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

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

• Dry mouth
• Headache

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

• Bronchitis
• Dizziness, drowsiness, muscle cramps in the hands and feet
• Dry eyes, blurred vision
• Dizziness
• Palpitations
• Difficulty digesting (dyspepsia), constipation, abdominal pain, excessive gas or air 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 up to 1 in 100 people):

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

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effects not mentioned in this prospectus, inform your doctor or pharmacist

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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Keep Detrusitol out of the sight and reach of children.

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

No special storage conditions are required

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Detrusitol Composition

The active ingredient in Detrusitol 2 mg tablets is tolterodine.

Each tablet contains 2 mg of tolterodine tartrate corresponding to 1.37 mg of tolterodine.

The excipients are:

Core: microcrystalline cellulose, dihydrate calcium hydrogen phosphate, sodium 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).

Product Appearance and Packaging Content

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

The sizes of packaging 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 packaging sizes may be marketed

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder:

Farmasierra Laboratorios, S.L.

Carretera de Inún, km. 26,200

28700 San Sebastian de los Reyes (Madrid)

Responsible manufacturer:

Pfizer Italia, S.r.l.

63100 Marino del Tronto.

Ascoli Piceno. Italy

This medicinal product is authorized in the member states of the European Economic Area under the following names:Austria, Belgium and Luxembourg, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom.

Last review date of this leaflet: February 2021

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/