Patient Information Leaflet: Detrusitol Neo 4 mg, prolonged-release hard capsules

(Tolterodine tartrate)

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

• Keep this leaflet, as you may need to read it again.
• If you are unsure about anything, 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, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Detrusitol Neo.

3. How to take Detrusitol Neo.

4. Possible side effects.

5. Storage of Detrusitol Neo.

6. Contents of the pack and additional information

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

Detrusitol Neo 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 that you increase the number of times you urinate during the day.

Do not take Detrusitol Neo if

• You are allergic (hypersensitive) to tolterodina or to any of the other components of Detrusitol Neo (listed in section 6).
• You are unable to urinate from the 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 Neo 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 blood levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia).

Other medicines and Detrusitol Neo:

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 Neo, may interact with other medicines.

Tolterodina should not be used in combination with:

• Some 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.

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

• Some medicines that affect 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 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 unsure.

Take Detrusitol Neo with food and drinks.

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

Pregnancy and Breastfeeding

Pregnancy

You should not use Detrusitol Neo 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 Neo is not recommended during breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery:

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

Detrusitol Neo contains saccharose (a type of sugar).If your doctor has informed you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Dosage :

Follow exactly the administration instructions for Detrusitol Neo that your doctor has prescribed. Consult your doctor or pharmacist if you have any doubts.

The recommended dose is one 4 mg capsule per 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 2 mg capsule per day.

Detrusitol Neo is not recommended for use in children.

Detrusitol Neo is taken orally. The capsules should be swallowed whole. Do not chew the capsules.

Treatment Duration:

Your doctor will inform you of the duration of your treatment with Detrusitol Neo. Do not stop treatment unless you observe an immediate effect, as your bladder needs time to adapt to it. Complete the treatment with the prescribed prolonged-release capsules. 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.

Opening the Packaging:

Detrusitol Neo may be packaged in blisters or bottles.

If the packaging of your Detrusitol Neo is a bottle, to open it, press down on the sealing ring. Then, press down on the cap and, while keeping it pressed, turn it counterclockwise.

If you take more Detrusitol Neo than you should:

If you or anyone else takes too many prolonged-release capsules, 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 Neo:

If you forget to take a dose, take it as soon as you remember. 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 capsules as your doctor has instructed.

Do not take a double dose to make up for the missed dose. If you have any additional questions about the use of this medication, consult your doctor or pharmacist.

Like all medications, Detrusitol Neo 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 with low frequency (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 with low frequency (less than 1 in 1,000 patients).

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

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

• Dry mouth

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

• Sinusitis
• Dizziness, drowsiness, headache.
• Dry eyes, blurred vision.
• Difficulty digesting (dyspepsia), constipation, abdominal pain, excessive amount of air or gas in the stomach or intestines.
• Pain or difficulty urinating.
• Fatigue.
• Swelling due to fluid accumulation (e.g., in the ankles).
• Diarrhea.

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

• Allergic reactions.
• Nervousness.
• Tingling in the fingers of the hands and feet.
• Dizziness.
• Palpitations, heart failure, irregular heartbeat.
• Inability to empty the bladder.
• Chest pain.
• Memory alteration.

Additional reported reactions include severe allergic reactions, confusion, hallucinations, increased heart rate, red skin, stomach burning, vomiting, angioedema, and skin dryness 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 effect not described 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 that does not appear 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 medication.

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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. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Blister: Keep the blister in the outer carton.

Bottles: Keep in the original container.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

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Composition of Detrusitol Neo

The active ingredient in Detrusitol Neo 4 mg, prolonged-release capsules is tolterodine. Each capsule contains 4 mg of tolterodine tartrate corresponding to 2.74 mg of tolterodine.

The excipients are:

Capule content: sugar granules (containing saccharose and cornstarch) [See section 2. Detrusitol Neo contains saccharose (a type of sugar)], hypromellose, surelease E-7-19040 transparent (containing ethylcellulose, medium-chain triglycerides, oleic acid).

Capsule: gelatin and colorants.

Colorants: indigo carmine (E132) and titanium dioxide (E171)

Printing ink: Shellac lacquer (E904), titanium dioxide (E171), propylene glycol (E1520) and simethicone.

Appearance of the product and contents of the package

Detrusitol Neo are prolonged-release capsules designed for daily administration of one capsule.

Detrusitol Neo 4 mg capsules are blue in color and have a symbol and a “4” printed in white.

Detrusitol Neo is available in the following package sizes:

Blister packs:

7 prolonged-release capsules (1 strip of 7)

14 prolonged-release capsules (2 strips of 7)

28 prolonged-release capsules (4 strips of 7)

49 prolonged-release capsules (7 strips of 7)

84 prolonged-release capsules (12 strips of 7)

98 prolonged-release capsules (14 strips of 7)

280 prolonged-release capsules (40 strips of 7)

Bottles: containing 30, 90 and 100 capsules.

They are available in clinical packs containing 80, 160 and 320 capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer:

Marketing authorization holder:

Farmasierra Laboratorios, S.L.

Carretera de Inún, km. 26,200

28709 San Sebastian de los Reyes (Madrid)

Spain

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 with the following names:

Detrusitol Retard in: Austria, Belgium, Luxembourg, Denmark, Germany, Iceland, Italy and Portugal.

Detrusitol SR in: Finland, Greece, Ireland, Netherlands, Norway and Sweden Detrusitol LP in: France Detrusitol Neo in: Spain

Detrusitol XL in: United Kingdom

This leaflet was approved in December 2022