DETRUSITOL NEO 4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Detrusitol Neo 4 mg, prolonged-release hard capsules

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

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

The active substance in Detrusitol Neo is tolterodine. Tolterodine is a medication that belongs to the group of medications called antimuscarinics.

Detrusitol Neo 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 that you urinate more frequently during the day.

2. What you need to know before taking Detrusitol Neo

Do not take Detrusitol Neo if:

• You are allergic (hypersensitive) to tolterodine or any of the other components of Detrusitol Neo (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 visual field, 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 Detrusitol Neo if you think any of the following 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 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 Detrusitol Neo

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

Tolterodine, the active substance in Detrusitol Neo, may interact with other medications.

The use of tolterodine is not recommended in combination with:

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

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

• certain medications that affect food passage (e.g., metoclopramide and cisapride).
• medications for the treatment of irregular heart rhythm (e.g., amiodarone, sotalol, quinidine, and procainamide).
• other medications that have a similar mechanism of action to Detrusitol Neo (antimuscarinic properties) or medications that have an opposite mechanism of action to Detrusitol Neo (cholinergic properties). Consult your doctor if you are 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, think you may be pregnant, or are planning to become pregnant.

Breastfeeding

It is unknown whether tolterodine is excreted in breast milk. The use of Detrusitol Neo is not recommended during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and Using Machines

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

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

3. How to Take Detrusitol Neo

Dose:

Follow your doctor's instructions for taking Detrusitol Neo exactly. 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 bothersome side effects, in which case your doctor may reduce your dose to one 2 mg capsule per day.

The use of Detrusitol Neo is not recommended in children.

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

Duration of treatment:

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

Opening the Package

Detrusitol Neo may be packaged in blister packs or bottles.

If the package of your Detrusitol Neo is a bottle, to open it, press down on the seal 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 Toxicology Information Service, phone 91 562 04 20.

If You Forget to Take Detrusitol Neo

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.

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

4. Possible Side Effects

Like all medications, Detrusitol Neo can also have side effects, although not everyone 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 (less than 1 in 1,000 patients).

Tell your doctor or go to the emergency room 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 (less than 1 in 1,000 patients).

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

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

• Dry mouth

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

• Sinusitis
• Dizziness, somnolence, headache.
• Dry eyes, blurred vision.
• Difficulty digesting (dyspepsia), constipation, abdominal pain, excessive gas in the stomach or intestine.
• Difficulty or pain when urinating.
• Fatigue.
• Swelling due to fluid accumulation (e.g., in the ankles).
• Diarrhea.

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

• Allergic reactions.
• Nervousness.
• Ingrown toenails in the fingers and toes.
• Vertigo.
• Palpitations, heart failure, irregular heartbeat.
• Inability to empty the bladder.
• Chest pain.
• Memory impairment.

Additional reactions reported include severe allergic reactions, confusion, hallucinations, increased heart rate, red skin, stomach burning, vomiting, angioedema, and dry skin and disorientation. There have been reports of worsening dementia symptoms 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 effect not listed in this package leaflet, tell your doctor or pharmacist.

Reporting 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 Medication Monitoring System for Human Use: www.notificaram.es.

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

5. Storage of Detrusitol Neo

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

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

Do not store above 25°C.

Blister pack: Keep the blister pack in the outer carton.

Bottles: Keep in the original package.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in your usual pharmacy. Ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Detrusitol Neo

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

The excipients are:

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

Capsule: gelatin and colorants.

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

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

Appearance of the Product and Package Contents

Detrusitol Neo is a prolonged-release capsule designed for once-daily administration.

The Detrusitol Neo 4 mg capsules are blue 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.

Clinical packages containing 80, 160, and 320 capsules are available.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Farmasierra Laboratorios, S.L.

Carretera de Inún, km. 26,200

28709 San Sebastian de los Reyes (Madrid)

Spain

Manufacturer:

Pfizer Italia, S.r.l.

63100 Marino del Tronto.

Ascoli Piceno. Italy

This medication is authorized in the Member States of the European Economic Area under 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 package leaflet was approved in December 2022