UROTROL NEO 4 mg PROLONGED-RELEASE HARD CAPSULES

2. What you need to know before taking Urotrol Neo

Do not take Urotrol Neo if

• You are allergic (hypersensitive) to tolterodine or 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 loss of vision, 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 Urotrol Neo 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 heart rhythm)
• heart failure

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

Other medications and Urotrol Neo

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

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

The use of tolterodine in combination with the following medications is not recommended:

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

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

• certain medications that affect food transit (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 Urotrol Neo (antimuscarinic properties) or medications that have an opposite mechanism of action to Urotrol Neo (cholinergic properties). Consult your doctor if you are unsure.

Taking Urotrol Neo with food and drinks

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

Pregnancy and Breastfeeding

Pregnancy

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

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

Urotrol Neo contains sucrose (a type of sugar)

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Urotrol Neo

Dose

Follow the instructions for taking Urotrol Neo exactly as your doctor has indicated. 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 Urotrol Neo is not recommended in children.

Urotrol 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 Urotrol 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 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.

If you take more Urotrol 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 Urotrol 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. In this case, continue taking the capsules as your doctor has indicated.

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

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

4. Possible side effects

Like all medications, this medication can cause 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
• 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 1000 patients).

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

• Chest pain, difficulty breathing, or fatigue (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 1000 patients).

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

The very commonside effects that may affect more than 1 in 10 people are:

• Dry mouth

The commonside effects that may affect at least 1 in 100 people are:

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

The uncommonside effects that may affect at least 1 in 1000 people are:

• Allergic reactions
• Nervousness
• Finger or toe paresthesia
• Vertigo
• Palpitations, heart failure, irregular heartbeat
• Inability to empty the bladder
• Chest pain
• Memory impairment

Additional reported reactions include severe allergic reactions, confusion, hallucinations, increased heart rate, skin redness, stomach burning, vomiting, angioedema, and dry skin and disorientation. There have been reports of worsening dementia symptoms in patients being treated for dementia.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: https://www.notificaram.es.

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

5. Storage of Urotrol Neo

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

Do not use this medication after the expiration date shown on the packaging after CAD. 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Urotrol Neo

The active ingredient in Urotrol 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 other components are:

Capsule contents: sugar granules (containing sucrose and cornstarch) [see section 2. Urotrol 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

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

The Urotrol Neo 4 mg capsules are blue and have a symbol and a "4" printed in white.

Urotrol Neo is available in the following package sizes:

Blister packs:

• 7 prolonged-release capsules
• 14 prolonged-release capsules
• 28 prolonged-release capsules
• 49 prolonged-release capsules
• 84 prolonged-release capsules
• 98 prolonged-release capsules
• 280 prolonged-release capsules

Bottles: containing 30, 90, and 100 capsules.

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

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Almirall, S.A.

General Mitre, 151

08022 - Barcelona

Spain

Manufacturer

Pfizer Italia, S.r.l.

Località Marino del Tronto

63100 Ascoli Piceno, Italy

This medication is authorized in the member states of the European Economic Area under the following names:

Protol SR: Sweden

Urotrol Neo: Spain

Date of the last revision of this leaflet: December 2022

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