Package Insert: Information for the User

Urotrol Neo 4 mg Extended-Release Hard Capsules

Tolterodine Tartrate

Read this package insert carefully before taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed only for you, 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 package insert. See section 4.

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

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

Do not take Urotrol Neo if

• You are allergic (hypersensitive) to tolterodina or to 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 visual field, 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 Urotrol 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)
• Slow 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 medications and Urotrol Neo

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

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

Tolterodina should not be used in combination with:

• Some antibiotics (containing e.g. erythromycin and clarithromycin).
• Medications used to treat fungal infections (containing e.g. ketoconazole and itraconazole).
• Medications for HIV treatment.

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

• Some medications that affect food transit (containing e.g. metoclopramide and cisapride).
• Medications for irregular heart rhythm (containing e.g. amiodarone, sotalol, quinidine, and procainamide).
• Other medications with a similar mode of action to Urotrol Neo (antimuscarinic properties) or medications with an opposite mode of action to Urotrol Neo (cholinergic properties). Consult your doctor if 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 or think you may be pregnant or if you are planning to become pregnant.

Breastfeeding

The excretion of tolterodina in breast milk is unknown. Urotrol Neo is not recommended during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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 saccharose (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.

Dose

Follow exactly the administration instructions for Urotrol 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.

Urotrol Neo is not recommended for use in children.

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

Treatment Duration

Your doctor will tell you the duration of your treatment with Urotrol Neo. Do not stop treatment unless you observe an immediate effect, as your bladder needs time to adapt to it. Finish 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.

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 Toxicological Information Service, Tel. 91 562 04 20.

If you forgot 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 until the next 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 doses.

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

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

You must 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, inflammation of the legs.

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 Urotrol Neo with the following frequencies.

The side effectsvery frequentthat may affect more than 1 in 10 people are:

• Dry mouth

The side effectscommonthat may affect at least 1 in 100 people are:

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

The side effectsinfrequentthat may affect at least 1 in 1,000 people are:

• 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 dry skin and disorientation. Cases of worsening of dementia symptoms in patients being treated for dementia have been reported.

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 of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

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

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 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 packaging.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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 corresponding to 2.74 mg of tolterodine

The other components are:

Caplet content: 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: 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

Urotrol Neo are prolonged-release capsules designed for the administration of one capsule per day.

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

There are also available clinical packs containing 80, 160 and 320 capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Almirall, S.A.

General Mitre, 151

08022 - Barcelona

Spain

Responsible manufacturer

Pfizer Italia, S.r.l.

Marino del Tronto

63100 Ascoli Piceno.Italy

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Protol SR: Sweden

Urotrol Neo: Spain

Last review date of this leaflet: December 2022

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.gob.es/