Urotrol Neo 4 mg prolonged-release hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Urotrol Neo 4 mg prolonged-release hard capsules

tartrate of tolterodine

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

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

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

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Urotrol Neo is and what it is used for.
2. What you need to know before taking Urotrol Neo.
3. How to take Urotrol Neo.
4. Possible side effects.
5. How to store Urotrol Neo.
6. Contents of the pack and other information

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

The active substance in Urotrol Neo is tolterodine. Tolterodine is a medicine that belongs to a group of medicines called antimuscarinics.

Urotrol 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 voluntarily control your urine
• you experience a sudden and urgent need to urinate without prior warning and/or an increased number of times you urinate during the day.

2. What you need to know before starting to take Urotrol Neo

Do not take Urotrol Neo if

• You are allergic (hypersensitive) to tolterodine or to any of the other components of this medicine (listed in section 6).
• You are unable to empty urine from the bladder (urinary retention).
• You have uncontrolled narrow-angle glaucoma (high intraocular pressure with loss of visual field, which is not being adequately treated).
• You have myasthenia gravis (excessive muscle weakness).
• You have severe ulcerative colitis (ulceration and inflammation of 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 the following situations may apply to you.

• If you have difficulty passing urine and/or have a weak or slow urinary stream.

• If you have a gastrointestinal disorder affecting the passage and/or digestion of food.

• If you have kidney problems (renal failure).

• If you have liver disease.

• If you have neurological disorders affecting your blood pressure, intestinal or sexual function (any autonomic nervous system neuropathy).

• If you have a hiatal hernia (herniation of an abdominal organ).

• If you ever experience reduced intestinal movements or suffer from severe constipation (reduced gastrointestinal motility).

• If you have a significant heart condition such as:

• abnormal heart rhythm (ECG)

• slow heart rate (bradycardia)

• pre-existing heart diseases such as:

• cardiomyopathy (weakness of the heart muscle)

• myocardial ischemia (reduced 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 medicines and Urotrol Neo

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

Tolterodine, the active substance in Urotrol Neo, may interact with other medicines.

The use of tolterodine is not recommended in combination with:

• certain antibiotics (containing e.g.: erythromycin and clarithromycin).
• medicines used to treat fungal infections (containing e.g.: ketoconazole and itraconazole).
• medicines used to treat HIV.

Urotrol Neo should be used with caution when administered together with:

• certain medicines affecting food transit (containing e.g.: metoclopramide and cisapride).
• medicines used to treat irregular heart rhythm (containing e.g.: amiodarone, sotalol, quinidine, and procainamide).
• other medicines with a similar mode of action to Urotrol Neo (antimuscarinic properties) or medicines with an opposite mode of action to Urotrol Neo (cholinergic properties). Consult your doctor if you are unsure.

Taking Urotrol Neo with food and drinks

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

Pregnancy and Breast-feeding

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.

Breast-feeding

It is unknown whether tolterodine is excreted in breast milk. The use of Urotrol Neo is not recommended during breast-feeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Urotrol Neo may cause dizziness, tiredness, 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 informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Urotrol Neo

Dosage

Follow exactly the instructions for administration of Urotrol Neo given to you by your doctor. Consult your doctor or pharmacist if you have any doubts.

The recommended dose is one 4 mg capsule per day, except for patients with hepatic or renal disease, or those experiencing 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 must be swallowed whole. Do not chew the capsules.

Duration of treatment

Your doctor will determine the duration of your treatment with Urotrol Neo. Do not stop treatment prematurely 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 as prescribed by your doctor. If you do not notice any effect, consult your doctor.

The benefit of the treatment should be reevaluated after 2–3 months of use.

Always consult your doctor if you are considering discontinuing 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 contact the Toxicology Information Service at phone number 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 and take the next dose at the usual time. In this case, continue taking the capsules as directed by your doctor.

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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

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

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

• Chest pain, difficulty breathing, or fatigue (even at rest), nighttime shortness of breath, swelling of the legs.

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

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

Very common adverse effects, which may affect more than 1 in 10 people, are:

• Dry mouth

Common adverse effects, which may affect at least 1 in 100 people, are:

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

Uncommon adverse effects, which may affect at least 1 in 1,000 people, are:

• Allergic reactions
• Nervousness
• Tingling in the fingers and toes
• Dizziness
• Palpitations, heart failure, irregular heartbeat
• Inability to empty the bladder
• Chest pain
• Memory disturbance

Additional reported reactions include severe allergic reactions, confusion, hallucinations, increased heart rate, red skin, stomach burning, vomiting, angioedema, dry skin, and disorientation. Cases of worsening dementia symptoms have been reported in patients receiving treatment for dementia.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

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

5. Storage of Urotrol Neo

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

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

Bottles: Store in the original container.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Urotrol Neo

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

The other components are:

Capsule contents: sugar granules (containing sucrose and maize starch) [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 shell: 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 pack

Urotrol Neo consists of prolonged-release capsules designed for once-daily administration.

Urotrol Neo 4 mg capsules are blue in color and marked in white with a symbol and a "4".

Urotrol Neo is available in the following pack 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

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

Only some pack sizes may be commercially available.

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

or

Medis International A.S., Bolatice manufacturing plant

Prümyslová 961/16

747 23 Bolatice

Czech Republic

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

Protol SR: Sweden

Urotrol Neo: Spain

Date of the most recent review of this leaflet: December 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/