TOLTERODINE NEO NORMON 4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Tolterodine Neo Normon 4 mg prolonged-release hard capsules EFG

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 questions, 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.

Contents of the Package Leaflet

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

1. What is Tolterodine Neo Normon and what is it used for

The active substance in this medication is tolterodine. Tolterodine belongs to a group of medications called antimuscarinics.

This medication 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 Tolterodine Neo Normon

Do not take Tolterodine Neo Normon

• if you are allergic to tolterodine or any of the other components of this medication (listed in section 6).
• if you are unable to empty your bladder (urinary retention).
• if you have uncontrolled narrow-angle glaucoma (high intraocular pressure with loss of vision, which is not being treated properly).
• if you have myasthenia gravis (excessive muscle weakness).
• if you have severe ulcerative colitis (ulceration and inflammation in the colon).
• if you have toxic megacolon (acute dilation of the colon).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• 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 decreased intestinal motility or severe constipation (decreased gastrointestinal motility).
• if you have heart disease, such as:
• • altered cardiac recording (ECG)
  • slow heart rate (bradycardia),
  • pre-existing heart diseases such as cardiomyopathy (weakness of the heart muscle), 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).

Consult your doctor or pharmacist before starting treatment with this medication if you think any of these situations may apply to you.

Other medications and Tolterodine Neo Normon

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Tolterodine, the active substance in this medication, may interact with other medications.

The use of tolterodine in combination with the following 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.

This medication 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 tolterodine (antimuscarinic properties) or medications that have an opposite mechanism of action to tolterodine (cholinergic properties). The reduction in gastric motility caused by antimuscarinic medications may affect the absorption of other medications. Consult your doctor if you are unsure.

Taking Tolterodine Neo Normon with food and drinks

This medication can be taken before, during, or after a meal.

Pregnancy and breastfeeding

Pregnancy

Do not use this medication if you are pregnant. Inform your doctor immediately if you are pregnant, think you may be pregnant, or plan to become pregnant.

Breastfeeding

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

Consult your doctor or pharmacist before using any medication.

Driving and using machines

This medication may make you feel dizzy, tired, or affect your vision. If you experience any of these symptoms, do not drive or operate heavy machinery.

Tolterodine Neo Normon contains lactose and sodium

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

This medication contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free".

3. How to take Tolterodine Neo Normon

Follow the instructions for administration of this medication indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

How to take your Tolterodine Neo Normon capsule:

The prolonged-release hard capsules are taken orally and should be swallowed whole. Do not chew the capsules.

Dose:

Adults:

The usual dose is one 4 mg prolonged-release hard capsule per day.

Liver or kidney disease:

In patients with liver or kidney problems, the doctor may reduce the dose to 2 mg of tolterodine per day.

Use in children:

The use of Tolterodine Neo Normon is not recommended in children.

If you take more Tolterodine Neo Normon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to take the package and package leaflet of the medication to the healthcare professional.

The symptoms of an overdose include hallucinations, excitement, accelerated heart rate, dilated pupils, and inability to urinate or breathe normally.

If you forget to take Tolterodine Neo Normon

If you forget to take the dose at the usual time, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with the usual schedule.

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

If you stop taking Tolterodine Neo Normon

Your doctor will indicate the duration of treatment with Tolterodine Neo Normon. Do not stop treatment before because you do not see an immediate effect. Your bladder needs time to adapt to this medication. 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.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. Some of these effects may be due to the underlying disease.

You should consult your doctor immediately or go to the emergency department if you experience 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, urticaria, and difficulty breathing). This occurs rarely (affects up to 1 in 100 people).

Tell your doctor immediately 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 (affects up to 1 in 100 people).

The following side effects have been observed during treatment with tolterodine, with the following frequencies:

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

• dry mouth

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

• sinusitis
• drowsiness
• dry eyes
• difficulty digesting (dyspepsia)
• abdominal pain
• pain or difficulty urinating
• swelling due to fluid accumulation (e.g., in the ankles)
• dizziness
• headache
• blurred vision
• constipation
• excessive air or gas in the stomach or intestine
• diarrhea
• fatigue

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

• allergic reactions
• nervousness
• palpitations
• inability to empty the bladder
• vertigo
• heart failure
• irregular heartbeat
• chest pain
• tingling sensation in the fingers and toes
• 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. Cases of worsening dementia symptoms have been reported 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 package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tolterodine Neo Normon

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

Store below 25°C.

Do not use this medication after the expiration date shown on the package after "EXP". The expiration date is the last day of the month indicated.

The contents of the bottle should be used within 200 days after opening.

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 the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Tolterodine Neo Normon

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

The other components (excipients) of the tablets are: lactose monohydrate, microcrystalline cellulose, polyvinyl acetate, povidone, sodium lauryl sulfate, anhydrous colloidal silica, hypromellose, sodium docusate, magnesium stearate, ethylcellulose, triethyl citrate, methacrylic acid and ethyl acrylate copolymer, propylene glycol.

The other components (excipients) of the capsules are: carmine indigo (E132), titanium dioxide (E171), and gelatin

Appearance of the product and package contents

The 4 mg prolonged-release hard capsules are blue, opaque, size 1, hard gelatin capsules that contain four white, round, and biconvex coated tablets.

Each package contains 28 capsules in blisters or 28 capsules in bottles.

Marketing authorization holder

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

or

PHARMATHEN S.A.

6, Dervenakion Str. - 15351 Pallini Attikis (GREECE)

or

PHARMATHEN INTERNATIONAL

Sapes Industrial Park, Block 5- 69300 Rodopi (GREECE)

Date of the last revision of this package leaflet:February 2025

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/

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78266/P_78266.html