Patient Information Leaflet

Tolterodina Neo Normon 4 mg prolonged-release hard capsules EFG

Tolterodina,tartrate

Read this 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. Do 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 leaflet.

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

2.What you need to know before you start taking Tolterodina Neo Normon

3.How to take Tolterodina Neo Normon

4.Possible side effects

5.Storage of Tolterodina Neo Normon

6.Contents of the pack and additional information

The active ingredient in this medication is tolterodina. Tolterodina belongs to a group of medications called antimuscarinics.

This medication is used for the treatment of 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 Tolterodina Neo Normon

• If you are allergic to tolterodina or any of the other components of this medication (listed in section 6).
• If you are unable to urinate from the bladder (urinary retention).
• If you have uncontrolled narrow-angle glaucoma (high intraocular pressure with loss of visual field, not being adequately treated).
• If you have myasthenia gravis (excessive muscle weakness).
• If you have severe ulcerative colitis (colon ulceration and inflammation).
• 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 experience 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 experience a decrease in intestinal movement or have severe constipation (gastrointestinal motility decrease).
• If you have heart disease, such as:
• • Altered cardiac rhythm (ECG)
  • Slowed heart rate (bradycardia),
  • Pre-existing heart conditions 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.

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 Tolterodina Neo Normon

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

Tolterodina, the active ingredient in this medication, may interact with other medications.

Tolterodina should not be used in combination with:

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

This medication should be used with caution when administered in combination with:

• Some medications that affect food transit (e.g., metoclopramide and cisapride).
• Medications used to treat irregular heart rhythm (e.g., amiodarone, sotalol, quinidine, and procainamide).
• Other medications with a similar mode of action to tolterodina (antimuscarinic properties) or medications with an opposite mode of action to tolterodina (cholinergic properties). The reduction of gastric motility produced by antimuscarinic medications may affect the absorption of other medications. Consult your doctor if unsure.

Taking Tolterodina 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 intend to become pregnant.

Breastfeeding

The excretion of tolterodina in breast milk is unknown. Do not use this medication during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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.

Tolterodina Neo Normon contains lactose and sodium

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How to take your Tolterodina Neo Normon capsules:

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

Dose:

Adults:

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

Liver or kidney disease:

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

Use in children:

Tolterodina Neo Normon is not recommended for use in children.

If you take more Tolterodina 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 bring the packaging and the medication leaflet to the healthcare professional.

The symptoms of an overdose include hallucinations, excitement, rapid heartbeat, dilated pupils, and inability to urinate or breathe normally.

If you forget to take Tolterodina 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, omit the missed dose and continue with your usual schedule.

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

If you interrupt treatment with Tolterodina Neo Normon:

Your doctor will indicate the duration of treatment with Tolterodina Neo Normon. Do not interrupt treatment because you do not observe an immediate effect. Your bladder needs time to adapt to this.

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

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

You should consult your doctor immediately or go to the emergency service if you experience 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 an allergic reaction (for example: itching, rash, hives, and difficulty breathing). This occurs with low frequency (affects up to 1 in 100 people).

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

• chest pain, difficulty breathing, or fatigue (even at rest), difficulty breathing at night, leg inflammation.

These may be symptoms of heart failure. This occurs with low frequency (affects up to 1 in 100 people).

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

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

• dry mouth

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

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

Side effectsinfrequent(may affect up to 1 in 100 people):

• allergic reactions
• anxiety
• palpitations
• inability to empty the bladder
• dizziness
• heart failure
• irregular heartbeat
• chest pain
• sensation of tingling in the fingers of the hands and feet
• 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 for 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.

Store below 25°C.

Do not use this medicationafter the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

The contents of the bottle must be used, once opened, within 200 days.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Tolterodina Neo Normon

The active ingredient 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, cellulose microcrystalline, polyvinyl acetate, povidone, sodium lauryl sulfate, anhydrous colloidal silica, hypromellose, sodium docusate, magnesium stearate, ethylcellulose, triethyl citrate, copolymer of methacrylic acid and ethyl acrylate, propylene glycol.

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

Appearance of the product and content of the container

The hard prolonged-release capsules of 4 mg are hard gelatin capsules of bright blue opaque color, size 1, containing four white, round, and biconvex coated tablets.

Each container contains 28 capsules in blister pack or28capsules in bottles.

Marketing Authorization Holder

LABORATORIOS NORMON, S.A.

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

Responsible for manufacturing

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)

Last review date of this leaflet:February 2025

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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