Tolterodine Neo Normon 4 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tolterodine Neo Normon 4 mg prolonged-release hard capsules EFG

Tolterodine tartrate

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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents

1. What Tolterodine Neo Normon is and what it is 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. How to store Tolterodine Neo Normon
6. Contents of the pack and other information

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

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

This medicine 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 urination
• 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 Tolterodine Neo Normon

Do not take Tolterodine Neo Normon

• If you are allergic to tolterodine or to any of the other ingredients of this medicine (listed in section 6).
• If you are unable to empty urine from the bladder (urinary retention).
• If you have uncontrolled narrow-angle glaucoma (high intraocular pressure with loss of visual field, not adequately treated).
• If you have myasthenia gravis (excessive muscle weakness).
• If you have severe ulcerative colitis (ulceration and inflammation of the colon).
• If you have toxic megacolon (acute dilation of the colon).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• if you notice difficulty passing urine and/or 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 insufficiency).
• if you have liver disease.
• if you have neurological disorders affecting your blood pressure, intestinal or sexual function (any autonomic neuropathy).
• if you have hiatal hernia (hernia involving an abdominal organ).
• if you ever experience reduced intestinal movements or suffer from severe constipation (decreased gastrointestinal motility).
• if you have heart disease, such as:
  • abnormal heart rhythm (ECG changes)
  • slow heart rate (bradycardia),
  • pre-existing heart conditions such as: cardiomyopathy (weakened 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).

Talk to your doctor or pharmacist before starting treatment with this medicine if you think any of these conditions may apply to you.

Other medicines and Tolterodine Neo Normon

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

Tolterodine, the active substance in this medicine, may interact with other medicines.

The use of tolterodine is not recommended in combination with:

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

This medicine should be used with caution when administered together with:

• certain medicines affecting gastrointestinal transit (containing, for example: metoclopramide and cisapride).
• medicines used to treat irregular heart rhythm (containing, for example: amiodarone, sotalol, quinidine, and procainamide).
• other medicines with a similar mode of action to tolterodine (antimuscarinic properties) or medicines with an opposite mode of action to tolterodine (cholinergic properties). The reduction in gastric motility caused by antimuscarinic medicines may affect the absorption of other medicines. Consult your doctor if you are unsure.

Taking Tolterodine Neo Normon with food and drink

This medicine may be taken before, during, or after a meal.

Pregnancy and breastfeeding

Pregnancy

You must not use this medicine 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 human breast milk. The use of this medicine is not recommended during breastfeeding.

Talk to your doctor or pharmacist before using any medicine.

Driving and using machines

This medicine may cause dizziness, tiredness, or affect your vision. If you experience any of these symptoms, you must not drive or operate heavy machinery.

Tolterodine Neo Normon contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; thus, it is essentially “sodium-free”.

3. How to take Tolterodine Neo Normon

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

How to take your Tolterodine Neo Normon capsules:

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

Dosage:

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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

Symptoms of overdose include hallucinations, excitement, increased heart rate, pupil dilation, and inability to urinate or breathe normally.

If you forget to take Tolterodine Neo Normon

If you forget to take your 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 your regular schedule.

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

If you stop taking Tolterodine Neo Normon

Your doctor will advise you on the duration of treatment with Tolterodine Neo Normon. Do not stop treatment prematurely because you do not observe an immediate effect. Your bladder needs time to adapt to it. Complete the course of prolonged-release capsules as prescribed by your doctor. If you notice no effect, consult your doctor.

The benefit of treatment should be re-evaluated after 2–3 months of use. Always consult your doctor if you are considering discontinuing treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Some of these effects may be due to the underlying disease itself.

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
• urticaria and breathing difficulties

You should also seek medical attention if you experience a hypersensitivity reaction (for example: itching, rash, urticaria, and breathing difficulties). These occur infrequently (affecting up to 1 in 100 people).

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

• chest pain, breathing difficulties, or fatigue (even at rest), nighttime breathing difficulties, leg swelling.

These may be symptoms of heart failure. These occur infrequently (affecting up to 1 in 100 people).

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

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

• dry mouth

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

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

Uncommon adverse 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 of the hands and feet
• 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 they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tolterodine Neo Normon

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

Store below 25°C.

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.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other 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, colloidal anhydrous silica, hypromellose, sodium docusate, magnesium stearate, ethylcellulose, triethyl citrate, methacrylic acid-ethyl acrylate copolymer, propylene glycol.

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

Appearance of the medicine and contents of the pack

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

Each pack contains 28 capsules in blister packs 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 most recent review of this leaflet: February 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78266/P_78266.html