TOLTERODINE NEO AUROVITAS 4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Tolterodine Neo Aurovitas 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, 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. See section 4.

Contents of the Package Leaflet

1. What Tolterodine Neo Aurovitas is and what it is used for
2. What you need to know before taking Tolterodine Neo Aurovitas
3. How to take Tolterodine Neo Aurovitas
4. Possible side effects

5 Storage of Tolterodine Neo Aurovitas

1. Package contents and additional information

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

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

Tolterodine 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 Aurovitas

Do not take Tolterodine Neo Aurovitas

• if you are allergic to tolterodine or any of the other ingredients 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 Tolterodine Neo Aurovitas if:

• you have difficulty urinating and/or urinate with a weak or slow stream.
• you have a gastrointestinal disorder that affects the passage and/or digestion of food.
• you have kidney problems (renal insufficiency).
• you have liver disease.
• you have neuronal disorders that affect your blood pressure, intestinal function, or sexual function (any autonomic nervous system neuropathy).
• you have a hiatal hernia (hernia in an abdominal organ).
• you have decreased intestinal motility or severe constipation.
• 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 (irregular heartbeat), heart failure.
• you have abnormally low blood levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia).

Using Tolterodine Neo Aurovitas with other medications

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

Tolterodine, the active substance in Tolterodine Neo Aurovitas, may interact with other medications.

The use of tolterodine in combination with the following is not recommended:

• certain antibiotics (containing, for example, erythromycin and clarithromycin).
• medications used to treat fungal infections (containing, for example, ketoconazole and itraconazole).
• medications for the treatment of HIV.

Tolterodine should be used with caution when administered in combination with:

• certain medications that affect food transit (containing, for example, metoclopramide and cisapride).
• medications for the treatment of irregular heartbeat (containing, for example, amiodarone, sotalol, quinidine, and procainamide).
• other medications that have a similar mode of action to tolterodine (antimuscarinic properties) or medications that have an opposite mode of action to tolterodine (cholinergic properties). Consult your doctor if you are unsure.

Taking Tolterodine Neo Aurovitas with food, drinks, and alcohol

Tolterodine can be taken before, during, or after a meal.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should not use tolterodine 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, the active substance in Tolterodine Neo Aurovitas, is excreted in breast milk. The use of tolterodine during breastfeeding is not recommended.

Driving and using machines

Tolterodine 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 Aurovitas 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 4 mg capsule; it is essentially "sodium-free".

3. How to take Tolterodine Neo Aurovitas

Dose:

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The prolonged-release hard capsules are taken orally and should be swallowed whole.

Do not chew the capsules.

Adults:

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

Patient with liver or kidney problems

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

Use in children and adolescents

The use of tolterodine is not recommended in children.

If you take more Tolterodine Neo Aurovitas 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 package and the package leaflet of the medication to the healthcare professional.

If you forget to take Tolterodine Neo Aurovitas

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 Aurovitas

Your doctor will indicate the duration of treatment with tolterodine. Do not stop treatment before because you do not see an immediate effect. Your bladder needs time to adapt to it. 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 reassessed 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 experiences them.

You should consult your doctor immediately or go to the emergency room 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 (for example, itching, rash, hives, and difficulty breathing). This occurs rarely (affects up to 1 in 100 people).

Tell your doctor immediately or go to the emergency room 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.
• Dizziness, drowsiness, headache.
• Dry eyes, blurred vision.
• Difficulty digesting (dyspepsia), constipation.
• Abdominal pain, excessive gas in the stomach or intestine.
• Pain or difficulty urinating.
• Fatigue.
• Swelling due to fluid accumulation (e.g., in the ankles).
• Diarrhea.

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

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

Additional reported reactions include severe allergic reactions, confusion, hallucinations, increased heart rate, red skin, stomach burning, vomiting, angioedema, and dry skin and disorientation. There have been reports of worsening dementia symptoms 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 Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Tolterodine Neo Aurovitas

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

Do not use this medication after the expiration date stated on the carton and blister after EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

HDPE bottle: the validity period after first opening is 200 days.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Tolterodine Neo Aurovitas

• The active substance in Tolterodine Neo Aurovitas 4 mg prolonged-release hard capsules is 4 mg of tolterodine tartrate, equivalent to 2.74 mg of tolterodine.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, polyvinyl acetate, povidone, silica, sodium lauryl sulfate, sodium docusate, magnesium stearate, hypromellose. Capsule composition: indigo carmine (E132), titanium dioxide (E171), and gelatin. Composition of the internal tablet coating: ethylcellulose, triethyl citrate, ethyl acrylate-methacrylic acid copolymer, 1,2-propylene glycol.

Appearance of the product and package contents

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

The 4 mg prolonged-release hard capsules of Tolterodine Neo Aurovitas are light blue opaque-light blue opaque.

Tolterodine Neo Aurovitas 4 mg prolonged-release hard capsules EFG are available in the following package sizes:

Blister packs with 7, 14, 28, 30, 49, 56, 60, 84, 98, and 100 prolonged-release hard capsules.

HDPE bottles with 30, 100, and 200 capsules

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

Pharmathen S.A.

6, Dervenakion Str.,

153 51 Pallini Attiki

Greece

Or

Pharmathen International S.A.

Sapes Industrial Park

Block 5, 69300 Rodopi

Greece

Date of the last revision of this package leaflet:September 2018

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).