Prospecto: Information for the User

Tolterodina Neo Aurovitas 4mg prolonged-release hard capsules EFG

Tolterodine tartrate

Read this prospectus carefully before starting to take this medication, as it contains important information for you.

-Keep this prospectus, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed to you, and you should not give it to other people who have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

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

2.What you need to know before starting to take Tolterodine Neo Aurovitas

3.How to take Tolterodine Neo Aurovitas

4.Possible adverse effects

5Storage of Tolterodine Neo Aurovitas

6.Contents of the package and additional information

The active ingredient in Tolterodina NeoAurovitasis tolterodina. Tolterodina belongs to a group of medicines called antimuscarinics.

Tolterodina 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.

Do not takeTolterodina NeoAurovitas

•ifyou are allergic to tolterodina or any of the other ingredients in this medicine (listed in section 6).

•ifyou are unable to urinate from the bladder (urinary retention).

•ifyou have uncontrolled narrow-angle glaucoma (high intraocular pressure with loss of vision that is not being adequately treated).

•ifyou have myasthenia gravis (excessive weakness in the muscles).

•ifyou have severe ulcerative colitis (ulceration and inflammation in the colon).

•ifyou have toxic megacolon (acute dilation of the colon).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tolterodina Neo Aurovitas if:

•you experience difficulties with urination and/or weak or slow urine flow.

•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 disorders of the nervous system that affect your blood pressure, intestinal function, or sex (any autonomic nervous system neuropathy).

•you have hiatal hernia (hernia in an abdominal organ).

•you experience a decrease in intestinal movement or have severe constipation (decreased gastrointestinal motility).

•you have heart disease, such as:

-altered heart rhythm (ECG).

-slow heart rate (bradycardia).

-pre-existing heart conditions such as: cardiomyopathy (heart muscle weakness), myocardial ischemia (decreased blood flow to the heart), arrhythmia (altered heart rhythm), heart failure.

•you have abnormally low levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia) in your blood.

Use of Tolterodina Neo Aurovitas with other medicines

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

Tolterodina, the active ingredient in Tolterodina Neo Aurovitas, may interact with other medicines.

Tolterodina should not be used in combination with:

•some antibiotics (containing, for example: erythromycin and clarithromycin).

•medicines used to treat fungal infections (containing, for example: ketoconazole and itraconazole).

•medicines for the treatment of HIV.

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

•some medicines that affect the passage of food (containing, for example: metoclopramide and cisapride).

•medicines for the treatment of irregular heart rhythm (containing, for example: amiodarone, sotalol, quinidine, and procainamide).

•other medicines that have a similar mode of action to tolterodina (antimuscarinic properties) or medicines that have an opposite mode of action to tolterodina (cholinergic properties). Consult your doctor if you are unsure.

Taking Tolterodina Neo Aurovitas with food, drinks, and alcohol

Tolterodina 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 medicine.

Pregnancy

You should not use tolterodina if you are pregnant. Inform your doctor immediately if you are pregnant, think you may be pregnant, or have plans to become pregnant.

Breastfeeding

The excretion of tolterodina, the active ingredient in Tolterodina Neo Aurovitas, in breast milk is unknown. It is not recommended to use tolterodina during breastfeeding.

Driving and operating machinery

Tolterodina 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 Aurovitas contains lactose

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

This medicine contains less than 1 mmol of sodium (23 mg) per 4 mg capsule; it is essentially "sodium-free".

Dose :

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

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

Do not chew the capsules.

Adults:

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

Patients with liver or kidney problems:

Your doctor may reduce the dose to 2 mg of tolterodina per day in patients with liver or kidney problems.

Use in children and adolescents:

Tolterodina is not recommended for use in children.

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

If you forgot to take Tolterodina Neo Aurovitas

If you forgot 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 regular schedule.

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

If you interrupt the treatment with Tolterodina Neo Aurovitas

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

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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

You must 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.

In addition, you must seek medical attention if you experience an allergic reaction (for example: itching, rash, hives, and difficulty breathing). This occurs infrequently (affects up to 1 in 100 people).

Inform your doctorimmediatelyor go to the emergency service if you experience:

•Chest pain, difficulty breathing or fatigue (even at rest), difficulty breathing at night, inflammation of the legs.

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

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

Frequent 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 amount of air or gas in the stomach or intestines.

•Pain or difficulty urinating.

•Fatigue.

•Swelling due to fluid accumulation (e.g. in the ankles).

•Diarrhea.

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

•Allergic reactions.

•Nervousness.

•Palpitations, heart failure, irregular heartbeat.

•Inability to empty the bladder.

•Sensation of tingling in the fingers of the hands and feet.

•Dizziness.

•Chest pain.

•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: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.

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

Composition ofTolterodina NeoAurovitas

-The active ingredient ofTolterodina NeoAurovitas 4mg prolonged-release hard capsules is 4 mg of tolterodina tartrate, equivalent to 2.74 mg of tolterodina.

-The other components are: lactose monohydrate, microcrystalline cellulose, polyvinyl acetate, povidone, silica, sodium lauryl sulfate, sodium docusate, magnesium stearate, hydroxypropyl methylcellulose.Composition of the capsule: indigo carmine (E132), titanium dioxide (E171) and gelatin.Composition of the internal tablet coating: ethylcellulose, triethyl citrate, copolymer of methacrylic acid-ethyl acrylate, 1,2-propylene glycol.

Appearance of the product and contents of the package

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

The prolonged-release hard capsules of Tolterodina Neo Aurovitas 4 mg are ofblueclear light blue color.

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

PVC 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 prolonged-release hard capsules.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible for manufacturing

Pharmathen S.A.

6, Dervenakion Str.,

153 51 Pallini Attiki

Greece

Or

Pharmathen International S.A.

Sapes Industrial Park

Block 5, 69300 Rodopi

Greece

Last review date of this leaflet:September 2018

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