Prospect: Information for the user

Tolterodina Neo STADA 4 mg prolonged-release hard capsules EFG

Tolterodine tartrate

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospect, inform your doctor or pharmacist.

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

2.Before taking Tolterodina Neo STADA

3.How to take Tolterodina Neo STADA

4.Possible adverse effects

5Storage of Tolterodina Neo STADA

6.Additional information

The active ingredient in Tolterodina Neo Stada is tolterodina. Tolterodina belongs to a group of medicines called antimuscarinics.

Tolterodina 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 urinate more frequently during the day

Do not takeTolterodina NeoStada if

• you are allergic to tolterodina or any of the other ingredients in this medicine (listed in section 6).
• you are unable to urinate from your bladder (urinary retention).
• you have uncontrolled narrow-angle glaucoma (high intraocular pressure with vision loss that is not being adequately treated).
• you have myasthenia gravis (excessive muscle weakness).
• you have severe ulcerative colitis (colon ulceration and inflammation).
• you have toxic megacolon (acute colon dilation).

Warnings and precautions

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

• you experience difficulty urinating 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 (gastrointestinal motility decrease).
• 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 (heart rhythm alteration), heart failure

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

Other medicines and Tolterodina Neo Stada

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

Tolterodina, the active ingredient oftolterodinamay interact with other medicines.

Tolterodina is not recommended for use 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.

Tolterodinashould be used with caution when administered in combination with:

• some medicines that affect food transit (containing, for example, metoclopramide and cisapride).
• medicines for the treatment of irregular heart rhythm (containing, for example, amiodarone, sotalol, quinidine, and procainamide.
• other medicines with a similar mode of action to tolterodina (antimuscarinic properties) or medicines with an opposite mode of action to tolterodina (cholinergic properties). The reduction in gastric motility produced by antimuscarinic medicines may affect the absorption of other medicines. Consult your doctor if unsure.

Taking Tolterodina Neo Stada with food and drinks

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

Pregnancy and breastfeeding

Pregnancy

Do not use tolterodina if you are pregnant.If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine

Breastfeeding

The safety of tolterodina during breastfeeding is unknown. Tolterodina is not recommended for use during breastfeeding.

Consult your doctor or pharmacist before using any medicine.

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 Stadacontains lactose and sodium

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 23 mg of sodium (1 mmol) per capsule; it is essentially "sodium-free".

Dose:

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

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

Tolterodina is not recommended for use in children.

Administration Form

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

Do not chew the capsules.

Treatment Duration

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 prescribed prolonged-release capsules. 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 take moreTolterodina NeoStada 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, acceleration of heartbeats, dilation of the pupil, and inability to urinate or breathe normally.

If you forgot to takeTolterodina NeoStada

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 usual schedule.

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

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 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.
• urticaria and difficulty breathing.

You should also seek medical attention if you experience an allergic reaction (for example: itching, rash, urticaria, and difficulty breathing). This occurs with low frequency (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 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(may affect more than 1 in 10 people):

• dry mouth

Frequent(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 amount of air or gas in the stomach or intestine
• diarrhea
• fatigue

Infrequent(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 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 of 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.

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

Do not store at a temperature above25°C.

HDPE bottle: the shelf life after the first opening is 200 days.

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

Composition ofTolterodina NeoSTADA

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

-The other components are: lactose monohydrate, microcrystalline cellulose, polyvinyl acetate, povidone, silica, sodium lauryl sulfate, sodium docusate, magnesium stearate, hydroxypropylmethylcellulose.Composition of the capsule: Indigo carmine (E132), titanium dioxide (E171) and gelatin.

Composition of the internal tablet coating: Ethylcellulose, triethyl citrate, acrylic acid-ethyl acrylate copolymer, 1,2-propanediol.

Appearance of the product and contents of the package

Tolterodina Neo STADA are prolonged-release hard capsules designed for once-daily administration.

The prolonged-release hard capsules of Tolterodina Neo STADA 4 mg are light blue opaque - light blue opaque.

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

Pouches containing7, 14,28, 30, 49, 56, 84, 98, 100, 112 or 126prolonged-release hard capsules.

HDPE bottles containing: 30 or 100 prolonged-release hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Manufacturer:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

Pharmathen S.A

6, Dervenakion Str.,

153 51 Pallini Attiki

Greece

or

Pharmathen International S.A

Sapes Industrial Park Block 5,

69300 Rodopi

Greece

or

Eurogenerics N.V.

Heizel Esplanade B22

1020 Brussels

Belgium

or

LAMP SAN PROSPERO S.p.A.,

Vía della Pace, 25/A

41030 San Prospero (Modena)

Italy

or

Clonmel Healthcare Ltd

Waterford Road

Clonmel, Co. Tipperary

Ireland

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

UK:Toltrat XL4mg, prolonged release capsules

DK:TolterodinSTADA

ES:Tolterodina Neo STADA 4mg prolonged-release hard capsules EFG

IE:Toltertan SR4mg, prolonged release capsules

SE:Tolterodin STADA depotkapsel, hård

Date of the last review of this leaflet:September2020

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