Package Insert: Information for the Patient

Tolterodine Neo Sandoz 4 mg Extended-Release Hard Capsules EFG

Tolterodine Tartrate

Read this package insert carefully before you start taking this medicine because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given 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 package insert. See section 4.

The active ingredient of Tolterodina Neo Sandoz is tolterodina. Tolterodina belongs to the group of medicines called antimuscarinics.

Tolterodina is used for the treatment of 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 increase the number of times you urinate during the day.

Do not take Tolterodina Neo Sandoz

• 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 food passage and/or digestion,
• 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 a relevant heart disease, such as:
• • altered heart rhythm (ECG),
  • slow heart rate (bradycardia),
  • pre-existing heart diseases, such as: cardiomyopathy (heart muscle weakness), myocardial ischemia (decreased blood flow to the heart), arrhythmia (heart rhythm alteration), heart failure,
• if your blood levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia) are abnormally low.

Consult your doctor or pharmacist before starting to take Tolterodina Neo Sandoz if you think any of these situations may apply to you.

Taking Tolterodina Sandoz Neo with other medications

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

Tolterodina, the active ingredient in Tolterodina Neo Sandoz, 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 for HIV treatment.

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

-some medications that affect food transit (e.g., metoclopramide and cisapride),

-medications for irregular heart rhythm treatment (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 in gastric motility caused by antimuscarinics may affect the absorption of other medications. Consult your doctor if you are unsure.

Use of Tolterodina Neo Sandoz with food and beverages

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

Pregnancy and breastfeeding

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

Pregnancy

You should not use Tolterodina Neo Sandoz if you are pregnant. Inform your doctor immediately if you are pregnant or think you may be pregnant or if you are planning to become pregnant.

Breastfeeding

The excretion of tolterodina in breast milk is unknown. It is not recommended to breastfeed while using Tolterodina Neo Sandoz.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Tolterodina Neo Sandoz may make you feel dizzy, tired, or affect your vision; your ability to drive or operate machinery may be affected.

Tolterodina Neo Sandoz contains lactose and sodium

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 23 mg of sodium (1 mmol) per hard capsule; this 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.

The prolonged-release hard capsules are taken orally and should 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 your dose to one capsule of 2 mg per day in patients with liver or kidney problems.

Children

Tolterodina is not recommended for use in children.

If you take more Tolterodina Neo Sandoz than you should

If you or anyone else takes too many prolonged-release capsules, consult your doctor or pharmacist immediately. Symptoms of an overdose include: hallucinations, excitement, rapid heartbeat, dilated pupils, and inability to urinate or breathe normally.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Tolterodina Neo Sandoz

If you forget to take a dose at your usual time, take it as soon as you remember, unless it is almost time for your next dose. In this case, wait for the next dose and take it at your usual time. Continue taking the capsules as directed by your doctor.

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

If you interrupt treatment with Tolterodina Neo Sandoz

Your doctor will indicate the duration of treatment with Tolterodina Neo Sandoz. Do not stop treatment unless you see 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 anyother doubts about theuse of thismedication, ask your doctororpharmacist.

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

You should consult your doctor immediately if you notice symptoms of angioedema such as:

• swelling of the face, tongue, or throat,
• difficulty swallowing,
• hives and difficulty breathing.

You should also seek medical attention if you experience an allergic reaction (e.g., itching, rash, hives, and difficulty breathing). This occurs infrequently (may affect up to 1 in 100 people).

Inform your doctor 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 infrequently (may affect up to 1 in 100 people).

The following side effects have been observed during treatment with Tolterodina Neo Sandoz with the following frequencies:

Very frequent side effects(may affectmore than 1 in 10people) are:

• dry mouth.

Frequent side effects(may affectup to 1 in 10people) are:

• sinusitis,
• drowsiness,
• dry eyes,
• difficulty digesting (dyspepsia),
• abdominal pain,
• 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 intestines,
• diarrhea,
• fatigue.

Infrequent side effects(may affectup to 1 in 100people) are:

• allergic reactions,
• nervousness,
• palpitations,
• inability to empty the bladder,
• dizziness,
• heart failure,
• irregular heartbeat,
• chest pain,
• muscle cramps in the hands and feet,
• 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. Cases of worsening dementia symptoms in patients being treated for dementia have been reported.

Reporting side effects

If you experienceanytype ofside effect, consultyour 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.

Do not use Tolterodina Neo Sandoz after the expiration date that appears on the label and the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Shelf life after first opening:

HDPE bottle: 200 days.

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

Tolterodina Neo Sandoz Composition

• The active ingredient is tolterodine tartrate. Each hard capsule contains 4 mg of tolterodine tartrate.
• The other components are: lactose monohydrate, microcrystalline cellulose, poly(vinyl acetate), povidone, anhydrous colloidal silica, sodium lauryl sulfate, sodium docusate, magnesium stearate, hydroxypropylmethylcellulose, indigo carmine (E132), titanium dioxide (E 171), gelatin, ethylcellulose, triethyl citrate, copolymer of methacrylic acid and ethyl acrylate and 1, 2-propylene glycol.

Product Appearance and Packaging Contents

Hard, light blue opaque capsules containing four white, round, biconvex coated tablets.

The prolonged-release capsules are packaged in Alu/PVC/PE/PVDC blisters or HDPE bottles with a safety closure within a cardboard carton.

Package sizes:

Alu/PVC/PE/PVDC blisters with 7, 14, 28, 30, 49, 50, 56, 60, 80, 84, 90, 98, 100, 112, 160, 280, 320 hard capsules of prolonged release.

HDPE bottles with: 30, 60, 100, and 200 hard capsules of prolonged release.

Only some package sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible Manufacturer:

Pharmaten, S.A.

6, Dervenakion Str., 153 51

Pallini, Attiki

Greece

Or

Pharmathen International S.A.

Sapes Industrial Park Block 5,

69300 Rodopi

Greece

Salutas Pharma GmbH

Otto-von-Guericke Allee 1,

39179, Barleben

Germany

Or

Lek Pharmaceuticals dd

Verovskova 57,

1526 Ljubljana

Slovenia

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

Germany:Tolterodin - 1 A Pharma 4 mg Hartkapseln, retardiert

Belgium:Tolterodin Sandoz 4 mg capsules met verlengde afgifte, hard

Denmark:Tolterodine “Sandoz”

Finland:Tolterodine Sandoz 4 mg, depotkapselit, kovat

United Kingdom:Inconex XL 4 mg, Prolonged-release Capsules, hard

Greece:Tolterodine/Sandoz 4 mg, καψ?κια παρατεταμ?νης αποδ?σμευσης, σκληρ?

Netherlands:Tolterodinetartraat Sandoz retard 4 mg, harde capsules met verlengde afgifte

Ireland:Tolusitol 4 mg Prolonged-Release Capsules, Hard

Iceland:Tolterodine Sandoz 4 mg, forðahylki, hörð

Malta: Inconex XL 4mg, prolonged release capsules, hard

Norway:Tolterodine Sandoz 4 mg depotkapsler, harde

Sweden:Tolterodine Sandoz 4 mg, depotkapslar, hårda

This leaflet was approved in March 2020