Package Leaflet: Information for the User

Tolterodine Neo Teva 4 mg Hard Capsules with Prolonged Release EFG

tolterodine, tartrate

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Tolterodine Neo Teva

3. How to take Tolterodine Neo Teva

4. Possible side effects

5. Storage of Tolterodine Neo Teva

6. Contents of the pack and additional information

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

Tolterodina Neo Teva 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 increase the number of times you urinate during the day.

Do not take Tolterodina Neo Teva

•if you are allergic to tolterodina or any of the other ingredients 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 (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 Tolterodina Neo Teva:

•if you experience difficulty urinating and/or weak or slow urine flow.

•if you have a gastrointestinal disorder that affects the passage and/or digestion of food.

•if you have kidney problems (renal insufficiency).

•if you have liver disease.

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

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

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

•if you have heart disease, such as:

- altered heart rhythm (ECG)

- bradycardia (slow heart rate),

- pre-existing heart diseases such as: cardiomyopathy (heart muscle weakness), myocardial ischemia (decreased blood flow to the heart), arrhythmia (alteration of heart rhythm), heart failure

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

Taking Tolterodina Neo Teva with other medications

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

Tolterodina, the active ingredient of Tolterodina Neo Teva, may interact with other medications.

Do not take tolterodina in combination with:

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

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

•medications used to treat HIV.

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

•some medications that affect food transit (containing, for example: metoclopramide and cisapride).

•medications used to treat irregular heart rhythm (containing, for example: amiodarone, sotalol, quinidine, and procainamide).

•other medications that have a similar mode of action to tolterodina (antimuscarinic properties) or medications that have an opposite mode of action to Tolterodina Neo Teva (cholinergic properties).

The reduction of gastric motility produced by antimuscarinic medications may affect the absorption of other medications.

Taking Tolterodina Neo Teva with food

Tolterodina Neo Teva 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

Do not take Tolterodina Neo Teva if you are pregnant.

Breastfeeding

The excretion of tolterodina in breast milk is unknown. Do not use Tolterodina Neo Teva during breastfeeding.

Driving and operating machinery

Tolterodina Neo Teva 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 Teva contains lactose and sodium

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Adults

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

Patients with liver or kidney problems

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

Use in children

Tolterodina Neo Teva is not recommended for use in children.

Administration form

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

Do not chew the capsules.

Treatment duration

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

If you take more Tolterodina Neo Teva 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 take Tolterodina Neo Teva

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 interrupt treatment with Tolterodina Neo Teva

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 can 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 (can affect up to 1 in 100 people).

Inform your doctor immediately 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 with low frequency (can affect 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(can affect more than 1 in 10 people):

•Dry mouth

Common side effects(can 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 intestine

•Pain or difficulty urinating

•Diarrhea

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

•Fatigue

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

•Allergic reactions

•Heart failure

•Nervousness

•Irregular heartbeat, palpitations

•Chest pain

•Inability to empty the bladder

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

•Dizziness

•Memory alteration

Additional reported reactions include severe allergic reactions, confusion, hallucinations, increased heart rate, red skin, stomach burning, vomiting, angioedema, and skin dryness 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 on the blister pack. 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 200 days.

Medicines should not be thrown into the drains or trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. 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 of Tolterodina Neo Teva

- The active ingredient istolterodine tartrate.

Eachhard prolonged-release capsule contains 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, hydroxypropyl methylcellulose.Composition of the capsule: Indigo Carmine (E132), titanium dioxide (E171) and gelatin.Composition of the tablet coating: ethylcellulose, triethyl citrate, acrylic acid-ethyl acrylate copolymer, 1,2-propanediol.

Appearance of the product and contents of the package

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

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

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

Pouches of 7, 14, 28, 30, 49, 50, 80, 84, 90, 98, 100, 160, 200 and 280 hard prolonged-release capsules.

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

28108 Alcobendas, Madrid

Spain

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

Or

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem Netherlands

Or

Merckle GmbH

Ludwig-Merckle-Str. 3

89143 Blaubeuren Germany

Or

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13,

4042 Debrecen Hungary

Or

Teva Pharma B.V.

Swensweg 5,

2031 GA Haarlem Netherlands

Or

Teva Operations Poland Sp. z.o.o.

ul. Mogilska 80.

31-546, Krakow Poland

This medicine is authorized in the member states of the European Economic Area with the following names:

United Kingdom: Mariosea XL 4 mg prolonged-release capsules

Belgium: Tolterodine Retard Teva 4 mg capsules with prolonged release, hard

Germany: Tolterodin-ratiopharm 4 mg Retardkapseln

Denmark: Tolterodintartrat Teva

Greece: Tolterodine Teva 4 mgκαψ?κιαπαρατεταμ?νηςαποδ?σμευσης,σκληρ?

Spain: Tolterodina Neo Teva 4 mg hard prolonged-release capsules EFG

Finland: Tolterodin ratiopharm

Ireland: Trusitev 4 mg Prolonged-release Capsules, hard

Luxembourg: Tolterodin-ratiopharm 4 mg Retardkapseln

Netherlands: Tolterodinetartraat retard 4 mg Teva, capsules with prolonged release

Norway: Tolterodine Teva

Poland: Defur

Sweden: Tolterodine Teva

Slovenia: Tolterodin Teva Pharma 4 mg trde kapsule s podaljšanim sproščanjem

Slovakia: TolterodinTeva 4 mg

Date of the last review of this leaflet: November 2020

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