Package Insert: Information for the Patient

Tolterodine Neo ratiopharm 4 mg Extended-Release Hard Capsules EFG

tolterodine, tartrate

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

- Keep this package insert, as you may need to refer to it again.

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

- This medication 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Tolterodine Neo ratiopharm and how is it used

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

3. How to take Tolterodine Neo ratiopharm

4. Possible adverse effects

5. Storage of Tolterodine Neo ratiopharm

6. Contents of the package and additional information

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

Tolterodina Neo ratiopharm 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 take Tolterodina Neo ratiopharm

•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 (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 Tolterodina Neo ratiopharm:

•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 disorders of the nervous system 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 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 (heart rhythm alteration), heart failure

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

Taking Tolterodina Neo ratiopharm 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 ratiopharm, may interact with other medications.

Tolterodina Neo ratiopharm should not be taken in combination with:

•some antibiotics (e.g., erythromycin and clarithromycin).

•medications used to treat fungal infections (e.g., ketoconazole and itraconazole).

•medications used to treat HIV.

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

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

•medications used to treat irregular heart rhythm (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 Neo ratiopharm (cholinergic properties). The reduction of gastric motility produced by antimuscarinic medications may affect the absorption of other medications.

Taking Tolterodina Neo ratiopharm with food

Tolterodina Neo ratiopharm 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 ratiopharm if you are pregnant.

Breastfeeding

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

Driving and operating machinery

Tolterodina Neo ratiopharm 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 ratiopharm 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 ratiopharm 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 ratiopharm. 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 ratiopharm 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 ratiopharm

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 dose.

If you interrupt treatment with Tolterodina Neo ratiopharm

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 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.

•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 infrequently (it may 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 infrequently (it may 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(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 or air in the stomach or intestines

•Pain or difficulty urinating

•Diarrhea

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

•Fatigue

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

•Allergic reactions

•Heart failure

•Anxiety

•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 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. The expiration date is the last day of the month indicated.

Do not store above 25°C.

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

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

Tolterodina Neo ratiopharm Composition

- The active ingredient istolterodine tartrate.

Cada cápsula dura de liberación prolongada contiene4 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.

Capsule Composition: indigo carmine (E132), titanium dioxide (E171) and gelatin.

Internal Tablet Coating Composition: ethylcellulose, triethyl citrate, methacrylic acid - ethyl acrylate copolymer, 1,2-propylene glycol.

Product Appearance and Packaging Contents

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

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

Tolterodina Neo ratiopharm 4 mg hard, prolonged-release capsules are available in the following packaging 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 packaging sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid

Responsible 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

Or

MERCKLE GMBH

Ludwig-Merckle-Street, 3

D-89143 Blaubeuren, Germany

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

United Kingdom: Dengaff XL 4 mg prolonged-release capsules

Germany: Tolterodin-CT 4 mg Retardkapseln

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

Finland: Tolterodine Teva4mg depotkapseli, kova

Last reviewed date of this leaflet: September 2020

More detailed and up-to-date 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/)