Package Insert: Information for the User

Tolterodine Tartrate Extended-Release 4 mg 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 for you only, and you should not give it to others who 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 cinfa is tolterodine tartrate. Tolterodine is a drug that belongs to the group of medications called antimuscarinics.

Tolterodina neo cinfa 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 cinfa

• If you are allergic to tolterodina tartrate 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

• If you have 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 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 have noticed a decrease in intestinal movement or have severe constipation (decreased gastrointestinal motility).
• If you have a relevant heart disease such as:
• Abnormal heart rhythm (ECG)
• Slowed heart rate (bradycardia)
• 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.

Consult your doctor or pharmacist before starting to take tolterodina neo cinfa.

Taking tolterodina neo cinfa with other medications

Tolterodina tartrate, the active ingredient of tolterodina neo, may interact with other medications. Tolterodina neo should not be used 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 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 with a similar mode of action to tolterodina (antimuscarinic properties) or medications with an opposite mode of action to tolterodina neo (cholinergic properties). Consult your doctor if you are unsure.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take other medications, including those purchased without a prescription.

Taking tolterodina neo cinfa with food and drinks

Tolterodina neo 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 taking this medication.

Pregnancy

You should not use tolterodina neo if you are pregnant.

Breastfeeding

The excretion of tolterodina in breast milk is unknown. Tolterodina neo is not recommended during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Tolterodina neo cinfa contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Tolterodina neo cinfa contains sodium

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

Dosage:

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

The recommended dose is one 4 mg capsule per day, except in patients with liver or kidney disease, or in cases of bothersome side effects, in which case your doctor may reduce your dose to 2 mg per day.

Tolterodine neo is not recommended for use in children.

Tolterodine neo is taken orally. Capsules should be swallowed whole. Do not chew the capsules.

If you take more tolterodine neo cinfa than you should

If you or anyone else takes too many prolonged-release capsules, consult your doctor or pharmacist immediately.

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.

If you forget to take tolterodine neo cinfa

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, wait until the next scheduled dose and take it at the usual time. In this case, 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 tolterodine neo cinfa

Your doctor will indicate the duration of your treatment with tolterodine neo. Do not stop treatment unless you see an immediate effect, as your bladder needs time to adapt to it. 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 any other questions 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 if you notice 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 (it may affect up to 1 in 100 patients).

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 with low frequency (it may affect up to 1 in 100 patients).

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

Very frequent side effects(may affect more than 1 in 10 patients):

• Dry mouth
• Headache

Frequent side effects(may affect up to 1 in 10 patients):

• Bronchitis
• Dizziness, drowsiness, muscle cramps in the hands and feet
• Dry eyes, blurred vision
• Dizziness
• Palpitations
• Difficulty digesting (dyspepsia), constipation, abdominal pain, excessive amount of air or gas in the stomach or intestine, vomiting.
• Dry skin
• Pain or difficulty urinating, inability to empty the bladder
• Fatigue, chest pain, swelling due to fluid accumulation (e.g. in the ankles)
• Weight gain

Rare side effects(may affect up to 1 in 100 patients):

• Allergic reactions
• Nervousness
• Muscle cramps in the hands and feet
• Increased heart rate, heart failure, irregular heartbeat
• Stomach burning
• Memory alteration

Additional reported reactions include severe allergic reactions, confusion, hallucinations, increased heart rate, red skin, angioedema, and disorientation. Cases of worsening dementia symptoms in patients being treated for dementia have been reported.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

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 not listed 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 sight and reach of children.

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

Do not store at a temperature above 25°C.

Medications 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. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Tolterodine Neo Cinfa Composition

• The active ingredient of tolterodine neo cinfa is tolterodine tartrate. Each prolonged-release hard 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, anhydrous colloidal silica, sodium lauryl sulfate, sodium docusate, magnesium stearate (E-470b), and hydroxypropylmethylcellulose.

Coating: Ethylcellulose, triethyl citrate, methacrylic acid - ethyl acrylate copolymer (dispersion at 30%) and 1,2-propanediol.

Capsule Composition: Indigo carmine (E-132), titanium dioxide (E-171), and gelatin.

Product Appearance and Packaging Contents

The prolonged-release hard capsules of tolterodine neo cinfa 4 mg are hard gelatin capsules of light blue opaque - light blue opaque color that contain four white, round, and biconvex coated tablets.

Tolterodine neo cinfa 4 mg prolonged-release hard capsules are available in the following packaging sizes:

Pouches of 7, 14, 28, 49, 84, and 98 prolonged-release hard capsules.

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Manufacturer Responsible

Marketing Authorization Holder

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Manufacturer Responsible

Pharmathen, S.A.

6, Dervenakion Str.

Pallini Attiki

15351 Greece

or

Pharmathen International, S.A.

Industrial Park Sapes,

Rodopi Prefecture, Block no. 5

Rodopi 69300

Greece

Last Review Date of this Leaflet:August 2020

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/77250/P_77250.html

QR Code to:https://cima.aemps.es/cima/dochtml/p/77250/P_77250.html