Tolterodine Neo CINFA 4 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

tolterodine neo cinfa 4 mg prolonged-release hard capsules EFG

Tolterodine tartrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What tolterodine neo cinfa is and what it is used for
2. What you need to know before taking tolterodine neo cinfa
3. How to take tolterodine neo cinfa
4. Possible adverse effects
5. How to store tolterodine neo cinfa
6. Contents of the pack and other information

1. What tolterodine neo cinfa is and what it is used for

The active substance in tolterodine neo cinfa is tolterodine tartrate. Tolterodine belongs to a group of medicines called antimuscarinics.

Tolterodine neo cinfa is used to treat the symptoms of overactive bladder syndrome.

If you have overactive bladder syndrome, you may notice that:

• You are unable to voluntarily control your urine.
• You experience a sudden and urgent need to urinate without prior warning and/or an increased number of times you urinate during the day.

2. What you need to know before taking tolterodine neo cinfa

Do not take tolterodine neo cinfa

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

Warnings and precautions

• If you have difficulty passing urine and/or have a weak or slow urinary stream.
• If you have a gastrointestinal disorder affecting the passage and/or digestion of food.
• If you have kidney problems (renal insufficiency).
• If you have liver disease.
• If you have neurological disorders affecting your blood pressure, intestinal or sexual function (any autonomic neuropathy).
• If you have hiatal hernia (herniation of an abdominal organ).
• If you ever experience reduced intestinal movement or suffer from severe constipation (decreased gastrointestinal motility).
• If you have a relevant heart condition such as:
• abnormal heart recording (ECG)
• slow heart rate (bradycardia)
• pre-existing heart diseases such as:
• cardiomyopathy (weakness of the heart muscle)
• myocardial ischemia (reduced blood flow to the heart)
• arrhythmia (irregular heart rhythm)
• heart failure
• If you have abnormally low blood levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia).

Consult your doctor or pharmacist before starting tolterodine neo cinfa.

Taking tolterodine neo cinfa with other medicines

Tolterodine tartrate, the active ingredient in tolterodine neo, may interact with other medicines. The use of tolterodine is not recommended in combination with:

• Certain antibiotics (containing e.g.: erythromycin and clarithromycin).
• Medicines used to treat fungal infections (containing e.g.: ketoconazole and itraconazole).
• Medicines for the treatment of HIV.

Tolterodine neo should be used with caution when administered in combination with:

• Certain medicines affecting food transit (containing e.g.: metoclopramide and cisapride).
• Medicines for the treatment of irregular heart rhythm (containing e.g.: amiodarone, sotalol, quinidine, and procainamide).
• Other medicines with a similar mode of action to tolterodine (antimuscarinic properties) or medicines with an opposite mode of action to tolterodine neo (cholinergic properties). Consult your doctor if you are unsure.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Taking tolterodine neo cinfa with food and drink

Tolterodine neo may be taken before, during, or after a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

You should not use tolterodine neo if you are pregnant.

Breastfeeding

It is unknown whether tolterodine is excreted in breast milk. The use of tolterodine neo is not recommended during breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Tolterodine neo may cause dizziness, tiredness, or affect your vision; your ability to drive or operate machinery may be impaired.

tolterodine neo cinfa contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

tolterodine neo cinfa contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; essentially “sodium-free”.

3. How to take tolterodine neo cinfa

Dosage:

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one 4 mg capsule daily, except for patients with hepatic or renal disease, or bothersome side effects, in which case your doctor may reduce your dose to 2 mg daily.

The use of tolterodine neo is not recommended in children.

Tolterodine neo is taken orally. The capsules must 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, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take tolterodine neo cinfa

If you forget to take a dose, take it as soon as possible. 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 stop treatment with tolterodine neo cinfa

Your doctor will advise you on the duration of your treatment with tolterodine neo. Do not discontinue treatment prematurely if you do not observe an immediate effect, as your bladder needs time to adapt to it. Complete the course of prolonged-release capsules as prescribed by your doctor. If you notice no effect, consult your doctor.

The benefit of treatment should be reevaluated after 2–3 months of use. Always consult your doctor if you are considering stopping treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone experiences them.

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

• Swelling of the face, tongue or pharynx.
• Difficulty swallowing.
• Hives and difficulty breathing.

You should also seek medical attention if you experience a hypersensitivity reaction (for example: itching, rash, hives and difficulty breathing). This occurs infrequently (may affect up to 1 in 100 patients).

Inform your doctor or go to the emergency department if you experience:

• Chest pain, difficulty breathing or fatigue (even at rest), difficulty breathing at night, swelling of the legs.
• These may be symptoms of heart failure. This occurs infrequently (may affect up to 1 in 100 patients).

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

Very common adverse effects (may affect more than 1 in 10 patients):

• Dry mouth
• Headache

Common adverse effects (may affect up to 1 in 10 patients):

• Bronchitis
• Dizziness, drowsiness, tingling in the fingers and toes
• Dry eyes, blurred vision
• Vertigo
• Palpitations
• Difficulty digesting (dyspepsia), constipation, abdominal pain, excessive air or gas in the stomach or intestines, 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

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Allergic reactions
• Nervousness
• Tingling in the fingers and toes
• Increased heart rate, heart failure, irregular heartbeat
• Heartburn
• Memory disturbance

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of tolterodine neo cinfa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and containers. This helps protect the environment.

6. Contents of the pack and other information

Composition of tolterodine neo cinfa

• The active substance 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: monohydrate lactose, microcrystalline cellulose, polyvinyl acetate, povidone, anhydrous colloidal silica, sodium lauryl sulfate, sodium docusate, magnesium stearate (E-470b) and hypromellose.

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

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

Appearance of the product and contents of the pack

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

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Poligono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

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

Date of the most recent revision of this leaflet: August 2020

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

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. 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