Tolterodine Neo Sandoz 4 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tolterodine Neo Sandoz 4 mg prolonged-release hard capsules EFG

Tolterodine tartrate

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Tolterodine Neo Sandoz is and what it is used for
2. What you need to know before taking Tolterodine Neo Sandoz
3. How to take Tolterodine Neo Sandoz
4. Possible side effects
5. How to store Tolterodine Neo Sandoz
6. Contents of the pack and other information

1. What Tolterodina Neo Sandoz is and what it is used for

The active substance of Tolterodina Neo Sandoz is tolterodine. Tolterodine belongs to a group of medicines called antimuscarinics.

Tolterodine 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 feel a sudden and urgent need to urinate without prior warning, and/or you urinate more frequently during the day.

2. What you need to know before taking Tolterodine Neo Sandoz

Do not take Tolterodine Neo Sandoz

• if you are allergic to tolterodine 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 (high intraocular pressure with loss of visual field that is not being adequately treated),
• if you have myasthenia gravis (excessive muscle weakness),
• if you have severe ulcerative colitis (ulceration and inflammation of the colon),
• if you have toxic megacolon (acute dilation of the colon).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• if you experience 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 failure),
• if you have liver disease,
• if you have neurological disorders affecting your blood pressure, intestinal or sexual function (any neuropathy of the autonomic nervous system),
• if you have hiatal hernia (hernia involving an abdominal organ),
• if you ever experience reduced intestinal movement or suffer from severe constipation (reduced gastrointestinal motility),
• if you have significant heart disease such as:
  • abnormal heart rhythm (ECG),
  • slow heart rate (bradycardia),
  • pre-existing heart conditions such as: cardiomyopathy (weakness of the heart muscle), myocardial ischemia (reduced blood flow to the heart), arrhythmia (irregular heart rhythm), heart failure,
• if your blood levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia) are abnormally low.

Consult your doctor or pharmacist before starting Tolterodine Neo Sandoz if you think any of these conditions may apply to you.

Taking Tolterodine Neo Sandoz with other medicines

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

Tolterodine, the active substance in Tolterodine Neo Sandoz, 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 should be used with caution when administered together 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 (cholinergic properties).

The reduction in gastric motility caused by antimuscarinics may affect the absorption of other medicines. Consult your doctor if you are unsure.

Use of Tolterodine Neo Sandoz with food and drink

Tolterodine Neo Sandoz can 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 using this medicine.

Pregnancy

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

Breastfeeding

It is unknown whether tolterodine is excreted in breast milk. Breastfeeding is not recommended during treatment with Tolterodine Neo Sandoz.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Tolterodine Neo Sandoz contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per hard capsule; i.e., it is essentially “sodium-free”.

3. How to take Tolterodine Neo Sandoz

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

The prolonged-release hard capsules are taken orally and must be swallowed whole. Do not chew the capsules.

Adults

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

Patients with hepatic or renal problems

In patients with hepatic or renal impairment, your doctor may reduce your dose to one 2 mg capsule per day.

Children

The use of tolterodine is not recommended in children.

If you take more Tolterodine Neo Sandoz than you should

If you or anyone takes too many prolonged-release capsules, contact your doctor or pharmacist immediately. Symptoms of overdose may include: hallucinations, excitement, rapid heartbeat, pupil dilation, and inability to urinate or breathe normally.

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 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 that case, skip the missed dose and take the next one at the regular time. In this case, continue taking the capsules as directed by your doctor.

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

If you stop taking Tolterodine Neo Sandoz

Your doctor will advise you on the duration of treatment with Tolterodine Neo Sandoz. Do not discontinue treatment prematurely even if you do not observe an immediate effect. Your bladder needs time to adapt to this treatment. 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 re-evaluated 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 also have 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 (e.g., itching, rash, hives, and difficulty breathing). This occurs uncommonly (may affect up to 1 in 100 people).

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 uncommonly (may affect up to 1 in 100 people).

The following adverse effects have been observed during treatment with Tolterodine Neo Sandoz with the following frequencies:

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

• dry mouth.

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

• sinusitis,
• drowsiness,
• dry eyes,
• difficulty in digestion (dyspepsia),
• abdominal pain,
• pain or difficulty when urinating,
• swelling due to fluid accumulation (e.g., in the ankles),
• dizziness,
• headache,
• blurred vision,
• constipation,
• excessive air or gas in the stomach or intestines,
• diarrhea,
• fatigue.

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

• allergic reactions,
• nervousness,
• palpitations,
• inability to empty the bladder,
• dizziness,
• heart failure,
• irregular heartbeat,
• chest pain,
• cramps in the fingers and toes,
• memory disturbance.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 Sandoz

Keep this medicine out of sight and reach of children.

Do not use Tolterodine Neo Sandoz after the expiry date which is stated on the label and packaging after CAD/EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Validity period after first opening:

HDPE bottle: 200 days.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Tolterodine Neo Sandoz

• The active substance is tolterodine tartrate. Each hard capsule contains 4 mg of tolterodine tartrate.
• The other components are: lactose monohydrate, microcrystalline cellulose, poly(vinyl acetate), povidone, colloidal anhydrous silica, sodium lauryl sulfate, sodium docusate, magnesium stearate, hypromellose, indigo carmine (E132), titanium dioxide (E171), gelatin, ethylcellulose, triethyl citrate, methacrylic acid and ethyl acrylate copolymer, and 1,2-propylene glycol.

Appearance of the product and contents of the pack

Light opaque blue hard capsules containing four white, round, biconvex coated tablets.

The prolonged-release capsules are packed in Alu/PVC/PE/PVDC blisters or in HDPE bottles with child-resistant closure, all contained within a cardboard carton.

Pack sizes:

Blister packs containing 7, 14, 28, 30, 49, 50, 56, 60, 80, 84, 90, 98, 100, 112, 160, 280, 320 prolonged-release hard capsules.

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

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

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 d.d.

Verovskova 57,

1526 Ljubljana

Slovenia

This medicinal product is authorised 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