TOLTERODINE NEO STADA 4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Tolterodina Neo STADA 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is Tolterodina Neo STADA and what is it used for
2. Before taking Tolterodina Neo STADA
3. How to take Tolterodina Neo STADA
4. Possible side effects

5 Conservation of Tolterodina Neo STADA

1. Additional information

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

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

Tolterodine is used for the treatment of the symptoms of overactive bladder syndrome. If you have overactive bladder syndrome, you may experience:

• that you are not able to control urination voluntarily
• a sudden and urgent need to urinate without prior warning and/or an increase in the number of times you urinate during the day

2. What you need to know before taking Tolterodina Neo Stada

Do not takeTolterodina NeoStada if

• you are allergic to tolterodine or any of the other ingredients of this medicine (listed in section 6).
• you are unable to empty your bladder (urinary retention).
• you have uncontrolled narrow-angle glaucoma (high eye pressure with loss of vision, which is not being treated properly).
• you have myasthenia gravis (excessive weakness in the muscles).
• you have severe ulcerative colitis (ulceration and inflammation in the colon).
• you have toxic megacolon (acute dilation of the colon).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tolterodina Neo Stada if:

• you have difficulty emptying your bladder and/or urinate with a weak or slow stream.
• you have a gastrointestinal disorder that affects the passage and/or digestion of food.
• you have kidney problems (renal insufficiency).
• you have liver disease.
• you have autonomic neuropathy (a disorder that affects the nerves that control bodily functions such as blood pressure, intestinal and sexual function).
• you have a hiatal hernia (a hernia in an abdominal organ).
• you have decreased intestinal motility or severe constipation.
• you have a heart condition, such as:

• altered heart rhythm (ECG)
• slow heart rate (bradycardia),
• pre-existing heart conditions such as cardiomyopathy (weakness of the heart muscle), myocardial ischemia (decreased blood flow to the heart), arrhythmia (abnormal heart rhythm), heart failure

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

Other medicines and Tolterodina Neo Stada

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

Tolterodine, the active substance in tolterodine, may interact with other medicines.

The use of tolterodine in combination with the following medicines is not recommended:

• certain antibiotics (e.g. erythromycin and clarithromycin).
• medicines used to treat fungal infections (e.g. ketoconazole and itraconazole).
• medicines used to treat HIV.

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

• certain medicines that affect the passage of food (e.g. metoclopramide and cisapride).
• medicines used to treat irregular heart rhythm (e.g. amiodarone, sotalol, quinidine, and procainamide.
• other medicines that have a similar mode of action to tolterodine (antimuscarinic properties) or medicines that have an opposite mode of action to tolterodine (cholinergic properties). The reduction in gastric motility produced by antimuscarinic medicines may affect the absorption of other medicines. Consult your doctor if you are unsure.

Taking Tolterodina Neo Stada with food and drink

Tolterodine can be taken before, during, or after a meal.

Pregnancy and breastfeeding

Pregnancy

Do not use tolterodine if you are pregnant. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Breastfeeding

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

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Tolterodine 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 Stadacontains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Tolterodina Neo Stada

Dose:

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Adults:

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

Patient with liver or kidney problems:

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

Use in children

The use of tolterodine in children is not recommended.

Method of administration

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

Do not chew the capsules.

Duration of treatment

Your doctor will tell you how long to take tolterodine. Do not stop treatment early because you do not see an immediate effect. Your bladder needs time to adapt to this. 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 reassessed after 2-3 months of use. Always consult your doctor if you are thinking of stopping treatment.

If you take moreTolterodina NeoStada than you should

If you have taken more tolterodine than you should, talk to a doctor or pharmacist immediately or go to the nearest hospital casualty department. Take the medicine pack with you. The symptoms of an overdose include hallucinations, excitement, rapid heartbeat, dilated pupils, and inability to urinate or breathe normally.

If you forget to takeTolterodina NeoStada

If you forget to take a dose at the usual time, take it as soon as you remember, unless it is almost time for your next dose. In this case, skip the missed dose and continue with your regular schedule.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should consult a doctor immediately or go to the emergency department if you experience symptoms of angioedema such as:

• swelling of the face, tongue, or pharynx.
• difficulty swallowing.
• hives and difficulty breathing.

In addition, seek medical attention if you experience a hypersensitivity reaction (e.g. itching, rash, hives, and difficulty breathing). This occurs rarely (affects up to 1 in 100 people).

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

• chest pain, difficulty breathing, or tiredness (even at rest), difficulty breathing at night, swelling of the legs.

These may be symptoms of heart failure. This occurs rarely (affects up to 1 in 100 people).

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

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

• dry mouth

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

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

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

• allergic reactions
• nervousness
• palpitations
• inability to empty the bladder
• vertigo
• heart failure
• irregular heartbeat
• chest pain
• tingling sensation in the fingers and toes
• memory impairment

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

Reporting of side effects:

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Tolterodina Neo Stada

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month.

Do not store above 25°C.

HDPE bottle: the shelf life after first opening is 200 days.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Additional information

Composition ofTolterodina NeoSTADA

• The active substance in Tolterodina Neo STADA 4 mg prolonged-release hard capsules is 4 mg of tolterodine tartrate, equivalent to 2.74 mg of tolterodine.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, polyvinyl acetate, povidone, silica, sodium lauryl sulfate, sodium docusate, magnesium stearate, hypromellose. Capsule composition: Indigo carmine (E132), titanium dioxide (E171), and gelatin.

Composition of the internal tablet coating: Ethylcellulose, triethyl citrate, methacrylic acid - ethyl acrylate copolymer, 1,2-propylene glycol.

Appearance and packaging

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

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

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

Blisters containing 7, 14, 28, 30, 49, 56, 84, 98, 100, 112, or 126 prolonged-release hard capsules.

HDPE bottles containing: 30 or 100 prolonged-release hard capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Marketing authorisation holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

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

Eurogenerics N.V.

Heizel Esplanade B22

1020 Brussels

Belgium

or

LAMP SAN PROSPERO S.p.A.,

Vía della Pace, 25/A

41030 San Prospero (Modena)

Italy

or

Clonmel Healthcare Ltd

Waterford Road

Clonmel, Co. Tipperary

Ireland

This medicine is authorised in the Member States of the European Economic Area under the following names:

UK: Toltrat XL4mg, prolonged release capsules

DK: TolterodinSTADA

ES: Tolterodina Neo STADA 4mg prolonged-release hard capsules EFG

IE: Toltertan SR 4mg, prolonged release capsules

SE: Tolterodin STADA depotkapsel, hård

Date of last revision of this leaflet:September 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/