Tolterodine Neo Stada 4 mg prolonged-release hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Tolterodine Neo STADA 4 mg prolonged-release hard capsules EFG

Tartrate of tolterodine

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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects you experience is serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Leaflet contents:

1. What Tolterodine Neo STADA is and what it is used for
2. Before you take Tolterodine Neo STADA
3. How to take Tolterodine Neo STADA
4. Possible side effects
5. How to store Tolterodine Neo STADA
6. Further information

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

The active substance in Tolterodine Neo Stada 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 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 Tolterodina Neo Stada

Do not take Tolterodina Neo Stada if

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Tolterodina Neo Stada if:

• you experience difficulty passing urine and/or have a weak or slow urinary stream.

• you have a gastrointestinal disorder affecting the passage and/or digestion of food.

• you have kidney problems (renal insufficiency).

• you have liver disease.

• you have neurological disorders affecting your blood pressure, intestinal or sexual function (any autonomic nervous system neuropathy).

• you have a hiatal hernia (herniation of an abdominal organ).

• you ever experience reduced intestinal motility or suffer from severe constipation (reduced gastrointestinal motility).

• you have heart disease, such as:

• abnormal heart rhythm (ECG),

• slow heart rate (bradycardia),

• pre-existing heart conditions such as: cardiomyopathy (weakened heart muscle), myocardial ischemia (reduced blood flow to the heart), arrhythmia (irregular heart rhythm), heart failure.

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

Other medicines and Tolterodina Neo Stada

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 Tolterodina Neo Stada, may interact with other medicines.

The use of tolterodine is not recommended in combination with:

• certain antibiotics (containing, for example: erythromycin and clarithromycin).
• medicines used to treat fungal infections (containing, for example: ketoconazole and itraconazol).
• medicines used to treat HIV.

Tolterodine should be used with caution when administered together with:

• certain medicines affecting food transit (containing, for example: metoclopramide and cisapride).
• medicines used to treat irregular heart rhythm (containing, for example: 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 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 may be taken before, during, or after a meal.

Pregnancy and breastfeeding

Pregnancy

You must not use tolterodine if you are pregnant. 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.

Breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Tolterodine may cause dizziness, tiredness, or affect your vision. If you experience any of these symptoms, you should not drive or operate heavy machinery.

Tolterodina Neo Stada 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 capsule; this is essentially “sodium-free”.

3. How to take Tolterodine Neo Stada

Dosage:

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Adults:

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

Patients with liver or kidney problems:

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

Use in children:

The use of tolterodine is not recommended in children.

Method of administration

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

Do not chew the capsules.

Duration of treatment

Your doctor will determine the duration of treatment with tolterodine. Do not stop treatment prematurely because you do not observe an immediate effect. Your bladder needs time to adapt to this medication. Complete the treatment with 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 discontinuing treatment.

If you take more Tolterodine Neo Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Poison Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested. It is recommended to take the medicine packaging and leaflet to the healthcare professional.

Symptoms of overdose include hallucinations, excitement, increased heart rate, pupil dilation, and inability to urinate or breathe normally.

If you forget to take Tolterodine Neo Stada

If you forget to take your dose at the 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 continue with your regular schedule.

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

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 cause adverse effects, although not everyone will experience them.

You should consult your 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
• urticaria and difficulty breathing

You should also seek medical attention if you experience a hypersensitivity reaction (for example: itching, rash, urticaria and difficulty breathing). These occur uncommonly (affecting up to 1 in 100 people).

Inform your doctor immediately 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 (affecting up to 1 in 100 people).

The following adverse 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
• somnolence
• dry eyes
• difficulty in digestion (dyspepsia)
• abdominal pain
• pain or difficulty 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
• diarrhoea
• 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 fingers of hands and feet
• memory disturbance

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

Reporting of adverse effects:

If you experience any 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 through 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 Stada

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

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

Do not store above 25°C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Information provided

Composition of Tolterodine NeoSTADA

• The active substance in Tolterodine NeoSTADA 4 mg prolonged-release hard capsules is 4 mg of tolterodine tartrate, equivalent to 2.74 mg of tolterodine.
• The other components are: monohydrate lactose, 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.

Presentation of the product and contents of the pack

Tolterodine NeoSTADA are prolonged-release hard capsules designed for once-daily administration.

Tolterodine NeoSTADA 4 mg prolonged-release hard capsules are light opaque blue – light opaque blue in colour.

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

Blister packs 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.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Marketing Authorization 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.,

Via della Pace, 25/A

41030 San Prospero (Modena)

Italy

or

Clonmel Healthcare Ltd

Waterford Road

Clonmel, Co. Tipperary

Ireland

This medicinal product is authorized 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 cápsulas duras de liberación prolongada EFG

IE: Toltertan SR 4mg, prolonged release capsules

SE: Tolterodin STADA depotkapsel, hård

Date of the most recent review of this leaflet: September 2020

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