Defur

Package leaflet: information for the patient

Defur, 4 mg, prolonged-release capsules, hard
Tolterodini tartras
Read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Defur is and what it is used for
2. Important information before taking Defur
3. How to take Defur
4. Possible side effects
5. How to store Defur
6. Contents of the pack and other information

1. What Defur is and what it is used for

The active substance in Defur is tolterodine. Tolterodine belongs to a group of medicines called antimuscarinic agents.
Defur is used to treat symptoms of overactive bladder syndrome, such as:

• urge incontinence
• sudden and (or) frequent need to urinate.

2. Important information before using Defur

When not to use Defur

• if the patient is allergic to tolterodine or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has reduced ability to empty the bladder (urinary retention).
• if the patient has uncontrolled narrow-angle glaucoma (increased intraocular pressure with vision loss, not responding to treatment).
• if the patient has been diagnosed with myasthenia gravis (excessive muscle weakness).
• if the patient has been diagnosed with severe ulcerative colitis (ulceration and inflammation of the large intestine).
• if the patient has been diagnosed with toxic megacolon (acute dilation of the colon).

Warnings and precautions
Before starting treatment with this medicine, discuss the following with your doctor or pharmacist:

• if the patient has difficulty passing urine and/or passes only small amounts of urine.
• if the patient has been diagnosed with a gastrointestinal disorder causing disturbances in food passage and/or digestion.
• if the patient has kidney function disorders (renal failure).
• if the patient has liver disease.
• if the patient has neurological disorders affecting blood pressure, intestinal function, and sexual performance (any autonomic neuropathy).
• if the patient has a hiatal hernia (herniation of an abdominal organ).
• if the patient has ever experienced slowed intestinal peristalsis or severe constipation (reduced gastrointestinal motility).
• if the patient has heart disorders such as:
  • abnormal ECG findings
  • slowed heart rate (bradycardia)
  • significant pre-existing heart conditions such as: cardiomyopathy (weakened heart muscle), myocardial ischemia (reduced blood flow to the heart), cardiac arrhythmias (irregular heartbeat), and heart failure
• if the patient has low levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia) in the blood.

Defur and other medicines
You must tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Tolterodine, the active substance in Defur, may interact with other medicines.
Concomitant use of tolterodine with the following medicines is not recommended:

• certain antibiotics (containing, among others, erythromycin, clarithromycin)
• medicines used to treat fungal infections (containing, among others, ketoconazole, itraconazole)
• medicines used to treat HIV infections.

Caution is advised when using Defur together with the following medicines:

• medicines affecting gastrointestinal motility (containing, among others, metoclopramide, cisapride)
• medicines used to treat cardiac arrhythmias (containing, e.g., amiodarone, sotalol, quinidine, procainamide)
• other medicines with effects similar to Defur (antimuscarinic properties) or with opposing effects (cholinergic properties). Slowed gastrointestinal motility caused by antimuscarinic medicines may affect the absorption of other medicines.

Defur and food
Defur can be taken regardless of meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Defur should not be used during pregnancy.

Breastfeeding
It is not known whether tolterodine, the active substance in Defur, passes into human milk. Breastfeeding is not recommended during treatment with Defur.

Before taking any medicine, consult your doctor or pharmacist.

Driving and operating machinery
Defur may cause dizziness, fatigue, or visual disturbances. If any of these symptoms occur, the patient should not drive or operate machinery.

Defur contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release capsule, meaning the medicine is considered "sodium-free".

3. How to use Defur

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
Adults
The usual recommended dose is one prolonged-release hard capsule 4 mg once daily.
Patients with liver or kidney function disorders
In patients with impaired liver or kidney function, the doctor may reduce the dose to 2 mg
of Defur per day.
Use in children
Defur is not recommended for use in children.
Method of administration
Prolonged-release hard capsules are intended for oral administration and should be swallowed whole.
Do not chew the capsules.
Duration of treatment
Your doctor will inform you about the duration of treatment with Defur. Do not stop treatment if
you do not notice immediate improvement. The bladder will require some time to adapt. Complete
the full course of treatment with prolonged-release capsules as prescribed by your doctor. If after
this time you do not notice any improvement, you should contact your doctor.
After 2 or 3 months, the effectiveness of treatment should be re-evaluated.
Taking more Defur than recommended
If you take more prolonged-release capsules than recommended, seek immediate advice from your
doctor or pharmacist. Symptoms of overdose include hallucinations, agitation, rapid heartbeat,
dilated pupils, difficulty urinating and breathing difficulties.
Missing a dose of Defur
If you forget to take your capsule 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
dosing schedule.
Do not take a double dose to make up for a missed dose.
Stopping Defur
Always consult your doctor before stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact your doctor immediately or go to hospital if you experience symptoms of angioedema, such as:

• swelling of the face, tongue or throat
• difficulty swallowing
• rash and breathing difficulties.

You should also seek medical help if you experience hypersensitivity reactions (for example: itching, rash, urticaria, breathing difficulties). These reactions occur uncommonly (in no more than 1 in 100 people).
If you notice any of the following symptoms, you should contact your doctor or go to the nearest hospital:

• chest pain, breathing difficulties or rapid fatigue (even at rest), breathing difficulties at night, swelling of the legs. These may be symptoms of heart failure, which occur uncommonly (in no more than 1 in 100 people).

The following adverse reactions have been observed during treatment with Defur, with the following frequency:
Very common adverse reactions (occur in more than 1 in 10 people):

• dry mouth

Common adverse reactions (occur in no more than 1 in 10 people):

• sinusitis
• dizziness, drowsiness, headache
• dry eyes, blurred vision
• indigestion (dyspepsia), constipation, abdominal pain, excessive gas accumulation in the stomach or intestines
• painful or difficult urination
• diarrhoea
• fluid retention causing oedema (e.g. of the ankles)
• fatigue

Uncommon adverse reactions (occur in no more than 1 in 100 people):

• allergic reactions
• palpitations
• nervousness
• heart rhythm disorders, heart failure
• chest pain
• urinary retention
• tingling sensation in fingers and toes
• labyrinthine dizziness
• memory disturbances

In addition, the following adverse reactions have been reported: severe allergic reactions, confusion, hallucinations,
increased heart rate, sudden skin flushing, heartburn, vomiting, angioedema,
dry skin and disorientation. Cases of worsening dementia symptoms have also been reported
in patients treated for dementia.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Defur

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton, after EXP.
The expiry date refers to the last day of the specified month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This helps protect the environment.

6. Package contents and other information

What Defur contains
The active substance is tolterodine tartrate. Each prolonged-release hard capsule contains 4 mg of tolterodine tartrate, equivalent to 2.74 mg of tolterodine.
Other ingredients are:
monohydrate lactose, microcrystalline cellulose, polyvinyl acetate, povidone, colloidal anhydrous silica, sodium lauryl sulfate, sodium docucyl sulfate, magnesium stearate, hydroxypropylmethylcellulose.
Capsule composition: indigo carmine (E132), titanium dioxide (E171), gelatin.
Inner tablet coating: ethylcellulose, triethyl citrate, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, propylene glycol.

What Defur looks like and contents of the pack
Defur is a prolonged-release hard capsule for once-daily administration, with a light blue opaque cap and a light blue opaque body.

Defur is available in the following pack sizes:
Blister packs containing 14, 28, and 90 prolonged-release capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Tel: (22) 345 93 00

Manufacturers:
Pharmathen S.A., 6, Dervenakion Str. 153 51 Pallini Attiki, Greece
Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków, Poland
Pharmathen International S.A., Sapes Industrial Park, Block 5, 69300 Rodopi, Greece
Pharmadox Healthcare Ltd, KW20A Kordin Industrial Park, Paola, PLA 3000, Malta
Pharmacare Premium Ltd, HHF 003, Hal Far Industrial Estate, Birzebbugia BBG3000, Malta
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
Pharmachemie B.V, Swensweg 5, 2031 GA Haarlem, Netherlands
Merckle GmbH, Ludwig-Merckle Straße 3, 89143 Blaubeuren, Germany

This medicinal product is authorised in the European Economic Area under the following names:
Belgium: Tolterodine Teva Retard 4 mg capsules met verlengde afgifte, hard
Denmark: Tolterodintartrat Teva
Finland: Tolterodine ratiopharm
Greece: Tolterodine Teva 4 mg καψάκια παρατεταμένης αποδέσμευσης, σκληρά
Spain: Tolterodina Neo Teva-ratiopharm 4 mg cápsulas duras de liberación prolongada EFG
Netherlands: Tolterodinetartraat retard 4 mg Teva, capsules met verlengde afgifte
Ireland: Trusitev 4 mg Prolonged-release Capsules, hard
Luxembourg: Tolterodin-ratiopharm 4 mg Retardkapseln
Germany: Tolterodin-ratiopharm 4 mg Retardkapseln
Norway: Tolterodine Teva
Poland: Defur
Slovakia: Tolterodin Teva 4 mg
Slovenia: Tolterodin Teva 4 mg trde kapsule s podaljšanim sproščanjem
Sweden: Tolterodine Teva
United Kingdom: SASPRED 4 mg Prolonged-release Capsules, hard