Uroflow sr

Patient Information Leaflet: Read this leaflet carefully before using the medicine, as it contains important information for you.

Uroflow SR, 4 mg, prolonged-release capsules, hard
Tolterodini tartras
Please read all of this leaflet carefully before 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

1. What Uroflow SR is and what it is used for

The active substance in Uroflow SR is tolterodine. Tolterodine belongs to a group of medicines called antimuscarinics.
Uroflow SR is used in the treatment of symptoms of overactive bladder syndrome. When overactive bladder syndrome occurs, patients may experience:

• Inability to control urination.
• Sudden urgent need to rush to the toilet without prior warning (and/or) increased frequency of urination.

2. Important information before taking Uroflow SR

When not to use Uroflow SR:

• if the patient is allergic to the active substance 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 untreated narrow-angle glaucoma (increased pressure in the eye with risk of vision loss, which has not been adequately treated),
• if the patient has myasthenia gravis (excessive muscle weakness),
• if the patient has severe ulcerative colitis (inflammation of the large intestine with ulcers),
• if the patient has toxic megacolon (acute dilation of the colon).

Warnings and precautions
Before starting treatment with Uroflow SR, discuss with your doctor or pharmacist if:

• the patient has difficulty passing urine or a weak urine stream,
• the patient has a gastrointestinal disorder affecting the movement of food and/or digestion,
• the patient has kidney problems (renal impairment),
• the patient has liver disease,
• the patient has nervous system disorders that may affect blood pressure, intestinal function, or sexual performance (any autonomic neuropathy),
• the patient has a hiatal hernia (protrusion of an abdominal organ into the chest),
• the patient has reduced intestinal motility or severe constipation (impaired gastrointestinal motility),
• the patient has heart conditions such as:
• abnormal ECG findings,
• slow heart rate (bradycardia),
• significant pre-existing heart disease, such as cardiomyopathy (weakened heart muscle), myocardial ischemia (reduced blood flow to the heart), arrhythmias (irregular heartbeat), or heart failure,
• the patient has low levels of potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia) in the blood.

Uroflow SR and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Some medicines may interact with tolterodine, the active substance in Uroflow SR.
Concomitant use of tolterodine is not recommended with:

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

Use Uroflow SR with caution when taken together with:

• medicines affecting gastrointestinal motility (containing, for example, metoclopramide or cisapride),
• medicines used to treat irregular heartbeat (containing, for example, amiodarone, sotalol, quinidine, procainamide), or other medicines with similar action to Uroflow SR (antimuscarinic properties), or medicines with opposing action to Uroflow SR (cholinergic properties). Reduced gastrointestinal motility caused by antimuscarinic medicines may affect the absorption of other medicines. If in doubt, consult your doctor.

Uroflow SR with food and drink
Uroflow SR can be taken before, after, or during a meal.

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

Pregnancy
Uroflow SR is not recommended during pregnancy. Inform your doctor immediately if the patient is pregnant, suspects she may be pregnant, or is planning a pregnancy.

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

Driving and operating machinery
Uroflow SR may cause dizziness, tiredness, or blurred vision. If the patient experiences any of these symptoms, he or she should not drive or operate machinery.

Uroflow SR contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Uroflow SR

Dosage
This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults
The recommended dose is one 4 mg prolonged-release hard capsule once daily.
Patients with impaired kidney or liver function
For patients with impaired kidney or liver function, the doctor may reduce the dose of Uroflow SR to 2 mg once daily.
Children
Uroflow SR is not recommended for use in children.
Prolonged-release hard capsules are intended for oral administration and must be swallowed whole.
Do not chew the capsules.
Taking more Uroflow SR than recommended
If too many prolonged-release capsules are taken, contact a doctor or pharmacist immediately. Symptoms of overdose include hallucinations, severe agitation, rapid heartbeat, dilated pupils, difficulty urinating, and breathing problems.
Missed dose of Uroflow SR
If a patient forgets to take a dose at the usual time, they should take it as soon as they remember, unless it is almost time for the next dose. In that case, the missed dose should be skipped and treatment should continue according to the normal dosing schedule.
Do not take a double dose to make up for a missed dose.
Stopping Uroflow SR treatment
The doctor will inform the patient about the duration of treatment with Uroflow SR. Do not stop treatment prematurely because immediate effects are not felt. Time is needed for the bladder to adapt. Complete the course of prolonged-release capsules as directed by the doctor. Contact the doctor if no treatment effect has occurred by then.
The benefits of treatment should be reassessed after 2 or 3 months. Always consult a doctor if considering stopping treatment.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Seek medical attention or go to the emergency room if any of the following symptoms occur:

• severe allergic reaction or angioedema (frequency unknown, cannot be estimated from available data), such as:
• swelling of the face, tongue or throat, difficulty swallowing or breathing;
• hives, rash, itching;
• heart failure (uncommon - may affect up to 1 in 100 patients), such as:
• chest pain, shortness of breath or easy fatigue (even at rest), difficulty breathing at night, swelling of the legs.

The adverse effects listed below have been observed during treatment with tolterodine, with the following frequencies:
Very common (may affect more than 1 in 10 patients):

• dry mouth.

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

• sinusitis – central dizziness
• drowsiness – headache
• dry eyes – blurred vision
• indigestion – constipation (dyspepsia)
• abdominal pain – excessive air or gas in the stomach or intestines
• painful or difficult – diarrhoea urination
• fluid retention – fatigue causing swelling in the body (e.g. around the ankles)

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

• allergic reactions – heart failure
• nervousness – irregular heartbeat
• palpitations – chest pain (heart pounding)
• inability to empty the bladder – tingling sensation in fingers and feet
• peripheral (vestibular) dizziness – memory impairment

Unknown (frequency cannot be estimated from available data):

Worsening of dementia symptoms has also been reported in patients treated for this condition.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.
Adverse effects can also be reported to the marketing authorisation holder or the representative of the marketing authorisation holder in Poland.

5. How to store Uroflow SR

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the HDPE bottle or blister pack and on the outer carton. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Shelf life after first opening of the HDPE bottle: 200 days.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the package and other information

What Uroflow SR contains
The active substance in Uroflow SR, prolonged-release hard capsules, is 4 mg
of tolterodine tartrate, corresponding to 2.74 mg of tolterodine.
Other ingredients of the medicinal product:
monohydrate lactose, microcrystalline cellulose, polyvinyl acetate, povidone (K 30), anhydrous colloidal silicon dioxide, sodium lauryl sulfate, sodium docusate, magnesium stearate, hypromellose (75000 – 140000 mPas).
Capsule shell: indigo carmine (E 132), titanium dioxide (E 171), gelatin.
Inner tablet coating: ethylcellulose (8 – 11 mPas), triethyl citrate, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, propylene glycol.

What Uroflow SR looks like and contents of the pack
Uroflow SR is a prolonged-release hard capsule for once-daily administration.
Uroflow SR 4 mg prolonged-release hard capsule (19.4 x 6.9 mm) is opaque light blue – opaque light blue.
The medicine is packed in blisters containing: 7, 14, 28, 49, 84, or 98 prolonged-release hard capsules.
HDPE bottles contain: 30, 100 or 200 prolonged-release hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer
Pharmathen S.A.
Dervenakion 6
153 51 Pallini Attiki
Greece
Pharmathen International SA
Industrial Park Sapes Rodopi Prefecture
Block No 5
693 00 Rodopi
Greece

For further information about this medicinal product and its names in the European Economic Area member states, please contact:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00