Uroflov Sr

Package Leaflet: Information for the User

Uroflow SR 4 mg, prolonged-release hard capsules
Tolterodine tartrate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 1. What Uroflow SR is and what it is used for
• 2. Important information 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 of Uroflow SR is tolterodine. Tolterodine belongs to a group of medicines called antimuscarinic agents.
Uroflow SR is used to treat the symptoms of overactive bladder. When overactive bladder occurs, the patient may experience:

• inability to control urination.
• sudden need to urinate quickly without prior sensation (urge incontinence) or frequent urination.

2. Important information before taking Uroflow SR

When not to take Uroflow SR:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if you have reduced ability to empty the bladder (urinary retention),
• if you have uncontrolled narrow-angle glaucoma (high pressure in the eye with vision loss, not treated),
• if you have myasthenia gravis (excessive muscle weakness),
• if you have severe ulcerative colitis (inflammation of the large intestine with ulcers),
• if you have toxic megacolon (acute dilation of the colon).

Warnings and precautions

Before starting to take Uroflow SR, discuss with your doctor or pharmacist:

• if you have difficulty urinating or a weak urine stream,
• if you have a gastrointestinal disease that affects the movement of food and/or digestion,
• if you have kidney problems (renal insufficiency),
• if you have liver disease,
• if you have autonomic nervous system disorders that may affect blood pressure, bowel movements, or sexual function (any autonomic neuropathy),
• if you have a hiatal hernia (protrusion of the stomach into the chest),
• if you have weakened intestinal movements or severe constipation (decreased gastrointestinal motility),
• if you have heart rhythm disorders, such as:
• abnormal ECG,
• slow heart rate (bradycardia),
• pre-existing heart conditions, such as cardiomyopathy (heart muscle weakness), myocardial ischemia (reduced blood flow to the heart), arrhythmias (irregular heart rhythm), and heart failure,
• if you have 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 you are taking or have recently taken, as well as any medicines you plan to take.
Some medicines may interact with tolterodine, the active substance of Uroflow SR.
It is not recommended to take tolterodine at the same time as:

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

Be cautious when taking Uroflow SR at the same time as:

• medicines that affect the movement of food (containing e.g. metoclopramide and cisapride),
• medicines used to treat irregular heart rhythm (containing e.g. amiodarone, sotalol, quinidine, procainamide) or other medicines with similar effects to Uroflow SR (antimuscarinic properties) or medicines with opposite effects to Uroflow SR (cholinergic properties). Reduced gastrointestinal motility caused by antimuscarinic agents 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Uroflow SR should not be used during pregnancy. Inform your doctor immediately if you are pregnant, think you may be pregnant, or plan to become pregnant.
Breastfeeding
It is not known whether tolterodine, the active substance of Uroflow SR, passes into breast milk. Breastfeeding is not recommended during treatment with Uroflow SR.

Driving and using machines

Uroflow SR may cause dizziness, fatigue, or blurred vision.
If you experience any of these symptoms, do not drive or operate machinery.

Uroflow SR contains lactose

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Uroflow SR

Dosage

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Adults
The recommended dose is one 4 mg prolonged-release hard capsule per day.
Patients with kidney or liver problems
Your doctor may reduce the dose of Uroflow SR to 2 mg once daily if you have kidney or liver problems.
Children
Uroflow SR is not recommended for children.
The prolonged-release hard capsules are for oral use and should be swallowed whole.
Do not chew the capsules.

If you take more Uroflow SR than you should

If you have taken too many capsules, contact your doctor or pharmacist immediately. Symptoms of overdose include hallucinations, severe excitement, rapid heartbeat, dilated pupils, difficulty urinating, and breathing difficulties.

If you forget to take Uroflow SR

If you forget to take a dose at the usual time, take it as soon as you remember, unless it is time for the next dose. In this case, skip the missed dose and continue with your normal dosing schedule.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Uroflow SR

Your doctor will tell you how long to take Uroflow SR. Do not stop treatment early because you do not feel an immediate effect. Time is needed for the bladder to adapt. Finish taking the prolonged-release hard capsules as prescribed by your doctor. If you have not seen any effect by then, consult your doctor.
The benefits of treatment should be reassessed after 2 or 3 months. Always consult your doctor if you are considering stopping treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Uroflow SR can cause side effects, although not everybody gets them.
See a doctor or go to a hospital if you experience:

• severe allergic reaction or angioedema (frequency not known, 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 people), such as:
• chest pain, difficulty breathing or tiredness (even at rest), difficulty breathing at night, swelling of the legs.

The following side effects have been reported with tolterodine:

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

• dry mouth.

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

• sinusitis
• central nervous system dizziness
• drowsiness
• headache
• dry eyes
• blurred vision
• difficulty digesting
• constipation (indigestion)
• abdominal pain
• excess air or gas in the stomach or intestines
• painful or difficult urination
• fluid accumulation
• fatigue in the body causing swelling (e.g. around the ankles)

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

• allergic reactions
• heart failure
• nervousness
• irregular heartbeat
• palpitations
• chest pain (palpitations)
• inability to empty the bladder
• tingling sensation in fingers and toes
• peripheral dizziness
• memory disorders (peripheral)

Not known(frequency cannot be estimated from available data):

There have also been reports of worsening dementia symptoms in patients treated for this condition.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Jerozolimskie Avenue 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl By reporting side effects, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder or its representative in Poland.

5. How to store Uroflow SR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, blister, or carton. The expiry date refers to the last day of the month.
Do not store above 30°C.
Shelf life after first opening of the HDPE bottle: 200 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Uroflow SR contains

The active substance of Uroflow SR, prolonged-release hard capsules, is 4 mg tolterodine tartrate, equivalent to 2.74 mg tolterodine.
Other ingredients of the medicine:
lactose monohydrate, microcrystalline cellulose, polyvinyl acetate, povidone (K 30), colloidal silica, sodium lauryl sulfate, sodium docusate, magnesium stearate, hypromellose (75000 - 140000 mPa·s).
Cap shell: indigo carmine (E 132), titanium dioxide (E 171), gelatin.
Inner tablet coating: ethyl cellulose (8 - 11 mPa·s), 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 oral use.
Uroflow SR, 4 mg, prolonged-release hard capsule (19.4 x 6.9 mm) is blue-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 authorization 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 on this medicine and its authorized names in the European Economic Area, please contact:

Zentiva Polska Sp. z o.o.
Bonifraterska 17 Street
00-203 Warsaw
phone: +48 22 375 92 00

Date of last revision of the leaflet: