UROFLOW 1 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
2. What is Uroflow and what is it used for
3. Important information before taking Uroflow
   1. When not to take Uroflow:
   2. Warnings and precautions
   3. Uroflow and other medicines
   4. Uroflow with food and drink
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Uroflow contains sodium
4. How to take Uroflow
   1. Use in children and adolescents
   2. Overdose of Uroflow
   3. Missed dose of Uroflow
   4. Stopping Uroflow treatment
5. Possible side effects
   1. Stop taking Uroflow and contact your doctor immediately if you experience any of the following side effects with unknown frequency:
   2. Reporting side effects
6. How to store Uroflow
7. Contents of the pack and other information
   1. What Uroflow contains
   2. What Uroflow looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. For more information about this medicine and its authorized names in the Member States of the European Economic Area, please contact:

Package Leaflet: Information for the User

UROFLOW 1, 1 mg, coated tablets
UROFLOW 2, 2 mg, coated tablets
Tolterodine hydrogen tartrate

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

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

Table of Contents of the Leaflet

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

1. What is Uroflow and what is it used for

Uroflow belongs to a group of medicines that reduce bladder muscle tension.
Uroflow is used to treat symptoms of an overactive bladder, such as: sudden, frequent urination or incontinence with urgent need to urinate.
The medicine is intended for use in adults.

2. Important information before taking Uroflow

When not to take Uroflow:

• if you are allergic to tolterodine or any of the other ingredients of this medicine (listed in section 6),
• if you have reduced ability to empty the bladder,
• if you have glaucoma (high pressure in the eye and eye pain) that is difficult to treat,
• if you have myasthenia (nerve-muscle function disorders with muscle weakness),
• if you have severe ulcerative colitis (inflammation of the intestine with ulcers and bloody diarrhea) or toxic megacolon (a life-threatening complication of ulcerative colitis or other intestinal diseases).

Warnings and precautions

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

• if you have difficulty urinating or a weak urine stream,
• if you have acute painful abdominal distension affecting digestion and movement of food or have had or have severe constipation,
• if you have kidney or liver problems. In such cases, the doctor will usually reduce the recommended dose of the medicine,
• if you have been diagnosed with autonomic neuropathy (a nerve disorder, sometimes with diabetes, which can lead to diarrhea, erection disorders, or low blood pressure),
• if you have a hiatal hernia (displacement of a fragment of the stomach from the abdominal cavity to the chest through a natural opening in the diaphragm),
• if you have heart rhythm disorders, such as:
• abnormal ECG recording,
• slow heart rate (bradycardia) or if you are taking any medicines that are known to affect heart rate,
• significant pre-existing heart diseases, such as:
• cardiomyopathy (heart muscle weakness);
• myocardial ischemia (reduced blood flow to the heart);
• heart rhythm disorders (irregular heart rhythm);
• heart failure.
• if you have low potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia) levels in the blood.

Uroflow 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 Uroflow and enhance its effect:

• antibiotics containing erythromycin and clarithromycin,
• medicines used to treat fungal infections,
• medicines used to treat HIV infections,
• medicines used to treat irregular heart rhythm (containing, for example, amiodarone, sotalol, quinidine, procainamide),
• other medicines with a similar effect to Uroflow (antimuscarinic properties) or medicines with an opposite effect to Uroflow (cholinergic properties).

Uroflow may reduce the effect of medicines that stimulate bowel movements (medicines containing metoclopramide or cisapride). If you are unsure whether the above information applies to you, consult your doctor.

Uroflow with food and drink

The medicine can be taken with or without food, with a glass of water.

Pregnancy and breastfeeding

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.
Uroflow is not recommended during pregnancy.
Breastfeeding women should avoid taking this medicine.

Driving and using machines

Uroflow may cause blurred vision and reduce reaction ability. Always consult your doctor if you plan to drive or operate machinery.

Uroflow contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Uroflow

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, ask your doctor or pharmacist.
Adults (including elderly patients)
The recommended dose is 2 mg (1 tablet of Uroflow 2) twice a day. The tablet should be swallowed whole.
Patient with kidney or liver impairment
The recommended dose is 1 mg (1 tablet of Uroflow 1) twice a day.
After 2 or 3 months, the effectiveness of the treatment should be re-evaluated.

Use in children and adolescents

Uroflow is not recommended for use in children and adolescents.

Overdose of Uroflow

Do not take more tablets than your doctor has recommended. If you accidentally take more tablets than recommended, seek medical attention immediately or go to the nearest hospital. If a child accidentally takes the medicine, seek medical attention immediately.

Missed dose of Uroflow

If you forget to take a tablet at the usual time, take it as soon as you remember, unless it is time for your next dose.
Do not take a double dose to make up for a forgotten dose.

Stopping Uroflow treatment

Do not stop treatment.
Your doctor will inform you about the duration of treatment with Uroflow.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking Uroflow and contact your doctor immediately if you experience any of the following side effects with unknown frequency:

if you experienceany of the following side effects with unknown frequency:

• allergic reaction with skin rash, facial swelling, or difficulty breathing (angioedema);
• hives, sudden swelling around the eyes, feeling of pressure on the chest with difficulty breathing or swallowing, blue discoloration of the skin, low blood pressure (anaphylactoid reaction).

During treatment with tolterodine (the active substance of Uroflow), the following side effects may occur (divided according to their frequency); if any of these side effects bother you, tell your doctor, who may reduce the dose of the medicine.
Very common(may affect more than 1 in 10 people):

• dry mouth,
• headache.

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

• bronchitis,
• dizziness of central origin, drowsiness, sensory disturbances - feeling of tingling in fingers and toes (paresthesia),
• dry eyes, abnormal vision (blurred vision),
• dizziness of peripheral origin (vestibular),
• palpitations,
• discomfort in the stomach after meals (dyspepsia), constipation, abdominal pain, bloating, vomiting, diarrhea,
• painful or difficult urination, urinary retention,
• dry skin,
• fatigue, chest pain, fluid retention leading to swelling (e.g., of the ankles),
• weight gain.

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

• allergic reactions (allergic),
• nervousness,
• rapid heart rate, heart failure, irregular heart rhythm,
• heartburn,
• memory disorders.

Unknown(frequency cannot be estimated from available data):

• confusion, hallucinations, and disorientation,
• redness of the skin,
• in patients treated for dementia, cases of worsening of dementia symptoms have also been reported.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. 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.
Al. Jerozolimskie 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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after 'EXP'.
The expiry date refers to the last day of that month.
Store in the original package to protect from moisture.
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 contains

The active substance is tolterodine hydrogen tartrate. Each coated tablet contains 1 mg or 2 mg of tolterodine hydrogen tartrate.
The medicine also contains:
Tablet core:microcrystalline cellulose, sodium carboxymethylcellulose (type A), anhydrous colloidal silica, sodium stearyl fumarate.
Tablet coating:
Uroflow 1: hypromellose 2910/5, macrogol 6000, titanium dioxide (E171), yellow iron oxide (E172), talc.
Uroflow 2: hypromellose 2910/5, macrogol 6000, titanium dioxide (E171), talc.

What Uroflow looks like and contents of the pack

Uroflow 1: yellow, round, biconvex coated tablets.
Uroflow 2: white, round, biconvex coated tablets.
Pack size: 28 or 56 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s., U kabelovny 130, Dolni Měcholupy, 10237 Praha 10, Czech Republic

Manufacturer

Zentiva, k.s., U kabelovny 130, Dolni Měcholupy, 10237 Praha 10, Czech Republic

For more information about this medicine and its authorized names in the Member States of the European Economic Area, please contact:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
Date of last revision of the leaflet:January 2021