URODIE 2 mg Tablet

Зміст інструкції

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

URODIE 2 mg tablets, 5 mg tablets

Terazosin base

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is URODIE and what is it used for

URODIE contains the active substance terazosin, which belongs to the group of medicines
called “alpha-adrenergic receptor antagonists”. These medicines induce a
relaxation of the muscles of the bladder and prostate, promoting bladder emptying.
This medicine is used in the treatment of a condition called Benign Prostatic Hyperplasia (or BPH). This condition is caused by an increase in the volume of the
prostate.
An enlarged prostate can partially block the outflow of urine from the bladder. This
partial blockage leads to symptoms such as:

• weak or intermittent urine flow;
• the need to urinate frequently or at night;
• urgent urge to urinate.

2. What you need to know before taking URODIE

Do not take URODIE

• if you are allergic to the active ingredient, terazosin, or to other quinazoline medicines (such as prazosin, doxazosin) or to any of the other ingredients of this medicine (listed in section 6);
• if you have experienced a brief loss of consciousness while urinating or immediately after urinating. This symptom is more common if you move quickly from a sitting or lying position to a standing position;
• if you suffer from low blood pressure (orthostatic hypotension).

Warnings and precautions
Talk to your doctor or pharmacist before taking URODIE.
Talk to your doctor before taking URODIE if you suffer or have suffered from any of the
following conditions:

• fainting, feeling unstable or dizzy (head spinning), due to low blood pressure when standing (upright position). This is more likely to happen: or when you start treatment; or when you restart treatment after a break of a few days; or if you are elderly (over 65 years of age). You are at greater risk of fainting when standing if: or your dose of URODIE is increased rapidly; or if you are taking medicines to make you urinate more (diuretics) or other medicines to lower blood pressure (medicines used to treat hypertension). If you are about to faint, you may experience some sensations such as: dizziness, lightheadedness, drowsiness and an increased heartbeat that becomes more intense (palpitations). If you experience any of these sensations, sit or lie down. Do not stand up until the sensations have subsided. If you experience these symptoms when you are sitting or lying down, inform your doctor.
• low blood pressure(hypotension). Your doctor will check your blood pressure;
• heart problems, pulmonary edema (fluid in the lungs), heart failure or myocardial infarction;
• liver problems(reduced liver function).

If you are going to have eye surgeryfor cataracts (clouding
of the lens), tell your ophthalmologist before the operationthat you are using or have
previously used this medicine.
This is because URODIE can cause complications during surgery. These
complications can be managed if your specialist is prepared in advance.

Other medicines and URODIE
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
It is particularly important that your doctor knows if you are taking:

• medicines used to treat high blood pressure (i.e. antihypertensives including diuretics) or enlarged prostate;
• medicines used to treat erectile dysfunction (e.g. sildenafil, tadalafil, vardenafil). In some patients taking therapy for high blood pressure or enlarged prostate with alpha-adrenergic receptor antagonists, such as this medicine, episodes of dizziness have occurred. These sensations

may be caused by low blood pressure when in a
sitting position or getting up quickly. Some patients have experienced these symptoms
while taking medicines for erectile dysfunction (impotence) together with alpha
adrenergic receptor antagonists, such as this medicine.

Pregnancy, breastfeeding and fertility
This medicine is intended for the treatment of a disease that only affects men,
therefore it should not be used in women.

Driving and using machines
This medicine has a significant influence on the ability to drive and use
machines.
When you take a first dose of this medicine, or when you take the first
dose after a period of stopping treatment, you may experience sensations such as
dizziness, lightheadedness or drowsiness.
Do not drive and do not use machines that require attention for at least 12 hours after
taking the first dose or whenever the usual dose is increased.

URODIE tablets contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before
taking this medicine.

URODIE tablets contain Sunset Yellow FCF (E110).
May cause allergic reactions.

3. How to take URODIE

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.
The recommended initial dose is half a 2 mg tablet per day (equal to 1 mg of terazosin).
The dose may be gradually increased every week or every two weeks until the dose suitable for you is reached. The maintenance dose is generally
between 1 and 2 5 mg tablets per day (equal to 5 mg - 10 mg of terazosin per day).

Method of administration
Take the daily dose of this medicine in a single administration. At the beginning of
treatment, take URODIE at bedtime, as there is always a risk of dizziness
or fatigue. Subsequently, you may take the daily dose in the morning.
Avoid sudden changes in position or any activities that may cause dizziness or
fatigue, especially if you are elderly(over 65 years of age) and/or at the beginning of
treatment.
The doctor may adjust the dose depending on your response to treatment.

Use in children
This medicine should be avoided in children because its efficacy and
safety are not known.

If you take more URODIE than you should
If you have taken a dose of this medicine higher than what has been prescribed by your doctor,

contact the emergency room of the nearest hospital. Bring this leaflet and the
package of the medicinewith you, even if it is empty.
An overdose of this medicine may lower your blood pressure too much and
cause other serious effects.

If you forget to take URODIE
Do not take a double dose to make up for a missed dose.

If you stop taking URODIE
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience difficulty breathing, shortness of breath, skin rash and
low blood pressure, immediately inform your doctorand stop
taking this medicine. These may be symptoms of an allergic reaction and you
may need immediate medical attention.
The following have been reported with the use of this medicine:

• muscle weakness (asthenia), dizziness, drowsiness, headache, widespread tingling (paresthesia), inability to achieve and maintain an erection (impotence);
• perception of your heartbeat (palpitations), fast heartbeat (tachycardia);
• low blood pressure (orthostatic hypotension), fainting (syncope);
• nausea;
• swelling of the extremities (peripheral edema), swelling (edema);
• inflammation of the paranasal sinuses (sinusitis);
• nasal congestion (frequency not known);
• difficulty breathing (dyspnea);
• decreased vision (amblyopia), blurred vision;
• back pain, pain in legs and arms;
• weight gain;
• decreased sexual desire, depression, nervousness.

The following side effects have also been reported in association with the use of this
medicine, but it is not yet known whether there is a relationship with treatment with URODIE:

• chest pain, abdominal pain, neck pain, shoulder pain;
• facial swelling (facial edema), fever;
• excessive dilation of blood vessels (vasodilation), changes in heart rate (arrhythmia);
• constipation, diarrhea, dry mouth (xerostomia), indigestion (dyspepsia), flatulence, vomiting;
• gout;
• joint pain and discomfort, joint inflammation (arthritis), muscle pain (myalgia);
• anxiety, insomnia;
• bronchitis, flu and cold symptoms, sore throat (pharyngitis), inflammation of the nasal mucosa (rhinitis), nosebleeds (epistaxis), increased cough;
• itching, skin rash;
• sweating;
• altered vision, eye inflammation (conjunctivitis);
• ringing in the ears (tinnitus);
• frequent urination, urinary tract infection and involuntary loss of urine (urinary incontinence);
• reduced number of platelets (thrombocytopenia), changes in blood composition (hemodilution);
• prolonged and painful erections (priapism).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet,
tell your doctor or pharmacist.
You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.
By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store URODIE

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What URODIE contains
URODIE 2 mg tablets:

• The active ingredient is terazosin base. Each tablet contains 2.374 mg of terazosin dihydrochloride dihydrate (corresponding to 2 mg of terazosin base).
• The other ingredients are lactose, corn starch, talc, magnesium stearate, sunset yellow FCF (E110).

URODIE 5 mg tablets:

• The active ingredient is terazosin base. Each tablet contains 5.935 mg of terazosin dihydrochloride dihydrate (corresponding to 5 mg of terazosin base).
• The other ingredients are lactose, corn starch, talc, magnesium stearate, sunset yellow FCF (E110), indigotine (E132).

Description of the appearance of URODIE and contents of the pack
URODIE 2 mg tablets are presented in a pack of 10 tablets in blisters.
URODIE 5 mg tablets are presented in a pack of 14 tablets in blisters.

Marketing Authorisation Holder
Laboratorio Farmaceutico S.I.T. S.r.l. – via Cavour, 70 – 27035 Mede (PV)

Manufacturer
Special Product’s Line S.p.A. – Strada Paduni, 240 – 03012 Anagni (FR)