TERAZOSINA 2 mg Coated Tablet

Зміст інструкції

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

TERAZOSINA ZENTIVA 2 mg tablets, 5 mg tablets

Generic medicine
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 their symptoms are the same as yours, as it could 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 TERAZOSINA ZENTIVA is and what it is used for
• 2. What you need to know before you take TERAZOSINA ZENTIVA
• 3. How to take TERAZOSINA ZENTIVA
• 4. Possible side effects
• 5. How to store TERAZOSINA ZENTIVA
• 6. Contents of the pack and other information

1. What is TERAZOSINA ZENTIVA and what it is used for

This medicine contains the active ingredient terazosin, which belongs to a class of medicines called
alpha-adrenergic antagonists or “alpha blockers”. Terazosin works by relaxing blood vessels, lowering
blood pressure and relaxing the bladder and muscles of the urinary system in order to help
urine elimination in patients affected by a prostate problem (benign prostatic hyperplasia).
TERAZOSINA ZENTIVA is indicated:

• for the treatment of high blood pressure (mild to moderate hypertension);
• in case of obstruction of the urinary tract due to prostate enlargement (benign prostatic hyperplasia).

2. What you need to know before taking TERAZOSINA ZENTIVA

Do not take TERAZOSINA ZENTIVA

• if you are allergic to terazosin, to similar substances (quinazolines such as prazosin, doxazosin) or to any of the other ingredients of this medicine (listed in section 6);
• if you have experienced temporary loss of consciousness while urinating (micturition syncope).

Warnings and precautions
Talk to your doctor or pharmacist before taking TERAZOSINA ZENTIVA.
During treatment with this medicine, your doctor needs to monitor you,
especially after taking the first dose or if your doctor has increased the dosage, as you may
experience a feeling of dizziness due to a marked decrease in blood pressure, particularly
when getting up (orthostatic hypotension). If you experience dizziness, lightheadedness, a feeling of
weakness, drowsiness or temporary loss of consciousness, lie down or sit down and tell your doctor.
The risk of a decrease in blood pressure is greater if:

• you are taking medicines for erectile dysfunction (phosphodiesterase type 5 inhibitors such as sildenafil, tadalafil, vardenafil, see section “Other medicines and TERAZOSINA ZENTIVA”);
• you have a problem with the prostate (benign prostatic hyperplasia);
• you are over 65 years of age;
• you restart therapy after forgetting a dose of this medicine (see section “If you forget to take TERAZOSINA ZENTIVA); in this case, be particularly careful and consult your doctor.

To reduce the risk of a decrease in blood pressure, take exactly the dose that your
doctor has prescribed. Take the first dose of this medicine before bedtime and avoid sudden movements,
especially if you are an elderly person.
Take TERAZOSINA ZENTIVA with caution and consult your doctor if:

• you have a heart problem (aortic or mitral stenosis) that causes fluid to build up in the lungs (pulmonary edema);
• severe heart problems (severe heart failure);
• you have had a heart attack (right ventricular infarction) caused by problems with the blood vessels that carry blood to the lungs (pulmonary embolism) or by fluid buildup in the membrane surrounding the heart (pericardial effusion);
• you have had a heart attack in a part of the heart called the left ventricle with low blood pressure.
• you are going to have eye surgery (cataract) and are taking or have previously taken tamsulosin or any other medicine belonging to the class of medicines called alpha-adrenergic antagonists or “alpha blockers” (alpha-1 adrenergic antagonists); in this case, inform your surgeon;
• you are taking other medicines that can affect liver function;
• you have liver problems, especially if you have severe liver problems, avoid taking TERAZOSINA ZENTIVA.

Children
There is insufficient data to establish the safety and efficacy of this medicine in children.

Other medicines and TERAZOSINA ZENTIVA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Take this medicine with caution and inform your doctor if you are taking:

• medicines used to treat certain sexual disorders in men (phosphodiesterase type 5 inhibitors such as sildenafil, tadalafil, vardenafil);
• medicines used to treat high blood pressure (ACE inhibitors, beta-blockers, calcium channel blockers and diuretics);
• other medicines that belong to the category of alpha-adrenergic antagonists “alpha blockers”.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine if you are pregnant unless absolutely necessary and under direct medical supervision.
Do not take this medicine if you are breastfeeding.

Driving and using machines
This medicine can cause dizziness, lightheadedness and drowsiness which can impair your ability to
drive and use machines. If you are taking this medicine for the first time, if you take this medicine
after forgetting a dose, if your doctor has increased the dosage or if you experience the symptoms described,
avoid driving and using machines for at least 12 hours after taking the dose.

TERAZOSINA ZENTIVA contains lactose monohydrate
Terazosina Zentiva contains lactose monohydrate
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this
medicine.

3. How to take TERAZOSINA ZENTIVA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Take the tablet by mouth with a glass of water.
The first time you take TERAZOSINA ZENTIVA or if the dosage is changed by your doctor, you must
swallow the first tablet in the evening before going to bed. Afterwards you can take the tablets in the
morning.
The tablet can be divided into equal parts.
The dose will have to be adjusted according to your health conditions. Therefore your doctor will evaluate the dose
most suitable for you and may vary the dose bearing in mind that:

Recommended initial dose
The maximum initial doseis 1 mg (half a divisible 2 mg tablet) to be taken in the evening before
going to bed to avoid a sudden drop in blood pressure (see the paragraph “Warnings and
precautions”)

Subsequent doses
The subsequent dosesdepend on the type of therapy:

Treatment of high blood pressure (mild to moderate hypertension)
Your doctor may double the dose of terazosin every week until the desired effect is achieved.
The recommended maximum maintenance dose is 20 mg per day. Do not exceed this dose.

Treatment of high blood pressure in association with other medicines (thiazide diuretics and other antihypertensive agents)
If, during treatment with TERAZOSINA ZENTIVA, you are prescribed a diuretic or another
medicine to treat high blood pressure (antihypertensive), your doctor may reduce the dose or discontinue the
treatment with TERAZOSINA ZENTIVA. When restarting treatment, begin with the lowest dose
gradually increasing the dose; your doctor will establish the appropriate dose for you in order to avoid sudden
drops in pressure (see the paragraph “Other medicines and TERAZOSINA ZENTIVA”).

Treatment of benign prostatic hyperplasia
The recommended initial dose is half a 2 mg tablet per day for 7 days. Subsequently, your
doctor may double the dose every week or every two weeks depending on your health conditions.
The treatment provides for the following scheme:

• half a 2 mg tablet per day for 7 days;
• 2 mg tablets for 14 days;
• 5 mg tablets for 7 days.

The usual maintenance dose is between 5 mg and 10 mg, taken once a day.
The doctor will have to evaluate the response to treatment every four weeks.
At the beginning of therapy or when the doctor changes the dosage, some transient side effects may occur,
if these effects persist, inform the doctor who will have to consider a reduction of the
dosage (see the paragraph “Possible side effects”).

Use in the elderly
If you are an elderly person, your doctor will carefully establish the initial dose of TERAZOSINA ZENTIVA. If the
treatment with this medicine is interrupted, when resuming it, it is recommended to take the
initial dose.

Use in patients with liver problems (hepatic insufficiency)
If you have liver problems, the optimal dose must be identified with particular attention.
If you have severe liver problems (severe hepatic dysfunction), the use of TERAZOSINA ZENTIVA should be avoided
(see the paragraph “Warnings and precautions”).

If you take more TERAZOSINA ZENTIVA than you should
In case of overdose, a sudden drop in pressure may occur. If you experience symptoms of low pressure, lie down and inform your doctor.
In case of ingestion/taking an excessive dose of this medicine, immediately notify your
doctor or go to the nearest hospital.

If you forget to take TERAZOSINA ZENTIVA
Do not take a double dose to make up for the missed tablet.
If you forget to take the tablet for several days, inform your doctor because it may be necessary
to start again from the lowest dose. In this case, take TERAZOSINA ZENTIVA with caution because you may
experience a decrease in blood pressure (see the paragraph “Warnings and precautions”).

If you stop taking TERAZOSINA ZENTIVA
If you are taking this medicine for the treatment of high blood pressure, do not interrupt the
therapy unless otherwise advised by your doctor.
If discontinuation of treatment with TERAZOSINA ZENTIVA is necessary, your doctor will have to
re-identify the optimal dose starting from the recommended initial dose of 1 mg at bedtime.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Inform your doctor if you experience any side effects, especially if they persist.
Terazosina may cause temporary loss of consciousness (syncope). This usually occurs 30-90
minutes after taking the first dose of terazosina or when the dosage is increased. Sometimes
it may be preceded by an increase in heart rate (tachycardia 120-160 beats per
minute). If you experience this symptom, lie down and inform your doctor if this condition persists.
If you move quickly from a sitting or lying position to an upright position, you may experience episodes
of dizziness, lightheadedness, or fainting. If this happens, you should lie down and remain
seated for a few minutes before getting up to prevent these episodes from recurring.
These adverse events, in most cases, do not recur after the initial period of therapy or
during subsequent titration.
The following side effects may occur:

• muscle weakness (asthenia);
• sensation of increased heartbeat (palpitations);
• nausea;
• swelling due to fluid retention in the arms or ankles (peripheral edema);
• dizziness, drowsiness;
• nasal congestion (nasal congestion) and inflammation of the nasal mucosa (rhinitis);
• visual disturbances (lazy eye or amblyopia) and blurred vision.
• back pain,
• headache;
• increased heart rate (tachycardia);
• sensation of dizziness when getting up due to a sudden drop in blood pressure (orthostatic hypotension), temporary loss of consciousness (syncope);
• swelling due to fluid retention (edema);
• weight gain;
• pain in the extremities;
• sexual disorders such as decreased sexual desire (decreased libido) and impotence;
• depression, nervousness;
• altered sensitivity in the arms and legs (paresthesia);
• vertigo;
• difficulty breathing (dyspnea);
• inflammation of the nasal cavities (sinusitis)
• severe allergic reactions (anaphylactoid reactions);
• decreased platelets in the blood (thrombocytopenia)
• painful and persistent erection not due to sexual desire (priapism)
• very fast and irregular heartbeat (atrial fibrillation);
• decrease in some blood components (hematocrit), hemoglobin, white blood cells (leukocytes), total protein content and albumin in the blood. Not known(frequency cannot be estimated based on available data):
• Nasal congestion

Other side effectsthat are not clearly associated with the use of terazosina include:

• chest pain;
• facial swelling due to fluid retention (facial edema);
• fever;
• abdominal pain,
• neck and/or shoulder pain;
• dilation of blood vessels (vasodilation);
• alterations in the rhythm of the heartbeat (arrhythmia);
• constipation, diarrhea;
• dry mouth (xerostomia);
• digestive disorders (dyspepsia);
• flatulence;
• vomiting;
• pain in the joints due to uric acid deposition (gout), joint pain (arthralgia), joint inflammation (arthritis), joint disorders;
• muscle pain (myalgia);
• anxiety, insomnia;
• bronchial inflammation (bronchitis);
• nosebleeds (epistaxis);
• flu-like symptoms; inflammation of the throat (pharyngitis), inflammation of the nasal mucosa (rhinitis), cold symptoms;
• itching, skin irritation (rash);
• increased cough;
• sweating;
• altered vision;
• eye inflammation (conjunctivitis);
• perception of ringing in the ears (tinnitus);
• increased need to urinate, urinary tract infection and urinary incontinence (mainly in postmenopausal women).

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

5. How to store TERAZOSINA ZENTIVA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Expiry.”.
The expiry date refers to the last day of that month.
Store in the original packaging.
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 TERAZOSINA ZENTIVA contains
TERAZOSINA ZENTIVA 2 mg divisible tablet contains

• The active ingredient is terazosin. Each tablet contains 2.374 mg of terazosin dihydrochloride dihydrate (equivalent to 2 mg of terazosin).
• The other ingredients are: lactose monohydrate, corn starch, talc, magnesium stearate

TERAZOSINA ZENTIVA 5 mg divisible tablet contains

• The active ingredient is terazosin. Each tablet contains 5.935 mg of terazosin dihydrochloride dihydrate (equivalent to 5 mg of terazosin).
• The other ingredients are: lactose monohydrate, corn starch, talc, magnesium stearate, E132.

Description of the appearance of TERAZOSINA ZENTIVA and contents of the pack
TERAZOSINA ZENTIVA 2 mg divisible tablet
Pack of 10 divisible tablets.

TERAZOSINA ZENTIVA 5 mg divisible tablet
Pack of 14 divisible tablets.

Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa 7, 20121 Milano

Manufacturer
ABC Farmaceutici S.p.A., Canton Moretti 29, 10090 San Bernardo d’ Ivrea - Torino