Terazosin Zentiva

Package leaflet: Information for the patient

TERAZOSIN ZENTIVA 2 mg tablets, 5 mg tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

This medicinal product contains the active substance terazosin, which belongs to a class of medicines called
alpha-adrenergic antagonists or "alpha-blockers". Terazosin works by relaxing blood vessels, thereby lowering
blood pressure, and by relaxing the bladder and muscles of the urinary system to help urine flow in patients
with prostate problems (benign prostatic hyperplasia).
TERAZOSINA ZENTIVA is indicated:

• for the treatment of high blood pressure (mild to moderate hypertension);
• for urinary obstruction due to enlargement of the prostate (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 previously experienced a temporary loss of consciousness while urinating (micturition syncope).

Warnings and precautions
Talk to your doctor or pharmacist before taking TERAZOSINA ZENTIVA.
While taking this medicine, your doctor should monitor you, especially after taking the first dose or if your doctor has increased your dose, as you may experience dizziness due to a marked drop in blood pressure, particularly when standing up (orthostatic hypotension). If you experience dizziness, lightheadedness, weakness, drowsiness or temporary loss of consciousness, lie down or sit down and contact your doctor immediately.
The risk of low blood pressure is higher 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 prostate problem (benign prostatic hyperplasia);
• you are over 65 years old;
• you restart treatment after missing a dose of this medicine (see section “If you forget to take TERAZOSINA ZENTIVA”); in this case, be especially careful and consult your doctor.

To reduce the risk of low blood pressure, take exactly the dose prescribed by your doctor. Take the first dose of this medicine just before going to bed and avoid sudden movements, especially if you are elderly.
Take TERAZOSINA ZENTIVA with caution and consult your doctor if:

• you have a heart condition (aortic or mitral stenosis) causing fluid accumulation in the lungs (pulmonary edema);
• you have severe heart problems (severe heart failure);
• you have had a heart attack (right ventricular infarction) caused by problems in the blood vessels supplying the lungs (pulmonary embolism) or by fluid accumulation in the membrane surrounding the heart (pericardial effusion);
• you have had a heart attack in a part of the heart called the left ventricle, associated with low blood pressure;
• you are scheduled for eye surgery (cataract surgery) and are currently taking or have previously taken tamsulosin or any other medicine belonging to the class of medicines known as alpha-adrenergic antagonists or "alpha-blockers" (alpha-1 adrenergic antagonists); in this case, inform your surgeon;
• you are taking other medicines that may affect liver function;
• you have liver problems; in particular, if you have severe liver problems, avoid taking TERAZOSINA ZENTIVA.

Children
There are insufficient data to establish the safety and efficacy of this medicine in children.
Other medicines and TERAZOSINA ZENTIVA
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Take this medicine with caution and inform your doctor if you are taking:

• medicines used for certain male sexual disorders (phosphodiesterase type 5 inhibitors such as sildenafil, tadalafil, vardenafil);
• medicines used to treat high blood pressure (ACE inhibitors, beta-blockers, calcium antagonists and diuretics);
• other medicines belonging to the class of alpha-adrenergic antagonists ("alpha-blockers").

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy unless absolutely necessary and under direct medical supervision.
Do not take this medicine if you are breastfeeding.
Driving and using machines
This medicine may cause dizziness, lightheadedness and drowsiness, which may impair your ability to drive or operate machinery. If this is the first time you are taking this medicine, if you are taking it after missing a dose, if your doctor has increased your dose, or if you experience any of the symptoms described, avoid driving or operating machinery for at least 12 hours after taking the dose.
TERAZOSINA ZENTIVA contains monohydrate lactose
Terazosina Zentiva contains monohydrate lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take TERAZOSIN ZENTIVA

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

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

Subsequent doses
Subsequent doses depend on the type of therapy:

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

Treatment of high blood pressure in combination with other medicines (thiazide diuretics and other antihypertensive agents)
If, during treatment with TERAZOSIN ZENTIVA, a diuretic or another medicine for high blood pressure (antihypertensive) is prescribed for you, your doctor may reduce or discontinue treatment with TERAZOSIN ZENTIVA. If treatment is restarted, it will begin again with the lowest dose, gradually increasing the dose. Your doctor will determine the appropriate dose for you to avoid sudden drops in blood pressure (see section “Other medicines and TERAZOSIN ZENTIVA”).

Treatment of benign prostatic hyperplasia
The recommended initial dose is half a 2 mg tablet per day for 7 days. Afterwards, your doctor may double the dose every week or every two weeks, depending on your health condition. The treatment follows this schedule:

• 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 ranges between 5 mg and 10 mg, taken once daily.
Your doctor should assess your response to treatment every four weeks.
At the beginning of therapy or when your doctor changes the dose, transient side effects may occur. If these effects persist, inform your doctor, who may consider reducing the dose (see section “Possible side effects”).

Use in elderly patients
If you are elderly, your doctor will carefully determine the initial dose of TERAZOSIN ZENTIVA. If treatment with this medicine is interrupted, it is recommended to restart with the initial dose.

Use in patients with liver problems (hepatic impairment)
If you have liver problems, the optimal dose should be determined with particular caution.
If you have severe liver problems (severe hepatic dysfunction), the use of TERAZOSIN ZENTIVA should be avoided (see section “Warnings and precautions”).

If you take more TERAZOSIN ZENTIVA than you should
In case of overdose, a sudden drop in blood pressure may occur. If you experience symptoms of low blood pressure, lie down and contact your doctor immediately.
If you have taken or ingested an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to take TERAZOSIN ZENTIVA
Do not take a double dose to make up for the forgotten tablet.
If you forget to take the tablet for several days, inform your doctor, as it may be necessary to restart treatment with the lowest dose. In this case, take TERAZOSIN ZENTIVA with caution, as you may experience a decrease in blood pressure (see section “Warnings and precautions”).

If you stop taking TERAZOSIN ZENTIVA
If you are taking this medicine for the treatment of high blood pressure, do not stop treatment unless otherwise advised by your doctor.
If treatment with TERAZOSIN ZENTIVA needs to be interrupted, your doctor will need to re-establish the optimal dose, starting again with the recommended initial dose of 1 mg at bedtime.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
Tell your doctor if you experience any side effects, especially if they persist.

Terazosin may cause temporary loss of consciousness (syncope). This usually occurs 30–90 minutes after taking the first dose of terazosin or when the dose is increased. Sometimes it may be preceded by an increased heart rate (tachycardia 120–160 beats per minute). If you experience this symptom, lie down and contact your doctor if the condition persists.

If you move quickly from a sitting or lying position to a standing position, episodes of dizziness, lightheadedness, or fainting may occur. If this happens, lie down and remain seated for a few minutes before standing up again to help prevent further episodes.

These adverse events usually do not recur after the initial period of treatment or during subsequent dose titrations.

The following side effects may occur:

• Muscle weakness (asthenia);
• Sensation of increased heartbeat (palpitations);
• Nausea;
• Swelling due to fluid accumulation in the arms or ankles (peripheral oedema);
• Dizziness, drowsiness;
• Stuffy nose (nasal congestion) and inflammation of the nasal mucosa (rhinitis);
• Vision disturbances (lazy eye or amblyopia) and blurred vision;
• Back pain;
• Headache (cephalalgia);
• Increased heart rate (tachycardia);
• Dizziness upon standing due to sudden drop in blood pressure (orthostatic hypotension), temporary loss of consciousness (syncope);
• Swelling due to fluid accumulation (oedema);
• Weight gain;
• Pain in the extremities;
• Sexual disorders such as reduced sexual desire (decreased libido) and impotence;
• Depression, nervousness;
• Altered sensation in arms and legs (paraesthesia);
• Dizziness;
• Difficulty in breathing (dyspnoea);
• Inflammation of the nasal sinuses (sinusitis);
• Severe allergic reactions (anaphylactoid reactions);
• Decrease in blood platelets (thrombocytopenia);
• Painful and prolonged erection not related to sexual desire (priapism);
• Very rapid and irregular heartbeats (atrial fibrillation);
• Decrease in certain blood components (haematocrit), haemoglobin, white blood cells (leucocytes), total blood protein, and albumin.

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

• Stuffy nose

Other side effects not clearly associated with the use of terazosin include:

• Chest pain;
• Facial swelling due to fluid accumulation (facial oedema);
• Fever;
• Abdominal pain;
• Neck and/or shoulder pain;
• Widening of blood vessels (vasodilation);
• Changes in heart rhythm (arrhythmia);
• Constipation, diarrhoea;
• Dry mouth (xerostomia);
• Digestive disturbances (dyspepsia);
• Flatulence;
• Vomiting;
• Joint pain due to uric acid deposition (gout), joint pain (arthralgia), joint inflammation (arthritis), joint disorders;
• Muscle pain (myalgia);
• Anxiety, insomnia;
• Inflammation of the bronchi (bronchitis);
• Nosebleeds (epistaxis);
• Influenza-like symptoms; sore throat (pharyngitis), inflammation of the nasal mucosa (rhinitis), cold-like symptoms;
• Itching, skin irritation (rash);
• Increased cough;
• Sweating;
• Altered vision;
• Eye inflammation (conjunctivitis);
• 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 TERAZOSIN 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TERAZOSIN ZENTIVA contains
TERAZOSIN ZENTIVA 2 mg scored tablet contains

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

TERAZOSIN ZENTIVA 5 mg scored tablet contains

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

Description of the appearance of TERAZOSIN ZENTIVA and package contents
TERAZOSIN ZENTIVA 2 mg scored tablet
Pack containing 10 scored tablets.
TERAZOSIN ZENTIVA 5 mg scored tablet
Pack containing 14 scored tablets.
Marketing Authorization Holder
Zentiva Italia S.r.l.
Via P. Paleocapa 7, 20121 Milan
Manufacturer
ABC Farmaceutici S.p.A., Canton Moretti 29, 10090 San Bernardo d’Ivrea - Turin