Teraprost

TERAPROST 2 mg tablets
TERAPROST 5 mg tablets
TERAPROST 10 mg tablets

• Terazosin

PHARMACOTHERAPEUTIC CATEGORY
Alpha-adrenergic receptor antagonists

THERAPEUTIC INDICATIONS
Functional disorders in the early stage of benign prostatic hyperplasia.

CONTRAINDICATIONS
Teraprost is contraindicated:
In patients with known hypersensitivity to the active substance "terazosin", to other
quinazolines (prazosin, doxazosin), or to any of the excipients;
In patients with a history of orthostatic hypotension.
Patients with a history of micturition-related syncope should not be treated with alpha-
blocker drugs.

PRECAUTIONS FOR USE
Treatment with terazosin requires regular clinical monitoring.
The drug may cause hypotension. Therefore, particular attention must be paid to
monitoring blood pressure in treated patients.
Terazosin, like other alpha-blocking agents, may cause a reduction in blood pressure
values, episodes of presyncope, orthostatic hypotension, and syncope, particularly
following the first dose or initial doses of therapy (first-dose effect), or when the dose
is increased.
Similar effects may also occur if treatment is interrupted for more than a few doses
and then restarted.
Patients should be informed about symptoms of orthostatic hypotension and advised
to sit or lie down if such symptoms occur (see also sections “Special Warnings –
Effects on the ability to drive and use machines” and “Undesirable effects”).
Cases of syncope have also been reported in association with rapid dose escalation or
the addition of antihypertensive drugs to therapy. Therefore, concomitant
antihypertensive treatment should be initiated cautiously.
Concomitant use of phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil,
vardenafil) and Teraprost may lead to symptomatic hypotension in some patients. To
minimize the risk of orthostatic hypotension, patients should be stabilized on alpha-
blocker therapy before initiating treatment with phosphodiesterase-5 inhibitors.
Since the likelihood of such events can be substantially reduced by starting treatment
with the lowest dose (1 mg) at bedtime and gradually increasing the dose, it is
recommended to carefully follow the instructions provided in the section “Dosage and
administration”.
To further minimize the risk of orthostatic hypotension, patients should be closely
monitored, especially at the beginning of treatment.
Patients should also be warned about the possible occurrence of these effects and
advised on appropriate measures to manage them.
In the event of such an episode, the patient should be placed in a supine position and
treated, if necessary, with appropriate supportive measures.
Other symptoms associated with reduced blood pressure values may also occur more
frequently, such as dizziness, lightheadedness, somnolence, and palpitations.
Patients whose occupations involve activities where the described symptoms could
pose a potential risk should be treated with particular caution.
Patients should be advised that if symptoms of low blood pressure occur, they should
sit or lie down; since these symptoms are not always orthostatic in nature, great care
should be taken when symptoms arise from a sitting or lying position.
For the first 12 hours after initiating therapy, after dose increases, or after restarting
treatment following interruption, patients should be informed about the possibility of
syncope-like or orthostatic symptoms and should avoid driving or engaging in risky
activities (see also section “Special Warnings – Effects on the ability to drive and use
machines”).
Due to its vasodilatory action, terazosin should be used with caution in patients with
any of the following cardiac conditions:

• Pulmonary edema due to aortic or mitral stenosis;
• Severe heart failure;
• Right ventricular infarction caused by pulmonary embolism or pericardial effusion;
• Left ventricular infarction with low blood pressure.

Use in patients with hepatic impairment
As with all drugs metabolized in the liver, terazosin should be used with particular
caution in patients with impaired liver function. Since no data are available in patients
with severe hepatic dysfunction, its use is not recommended in such cases.
Caution is also advised when terazosin is administered concomitantly with drugs that
may affect hepatic metabolism.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other
medication, including those without a prescription.
In patients receiving terazosin together with ACE inhibitors or diuretics, the incidence
of dizziness or related adverse effects has been higher compared to the overall
population of patients treated with terazosin in clinical studies.
Appropriate caution should be exercised when terazosin is administered with other
antihypertensive agents (ACE inhibitors, beta-blockers, calcium antagonists, and
diuretics) to avoid the possibility of significant hypotension. When terazosin is added
to a diuretic or another antihypertensive agent, dose reduction and re-titration may be
necessary.
Concomitant use of phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
and Teraprost may lead to hypotensive symptoms in some patients (see section
“Precautions for use”).
Combination use of terazosin with other alpha-receptor blockers is not recommended.

SPECIAL WARNINGS
If dizziness, lightheadedness, or palpitations become bothersome, inform your
physician so that dose adjustment may be considered.
Long-term administration of terazosin has not produced any clinically significant
changes in major laboratory parameters (blood glucose, uric acid, creatinine, blood
urea nitrogen, and transaminases); therefore, the drug can be used in diabetic
patients, patients with hyperuricemia, and elderly patients.
Patients should inform their ophthalmologist about current or previous treatment with
terazosin before undergoing cataract surgery (lens opacity). Terazosin may cause
intraoperative complications, which can be managed if the specialist is informed in
advance.

Pregnancy and lactation
This medicine is not intended for use in female subjects.

Effects on the ability to drive and use machines
Dizziness, lightheadedness, or somnolence may occur with the initial dose or when
doses have been missed and therapy is restarted. Patients should be aware of the
possible occurrence of these adverse effects and the circumstances under which they
may arise.
Patients should avoid driving or performing hazardous work for approximately the
first 12 hours after taking the initial dose or when the dose is increased.

Important information about certain excipients
TERAPROST tablets contain lactose. In case of confirmed sugar intolerance,
consult your doctor before taking this medicine.

DOSAGE, METHOD AND TIME OF ADMINISTRATION
The generally effective dosage ranges between 5 and 10 mg administered once daily.
The effective dose should be reached gradually, starting with 1 mg (1/2 of a 2 mg
divisible tablet) taken in the evening before bedtime (starter dose).
Subsequently, at weekly or biweekly intervals, the daily dose may be doubled to 2 mg
and increased up to 5 mg or 10 mg (one 5 mg or 10 mg tablet) as a single daily dose.

Method of administration
After taking the starter dose, patients should avoid sudden changes in posture or
activities that could be affected by dizziness or fatigue. This is particularly important
for elderly patients. This precaution should also be observed when taking the first
tablet at each dose increase. Subsequent tablets at each dosage level may be taken in
the morning.
If treatment is interrupted for more than a few days, therapy should be resumed using
the same approach, restarting from the starter dose (1 mg).

Renal impairment
Pharmacokinetic studies indicate that patients with reduced renal function do not
require any modification of the recommended dosage.

Hepatic impairment
See section “Precautions for use”.

Children
Safety and efficacy have not been established in children.

Elderly
Pharmacokinetic studies in elderly patients indicate that no substantial modification of
the recommended dosage is necessary. However, particular caution is required in the
dose titration of terazosin.

OVERDOSE
If administration of terazosin causes acute hypotension, cardiovascular supportive
measures are of primary importance. Restoration of blood pressure and normalization
of heart rate can be achieved by maintaining the patient in a supine position. If this
measure is inadequate, shock should be treated with plasma expanders and, if
necessary, vasopressors may be used subsequently.
Renal function should be monitored and general supportive measures applied as
needed. Dialysis may not be beneficial, as laboratory data indicate a high degree of
terazosin protein binding.
In case of accidental ingestion of excessive doses of the medicine, contact your
doctor or go to the nearest hospital.

IF YOU HAVE ANY DOUBTS ABOUT THE USE OF TERAPROST, CONSULT
YOUR DOCTOR OR PHARMACIST.

UNDESIRABLE EFFECTS
Like all medicines, TERAPROST may cause undesirable effects,
although not everyone experiences them.
Terazosin, like other alpha-adrenergic receptor antagonists, may cause syncope.
Syncopal episodes have occurred within 30 to 90 minutes after the initial dose of the
drug. Syncope has occasionally occurred in association with rapid dose escalation or
the addition of another antihypertensive agent.
Syncope is believed to result from excessive orthostatic hypotension; however, in
some cases, syncopal episodes have been preceded by signs of severe
supraventricular tachycardia with heart rates ranging from 120 to 160 beats per
minute.
In case of syncope, the patient should be laid down and managed with supportive
treatment as needed.
If a patient rapidly changes from a sitting or lying position to an upright position,
episodes of dizziness, lightheadedness, or fainting may occur. Patients should be
warned of this possibility and instructed to lie down immediately if such symptoms
occur, and to remain seated for several minutes before standing again to prevent
recurrence.
These adverse events are self-limiting and, in most cases, do not recur after the initial
phase of therapy or during subsequent dose titrations.
In clinical studies, the incidence of orthostatic hypotensive events was higher in
patients over 65 years of age (5.6%) compared to those under 65 years (2.6%).

Reporting of adverse events with terazosin
The most commonly reported adverse events were asthenia, palpitations, nausea,
peripheral edema, dizziness, somnolence, nasal congestion/rhinitis, and amblyopia/
blurred vision.
In addition, the following have been reported: back pain, headache, tachycardia,
orthostatic hypotension, syncope, edema, weight gain, extremity pain, decreased
libido, depression, nervousness, paresthesia, dizziness, dyspnea, sinusitis, and
impotence.
Other adverse reactions reported in clinical studies or during post-marketing use, but
not clearly associated with terazosin use, include: chest pain, facial edema, fever,
abdominal pain, neck pain, shoulder pain, vasodilation, arrhythmia, constipation,
diarrhea, xerostomia, dyspepsia, flatulence, vomiting, gout; arthralgia, arthritis, joint
disorders, myalgia, anxiety, insomnia, bronchitis, epistaxis, influenza-like symptoms,
pharyngitis, rhinitis, cold symptoms, pruritus, rash, increased cough, sweating,
altered vision, conjunctivitis, tinnitus, urinary frequency, urinary tract infection, and
urinary incontinence, mainly reported in postmenopausal women.
At least two cases of severe anaphylactoid reactions have been recorded in
concomitance with terazosin administration.
Post-marketing experience: cases of thrombocytopenia and priapism have been
reported. Atrial fibrillation has been reported; however, a causal relationship has not
been established.
Laboratory tests: in controlled clinical studies, small but significant decreases in
hematocrit, hemoglobin, white blood cells, total protein, and albumin were observed.
These laboratory findings suggest the possibility of hemodilution. Terazosin treatment
up to 24 months had no significant effect on prostate-specific antigen (PSA) levels.

Following the instructions in this leaflet reduces the risk of undesirable effects.
If any of the undesirable effects worsens, or if you notice any effect not listed in
this leaflet, inform your doctor or pharmacist.

EXPIRY DATE AND STORAGE
EXPIRY DATE: see the date on the packaging
The expiry date refers to the product stored properly and unopened.
ATTENTION: Do not use the medicine after the expiry date stated on the packaging.

COMPOSITION
TERAPROST 2 mg tablets
Each tablet contains: Active substance: Terazosin hydrochloride 2H₂O mg 2.374,
equivalent to Terazosin base mg 2; Excipients: Lactose, maize starch, talc, magnesium
stearate, E-110

TERAPROST 5 mg tablets
Each tablet contains: Active substance: Terazosin hydrochloride 2H₂O mg 5.935,
equivalent to Terazosin base mg 5; Excipients: Lactose, maize starch, talc, magnesium
stearate, E-132, E-110

TERAPROST 10 mg tablets
Each tablet contains: Active substance: Terazosin hydrochloride 2H₂O mg 11.87,
equivalent to Terazosin base mg 10; Excipients: Lactose, E-132, maize starch, talc,
magnesium stearate

PHARMACEUTICAL FORM AND CONTENT
Tablet
TERAPROST 2 mg: Blister pack of 10 divisible tablets
TERAPROST 5 mg: Blister pack of 14 divisible tablets
TERAPROST 10 mg: Blister pack of 14 tablets

MARKETING AUTHORIZATION HOLDER
MALESCI Istituto Farmacobiologico S.p.A. - Bagno a Ripoli (FI)

MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
2 mg and 5 mg tablets:
A. Menarini Manufacturing Logistics & Services s.r.l., Campo di Pile (L’Aquila)
10 mg tablets:
ABBOTT s.r.l.: - Campoverde di Aprilia (LT)
February 2012