TERAPROST 2 mg Tabletka Powlekana

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1. TERAPROST 2 mg tablets, 5 mg tablets, 10 mg tablets

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

• Terazosine

PHARMACOTHERAPEUTIC CATEGORY
Alpha-adrenergic receptor antagonists

THERAPEUTIC INDICATIONS
Functional disorders of the first phase of benign prostatic hyperplasia.

CONTRAINDICATIONS
Teraprost is contraindicated:
In patients with known hypersensitivity to the active ingredient "terazosine", to other
quinazoline derivatives (prazosin, doxazosin) or to any of the excipients;
In subjects with a history of orthostatic hypotension.
Patients with a history of syncope during urination should not be treated with alpha-blocking drugs.

PRECAUTIONS FOR USE
Therapy with terazosine requires regular clinical monitoring.
The drug may cause hypotension. Particular attention should therefore be paid
to assessing the blood pressure of patients undergoing treatment.
Terazosine, like other drugs with alpha-blocking action, can cause a
decrease in blood pressure values, episodes of lipothymia, orthostatic hypotension and syncope, especially associated with the first or initial doses of therapy
(first-dose effect) or when the dosage is increased.
Similar effects can also occur if therapy is interrupted for more than
a few administrations and then restarted.
Patients should be informed about the symptoms of orthostatic hypotension and advised, in
these cases, to sit or lie down (see also the sections “Special warnings -
Effects on the ability to drive and operate machinery” and “Undesirable effects”).
Cases of syncope associated with rapid dose increases or
introduction of antihypertensive drugs have also been reported. Therefore, any
concomitant antihypertensive treatment should be started with caution.
The concomitant use of type 5 phosphodiesterase inhibitors (e.g. sildenafil,
tadalafil, vardenafil) and Teraprost may lead to the onset of symptomatic hypotension
in some patients. In order to minimize the risk of developing
orthostatic hypotension, the patient should be stabilized with alpha-blocker treatment before starting therapy with type 5 phosphodiesterase inhibitors.

• 5. Because the probability of such phenomena can be substantially reduced by starting treatment with the lowest dose (1 mg) at bedtime and gradually increasing the doses, it is recommended to carefully follow the instructions in the "Dosage, method and time of administration" section. To minimize the risk of orthostatic hypotension, patients should also be carefully monitored, especially at the beginning of therapy. The patient should also be warned about the possible occurrence of these effects and advised on the measures to take to cope with them. In the event of an episode as described above, the patient should be placed in a supine position and treated - if necessary - with appropriate supportive measures.

Other symptoms associated with
decreased blood pressure values, namely dizziness, lightheadedness, drowsiness
and palpitations, may occur more frequently.
Patients with occupations for which the described symptoms may constitute a
potential risk should be treated with particular caution.
Advise the patient that if they experience symptoms of a drop in
blood pressure, they should sit or lie down; considering that these symptoms are not
always of an orthostatic nature, pay close attention when they occur from
a seated or lying position.
After the first 12 hours from the start of therapy, after increasing the dose or after
resuming treatment following interruption, patients should be informed
about the possibility of syncopal and orthostatic symptoms and avoid driving or
engaging in risky activities (see also the section “Special warnings” –
Effects on the ability to drive and operate machinery).
Due to its vasodilating action, terazosine should be used with caution
in patients who present one 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 pressure.

Use in patients with hepatic insufficiency
As with all drugs metabolized in the liver, terazosine should be used with
particular caution in patients with reduced liver function. Since there are no
data available in patients with severe hepatic dysfunction, it is recommended to avoid
its use in these cases.
Caution is also recommended when terazosine is administered in
concomitance with drugs that may affect hepatic metabolism.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any
other medicines, including those without a prescription.
In patients who were administered terazosine plus ACE inhibitors or diuretics,
the incidence of dizziness or related side effects was higher compared to the
total population of patients undergoing treatment with terazosine during
clinical studies.
Appropriate caution should be exercised when terazosine is
administered with other antihypertensive agents (ACE inhibitors, beta-blockers,
calcium channel antagonists and diuretics) in order to avoid the possibility of
significant hypotension. If terazosine is added to a diuretic or
another antihypertensive agent, a dose reduction and a new titration may be necessary.
The concomitant use of type 5 phosphodiesterase inhibitors (e.g. sildenafil, tadalafil,
vardenafil) and Teraprost may cause some patients to experience hypotensive symptoms (see section “precautions for use”).
The combined use of terazosine with other alpha-receptor blockers is not recommended.

SPECIAL WARNINGS
If dizziness, lightheadedness or palpitations become bothersome,
inform your treating physician so that they can consider a dosage adjustment.
Long-term administration of Terazosine has not produced any
clinically significant changes in the main laboratory parameters
(glycemia, uricemia, creatininemia, azotemia and transaminasemia); the drug may
therefore be used in diabetic, hyperuricemic and elderly patients.
It is advisable to inform your ophthalmologist about ongoing or previous treatment with
terazosine before undergoing cataract surgery (clouding of the lens). Terazosine may cause complications during
the operation that can be treated if the specialist has been warned in time.

Pregnancy and breastfeeding
The medicine is not intended for use in females.

Effects on the ability to drive and operate machinery.
Dizziness, lightheadedness or drowsiness may occur in conjunction with
taking the initial dose or in the event of failure to take the doses and
subsequent restart of terazosine-based therapy. Patients should be aware of the possible onset of these adverse effects and the circumstances in which
they may occur.
Avoid driving or performing dangerous work approximately
within the first 12 hours after taking the initial dose or if the dose is increased.

Important information about some excipients
TERAPROST tablets contain lactose. In case of ascertained
intolerance to sugars, contact your treating physician before taking the
medicine
DOSAGE, METHOD AND TIME OF ADMINISTRATION
The generally effective dosage is between 5 and 10 mg administered 1 time per
day. The effective dosage must be reached gradually, starting from 1 mg
(1/2 divisible tablet of 2 mg) to be taken in the evening before bedtime (starter dose).
Subsequently, at weekly or bi-weekly intervals, the daily dose can
be doubled to 2 mg and increased to 5 mg or 10 mg (1 tablet of 5 mg or
10 mg) in a single daily administration.

Method of administration
After taking the starter dose, the patient should avoid sudden changes in
position or activity that may be affected by dizziness or fatigue. This applies
in particular to elderly subjects. This precaution should also be observed
when taking the first tablet of each dosage. The
following tablets of each dosage can be taken in the morning.
If the administration of the drug is interrupted for more than a few days, resumption of
treatment should be carried out in the same way, starting from the starter dose (1 mg).

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

Hepatic insufficiency
See the section “Precautions for use”.

Children
Safety and efficacy criteria in children have not been established.

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

OVERDOSE
If the administration of terazosine should cause acute hypotension, supportive
cardiovascular interventions are of primary importance. Restoration of
blood pressure and normalization of heart rate can be achieved by keeping the patient in a supine position. If this
measure should prove inadequate, shock should be treated with
volume expanders and, if necessary, vasopressors can then be used.
Renal function should be monitored and general supportive measures should be applied, as needed. Dialysis may not be beneficial, in
as laboratory data indicate a high degree of terazosine binding to
proteins.

In case of accidental ingestion of excessive doses of the medicine, notify your
treating 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 can cause undesirable effects
although not all people will experience them.
Terazosin, like other alpha-adrenergic receptor antagonists, can cause
syncope. Syncopal manifestations have occurred within a time interval between
30 and 90 minutes from the initial dose of the drug. Syncope has occurred
occasionally in association with rapid dose increases or with the introduction of
another antihypertensive agent.
Syncope is believed to be due to an excessive effect of orthostatic hypotension;
however, occasionally, episodes of syncope have been preceded by signs of severe
supraventricular tachycardia with a heart rate of 120 to 160 beats per minute.
In case of syncope, the patient should be laid down and assisted with supportive
treatment as needed.
If the patient quickly moves 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 as soon as
such symptoms appear and remain seated for a few minutes
before getting up in order to prevent recurrence of such episodes.
These adverse events are self-limiting and, in most cases, do not
recur after the initial period of therapy or during subsequent dose titration.
In clinical studies, the incidence of orthostatic hypotensive events was higher in
patients over 65 years of age and older (5.6%), compared to those under 65 years of age (2.6%).
Reporting of adverse events with terazosin
The most common adverse events were asthenia, palpitations, nausea, peripheral
edema, dizziness, drowsiness, nasal congestion/rhinitis and amblyopia/blurred vision.
In addition, the following cases have been reported: back pain, headache,
tachycardia, orthostatic hypotension, syncope, edema, weight gain, limb pain, decreased
libido, depression, nervousness, paresthesia, vertigo,
dyspnea, sinusitis and impotence.
Other adverse reactions reported in clinical studies or reported during
commercialization, but not clearly associated with the use of terazosin,
include the following: 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, itching, rash, increased
cough, sweating, altered vision, conjunctivitis, tinnitus, urinary frequency,
urinary tract infection and urinary incontinence detected mainly in
menopausal women.
At least two cases of severe anaphylactoid reactions have been recorded in conjunction
with the administration of terazosin.
Post-marketing experience: cases of thrombocytopenia and priapism have been reported.
Atrial fibrillation has been reported: however, a cause-effect relationship has not been established.
Laboratory tests: during controlled clinical studies, small but
significant decreases in hematocrit, hemoglobin, leukocytes, total protein content and albumin were observed. These laboratory findings suggest the
possibility of hemodilution. Treatment with terazosin for up to 24
months had no significant effects on specific prostate antigen levels (PSA).

undesirable effects. If any of the undesirable effects worsen, or if
you notice the appearance of any undesirable effect not listed in this
EXPIRY DATE AND STORAGE
EXPIRY DATE: see the expiry date indicated on the packaging
The expiry date refers to the product that is intact and correctly stored.
WARNING: Do not use the medicine after the expiry date indicated on the
packaging.

COMPOSITION:

TERAPROST 2 mg tablets
Each tablet contains: Active ingredient: Terazosin hydrochloride 2H O mg 2.374 equivalent
to Terazosin base mg 2; Excipients: Lactose, Corn starch, Talc, Magnesium
stearate, E-110

TERAPROST 5 mg tablets
Each tablet contains: Active ingredient: Terazosin hydrochloride 2H O mg 5.935 equivalent
to Terazosin base mg 5; Excipients: Lactose, Corn starch, Talc, Magnesium
stearate, E-132, E-110

TERAPROST 10 mg tablets
Each tablet contains: Active ingredient: Terazosin hydrochloride 2H O mg 11.87 equivalent
to Terazosin base mg 10; Excipients: Lactose, E-132, Corn starch, Talc, Magnesium
stearate

PHARMACEUTICAL FORM AND CONTENT
Tablet

TERAPROST 2 mg: Blister packs of 10 divisible tablets

TERAPROST 5 mg: Blister packs of 14 divisible tablets

TERAPROST 10 mg: Blister packs of 14 tablets

A.I.C. HOLDER
MALESCI Istituto Farmacobiologico S.p.A. - Bagno a Ripoli (FI)

RESPONSIBLE PRODUCER 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