UNOPROST 2 mg Коированная Таблетка

Содержание инструкции

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

UNOPROST 2 mg tablets, 5 mg tablets, 10 mg tablets

Terazosin
PHARMACOTHERAPEUTIC CATEGORY
Alpha-adrenergic receptor antagonists

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

CONTRAINDICATIONS
Unoprost is contraindicated:
In patients with hypersensitivity to the active ingredient "terazosin", to other quinazolines (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 terazosin requires regular clinical monitoring.
The drug may cause hypotension. Particular attention should therefore be paid to the evaluation of
blood pressure in treated subjects.
Terazosin, 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 early 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 must be informed about the symptoms of orthostatic hypotension and advised, in these cases, to
sit or lie down (see also the paragraphs “Special warnings - Effects on the ability to drive vehicles
and operate machinery” and “Undesirable effects”).
Cases of syncope associated with rapid dose increases or the introduction of
antihypertensive drugs into therapy have also been reported. Therefore, any concomitant antihypertensive
treatment should be started with caution.
The concomitant use of phosphodiesterase type 5 inhibitors (e.g. sildenafil, tadalafil, vardenafil) and
Unoprost may determine 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 phosphodiesterase type 5 inhibitors.
Since the probability that such phenomena occur can be substantially reduced by starting
treatment with the lowest dosage (1 mg) at bedtime and gradually increasing the doses,
it is recommended to carefully follow the instructions reported in the paragraph “Dosage,
method and time of administration”.
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 onset 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 commonly 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 must
be treated with particular caution.
Warn the patient that if they experience symptoms of low 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 sitting or lying position.
After the first 12 hours from the start of therapy, after increasing the dose or after restarting 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 paragraph “Special warnings
- Effects on the ability to drive vehicles and operate machinery”).
Due to its vasodilating action, terazosin 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, terazosin should be used with particular caution
in patients with reduced liver function. Since no data are available in patients with severe hepatic dysfunction, it is recommended to avoid its use in these cases.
Caution is also recommended when terazosin is administered concurrently with drugs that
may affect hepatic metabolism.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those
available over the counter.
In patients who were administered terazosin plus ACE inhibitors or diuretics, the incidence of dizziness or
related adverse effects was higher compared to the total population of patients undergoing
treatment with terazosin during clinical studies.
Appropriate caution should be exercised when terazosin is administered with other antihypertensive agents (ACE inhibitors, beta-blockers, calcium channel blockers and diuretics) in order to avoid
the possibility of significant hypotension. If terazosin is added to a diuretic or other
antihypertensive agent, a dose reduction and re-titration may be necessary.
The concomitant use of phosphodiesterase type 5 inhibitors (e.g. sildenafil, tadalafil, vardenafil) and
Unoprost may determine the onset of hypotensive symptoms in some patients (See Precautions for
use).

SPECIAL WARNINGS
If dizziness, lightheadedness or palpitations become bothersome, the patient is required to
inform the treating physician so that he can consider a dosage adjustment.
Long-term administration of Terazosin has not produced any clinically significant changes in the main
laboratory parameters (glycemia, uricemia, creatinine, azotemia and
transaminases); the drug can therefore be used in diabetic, hyperuricemic and elderly patients.
It is advisable to inform your ophthalmologist about ongoing or previous treatment with terazosin before
undergoing cataract surgery (clouding of the lens). Terazosin 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 missing doses and subsequently restarting therapy based on
terazosin. Patients must take into account the possible onset of these negative 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 on some excipients
Unoprost tablets contain lactose. If you have confirmed sugar intolerance, contact
your doctor before taking the medicine.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
The generally effective dosage is between 5 mg and 10 mg administered once a day.
The effective dosage must be reached gradually, starting from 1 mg (1/2 divisible 2 mg tablet) 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 is especially true for elderly subjects. This precaution must also be observed when taking the first tablet
at each dosage increase. 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, resuming treatment should be done
using the same methods, starting from the starter dose (1 mg).

Renal insufficiency
Pharmacokinetic studies indicate that patients with reduced renal function do not require any
modification of 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 terazosin.

OVERDOSE
If the administration of terazosin should cause acute hypotension, cardiovascular support measures are of primary importance. Restabilization of blood pressure and
normalization of heart rate can be achieved by keeping the patient in
supine position. If this measure should prove inadequate, shock should be treated
with volume expanders and, if necessary, vasopressors can then be used. The
renal function should be monitored and general supportive measures should be applied, as
necessary. Dialysis may not be beneficial, as laboratory data indicate a high degree of
terazosin 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 UNOPROST, CONSULT YOUR DOCTOR OR
PHARMACIST.
UNDESIRABLE EFFECTS
Like all medicines, Unoprost can cause undesirable effects although not all people will
experience them.
Terazosine, like other alpha-adrenergic receptor antagonists, can cause syncope. Syncopal manifestations
have occurred within a time range of 30 to 90 minutes from the initial dose
of the drug. Syncope has occurred occasionally in association with rapid increases in
dosage or with the introduction of an 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 these symptoms appear and remain
seated for a few minutes before getting up in order to prevent the 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 titration.
In clinical studies, the incidence of orthostatic hypotensive events was higher in patients over the age of
65 years and older (5.6%), compared to those under the age of 65 years (2.6%).
Reporting of adverse events with terazosine
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, pain in the extremities, decreased libido, depression,
nervousness, paresthesia, vertigo, dyspnea, sinusitis and impotence.
Other adverse reactions reported in clinical studies or reported during post-marketing, but not
clearly associated with the use of terazosine, 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,
skin rash, increased cough, sweating, altered vision, conjunctivitis, tinnitus, urinary frequency,
urinary tract infection and urinary incontinence detected mainly in postmenopausal women.
At least two cases of severe anaphylactoid reactions have been recorded in conjunction with the
administration of terazosine.
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: in 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 based on
terazosine lasting up to 24 months had no significant effects on the levels of prostate-specific antigen
(PSA).
If any of the undesirable effects worsen, or if you notice any effects not listed in this leaflet, please tell your doctor or pharmacist.

COMPOSITION:

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

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

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

PHARMACEUTICAL FORM AND CONTENT
Divisible tablets of 2 and 5 mg
Tablets of 10 mg

UNOPROST 2 mg: Blister packs of 10 divisible tablets

UNOPROST 5 mg: Blister packs of 14 divisible tablets

UNOPROST 10 mg: Blister packs of 14 tablets

A.I.C. HOLDER
LABORATORI GUIDOTTI S.p.A. - via Livornese, 897 – Pisa - La Vettola

MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

2 mg and 5 mg tablets:

• A. Menarini Manufacturing Logistics and Services Sr.l. – Via Campo di Pile, L’Aquila 10 mg tablets: ABBOTT S.r.l. - Campoverde di Aprilia (LT)