UNOPROST

UNOPROST 2 mg tablets
UNOPROST 5 mg tablets
UNOPROST 10 mg tablets
Terazosin
PHARMACOTHERAPEUTIC CATEGORY
Alpha-adrenergic receptor antagonists
THERAPEUTIC INDICATIONS
Functional disturbances in the initial phase of benign prostatic hyperplasia.
CONTRAINDICATIONS
Unoprost is contraindicated:
In patients with 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 syncope during micturition must not be treated with alpha-blocker drugs.
PRECAUTIONS FOR USE
Treatment with terazosin requires regular clinical monitoring.
The drug may cause hypotension. Particular attention should therefore be paid to monitoring blood pressure in treated patients.
Terazosin, like other drugs with alpha-blocking activity, 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 dosage is increased.
Similar effects may also occur if treatment is interrupted for more than a few doses and then restarted.
Patients must 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 ability to drive and use machines” and “Undesirable Effects”).
Cases of syncope associated with rapid dose escalation or initiation of antihypertensive therapy have also been reported. Therefore, concomitant antihypertensive treatment should be initiated cautiously.
Concomitant use of phosphodiesterase type 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil) and Unoprost may lead to symptomatic hypotension in some patients. To minimize the risk of orthostatic hypotension, patients should be stabilized on alpha-blocker therapy before starting treatment with phosphodiesterase type 5 inhibitors.
Since the likelihood of such events can be substantially reduced by initiating treatment with the lowest dose (1 mg) at bedtime and gradually increasing the dose, it is recommended to strictly follow the instructions provided in the section “Dosage and method of administration”.
Additionally, to minimize the risk of orthostatic hypotension, patients should be closely monitored, especially at the beginning of therapy.
Patients should also be warned about the possible occurrence of these effects and advised on the measures to take should they occur.
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.

More frequently, other symptoms associated with reduced blood pressure may occur, namely dizziness, lightheadedness, somnolence, and palpitations.
Patients whose occupations involve situations where the described symptoms could pose a potential risk should be treated with particular caution.
Inform the patient 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 starting therapy, after dose increases, or after resuming treatment following interruption, patients should be informed about the possibility of syncopal and orthostatic symptoms and should avoid driving or engaging in risky activities (see also section “Special Warnings – Effects on ability to drive and use machines”).
Due to its vasodilatory action, terazosin must 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 medicines, including those without a prescription.
In patients receiving terazosin in combination with ACE inhibitors or diuretics, the incidence of dizziness or related adverse effects was 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 risk of significant hypotension. When terazosin is added to a diuretic or another antihypertensive agent, dosage reduction and re-titration may be necessary.
Concomitant use of phosphodiesterase type 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil) and Unoprost may lead to hypotensive symptoms in some patients (see Precautions for Use).
Combination use of terazosin with other alpha-receptor blockers is not recommended.
SPECIAL WARNINGS
If dizziness, lightheadedness, or palpitations become bothersome, patients should inform their physician, who may consider adjusting the dosage.
Long-term administration of terazosin has not produced any clinically significant changes in major laboratory parameters (blood glucose, uric acid, creatinine, BUN, and transaminases); therefore, the drug can be used in diabetic, hyperuricemic, and elderly patients.
Patients should inform their ophthalmologist about current or previous treatment with terazosin before undergoing cataract surgery (lens opacity). Terazosin may cause complications during surgery, 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 ability to drive and use machines
Dizziness, lightheadedness, or somnolence may occur after taking 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
Unoprost tablets contain lactose. In case of confirmed sugar intolerance, contact your physician before taking this medicine.
DOSAGE, METHOD AND TIME OF ADMINISTRATION
The generally effective dosage ranges between 5 mg and 10 mg administered once daily.
The effective dosage 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 bi-weekly intervals, the daily dose may be doubled to 2 mg and increased up to 5 mg or 10 mg (1 tablet of 5 mg or 10 mg) 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 dosage increase. Subsequent tablets at each dosage level may be taken in the morning.
If administration of the drug is interrupted for several days, treatment should be resumed following the same procedure, restarting from the starter dose (1 mg).
Renal impairment
Pharmacokinetic studies indicate that patients with reduced renal function do not require any adjustment in 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 required. However, particular caution is needed during 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 keeping the patient in a supine position. If this measure is inadequate, shock should be treated with plasma volume 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 protein binding of terazosin.
In case of accidental ingestion of excessive doses of the medicine, inform your physician
or go to the nearest hospital.
IF YOU HAVE ANY DOUBT ABOUT THE USE OF UNOPROST, CONSULT YOUR DOCTOR OR
PHARMACIST.
UNDESIRABLE EFFECTS
Like all medicines, Unoprost may cause undesirable effects, although not everyone experiences them.
Terazosin, like other alpha-adrenergic receptor antagonists, may cause syncope. Syncopal events occurred within 30 to 90 minutes after the initial dose of the drug. Syncope occurred occasionally in association with rapid dose increases or initiation of antihypertensive agents.
Syncope is believed to result from excessive orthostatic hypotensive effect; although, occasionally, syncopal episodes were 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 supported with appropriate treatment as needed.
When patients rapidly change from a sitting or lying position to a standing 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 appear, 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 common adverse events reported 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, vertigo, 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 association 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, leukocytes, total protein, and albumin were observed. These laboratory findings suggest possible hemodilution. Long-term 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 undesirable effect not listed in this leaflet, inform your doctor or pharmacist.
EXPIRY DATE AND STORAGE
EXPIRY DATE: see the date indicated on the packaging
The expiry date refers to the product stored unopened and under proper storage conditions.
WARNING: Do not use the medicine after the expiry date stated on the packaging.
COMPOSITION :
UNOPROST 2 mg tablets
Each tablet contains: Active substance: Terazosin hydrochloride 2H₂O 2.374 mg, equivalent to Terazosin base 2 mg; Excipients: Lactose, maize starch, talc, magnesium stearate, E-110
UNOPROST 5 mg tablets
Each tablet contains: Active substance: Terazosin hydrochloride 2H₂O 5.935 mg, equivalent to Terazosin base 5 mg; Excipients: Lactose, maize starch, talc, magnesium stearate, E-132, E-110
UNOPROST 10 mg tablets
Each tablet contains: Active substance: Terazosin hydrochloride 2H₂O 11.87 mg, equivalent to Terazosin base 10 mg; Excipients: Lactose, E-132, maize starch, talc, magnesium stearate
PHARMACEUTICAL FORM AND CONTENT
Divisible tablets of 2 mg and 5 mg
Tablets of 10 mg
UNOPROST 2 mg: Blister pack containing 10 divisible tablets
UNOPROST 5 mg: Blister pack containing 14 divisible tablets
UNOPROST 10 mg: Blister pack containing 14 tablets
MARKETING AUTHORIZATION HOLDER
LABORATORI GUIDOTTI S.p.A. - via Livornese, 897 – Pisa - La Vettola
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Tablets of 2 mg and 5 mg:
A. Menarini Manufacturing Logistics and Services S.r.l. – Via Campo di Pile, L’Aquila
Tablets of 10 mg:
ABBOTT S.r.l. - Campoverde di Aprilia (LT)