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1. Terasozine Teva 1 mg tablets, 2 mg tablets, 5 mg tablets

Terasozine Teva 1 mg tablets, 2 mg tablets, 5 mg tablets

terazosine

Generic medicine

COMPOSITION
Each tablet contains:
Terasozine Teva 1 mg

Active ingredient: 1.187 mg of terazosine dihydrochloride dihydrate equivalent to 1 mg of terazosine.

Excipients: lactose monohydrate, corn starch, povidone (K-30), crospovidone, talc, magnesium
stearate (E572).
Terasozine Teva 2 mg

Active ingredient: 2.374 mg of terazosine dihydrochloride dihydrate equivalent to 2 mg of terazosine.

Excipients: lactose monohydrate, corn starch, povidone (K-30), crospovidone, talc, magnesium
stearate (E572), quinoline yellow (E104).
Terasozine Teva 5 mg

Active ingredient: 5.935 mg of terazosine dihydrochloride dihydrate equivalent to 5 mg of terazosine.

Excipients: lactose monohydrate, corn starch, povidone (K-30), crospovidone, talc, magnesium
stearate (E572), yellow iron oxide (E172), red iron oxide (E172).

PHARMACEUTICAL FORM AND CONTENT
Tablets for oral use.

Terasozine Teva 1 mg:Pack of 7, 10, 14, 15, 50, 100 tablets.

Terasozine Teva 2 mg:Pack of 30 tablets.

Terasozine Teva 5 mg:Pack of 14 tablets.

PHARMACOTHERAPEUTIC CATEGORY
Alpha-adrenergic receptor antagonists. ATC code: G04CA03.

AIC TITLEHOLDER
Teva Italia S.r.l. – Via Messina, 38 – 20154 Milan

RESPONSIBLE PRODUCER OF BATCH RELEASE
PHARMACHEMIE B.V. – Swensweg, 5 – 2003 RN Haarlem (Netherlands)
Teva Pharmaceutical Works Co. Ltd. – Pallagi ùt 13 – 4042 Debrecen (Hungary)
Teva UK Ltd - Brampton Road, Hampden Park – BN 22 9AG Eastbourne – East Sussex (England)

THERAPEUTIC INDICATIONS
Terasozine Teva tablets are indicated for:

• Treatment of mild to moderate hypertension.
• Symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia (BPH).

CONTRAINDICATIONS
Terasozine is contraindicated:

• In patients with known hypersensitivity to the active ingredient "terazosine", to other quinazolines (e.g. prazosin, doxazosin) or to any of the excipients.
• History of syncope during urination.

PRECAUTIONS FOR USE
In clinical studies, the incidence of orthostatic hypotension was higher in patients treated with
terazosine for benign prostatic hyperplasia, compared to patients treated with terazosine for hypertension.
In the treatment of benign prostatic hyperplasia (BPH), the incidence of orthostatic hypotension
episodes was higher in patients over 65 years of age and older (5.6%), compared to those
under 65 years of age (2.6%).
If symptoms of orthostatic hypotension occur, it is necessary to sit or lie down (see also “Effects on
the ability to drive and operate machinery” and “Undesirable effects”).
Before treating the symptoms of BPH with alpha-blockers, it is necessary to exclude other causes
of urinary flow alteration or symptoms related to urination. Furthermore, if a diagnosis of BPH has
been established, the absence of concomitant upper urinary tract obstruction or any signs of infection
must be confirmed before starting treatment with terazosine.
Therapy with terazosine requires regular clinical monitoring.
In the initial phase of therapy (in particular after the first dose or when increasing the dosage),
patients may experience a severe drop in blood pressure values.
Dizziness, lightheadedness, weakness, drowsiness and, in rare cases, syncope may occur.
This is likely to happen even if some doses are missed and therapy with terazosine is resumed.
Patients must be alerted to these possible adverse events and the circumstances in which they may occur.
To minimize the risk of orthostatic hypotension, patients should be monitored at the beginning of
therapy. Since the incidence of this response occurs with doses higher than the initial
recommended dose, the recommended dosing regimen must be followed carefully.
The patient must take the first dose of terazosine at bedtime and must avoid
sudden changes in position or activity that may be affected by dizziness or fatigue.
These events may occur particularly in elderly patients.
Concomitant use of phosphodiesterase type 5 (PDE5) inhibitors (e.g. sildenafil, tadalafil, vardenafil) and
Terasozine Teva may lead to the onset of symptomatic hypotension in some patients. 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.
Iris floppy syndrome (IFIS, a variant of the small pupil syndrome) has been observed during cataract
surgery in some patients previously treated with or currently treated with tamsulosin. Isolated cases
have also been reported with other alpha-1 blockers and the possibility of a class effect cannot be
excluded).
Since IFIS can increase procedural complications during cataract surgery,
the ophthalmologist should be informed about the current or past use of
alpha-1 blockers before the procedure.
Due to its vasodilating action, terazosine should be used with caution in patients who
manifest one of the following heart conditions:

• pulmonary edema due to aortic or mitral stenosis;
• severe heart failure;
• right ventricular failure caused by pulmonary embolism or pericardial effusion;
• left ventricular failure with low pressure. Caution is recommended when terazosine is administered in association with drugs that can affect hepatic metabolism.

Use in patients with hepatic insufficiency
As with all drugs metabolized at the hepatic level, terazosine should be used with particular
caution in patients with impaired hepatic function. Since there are no data on the use of the
drug in patients with severe hepatic dysfunction, it is recommended to avoid its use in these cases.
If administration is interrupted for several days, therapy should be restarted using the
initial dosage regimen.

INTERACTIONS WITH OTHER MEDICINES AND OTHER INTERACTIONS
OF ANY KIND
In patients treated with terazosine in association with ACE inhibitors or diuretics, the incidence of
dizziness or other related effects was higher compared to the entire population of patients treated with
terazosine during clinical studies.
Particular caution should be exercised when terazosine is administered with other antihypertensive agents,
in order to avoid the onset of severe hypotension. If terazosine is
associated with a diuretic or other antihypertensive agent, a dose reduction and a new dose adjustment may be necessary.
Concomitant use of phosphodiesterase type 5 (PDE5) inhibitors (e.g. sildenafil, tadalafil, vardenafil) and
Terasozine Teva may cause some patients to experience hypotensive symptoms (see
Precautions for use).

SPECIAL WARNINGS
Pregnancy and breastfeeding
Safety during pregnancy and breastfeeding has not yet been established, although no
teratogenic effects have been detected in animal models.
However, data in animals have shown that terazosine can increase the duration of pregnancy or
inhibit labor.
Therefore, terazosine should not be used during pregnancy unless the potential benefit
outweighs the potential risk.
Breastfeeding should be avoided.

Effects on the ability to drive and operate machinery
With the initial dose or in the event of reintroduction of therapy after discontinuation, dizziness,
lightheadedness or drowsiness may occur.
Patients should be warned of these possible adverse effects and the circumstances in which
they may occur and in these cases should avoid driving or performing dangerous work
during the 12 hours following the initial dose or whenever the dose is
increased.

Important information on some excipients
This medicine contains lactose. If your doctor has diagnosed you with intolerance to some
sugars, consult him before taking this medicine.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Oral use.
Different dosages are available for the different dosage regimens.
The dose of terazosine should be adjusted based on the patient's response. The instructions for administration are reported below:

Initial dose
The lower single dose of 1 mg should not be exceeded to be taken before bedtime in all
patients. This recommendation should be strictly followed in order to reduce potential episodes
of acute first-dose hypotension.

Subsequent doses
Treatment of mild to moderate hypertension
The single daily dose can be approximately doubled at weekly intervals to achieve the desired blood pressure response.
The maintenance dose must be adjusted to the patient's response. 2 mg/day may be
sufficient with increases up to 10 mg if necessary (clinical studies support the use of 2 to 10 mg as
maintenance dose). The maximum dose is 20 mg/day of terazosine and must not be exceeded.
Use with thiazide diuretics and other antihypertensive agents during the treatment of hypertension
When a thiazide diuretic or another antihypertensive agent is added to the patient's treatment regimen,
the dose of terazosine should be reduced or discontinued and, if necessary, the dose should be readjusted.
Caution should be exercised when administering terazosine
simultaneously with thiazides or other antihypertensive agents, as hypotension may develop.
Treatment of benign prostatic hyperplasia
The dose can be approximately doubled at weekly or bi-weekly intervals
to achieve the desired reduction in symptoms. The usual maintenance dose is between 5 mg and 10 mg,
administered once a day. Improvement of symptoms
is detected approximately two weeks after starting treatment with terazosine.
Currently available data are insufficient to suggest further symptomatic improvement
with doses higher than 10 mg/day.
The treatment should be started using 1 mg tablets for a duration of seven days, the
2 mg tablets for a duration of 14 days, and the 5 mg tablets for a duration of 7 days. The
treatment response should be reviewed every four weeks. Transient side effects may occur during each phase
of dose adjustment. If side effects should persist, a dose reduction should be considered.
Renal insufficiency
Pharmacokinetic studies indicate that patients with reduced renal function do not require any
modification of the recommended dosage.

Children
Safety and efficacy have not been established.

Elderly
Pharmacokinetic studies in the elderly indicate that no significant modifications are necessary
of the recommended dosage.
However, particular caution is required for dose adjustment of terazosine.
If administration is interrupted for several days, therapy should be restarted using the initial dose regimen.
Use in patients with hepatic insufficiency
The dose of terazosine must be adjusted with particular
caution in patients with impaired hepatic function as terazosine is subjected to hepatic metabolism and is mainly
excreted through the biliary tract.
No clinical experience is available in patients with severe hepatic dysfunction.
Method of administration
The first tablet, regardless of the dosage, should be taken in the evening before bedtime.
Subsequent tablets of the same dosage can be taken in the morning. The tablets
must be swallowed with a sufficient amount of liquid (i.e. a glass of water).
Therapy with terazosine for hypertension is a long-term treatment that can only be interrupted
at the doctor's discretion. If the treatment with terazosine is interrupted, upon resumption,
the 1 mg dose to be taken at bedtime should be reused.

OVERDOSAGE
If the administration of terazosine causes acute hypotension, primary importance is
cardiovascular support measures. Restoration of normal blood pressure values and normalization
of the heart rate can be achieved by keeping the patient in a supine position. If this intervention proves inadequate, shock should be treated with plasma
expanders and, if necessary, vasopressors may be subsequently administered. The
renal function should be monitored and general supportive measures should be applied, as
needed.
Dialysis is not beneficial, as laboratory data indicate that terazosine has a high
binding to plasma proteins.

UNDESIRABLE EFFECTS
Terazosine, as well as other alpha-adrenoceptor antagonists, can cause syncope. Episodes of
syncope may occur within 30-90 minutes of taking the initial dose of the medicine.
Occasionally, these episodes may be preceded by tachycardia with heart rates of 120-160 beats
per minute.
The hypotension that may occur in connection with taking the first dose can lead to
dizziness and, in severe cases, syncope. To avoid hypotension, treatment with terazosine should be
started with a 1 mg dose taken in the evening, before bedtime.
The incidence of undesirable effects is based on the frequencies indicated below:
Common: ≥ 1% to < 10%
Uncommon: ≥ 0.1% to < 1%
Rare: ≥ 0.01% to < 0.1%
Very rare: < 0.01% including isolated cases

Blood and lymphatic system disorders:
Very rare: thrombocytopenia

Immune system disorders:
Very rare: anaphylactic reactions

Nervous system disorders:
Common: nervousness, drowsiness, paresthesia
Uncommon: depression

Eye disorders:
Common: blurred vision/amblyopia, disturbances of color perception

Ear and labyrinth disorders:
Common: dizziness

Cardiac disorders:
Common: palpitations, tachycardia, chest pain
Very rare: atrial fibrillation

Respiratory, thoracic and mediastinal disorders:
Common: dyspnea, nasal congestion, sinusitis, epistaxis

Gastrointestinal disorders:
Common: nausea, constipation, vomiting, diarrhea

Skin and subcutaneous tissue disorders:
Common: pruritus, rash
Uncommon: urticaria

Musculoskeletal and connective tissue disorders:
Common: lumbago

Renal and urinary disorders:
Rare: urinary tract infection and urinary incontinence (reported mainly in women in
post-menopause)

Reproductive system and breast disorders:
Common: impotence
Uncommon: decreased libido
Rare: priapism

Systemic disorders and conditions related to the site of administration:
Common: dizziness, mental confusion, fainting (particularly as a result of
rapidly moving from a sitting or lying position to an upright position – postural hypotension),
asthenia, edema, headache, pain in the extremities.
Uncommon: weight gain, syncope.
Further adverse reactions reported in clinical studies or during post-marketing experience but not
clearly associated with the use of terazosine include the following: facial edema, fever, pain
in the abdomen, neck and shoulders, vasodilation, arrhythmia, dry mouth, dyspepsia, flatulence,
gout, arthralgia, arthritis, joint disorders, myalgia, anxiety, insomnia, bronchitis, influenza-like symptoms,
pharyngitis, rhinitis, cold symptoms, increased cough, sweating, visual abnormalities, conjunctivitis, tinnitus, urinary frequency (increased urination).
Diagnostic tests:
laboratory results suggest the possibility of hemodilution (i.e. decrease in levels of
hematocrit, hemoglobin, leukocytes, total proteins and albumin). Treatment with terazosine for up to 24
months has not shown significant effects on levels of prostate-specific antigen (PSA).

It is important to inform your doctor of the occurrence of undesirable effects not described in the package leaflet.

EXPIRY DATE AND STORAGE PRECAUTIONS
Store at a temperature not exceeding 25°C.
Store in the original packaging.
Expiry date: see the expiry date indicated on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.
Caution: do not use the product after the expiry date stated on the packaging.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

PACKAGE LEAFLET REVIEW BY THE ITALIAN MEDICINES AGENCY
(AIFA): NOVEMBER 2012