Terazosin Doc Generici

Package leaflet: Information for the patient

TERAZOSIN DOC GENERICS 2 mg tablets, 5 mg tablets

Generic medicinal product
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What TERAZOSIN DOC GENERICS is and what it is used for
2. What you need to know before taking TERAZOSIN DOC GENERICS
3. How to take TERAZOSIN DOC GENERICS
4. Possible side effects
5. How to store TERAZOSIN DOC GENERICS
6. Contents of the pack and other information

1. What TERAZOSINA DOC Generici is and what it is used for

This medicinal product contains the active substance terazosin, which belongs to a class of medicines called
alpha-adrenergic antagonists or "alpha-blockers". Terazosin works by relaxing blood vessels, thereby lowering
blood pressure, and by relaxing the bladder and urinary tract muscles to help urine flow in patients with
prostate problems (benign prostatic hyperplasia).

TERAZOSINA DOC Generici is indicated:

• for the treatment of high blood pressure (hypertension);
• for urinary problems caused by enlargement of the prostate (benign prostatic hyperplasia).

2. What you need to know before taking TERAZOSINA DOC Generici

Do not take TERAZOSINA DOC Generici

• if you are allergic to terazosin, to similar substances (quinazolines such as prazosin, doxazosin) or to any of the other ingredients of this medicine (listed in section 6);
• if you have ever experienced a temporary loss of consciousness while urinating (micturition syncope).

Warnings and precautions
Talk to your doctor or pharmacist before taking TERAZOSINA DOC Generici.
During treatment with this medicine, your doctor should monitor you closely,
especially after taking the first dose or when the dose is increased, as you may experience
dizziness due to a marked drop in blood pressure, particularly when standing up (orthostatic hypotension). If dizziness, weakness, drowsiness or temporary loss of consciousness occur, lie down or sit down and contact your doctor.
The risk of low blood pressure is higher if:

• you are taking medicines for erectile dysfunction (phosphodiesterase type 5 inhibitors such as sildenafil, tadalafil, vardenafil; see section “Other medicines and TERAZOSINA DOC Generici”);
• you are taking this medicine for benign prostatic hyperplasia, especially if you are over 65 years old;
• you restart treatment after missing a dose of this medicine (see section “If you forget to take TERAZOSINA DOC Generici”); in this case, exercise particular caution and contact your doctor.

To reduce the risk of low blood pressure, take exactly the dose prescribed by your doctor. Take the first dose of this medicine before going to bed and avoid sudden movements, especially if you are elderly.
Take TERAZOSINA DOC Generici with caution and consult your doctor if:

• you have a heart condition (aortic or mitral stenosis) causing fluid accumulation in the lungs (pulmonary edema);
• you have severe heart problems (severe heart failure);
• you have had a heart attack (right ventricular infarction) caused by blood vessel problems affecting the lungs (pulmonary embolism) or by fluid accumulation in the membrane surrounding the heart (pericardial effusion);
• you have had a heart attack in a part of the heart called the left ventricle, associated with low blood pressure;
• you are scheduled for eye surgery (cataract surgery) and are currently taking or have previously taken terazosin or any other medicine belonging to the class of drugs known as alpha-adrenergic antagonists or "alpha-blockers" (alpha-1 adrenergic antagonists); in this case, inform your surgeon, as terazosin may cause complications during surgery that can be managed if the specialist is informed in advance;
• you are taking other medicines that may affect liver function;
• you have liver problems; in particular, avoid taking TERAZOSINA DOC Generici if you have severe liver problems.

Children
There are insufficient data to establish the safety and efficacy of this medicine in children.
Other medicines and TERAZOSINA DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take this medicine with caution and inform your doctor if you are taking:

• medicines used for certain male sexual disorders (phosphodiesterase type 5 inhibitors such as sildenafil, tadalafil, vardenafil);
• medicines used to treat high blood pressure (ACE inhibitors, beta-blockers, calcium channel blockers and diuretics);
• other medicines belonging to the class of alpha-adrenergic antagonists ("alpha-blockers").

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine during pregnancy unless absolutely necessary and under direct medical supervision.
Avoid taking this medicine if you are breastfeeding.

Driving and using machines
This medicine may cause dizziness, drowsiness and fatigue, which may impair your ability to drive or operate machinery. If you are taking this medicine for the first time, if you take it after missing a dose, if your doctor has increased your dose, or if you experience any of the symptoms described, avoid driving or operating machinery for at least 12 hours after taking the dose.

TERAZOSINA DOC Generici contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take TERAZOSINA DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take the tablet by mouth with a glass of water.
The first time you take TERAZOSINA DOC Generici, or if your doctor changes your dose, you must
take the first tablet in the evening before going to bed. Afterwards, you may take the tablets in the
morning.
The tablet can be divided into equal parts.
The dose should be adjusted according to your health condition. Your doctor will therefore determine the most suitable dose for you and may adjust it, bearing in mind the following:

Recommended initial dose
The maximum initial dose is 1 mg (half a 2 mg divisible tablet), taken in the evening before going to bed, to avoid a sudden drop in blood pressure (see section “Warnings and precautions”).

Subsequent doses
Subsequent doses depend on the type of therapy:

Treatment of high blood pressure (mild to moderate hypertension)
Your doctor may increase the dose of terazosin, approximately doubling it every week until the desired effect is achieved.
The maximum recommended maintenance dose is 20 mg per day; do not exceed this dose.

Treatment of high blood pressure in combination with other medicines (thiazide diuretics and other antihypertensives)
During treatment with terazosin, your doctor may decide to add a diuretic or another medicine to treat high blood pressure (antihypertensive). In such cases, your doctor will decide whether to reduce or discontinue treatment with TERAZOSINA DOC Generici. If treatment is resumed, therapy should be restarted at the lowest dose, gradually increasing the dose. Your doctor will determine the appropriate dose for you to avoid sudden drops in blood pressure (see section “Other medicines and TERAZOSINA DOC Generici”).

Treatment of benign prostatic hyperplasia
The recommended initial dose is half a 2 mg tablet daily for 7 days. Afterwards, your doctor may double the dose every week or every two weeks, depending on your health condition. The treatment follows this schedule:

• half a 2 mg tablet daily for 7 days;
• 2 mg tablets for 14 days;
• 5 mg tablets for 7 days.

The usual maintenance dose ranges between 5 mg and 10 mg, taken once daily.
Your doctor should evaluate your response to treatment every four weeks.
At the beginning of therapy or when your doctor adjusts the dose, transient side effects may occur. If these effects persist, inform your doctor, who may consider reducing the dose (see section “Possible side effects”).

Use in elderly patients
If you are elderly, your doctor will carefully determine the initial dose of TERAZOSINA DOC Generici.
If treatment with this medicine is interrupted, it is recommended to restart therapy with the lowest initial dose.

Use in patients with liver problems (hepatic impairment)
If you have liver problems, the optimal dose should be determined with particular care.
If you have severe liver problems (severe hepatic dysfunction), use of TERAZOSINA DOC Generici should be avoided (see section “Warnings and precautions”).

If you take more TERAZOSINA DOC Generici than you should
Overdose may cause a sudden drop in blood pressure. If you experience symptoms of low blood pressure, lie down and contact your doctor immediately.
In case of accidental ingestion or overdose of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to take TERAZOSINA DOC Generici
Do not take a double dose to make up for the missed tablet.
If you forget to take the tablet for several days, inform your doctor, as it may be necessary to restart treatment with the lowest dose. In this case, take TERAZOSINA DOC Generici with caution, as you may experience a drop in blood pressure (see section “Warnings and precautions”).

If you stop taking TERAZOSINA DOC Generici
If you are taking this medicine for the treatment of high blood pressure, do not stop ongoing therapy unless otherwise advised by your doctor.
If treatment with TERAZOSINA DOC Generici needs to be interrupted, your doctor should re-establish the optimal dose, starting again with the recommended initial dose of 1 mg at bedtime.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor if you experience any side effects, especially if they persist.

Terazosin may cause temporary loss of consciousness (syncope). This usually occurs within 30–90 minutes after taking the first dose of terazosin or when the dose is increased. Sometimes it may be preceded by an increased heart rate (tachycardia 120–160 beats per minute). If you experience this symptom, lie down and contact your doctor if the condition persists.

If you move quickly from a sitting or lying position to a standing position, you may experience episodes of dizziness, lightheadedness, or fainting. If this happens, lie down and remain sitting for a few minutes before standing up again, to help prevent further episodes.

These adverse events usually do not recur after the initial treatment period or during subsequent dose titration.

The following side effects may occur:

• muscle weakness (asthenia);
• sensation of increased heartbeat (palpitations);
• nausea;
• swelling due to fluid accumulation in the arms or ankles (peripheral edema);
• dizziness, drowsiness;
• stuffy nose (nasal congestion) and inflammation of the nasal mucosa (rhinitis);
• visual disturbances (lazy eye or amblyopia) and blurred vision;
• back pain;
• headache (cephalalgia);
• increased heart rate (tachycardia);
• dizziness upon standing due to a sudden drop in blood pressure (orthostatic hypotension), temporary loss of consciousness (syncope);
• swelling due to fluid accumulation (edema);
• weight gain;
• pain in the extremities;
• sexual dysfunction such as reduced sexual desire (decreased libido) and impotence;
• depression, nervousness;
• altered sensation in arms and legs (paraesthesia);
• dizziness;
• difficulty breathing (dyspnea);
• inflammation of the nasal sinuses (sinusitis);
• severe allergic reactions (anaphylactoid reactions);
• decreased platelet count in the blood (thrombocytopenia);
• painful and prolonged erection not related to sexual desire (priapism);
• very rapid and irregular heart contractions (atrial fibrillation);
• reduction in certain blood components (haematocrit), haemoglobin, white blood cells (leukocytes), total blood protein, and albumin.

Other side effects not clearly associated with the use of terazosin include:

• chest pain;
• facial swelling due to fluid accumulation (facial edema);
• fever;
• abdominal pain;
• neck and/or shoulder pain;
• dilation of blood vessels (vasodilation);
• changes in heart rhythm (arrhythmia);
• constipation, diarrhoea;
• dry mouth (xerostomia);
• digestive disturbances (dyspepsia);
• flatulence;
• vomiting;
• joint pain due to uric acid deposition (gout), joint pain (arthralgia), joint inflammation (arthritis), joint disorders;
• muscle pain (myalgia);
• anxiety, insomnia;
• inflammation of the bronchi (bronchitis);
• nosebleeds (epistaxis);
• flu-like symptoms; sore throat (pharyngitis), nasal mucosa inflammation (rhinitis), cold-like symptoms;
• itching, skin irritation (rash);
• increased cough;
• sweating;
• altered vision;
• eye inflammation (conjunctivitis);
• perception of ringing in the ears (tinnitus);
• increased need to urinate, urinary tract infection, and urinary incontinence (mainly in postmenopausal women).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TERAZOSINA DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TERAZOSINA DOC Generici contains
TERAZOSINA DOC Generici 2 mg tablets:

• The active substance is terazosin. Each tablet contains 2.374 mg of terazosin hydrochloride dihydrate (equivalent to 2 mg of terazosin).
• The other components are: lactose, maize starch, talc, magnesium stearate.

TERAZOSINA DOC Generici 5 mg tablets:

• The active substance is terazosin. Each tablet contains 5.935 mg of terazosin hydrochloride dihydrate (equivalent to 5 mg of terazosin).
• The other components are: lactose, maize starch, talc, magnesium stearate, E132.

Description of the appearance of TERAZOSINA DOC Generici and contents of the pack
TERAZOSINA DOC Generici 2 mg tablets
Pack containing 10 divisible tablets.
TERAZOSINA DOC Generici 5 mg tablets
Pack containing 14 divisible tablets.

Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati, 40 - 20121 Milan, Italy
Manufacturer
Special Product’s Line S.p.A. - Strada Paduni 240 - 03012 Anagni (Frosinone), Italy