Terazosin Teva

Patient Information Leaflet

Terazosin Teva 1 mg tablets, 2 mg tablets, 5 mg tablets

Equivalent medicinal product
Please read 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Terazosina Teva is and what it is used for

Terazosina Teva belongs to a group of medicines called alpha-blockers.
Terazosina Teva is used to treat patients with high blood pressure.
This medicine helps reduce blood pressure.
Terazosina Teva can also be used to treat a condition called benign prostatic hyperplasia, which is common in older men. This condition is caused by excessive growth of the prostate gland, which obstructs the flow of urine from the bladder. This leads to unpleasant symptoms such as weak or interrupted urine flow, frequent need to urinate, and/or sudden urge to urinate.
Terazosina Teva can relax the muscles of the prostate gland and bladder to help relieve these symptoms.
Ask your doctor or pharmacist if you need further information.

2. What you need to know before taking Terazosin Teva

Do NOT take Terazosin Teva:

• if you are allergic to terazosin or to any of the other ingredients of this medicine (listed in section 6);
• if you have ever experienced a brief loss of consciousness when urinating, or immediately after urinating. This symptom occurs more frequently when getting up during the night to urinate.

Warnings and precautions
Talk to your doctor or pharmacist before taking Terazosin Teva if you experience or suffer from any of the following symptoms:

• Fainting, unsteadiness, or dizziness (a spinning sensation), upon standing up, caused by low blood pressure.

These are more common:

• when starting treatment;
• when restarting treatment after a few days’ break;
• if your body lacks sufficient fluids;
• if you are on a low-salt diet;
• in elderly patients (over 65 years of age).

You are more likely to faint when standing up if:

• your dose of terazosin is increased rapidly;
• you are taking diuretics or other medicines that help lower blood pressure.

You may notice a rapid heartbeat shortly before fainting. The risk of fainting is highest between 30 and 90 minutes after taking your dose of terazosin.

• Hypotension (low blood pressure); your doctor will monitor your blood pressure;
• Heart problems such as fluid in the lungs or heart failure;
• Impaired liver function;
• Severe renal failure requiring intensive treatment or dialysis;
• Absence of urine production or reduced urine flow;
• Obstruction of the upper urinary tract (when it is difficult for urine to pass from the kidneys to the bladder);
• Persistent urinary tract infection (an infection that cannot be cured by treatment);
• Bladder stones.

If you are about to undergo eye surgery due to cataract (clouding of the lens), inform your ophthalmologist before the operation that you are currently using or have previously used terazosin. This is because terazosin may cause complications during surgery, which can be managed if your specialist has been informed in advance.

Children and adolescents
Terazosin Teva is not recommended for children and adolescents under 18 years of age.
The safety and efficacy of this medicine in children have not been established.

Other medicines and Terazosin Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• Other medicines used to treat high blood pressure (other antihypertensive agents, including ACE inhibitors, beta-blockers, calcium channel blockers, and diuretics);
• The combined use of Terazosin Teva with other alpha-blockers is not recommended;
• Medicines used to treat erectile dysfunction (PDE-5 inhibitors, e.g. sildenafil, tadalafil, vardenafil). Some patients taking alpha-blockers to treat high blood pressure or prostate enlargement may experience dizziness or lightheadedness, which may be caused by low blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms while taking medications for erectile dysfunction (impotence) together with alpha-blockers. To reduce the likelihood of these symptoms occurring, a stable daily dose of the alpha-blocker should be reached before starting treatment with erectile dysfunction medications.

Terazosin Teva with food, drinks, and alcohol
Food and drink do not affect your treatment with terazosin.
Be aware that alcohol may increase the risk of dizziness, lightheadedness, or drowsiness.

Pregnancy and breastfeeding
The use of terazosin is NOT recommended during pregnancy and breastfeeding.
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Terazosin tablets may impair your ability to drive vehicles or operate machinery.
Dizziness, lightheadedness, or drowsiness may occur with the initial dose, after missed doses, or when resuming treatment with terazosin. Patients should be warned about these possible adverse events and the circumstances under which they may occur. It is recommended to avoid driving and hazardous activities for approximately the first 12 hours after the initial dose or when the dose is increased.

Terazosin Teva contains lactose
Terazosin Teva contains milk sugar (lactose). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Terazosin Teva

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

1. READ THIS PARAGRAPH IF YOU ARE TAKING TERAZOSIN FOR THE

FIRST TIME OR IF YOU HAVE NOT TAKEN TERAZOSIN IN THE LAST WEEK.
IF YOU ARE CONTINUING TREATMENT WITHOUT INTERRUPTION,
READ PARAGRAPH 2 BELOW.
It is important that you take the correct tablet at the right time. The tablets must be
swallowed with a glass of water. The first tablet of a new dose should be taken in the evening,
before going to bed. Subsequent tablets of the same dosage may be taken in the morning.

Treatment of hypertension
Start by taking one 1 mg tablet daily (white tablet) from Day 1.
From Day 8 onwards, start taking one 2 mg tablet daily (yellow tablets).
Continue taking one tablet daily until Day 14.
Now read paragraph 2.

Treatment of benign prostatic hyperplasia
Start by taking one 1 mg tablet daily (white tablet) from Day 1.
From Day 8 onwards, start taking one 2 mg tablet daily (yellow tablet) for 14 days.
From Day 22 onwards, start taking one 5 mg tablet daily (light brown tablet) for 7 days.
When you have completed these 4 weeks of treatment, your doctor will prescribe further tablets.
Depending on your response to terazosin, your doctor will decide which tablet dosage is best for you.

After starting to take the tablets or after changing the dosage, it is important that you DO NOT drive or undertake any potentially hazardous activities for 12 hours. This is because dizziness, lightheadedness, or drowsiness may occur with the first dose, when changing dosage, or after missed doses followed by restarting treatment.

If you are unsure about when to take the tablets, you must consult your doctor.

2. READ THIS PARAGRAPH IF YOU HAVE ALREADY TAKEN TERAZOSIN AND ARE

CONTINUING WITH THE NEXT PACKAGE
When you have finished your last package, your doctor may prescribe you further tablets. Depending
on your response to terazosin, your doctor will decide which tablet strength you need.
You may be prescribed a new package of tablets containing 2 mg (yellow tablets) or 5 mg (light brown tablets).
The maintenance dose (usually 2–10 mg daily) will be adjusted according to your body's response to the medicine.
Take one tablet daily as indicated in paragraph 3, sub-paragraph 1.
If you are unsure about when to take the tablets, consult your doctor.
Continue taking your tablets until your doctor tells you to stop. Do not stop
treatment because you feel better.
Your doctor will monitor you periodically during treatment.

Use in children and adolescents
Terazosin is not recommended for children and adolescents under 18 years of age.

If you take more Terazosin Teva than you should
If you accidentally take an excessive dose (more than one tablet per day), contact your doctor immediately.
Taking too many tablets may cause excessive lowering of blood pressure and other serious effects.
Symptoms of overdose may include: dizziness, confusion, fainting, shortness of breath, low blood pressure,
pounding heartbeat (palpitations), rapid heartbeat, feeling unwell, muscle cramps, low blood sugar levels,
low potassium levels in the blood.

If you forget to take Terazosin Teva
If you forget to take a dose of Terazosin Teva, you can take it as soon as you remember, unless it is almost
time for your next dose. In this case, continue with your prescribed therapy. Do not take a double dose to
compensate for the missed dose.

If you stop treatment with Terazosin Teva
If you have not taken the tablet for several days, you must not continue using the same dosage.
Consult your doctor for advice.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some people may develop a severe allergic reaction. This is very rare (may affect up to 1 in 10,000 people) but is a very serious side effect. If you experience any of the following symptoms, stop taking Terazosina Teva immediately, contact your doctor or go to the nearest hospital emergency department:

• swelling of the face, hands, lips, tongue or throat;
• difficulty swallowing or breathing.

You must stop taking Terazosina Teva and contact your doctor immediately if you experience a prolonged and painful erection of the penis. This is a rare side effect (may affect up to 1 in 1,000 people).
When taking Terazosina Teva tablets for the first time or when starting a tablet with a higher dose, some people may experience dizziness, lightheadedness or fainting.
These side effects may also occur when getting up quickly from a lying or sitting position. In such cases, you should lie down until you feel better, then sit for a few minutes before standing up again to avoid recurrence of these effects.
These side effects usually disappear and do not return once your body has become accustomed to the tablets.

The following side effects have been classified according to frequency as follows:

Common (may affect up to 1 in 10 people):

• nervousness, drowsiness, tingling sensation (pins and needles), dizziness;
• blurred vision, problems with colour vision;
• irregular or rapid heartbeat, chest pain;
• difficulty breathing, sinusitis, nosebleeds;
• feeling unwell, malaise, constipation, diarrhoea;
• itching, skin rash;
• back pain;
• impotence;
• dizziness, lightheadedness, fainting, feeling of weakness, headache;
• swelling, pain in the extremities.

Uncommon (may affect up to 1 in 100 people):

• depression;
• urticaria;
• decreased sexual desire;
• weight gain;
• transient loss of consciousness.

Rare (may affect up to 1 in 1,000 people):

• urinary tract infections, urinary incontinence;
• prolonged and painful erection.

Very rare (may affect up to 1 in 10,000 people):

• blood disorders;
• heart rhythm abnormalities.

Not known (frequency cannot be estimated from the available data):

• nasal congestion;
• rhinitis;
• swelling of hands, ankles, feet and legs (peripheral oedema).

Additional effects reported in clinical studies or during post-marketing experience, but not clearly associated with the use of terazosin, include the following:

• facial swelling, fever, abdominal, neck and shoulder pain, skin redness, irregular heartbeat, indigestion, flatulence, dry mouth, gout, joint pain, arthritis, muscle pain, anxiety, difficulty sleeping, bronchitis, flu-like and cold symptoms, throat swelling or pain, rhinitis, cough, sweating, altered vision, conjunctivitis, perception of noises in the ears such as ringing or buzzing (tinnitus), increased urinary frequency (more frequent urination).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Terazosin Teva

This medicine has been prescribed for you personally; do not give it to others.
Unless your doctor tells you otherwise, do not keep these tablets longer than necessary.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and on the outer carton after EXP.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep 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 Terazosin Teva contains
The active substance is terazosin.
Each tablet contains 1.187 mg of terazosin hydrochloride dihydrate, equivalent to 1 mg of terazosin.
Each tablet contains 2.374 mg of terazosin hydrochloride dihydrate, equivalent to 2 mg of terazosin.
Each tablet contains 5.935 mg of terazosin hydrochloride dihydrate, equivalent to 5 mg of terazosin.
The other components are monohydrate lactose, maize starch, crospovidone, povidone (K-30), talc,
magnesium stearate (E572), and/or no colour (1 mg tablets), or E104 quinoline yellow (in
2 mg tablets), or red and yellow iron oxide E172 (in 5 mg tablets).

Description of the appearance of Terazosin Teva and package contents
Terazosin Teva 1 mg tablets
White to off-white, round, flat tablet with bevelled edges. Marked with "93" on one side and "760" on the other.
Terazosin Teva 2 mg tablets
Mottled yellow, round, flat tablet with bevelled edges. Marked with "93" on one side and "761" on the other.
Terazosin Teva 5 mg tablets
Mottled brown, round, flat tablet with bevelled edges. Marked with "93" on one side and "762" on the other.
The 1 mg dose is available in packs of 7, 10, 14, 15, 50 and 100 tablets.
The 2 mg dose is available in packs of 14, 15, 20, 28, 30, 50, 84, 98 and 100 tablets.
The 5 mg dose is available in packs of 7, 14, 20, 28, 30, 50, 84, 98 and 100 tablets.
The 1 mg, 2 mg and 5 mg tablets are also available in "starter packs".
Check the outer packaging or label for contents, e.g. number of tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 Milan, Italy
Manufacturer
Pharmachemie B.V. – Swensweg, 5 – 2003 RN Haarlem (The Netherlands)
Teva Pharmaceutical Works Co. Ltd. – Pallagi út 13 – 4042 Debrecen (Hungary)
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren (Germany)
Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków (Poland)