Kornam

Package Leaflet: Information for the Patient

Kornam, 2 mg, tablets

Kornam, 5 mg, tablets

Terazosin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Kornam and what is it used for
• 2. Important information before taking Kornam
• 3. How to take Kornam
• 4. Possible side effects
• 5. How to store Kornam
• 6. Contents of the pack and other information

1. What is Kornam and what is it used for

Kornam belongs to a group of medicines called alpha-adrenergic receptor antagonists (or alpha-adrenolytics).
Kornam causes a decrease in the tension of the walls of blood vessels (veins and arteries) and their dilation,
which facilitates blood flow through these vessels. The medicine also relaxes the muscles of the prostate and the neck
of the urinary bladder, making it easier to urinate.
Kornam is used to treat high blood pressure, to treat benign prostatic hyperplasia (enlarged prostate), and to treat
symptomatic urinary outflow obstruction due to benign prostatic hyperplasia.

2. Important information before taking Kornam

When not to take Kornam

Warnings and precautions

Before starting to take Kornam, discuss it with your doctor or pharmacist.
Kornam can significantly lower blood pressure, causing dizziness, and in severe cases, fainting.
The risk of these disorders occurs after taking the first dose or a few initial doses of the medicine, after
increasing the dose of the medicine, after a break in taking the medicine lasting 2 or more days, and then
resuming treatment, as well as in elderly patients (≥65 years) and after adding another antihypertensive or
diuretic medicine to the treatment.
If you resume taking Kornam after a few-day break, your doctor will recommend using the initial dose.
Patients may experience a significant decrease in blood pressure, especially after taking the first dose ("first
dose effect") or after increasing the dose, particularly when standing or changing position. They may then
experience symptoms such as weakness, dizziness, and, in very rare cases, loss of consciousness, sometimes
caused by supraventricular tachycardia.
These symptoms can also be expected when resuming treatment after a break lasting two or more days.
Usually, they only last for a short time and usually disappear after continuing treatment.
Avoid sudden changes in body position or prolonged standing after increasing the dose of the medicine and
resuming treatment after a break. This applies especially to elderly patients. Avoid stressful situations that can
cause fainting, sit or lie down when experiencing any symptoms of low blood pressure, although they do not
always have to be related to body position, and exercise caution when getting up from a sitting or lying
position. If you experience dizziness or palpitations, contact your doctor immediately, who will consider
adjusting the dose.
The medicine should not be taken in case of urinary retention, anuria, or advanced renal failure.
Due to the risk of excessive blood pressure reduction, caution should be exercised when taking terazosin
(the active substance of Kornam) and thiazide diuretics or other antihypertensive medicines. If these medicines
are added during terazosin treatment, your doctor will recommend reducing the dose or discontinuing terazosin.
It is necessary to gradually increase the new dose. If terazosin is taken in combination with other antihypertensive
medicines, your doctor will recommend reducing their dose before starting terazosin treatment and adjusting
their dose when the terazosin dose is stabilized.
Terazosin may cause prolonged (lasting more than 4 hours) or painful erections (so-called priapism). In case
of its occurrence, you should immediately contact your doctor, as otherwise, there is a risk of permanent
erection disorders.
Before starting treatment for symptoms of benign prostatic hyperplasia, your doctor will perform appropriate
examinations to rule out other causes of urinary outflow disorders or symptoms from the urinary system.
Patients with benign prostatic hyperplasia who also have urinary outflow obstruction in the upper urinary tract,
chronic urinary tract infections, or kidney stones should not take Kornam.
Your doctor will carefully monitor the course of treatment in patients with pulmonary edema caused by
mitral valve stenosis or with heart failure.
Concomitant use of Kornam and such medicines as sildenafil, tadalafil, or vardenafil requires special caution
due to the risk of hypotensive symptoms. You should consult your doctor about this.
You should inform your doctor if you have ever fainted after urinating, as Kornam is contraindicated in such
patients.
If you are to undergo surgical treatment for cataracts, you should inform the operating ophthalmologist about
taking Kornam currently or in the past.
Terazosin may affect the results of some blood laboratory tests.
Cautious use is required when taking medicines that may affect liver metabolism (e.g., 5-phosphodiesterase
inhibitors, such as sildenafil, tadalafil, and vardenafil [medicines used to treat erectile dysfunction], calcium
antagonists, angiotensin-converting enzyme (ACE) inhibitors [medicines used to treat high blood pressure or
certain heart diseases], and cimetidine [a medicine that inhibits stomach acid secretion]).
If you are to undergo a urine test to diagnose a pheochromocytoma (a tumor of the adrenal gland), you must
tell your doctor about taking Kornam.

Children

Kornam should not be used in children.

Kornam and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, as well as any medicines you
plan to take.
Before taking any additional medicine, including over-the-counter medicines, vitamins, and herbal preparations,
consult your doctor. Kornam and other concomitantly used medicines may affect each other's action.
This applies especially to the following medicines:

• other medicines that lower blood pressure (e.g., clonidine, moxonidine);
• diuretics;
• other alpha-adrenolytic medicines (e.g., doxazosin, prazosin);
• nitrates (e.g., nitroglycerin);
• medicines used to treat asthma;
• medicines used to treat heart diseases (e.g., beta-adrenergic blockers, calcium channel blockers, ACE
  inhibitors);
• sympathomimetic medicines (e.g., dopamine, ephedrine, adrenaline, metaraminol, methoxamine);
• medicines used to treat eye diseases;
• medicines used to relieve symptoms of rhinitis (e.g., phenylephrine);
• medicines used to treat erectile dysfunction (e.g., sildenafil, tadalafil, and vardenafil).

Kornam with food, drink, and alcohol

Tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water).
During Kornam treatment, you should avoid consuming alcoholic beverages.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor
before taking this medicine.
The medicine can be used during pregnancy and breastfeeding only if your doctor considers it necessary.
The medicine should not be used shortly before delivery.

Driving and using machines

Kornam significantly affects the ability to drive and use machines.
Especially at the beginning of treatment, dizziness, drowsiness, and/or fainting may occur. You should not drive
vehicles or operate machines for 12 hours after taking the first dose of the medicine, after increasing the dose,
and after resuming Kornam treatment after a break.
Kornam contains lactose monohydrate.If you have previously been diagnosed with intolerance to some
sugars, you should contact your doctor before taking the medicine.

3. How to take Kornam

This medicine should always be taken as directed by your doctor. In case of doubts, consult your doctor or
pharmacist.
Your doctor will prescribe the appropriate dose and decide how often you should take the medicine. They may
change the dose several times before finding the optimal one. Do not change the dose of the medicine or stop
treatment without consulting your doctor. Unless your doctor decides otherwise, you should take the medicine
before bedtime.
Tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water).
Hypertension
Usually, the initial dose of the medicine is 1 mg (half a 2 mg tablet) before bedtime and should not be
exceeded.
Then, your doctor will gradually increase the dose if necessary until blood pressure is normalized.
Usually, the maintenance dose is between 2 mg and 10 mg per day, taken before bedtime. The maximum daily
dose is 20 mg (in exceptional cases 40 mg).
Benign prostatic hyperplasia
The initial dose is 1 mg per day (half a 2 mg tablet) before bedtime. The dose of the medicine is increased
gradually until clinical improvement is achieved, according to your doctor's recommendations. Usually, a daily
dose of 10 mg of terazosin is used. The effect of treatment can be observed after 2 weeks from the start of
treatment. The best results are achieved after 4 to 6 weeks, using a dose of 10 mg of terazosin per day.
Usually, the maintenance dose is between 5 mg and 10 mg before bedtime. The maximum daily dose is 20 mg.
Elderly patients
Dose adjustment is not necessary.
Patients with renal impairment
The medicine should not be used by patients who excrete reduced amounts of urine or do not excrete it at all,
as well as patients with severe renal failure. In case of doubts, consult your doctor.
Patients with hepatic impairment
The medicine should not be used by patients with severe hepatic impairment. If you have doubts whether this
applies to you, consult your doctor.

Taking a higher dose of Kornam than recommended

In case of taking too much of the medicine, consult your doctor immediately, as excessive blood pressure
reduction is possible.

Missing a dose of Kornam

If you forgot to take Kornam at the usual time, take it as soon as possible and continue taking the medicine
according to the previous schedule. Do not take a double dose to make up for the missed dose.

Stopping Kornam treatment

Before deciding to stop Kornam treatment, always consult your doctor.
Even if you feel well, do not stop treatment without consulting your doctor.
After a break in terazosin treatment lasting several days, treatment should be resumed from the initial dose of
1 mg.
In case of any further doubts related to the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Kornam can cause side effects, although not everybody gets them.
Kornam can cause fainting. After taking the first dose, excessive blood pressure reduction may occur, causing
dizziness, and in severe cases, fainting.
Very common side effects(may occur more often than in 1 in 10 people):

• headache
• dizziness
• feeling of weakness

Common side effects(may occur less often than in 1 in 10 people):

• sinusitis
• nervousness
• drowsiness
• restlessness
• tingling sensation
• blurred vision, double vision
• palpitations, rapid heartbeat
• decreased blood pressure when changing position from lying to sitting or standing, causing dizziness
• shortness of breath
• nausea
• limb pain, back pain
• erectile dysfunction
• limb swelling
• feeling of fatigue
• swelling of mucous membranes

Uncommon side effects(may occur less often than in 1 in 100 people):

• decreased libido
• depression
• fainting
• swelling

Rare side effects(may occur less often than in 1 in 1000 people):

• weight gain

Frequency not known(cannot be estimated from the available data):

• bronchitis, flu-like symptoms, pharyngitis
• urinary tract infections
• decreased platelet count (thrombocytopenia)
• severe allergic reactions (anaphylactic reactions)
• gout
• insomnia
• conjunctivitis
• lazy eye (amblyopia)
• tinnitus
• arrhythmias, atrial fibrillation
• vasodilation
• cough, epistaxis
• abdominal pain, constipation, diarrhea, dry mouth, dyspepsia, flatulence, vomiting
• increased urination frequency, urinary incontinence
• excessive sweating
• pruritus
• rash
• arthralgia, arthritis, joint disorders (arthropathy), muscle pain, neck pain, shoulder pain
• increased urination frequency, urinary incontinence
• prolonged and/or painful erections (priapism)
• chest pain
• facial swelling
• increased body temperature
• decreased albumin, decreased hematocrit, decreased hemoglobin, decreased total protein
• decreased white blood cell count (leukopenia)
• nasal congestion.

A variant of the "small pupil" syndrome known as "intraoperative floppy iris syndrome" has been reported in
association with alpha-adrenolytic medicines during cataract surgery.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist,
or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for
Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Kornam

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Store in the original package.
Do not use this medicine after the expiry date stated on the package after EXP.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose
of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Kornam contains

The active substance of Kornam is terazosin.
2 mg tablets
One tablet contains 2 mg of terazosin in the form of terazosin hydrochloride dihydrate.
Other ingredients are: lactose monohydrate, microcrystalline cellulose, maize starch, talc, colloidal anhydrous
silica, magnesium stearate, quinoline yellow.
5 mg tablets
One tablet contains 5 mg of terazosin in the form of terazosin hydrochloride dihydrate.
Other ingredients are: lactose monohydrate, microcrystalline cellulose, maize starch, talc, colloidal anhydrous
silica, magnesium stearate, yellow iron oxide.

What Kornam looks like and contents of the pack

2 mg tablets
Yellow, round, flat tablets with beveled edges, with a score line on one side.
5 mg tablets
Yellow-orange, round, flat tablets with beveled edges, with a score line on one side.
Aluminum/PVC film-coated blisters in a cardboard box containing 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
To obtain more detailed information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

Date of last revision of the leaflet: