QUORUM 2 мг Коированная таблетка

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

QUORUM 2 mg tablets, 4 mg tablets

Doxazosina mesilato
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:
1 What QUORUM is and what it is used for
2 What you need to know before you take QUORUM
3 How to take QUORUM
4 Possible side effects
5 How to store QUORUM
6 Contents of the pack and other information

1. What is QUORUM and what is it used for

QUORUM contains the active substance doxazosin, which belongs to a group of drugs called alpha-
blockers used to lower high blood pressure, and to treat the symptoms of benign prostatic hyperplasia.
This medicine is indicated for the treatment:

• of high blood pressure (essential arterial hypertension)
• of the symptoms of a condition called benign prostatic hyperplasia, which causes a benign enlargement of the prostate in men.

2. What you need to know before taking QUORUM

Do not take QUORUM
if you are allergic to doxazosin, to other types of quinazolines (e.g. prazosin or terazosin) or to any of the
other ingredients of this medicine (listed in section 6);
if you have an enlarged prostate gland (benign prostatic hyperplasia) together with difficulty in
urinating, chronic urinary tract infection, or bladder stones;
if you have suffered from a condition known as “orthostatic hypotension”, a form of low blood
pressure that causes dizziness or a feeling of lightheadedness when getting up from a sitting or
lying position;
if you suffer from excessively low blood pressure (hypotension);
if you have a form of urinary incontinence (cannot control urination) or a condition in
which your body is unable to produce enough urine (anuria), with or without
kidney impairment. In this case, you must take this medicine in combination with other medicines.

Warnings and precautions
Talk to your doctor or pharmacist before taking QUORUM.
When you start taking QUORUM you may feel a sense of weakness, dizziness and, rarely, fainting caused
by a drop in blood pressure when getting up from a sitting or lying position. If you feel a
feeling of weakness, dizziness or fainting, you should sit or lie down until you feel better and
avoid situations where you could fall or get injured. Your doctor may decide to measure your blood
pressure regularly at the beginning of treatment to reduce the possibility of these
undesirable effects.
If you are about to undergo eye surgery for cataracts (clouding of a part of the eye
called the lens) tell your ophthalmologist before the operation that you are using or have previously
used QUORUM. Due to possible complications during the operation, the surgeon must be informed of
ongoing or previous treatments with QUORUM.
Tell your doctor or pharmacist before taking QUORUM if any of the following conditions apply to you, because
in these cases QUORUM must be used with caution:

• if you suffer from acute heart diseases such as:
• fluid accumulation in the lungs (pulmonary edema) due to a narrowing of the heart valves (aortic or mitral stenosis);
• problems with heart function (heart failure with high cardiac output per minute, right heart failure due to pulmonary embolism or pericardial effusion; left ventricular heart failure with low filling pressure);
• if you suffer from severe ischemic heart disease, a significant or sudden drop in pressure can lead to a worsening of your condition;
• if your liver function is reduced or if you are taking medicines that affect liver activity (e.g. cimetidine); if your liver function is severely impaired, your doctor will advise you against using QUORUM;
• if you are diabetic and also suffer from degeneration of the nerve fiber (diabetic autonomic neuropathy);
• if you are using medicines to treat erectile dysfunction (e.g. sildenafil, tadalafiland vardenafil), as the interaction between the medicines can cause the development of orthostatic hypotension. Your doctor will advise you to start with the lowest possible dose of the medicine for erectile dysfunction, waiting at least 6 hours after taking QUORUM, and will tell you how to behave if symptoms of orthostatic hypotension appear;

Also, be careful because the use of QUORUM can affect the result of some laboratory tests. The
doctor will take this into account when interpreting the test results.

Painful persistent erections of the penis– can occur very rarely. If this happens, contact
your doctor immediately.
Before starting therapy with Quorum, your doctor may perform some tests to rule out other diseases such as
prostate cancer, which may cause the same symptoms as benign prostatic hyperplasia.

Children and adolescents
QUORUM is not recommended for use in children and adolescents under 18 years of age as the safety and
efficacy of the treatment have not been established.

Other medicines and QUORUM
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tell your doctor or pharmacist before use if you are taking any of the following medicines, as
they may affect the effect of QUORUM:

• other medicines used to treat high blood pressure (especially nitrates and vasodilators). QUORUM can enhance the effect of these medicines and cause an excessive drop in pressure;
• medicines belonging to the class of sympathomimetics (substances that have a stimulating effect on a particular part of the nervous system) such as dopamine, ephedrine, metaraminol, adrenalineand phenylephrine. These medicines can reduce the effect of QUORUM on blood pressure and blood vessels;
• medicines used to treat erectile dysfunction. Taking these medicines at the same time as QUORUM may cause you to feel dizzy or lightheaded, which may be due to a drop in pressure caused by sitting or standing up quickly. To minimize the likelihood of these symptoms occurring, you should be on a regular daily dose of QUORUM before starting to use medicines for erectile dysfunction;
• medicines that can affect liver metabolism, e.g. cimetidine(medicine for stomach problems), clarithromycin, telithromycin(antibiotics for bacterial infections), itraconazole, ketoconazole, voriconazole(medicines for fungal infections (mycoses), nefazodone(medicine for depression), indinavir, nelfinavir, ritonavir, saquinavir(medicines for the treatment of HIV).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You can take QUORUM during pregnancy only if absolutely necessary and if your doctor has told you to
do so.
Breastfeeding
QUORUM should not be used during breastfeeding. Small amounts of doxazosin may be found in
breast milk. Do not breastfeed your baby unless your doctor advises you to do so.

Driving and using machines
QUORUM can interfere with your ability to drive vehicles or use machines, especially at the beginning of
treatment.

QUORUM contains lactose.
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this
medicine.

QUORUM contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take QUORUM

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
The initial dose of QUORUM is 1 mg administered as a single dose every day.

Essential hypertension
After 1-2 weeks, your doctor may increase the dose to 2 mg per day.
If necessary, after a further period of 1-2 weeks, your doctor may decide to increase the dose again to
4 mg per day. Your doctor, after a further period of 1-2 weeks and if necessary, may further increase
the dose to 8 mg per day, to lower blood pressure to the desired level. In some cases, the dose may
be increased to a maximum of 16 mg per day.
The recommended dose is 2-4 mg per day. The maximum recommended dose is 16 mg.

Benign prostatic hyperplasia (BPH)
After 1-2 weeks, your doctor may increase the dose to 2 mg per day, based on the results of your tests on
bladder and urethra function (small duct of the last part of the urinary tract that carries urine
from the bladder to the outside) or based on your response to therapy. If necessary, after a further period of 1-2
weeks, your doctor may increase the dose to 4 mg (1 tablet of 4 mg) and subsequently to 8 mg, if
necessary. The recommended daily dose is 2-4 mg, to be taken in a single administration per day.
However, 8 mg per day is the maximum recommended dose.
The dose should be increased with particular caution in patients with hepatic impairment.
QUORUM can be taken indifferently in the morning or in the evening.

If you take more QUORUM than you should
If taking an excessive amount of QUORUM causes you to feel dizzy or lightheaded,
you should lie down immediately with your head down.
In any case, in case of ingestion of an excessive dose of QUORUM, contact your doctor immediately or
go to the nearest hospital.

If you forget to take QUORUM
Do not take a double dose to make up for a missed dose.

If you stop taking QUORUM
If you stop taking QUORUM for a few days, you should resume treatment at the initial dose of
1 mg.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Common(may affect up to 1 in 10 people): respiratory tract infections, urinary tract infections,
drowsiness, dizziness, headache, palpitations, fast heartbeat, low blood pressure, postural hypotension,
bronchitis, cough, shortness of breath, allergic rhinitis (hay fever), abdominal pain, indigestion, dry mouth, nausea, itching, back pain, muscle pain, cystitis, involuntary urination (incontinence),
reduced muscle strength, chest pain, flu-like symptoms, swelling of different parts of the body
due to fluid retention.

Uncommon(may affect up to 1 in 100 people): allergic reaction to the medicine, gout (rheumatic disease
affecting the joints), increased appetite, anorexia, agitation, depression, anxiety, insomnia,
nervousness, stroke, decreased sensitivity, temporary loss of consciousness, tremor, tinnitus (perception of
a ringing in the ears), heart attack, feeling of tightness and pain in the chest (angina pectoris), nosebleeds, constipation, formation of gas in the intestine, vomiting, diarrhea, inflammation of the stomach and
intestines, abnormal results of liver enzymes and function tests, skin rash, joint pain, difficulty urinating, frequent urination, blood in the urine, impotence, general pain, facial swelling, weight gain.

Rare(may affect up to 1 in 1000 people): muscle cramps, muscle weakness, excessive
urine production.

Very rare(may affect up to 1 in 10,000 people): decreased number of white blood cells,
decreased number of platelets, dizziness when changing position, tingling, blurred vision, slow
heartbeat, irregular heartbeat, hot flushes, difficulty breathing due to spasms of the
respiratory muscles, yellowing of the skin or eyes (jaundice), liver inflammation, problems
with bile secretion, urticaria (hives), hair loss, bruising under the skin (purpura), increased excretion
of urine, urinary disorders, need to urinate at night, development of breasts in men, persistent and painful erection, fatigue, malaise, painful and persistent erection.

Not known(frequency cannot be estimated from available data): increased risk of
complications during cataract surgery (iris flag syndrome – IFS), ejaculation disorders.
alterations

In some cases
Increases in nitrogen and creatinine levels in your blood or a decrease in red blood cells may occur. In the
early stages of treatment, you may experience orthostatic hypotension or temporary loss of consciousness, especially
if you are taking high doses of the medicine. These effects may also occur when you restart treatment
after a short interruption.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through 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 QUORUM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What QUORUM 2 mg contains

• The active ingredient is doxazosin mesylate. Each tablet contains 2.43 mg of doxazosin mesylate, equivalent to 2 mg of doxazosin.
• The other ingredients are: microcrystalline cellulose, lactosemonohydrate, sodium starch glycolate, magnesium stearate, sodiumlauryl sulfate.

What QUORUM 4 mg contains

• The active ingredient is doxazosin mesylate. Each tablet contains 4.85 mg of doxazosin mesylate, equivalent to 4 mg of doxazosin.
• The other ingredients are: microcrystalline cellulose, lactosemonohydrate, sodium starch glycolate, magnesium stearate, sodiumlauryl sulfate.

Description of the appearance of QUORUM and contents of the pack
Pack containing 30 divisible tablets of 2 mg in blisters.
Pack containing 20 divisible tablets of 4 mg in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder:
S.F. Group S.r.l.
Via Tiburtina, 1143
00156 Roma

Manufacturer responsible for batch release:
LACHIFARMA S.r.l. – Laboratorio chimico farmaceutico salentino
S.S.16 Zona Industriale

• 73010 – Zollino (LE) Italy