PACKAGE LEAFLET: INFORMATION FOR THE USER

QUORUM 2 mg tablets, 4 mg tablets

Doxazosin mesilate
Equivalent medicine
Please read all of this leaflet carefully before you start 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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact 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 taking 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 QUORUM is and what it is used for

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

of high blood pressure (essential arterial hypertension)
of symptoms of a condition called benign prostatic hyperplasia, which causes non-cancerous enlargement of the prostate gland 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 components 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 causing dizziness or a feeling of lightheadedness when standing up from a sitting or lying position;
if you suffer from abnormally low blood pressure (hypotension);
if you have urinary incontinence (inability to retain urine) or a condition in which your body cannot produce sufficient urine (anuria), with or without kidney impairment. In this case, you should 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 experience weakness, dizziness, and, rarely, fainting caused by a drop in blood pressure upon standing up from a sitting or lying position. If you feel weak, dizzy, or faint, sit or lie down until you feel better and avoid situations where you could fall or get injured. Your doctor may decide to monitor your blood pressure regularly at the beginning of treatment to reduce the likelihood of these side effects.
If you are about to undergo eye surgery for cataract (clouding of a part of the eye called the lens), inform your ophthalmologist before the operation that you are currently taking or have previously taken QUORUM. Because of possible complications during surgery, the surgeon must be informed of any current or past treatment with QUORUM.
Inform your doctor or pharmacist before taking QUORUM if any of the following apply to you, as QUORUM should be used with caution in these cases:

if you suffer from acute heart diseases such as:
- fluid accumulation in the lungs (pulmonary edema) due to narrowing of heart valves (aortic or mitral stenosis);
- heart function problems (heart failure with high cardiac output, right-sided heart failure due to pulmonary embolism or pericardial effusion; left ventricular heart failure with low filling pressure);
- if you have severe ischemic heart disease, excessive or sudden lowering of blood pressure may worsen 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 against using QUORUM;
if you are diabetic and also suffer from nerve fiber degeneration (autonomic diabetic neuropathy);
if you are using medicines to treat erectile dysfunction (e.g. sildenafil, tadalafil, and vardenafil), since interaction between these medicines may lead to orthostatic hypotension. Your doctor will advise you to start with the lowest possible dose of the erectile dysfunction medicine, waiting at least 6 hours after taking QUORUM, and will instruct you on how to respond if symptoms of orthostatic hypotension occur;

Also be cautious, as the use of QUORUM may affect the results of certain laboratory tests. Your doctor will take this into account when interpreting test results.
Prolonged painful erections of the penis – may occur very rarely. If this happens, contact a doctor immediately.
Before starting treatment with Quorum, your doctor may perform tests to rule out other diseases such as prostate cancer, which could cause symptoms similar to 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist before use if you are taking any of the following medicines, as they may affect the action of QUORUM:

other medicines used to treat high blood pressure (especially nitrates and vasodilators). QUORUM may enhance the effect of these medicines and cause excessive lowering of blood pressure;
medicines belonging to the class of sympathomimetics (substances that stimulate a specific part of the nervous system) such as dopamine, ephedrine, metaraminol, adrenaline, and phenylephrine. These medicines may reduce the effect of QUORUM on blood pressure and blood vessels;
medicines used to treat erectile dysfunction. Taking these medicines together with QUORUM may cause dizziness or a sensation of lightheadedness, possibly due to low blood pressure when sitting or standing up quickly. To minimize the risk of these symptoms, you should already be on a regular daily dose of QUORUM before starting treatment with erectile dysfunction medicines;
medicines that may affect liver metabolism, e.g. cimetidine (a medicine for stomach problems), clarithromycin, telithromycin (antibiotics for bacterial infections), itraconazole, ketoconazole, voriconazole (medicines for fungal infections (mycoses)), nefazodone (a medicine for depression), indinavir, nelfinavir, ritonavir, saquinavir (medicines for the treatment of HIV).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You may take QUORUM during pregnancy only if absolutely necessary and only if your doctor has instructed you to do so.
Breastfeeding
QUORUM must not be used during breastfeeding. Small amounts of doxazosin may pass into breast milk. Do not breastfeed unless your doctor specifically advises you to do so.

Driving and using machines
QUORUM may affect your ability to drive or operate machinery, especially at the beginning of treatment.

QUORUM contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them 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 exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The initial dose of QUORUM is 1 mg taken as a single daily dose.

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

Benign prostatic hyperplasia (BPH)
After 1-2 weeks, your doctor may increase the dose to 2 mg daily, depending on the results of your bladder and urethra function tests (the urethra is the small duct in the final 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 1-2 weeks, your doctor may increase the dose to 4 mg (1 tablet of 4 mg) and subsequently to 8 mg, if needed. The recommended daily dose is 2–4 mg, taken as a single daily administration. However, 8 mg daily is the maximum recommended dose.

Dose increases should be made with particular caution in patients with hepatic impairment.

QUORUM may be taken in the morning or evening, as preferred.

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 lowered.

In any case, if you have taken 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 the missed dose.

If you stop taking QUORUM
If you interrupt treatment with QUORUM for a few days, you must restart treatment at the initial dose of 1 mg.

If you have any questions 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 everybody gets them.
Common (may affect up to 1 in 10 people): respiratory tract infections, urinary tract infections, drowsiness, dizziness, headache, palpitations, rapid heartbeat, low blood pressure, postural hypotension, bronchitis, cough, shortness of breath, allergic rhinitis, 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 accumulation.
Uncommon (may affect up to 1 in 100 people): allergic reaction to the medicine, gout (a rheumatic disease affecting the joints), increased appetite, anorexia, agitation, depression, anxiety, insomnia, nervousness, stroke, decreased sensitivity, temporary loss of consciousness, tremor, tinnitus (ringing in the ears), heart attack, sensation of tightness and pain in the chest (angina pectoris), nosebleeds, constipation, intestinal gas formation, vomiting, diarrhoea, inflammation of the stomach and intestine, abnormal liver enzyme and liver function test results, 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 1,000 people): muscle cramps, muscle weakness, excessive urine production.
Very rare (may affect up to 1 in 10,000 people): decrease in the number of white blood cells, decrease in the number of platelets, dizziness when changing position, tingling, blurred vision, slow heartbeat, irregular heartbeat, hot flushes, breathing difficulties due to spasms of the respiratory tract muscles, yellowing of the skin or eyes (jaundice), liver inflammation, problems with bile secretion, urticaria, hair loss, bruising under the skin (purpura), increased urine excretion, urinary disturbances, need to urinate at night, breast development in men, persistent and painful erection, fatigue, malaise, painful and prolonged erection.
Not known (frequency cannot be estimated from the available data): increased risk of complications during cataract surgery (intraoperative floppy iris syndrome – IFIS), ejaculation disorders.
In some cases
Increases in blood levels of nitrogen and creatinine or a reduction in red blood cells may occur. At the beginning of treatment, orthostatic hypotension or temporary loss of consciousness may occur, especially if you are taking high doses of this medicine. These effects may also occur when restarting treatment after a short interruption.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can 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 QUORUM

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.
This medicine does not require any special storage conditions.
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 QUORUM 2 mg contains

The active substance is doxazosin mesylate. Each tablet contains 2.43 mg of doxazosin mesylate, equivalent to 2 mg of doxazosin.
The other components are: microcrystalline cellulose, lactose monohydrate, sodium glycolate starch, magnesium stearate, sodium lauryl sulfate.

What QUORUM 4 mg contains

The active substance is doxazosin mesylate. Each tablet contains 4.85 mg of doxazosin mesylate, equivalent to 4 mg of doxazosin.
The other components are: microcrystalline cellulose, lactose monohydrate, sodium glycolate starch, magnesium stearate, sodium lauryl sulfate.

Description of the appearance of QUORUM and the contents of the pack
Box containing 30 2 mg divisible tablets in blisters.
Box containing 20 4 mg divisible tablets in blisters.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
S.F. Group S.r.l.
Via Tiburtina, 1143
00156 Rome
Italy

Manufacturer responsible for batch release:
LACHIFARMA S.r.l. – Laboratorio chimico farmaceutico salentino
S.S.16 Zona Industriale
73010 – Zollino (LE)
Italy

November 2022