Package leaflet: Information for the user

DOXAFIN 2 mg tablets, 4 mg tablets

Doxazosin mesylate
Generic medicine
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 pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What DOXAFIN is and what it is used for
What you need to know before taking DOXAFIN
How to take DOXAFIN
Possible side effects
How to store DOXAFIN
Contents of the pack and other information

1. What DOXAFIN is and what it is used for

DOXAFIN contains the active substance doxazosin, which belongs to a group of medicines called alpha-blockers used to lower blood pressure.
DOXAFIN is indicated for the treatment:

of high blood pressure (essential hypertension);
of symptoms caused by a condition called benign prostatic hyperplasia affecting the prostate gland in men.

2. What you need to know before taking DOXAFIN

Do not take DOXAFIN

if you are allergic to doxazosin, to quinazolines (e.g. prazosin, terazosin), or to any of the other ingredients of this medicine (listed in section 6);
if, in addition to benign enlargement of the prostate, you have a history of orthostatic hypotension. Orthostatic hypotension is the lowering of blood pressure upon standing, which may cause dizziness, lightheadedness, or fainting;
if, in addition to benign enlargement of the prostate, you suffer from upper urinary tract congestion or obstruction, chronic recurrent urinary tract infection, or bladder stones;
if you are breastfeeding and need to take this medicine for the treatment of high blood pressure (See section “Pregnancy and breastfeeding”);
if you suffer from excessively low blood pressure (this applies only if you are taking doxazosin for benign enlargement of the prostate);
if you suffer from urinary leakage (reflux incontinence) or absence of urine production (anuria). In this case, you should take this medicine only in combination with other medicines.

Warnings and precautions
Talk to your doctor or pharmacist before taking DOXAFIN.
Exercise particular caution in the following cases:

at the beginning of therapy, because this medicine may cause a drop in blood pressure (orthostatic hypotension) characterized by dizziness and weakness, or rarely, loss of consciousness. Your doctor should monitor your blood pressure in such cases (See section “Possible side effects”);
if you have heart problems such as:
fluid accumulation in the lungs (pulmonary edema) due to narrowing of heart valves (aortic or mitral stenosis);
impaired heart function (high-output cardiac failure, right ventricular heart failure due to pulmonary embolism or pericardial effusion; left ventricular heart failure with low filling pressure);
if you have liver problems (hepatic impairment). If you suffer from severe hepatic impairment, taking this medicine is not recommended (See section “Use in patients with liver problems”);
if you have complications caused by diabetes (autonomic diabetic neuropathy);
if you are taking medicines that affect liver activity such as cimetidine; if you are taking medicines used for erectile dysfunction such as sildenafil, tadalafil, and vardenafil. In this case, inform your doctor, who will indicate the appropriate dose. Take these medicines at least 6 hours after taking DOXAFIN (see section “Other medicines and DOXAFIN”);
if you are scheduled for eye surgery (cataract surgery), because this medicine may cause eye problems (intraoperative floppy iris syndrome);

This medicine may alter the results of urine tests.
Children
DOXAFIN is not recommended for children and adolescents under 18 years of age, as safety and efficacy have not yet been established.
Other medicines and DOXAFIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines:

medicines that dilate blood vessels (vasodilators and nitrates);
medicines used for inflammation (non-steroidal anti-inflammatory drugs);
medicines called sympathomimetics that act on the nervous system (such as dopamine, ephedrine, adrenaline, metaraminol, and phenylephrine);
medicines for erectile dysfunction called PDE-5 inhibitors (See section “Warnings and precautions”);
medicines used for high blood pressure (alpha-blockers and other medicines used in the treatment of high blood pressure).

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 using this medicine.
Take DOXAFIN during pregnancy only if necessary and under direct medical supervision for the treatment of high blood pressure.
DOXAFIN is contraindicated if you are breastfeeding (See section “Do not take DOXAFIN”).
Driving and using machines
DOXAFIN may impair your ability to drive or operate machinery, especially at the beginning of treatment. If this occurs, avoid driving and using machinery.
DOXAFIN contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take DOXAFIN

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take the tablets once daily with a sufficient amount of water. Your doctor will determine the
dose and duration of treatment.
Treatment of high blood pressure: The recommended dose ranges from 1 to 8 mg daily. The maximum
dose is 16 mg per day.
At the beginning of therapy, take 1 mg (half a 2 mg tablet) before going to bed for one or two
weeks. The dose may then be increased to 2 mg once daily for one or two weeks. If necessary, your
doctor may instruct you to increase the dose to 4, 8, and 16 mg daily, depending on your condition.
Treatment of benign prostatic hyperplasia: The recommended daily dose ranges from 2 to 4 mg daily.
At the beginning of therapy, take 1 mg (half a 2 mg tablet) for the first 8 days. From day 9 to
day 14, take 2 mg daily (1 tablet of 2 mg). If necessary, your doctor may instruct you to
increase the dose to 4 mg (1 tablet of DOXAFIN 4 mg) and, subsequently, to the maximum recommended
dose of 8 mg daily (2 tablets of DOXAFIN 4 mg).
Use in children
The use of doxazosin is not recommended in children and adolescents under 18 years of age due to
the lack of safety and efficacy data.
Use in elderly patients and patients with kidney problems
These patients should use this medicine cautiously, especially at the beginning of treatment; however,
no adjustment of the recommended dosage is necessary.
Use in patients with liver problems
In these patients, dose escalation must be carried out with great caution.
If you take more DOXAFIN than you should
In case of overdose, a drop in blood pressure may occur. In this case, the patient should be immediately
placed in a lying position with the head lowered, and the doctor must be contacted to establish appropriate
treatment, particularly monitoring kidney function.
In case of accidental ingestion/overdose of DOXAFIN, contact your doctor immediately or go to the nearest hospital.
If you forget to take DOXAFIN
Do not take a double dose to make up for the forgotten dose.
If you stop taking DOXAFIN
If you stop treatment with doxazosin for a few days, inform your doctor first. In this case, it is
recommended to restart treatment beginning with the lowest initial dose of 1 mg.
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 experiences them.
The following side effects may occur:

Common (may affect up to 1 in 10 people)

respiratory and urinary tract infections
problems with ejaculation (delayed ejaculation)
apathy, malaise
dizziness, headache (cephalalgia), drowsiness, vertigo
vision problems such as accommodation disorders
swelling due to fluid retention (edema)
palpitations; increased heart rate (tachycardia)
low blood pressure (hypotension), dizziness when standing up (postural hypotension)
bronchitis, nasal congestion, cough, difficulty breathing (dyspnea), cold symptoms (rhinitis)
abdominal pain, indigestion (dyspepsia), dry mouth, nausea
itching
back pain (lumbago), muscle pain (myalgia)
frequent need to urinate, increased urine production; urinary tract inflammation (cystitis), incontinence
feeling of weakness (asthenia)
chest pain, flu-like symptoms, swelling due to fluid accumulation in arms and legs (peripheral edema)

Uncommon (may affect up to 1 in 100 people)

allergic drug reactions
gout, a disease caused by accumulation of uric acid
increased appetite, anorexia, decreased potassium levels in the blood (hypokalemia)
sensation of heat and dryness (xerostomia)
constipation, gas (flatulence), vomiting, diarrhea, inflammation of the stomach and intestine (gastroenteritis)
restlessness, depression, anxiety, nervousness, insomnia, restless dreams, memory loss (amnesia), emotional disturbances
tremor, muscle stiffness
stroke (cerebrovascular accident)
abnormal eye tearing, excessive sensitivity to light (photophobia)
heart problems (angina pectoris, myocardial infarction)
problems due to reduced blood flow (peripheral ischemia)
decreased sensitivity (hypoesthesia)
loss of consciousness (syncope)
ringing in the ears (tinnitus)
nosebleeds (epistaxis)
sore throat, cough
abnormal liver function test results
skin irritation (cutaneous rash)
muscle and joint pain (arthralgia); joint swelling
difficulty urinating, frequent urination, blood in urine
impotence
facial pain and swelling due to fluid accumulation (facial edema), facial flushing, chills, fever, pallor, taste disturbances
weight gain

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

muscle cramps, muscle weakness
excessive urine production (polyuria)
decreased blood sugar levels (hypoglycemia)
eye inflammation (conjunctivitis)
cerebrovascular circulation problems (cerebrovascular disorders)
swelling of the larynx due to fluid accumulation (laryngeal edema)
stomach ache
sweating
decreased body temperature in the elderly, taste disturbances

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

blood disorders (leukopenia, thrombocytopenia)
moderate to severe dizziness occurring during changes in head position (positional vertigo), altered limb sensation (paresthesia)
blurred vision
heart rate irregularities (bradycardia, cardiac arrhythmias)
hot flushes
bronchial constriction (bronchospasm)
liver problems (cholestasis, hepatitis, jaundice)
skin irritation (urticaria)
hair loss (alopecia)
skin redness (purpura)
increased urine production, urinary problems, and need to urinate at night (nocturia)
breast enlargement in men
painful and prolonged penile erection (priapism). Seek immediate medical attention
fatigue, malaise

Not known (frequency cannot be estimated from available data)

eye problems (iris-flag syndrome)
problems with ejaculation (retrograde ejaculation)

Side effects such as increased levels of nitrogen and creatinine in the blood, decreased number of red blood cells in the blood, low blood pressure when standing up (orthostatic hypotension), and loss of consciousness (syncope) may occur especially at high doses and at the beginning of treatment. These effects may also occur when treatment is resumed after a brief interruption.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may 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 DOXAFIN

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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What DOXAFIN 2 mg tablets contain

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

What DOXAFIN 4 mg tablets contain

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

Description of the appearance of DOXAFIN and contents of the pack
DOXAFIN 2 mg tablets - Box containing 30 divisible 2 mg tablets in blister packs.
DOXAFIN 4 mg tablets - Box containing 20 divisible 4 mg tablets in blister packs.
Marketing Authorization Holder
FG S.r.l. - Via San Rocco, 6 – 85033 Episcopia (PZ) FG – Italy
Manufacturer
Doppel Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto de’ Stampi - Rozzano (Milan) - Italy