Package leaflet: Information for the patient

DOXAZOSINA ALTER 2 mg tablets, 4 mg tablets

Doxazosin mesylate
Generic medicine
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DOXAZOSIN ALTER is and what it is used for

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

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

2. What you need to know before taking DOXAZOSIN ALTER

Do not take DOXAZOSIN ALTER

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 you have a history of orthostatic hypotension. Orthostatic hypotension is a drop in blood pressure upon standing, which may cause dizziness, lightheadedness, or fainting;
if, in addition to benign prostatic enlargement, you suffer from upper urinary tract congestion or obstruction, recurrent (chronic) 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 prostatic enlargement);
if you suffer from continuous urinary leakage (reflux urinary 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 DOXAZOSIN ALTER.
Exercise particular caution in the following cases:

at the beginning of treatment, 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 heart failure, right ventricular failure due to pulmonary embolism or pericardial effusion; left ventricular heart failure with low filling pressure). In patients with severe heart disease (severe ischemic heart disease), a too rapid or pronounced drop in blood pressure may worsen angina;
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”). Caution is also required when doxazosin is administered together with medicines that affect liver metabolism (e.g. cimetidine);
if you are taking medicines used for erectile dysfunction such as sildenafil, tadalafil, and vardenafil. In this case, inform your doctor, who will advise you on the appropriate dose. Take these medicines at least 6 hours after taking DOXAZOSIN ALTER (see section “Other medicines and DOXAZOSIN ALTER”);
if you are scheduled for eye surgery (cataract surgery).

Children
DOXAZOSIN ALTER is not recommended for children and adolescents under 18 years of age, as safety and efficacy have not yet been established.

Other medicines and DOXAZOSIN ALTER
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
In particular, inform your doctor if you are taking any of the following medicines:

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);
non-steroidal anti-inflammatory drugs (NSAIDs), medicines for inflammation, which may reduce the effect of doxazosin;
sympathomimetic agents reduce the effect of doxazosin, and doxazosin inhibits the action of dopamine, ephedrine, adrenaline, metaraminol, and phenylephrine on blood pressure and blood vessels. Doxazosin may alter the results of certain laboratory tests because it may affect plasma renin activity and urinary excretion of vanillylmandelic acid.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Take DOXAZOSIN ALTER during pregnancy only if necessary and under direct medical supervision for the treatment of high blood pressure.
DOXAZOSIN ALTER is contraindicated during breastfeeding (See section “Do not take DOXAZOSIN ALTER”).

Driving and using machines
DOXAZOSIN ALTER may impair your ability to drive or operate machinery, especially at the beginning of treatment. If this occurs, avoid driving and using machinery.

DOXAZOSIN ALTER contains lactose
This medicine contains a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take DOXAZOSINA ALTER

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 daily.
At the beginning of treatment, take 1 mg (half a 2 mg tablet daily) 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, or 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 treatment, take 1 mg (half a 2 mg tablet daily) for the first 8 days. From day 9 to day 14, take 2 mg daily (one 2 mg tablet). If necessary, your doctor may instruct you to increase the dose to 4 mg (one DOXAZOSINA ALTER 4 mg tablet) and subsequently to the maximum recommended dose of 8 mg daily (two DOXAZOSINA ALTER 4 mg tablets).
Use in children
Doxazosin is not recommended in children and adolescents under 18 years of age, as safety and efficacy have not yet been established.
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 DOXAZOSINA ALTER than you should
Overdose may cause a drop in blood pressure. In this case, the patient should immediately be placed in a lying position with the head lowered, and the doctor must be contacted to establish appropriate therapy, with particular monitoring of kidney function.
In case of accidental ingestion/overdose of DOXAZOSINA ALTER, contact your doctor immediately or go to the nearest hospital.
If you forget to take DOXAZOSINA ALTER
Do not take a double dose to make up for the missed dose.
If you stop taking DOXAZOSINA ALTER
If you interrupt treatment with doxazosin for several days, inform your doctor beforehand. In this case, it is recommended to restart treatment at 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 everybody gets them.
The following side effects may occur:
Common (may affect up to 1 in 10 people)

respiratory and urinary tract infections (cystitis), urinary incontinence, frequent need to urinate, increased urine production;
headache (cephalalgia), drowsiness, dizziness, vertigo;
visual disturbances;
palpitations, increased heart rate (tachycardia);
low blood pressure (hypotension), orthostatic hypotension;
bronchitis, cough, difficulty breathing (dyspnea), cold symptoms (rhinitis), nasal congestion;
abdominal pain, digestive problems (dyspepsia), constipation, dry mouth, nausea;
back pain, muscle pain (myalgia), muscle cramps;
fatigue, feeling of weakness (asthenia), weakness;
delayed ejaculation, apathy, malaise;
chest pain, swelling (edema), flu-like symptoms, swelling due to fluid accumulation in arms and legs (peripheral edema), itching.

Uncommon (may affect up to 1 in 100 people)

allergic drug reactions;
decreased potassium levels (hypokalemia), thirst;
gout, a disease caused by uric acid accumulation;
increased appetite, anorexia;
agitation, nervousness, anxiety, depression, insomnia; restless dreams, memory loss (amnesia), emotional lability;
stroke (cerebrovascular accident), decreased sensation (hypoesthesia), loss of consciousness (syncope), tremor, muscle rigidity;
abnormal tearing, excessive sensitivity to light (photophobia);
heart problems (angina pectoris, myocardial infarction, palpitations, tachycardia);
edema;
ringing in the ears (tinnitus);
peripheral ischemia;
nosebleeds (epistaxis), sore throat, bronchospasm;
constipation (stipsis), gas (flatulence), inflammation of stomach and intestine (gastroenteritis), vomiting, diarrhea;
changes in liver function tests;
hair loss (alopecia), skin rash;
arthralgia, muscle pain, joint swelling and pain, muscle weakness;
difficulty urinating, frequent need to urinate and blood in urine, urinary disorders;
impotence, priapism;
facial swelling and redness due to fluid accumulation (facial edema), flushing, chills, fever, pallor, taste disturbances;
weight gain.

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

depression, agitation, loss of sensation (paresthesia);
muscle cramps;
excessive urine production (polyuria);
decreased blood sugar levels (hypoglycemia);
blurred vision; conjunctivitis;
cerebrovascular circulation disorders;
swelling due to fluid accumulation in the larynx (laryngeal edema);
stomach ache;
liver problems (jaundice, increased liver enzymes, hepatitis);
decreased body temperature in the elderly, taste disturbances;
sweating, purpura.

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

dizziness when standing up (positional vertigo), disturbances in limb sensation (paresthesias);
heart rate problems (bradycardia, cardiac arrhythmias);
hot flushes;
gallstones (cholestasis);
skin irritation (urticaria);
increased urine production, urinary problems, and need to urinate at night (nocturia);
breast enlargement in men (gynecomastia);
malaise;
decreased white blood cell count, decreased platelet count.

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

eye problems (iris-flag syndrome).

In some cases, increased levels of nitrogen and creatinine in the blood, and reduced red blood cell count may occur. At the beginning of treatment, dizziness upon standing due to a drop in blood pressure (orthostatic hypotension) and –rarely– loss of consciousness (syncope), especially at high doses, may occur. These effects may also appear when treatment is resumed after a short interruption.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can 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 DOXAZOSINA ALTER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 DOXAZOSINA ALTER 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 ingredients are: microcrystalline cellulose, anhydrous lactose, sodium starch glycolate, magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica.

What DOXAZOSINA ALTER 4 mg tablets contain

The active substance is doxazosin. One tablet contains 4.85 mg of doxazosin mesylate (equivalent to 2 mg of doxazosin base).
The other ingredients are: microcrystalline cellulose, anhydrous lactose, sodium starch glycolate, magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica.

Description of the appearance of DOXAZOSINA ALTER and contents of the pack
DOXAZOSINA ALTER 2 mg tablets - Carton pack containing 30 2 mg scored tablets in blister packs.
DOXAZOSINA ALTER 4 mg tablets - Carton pack containing 20 4 mg scored tablets in blister packs.
Marketing Authorization Holder
Laboratori Alter S.r.l. – Via Egadi 7 – 20144 Milan – Italy
Manufacturer
Laboratorios Alter S.A. – C/Mateo Inurria, 30 – Madrid – Spain