DOXAFIN 2 mg Tabletka

Treść ulotki

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

DOXAFIN 2 mg tablets, 4 mg tablets

Doxazosin mesylate
Generic medicine

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 others, even if their symptoms are the same as yours, as it could 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 DOXAFIN is and what it is used for
• 2. What you need to know before you take DOXAFIN
• 3. How to take DOXAFIN
• 4. Possible side effects
• 5. How to store DOXAFIN
• 6. Contents of the pack and other information

1. What is DOXAFIN and what is it used for

DOXAFIN contains the active ingredient 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 which affects the prostate of men.

2. What you need to know before you take 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 prostatic enlargement, you have a history of orthostatic hypotension. Orthostatic hypotension is the lowering of blood pressure when you stand up, which causes dizziness, lightheadedness or fainting;
• if, in addition to benign prostatic enlargement, you suffer from congestion or blockage of the upper urinary tract, 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 the section “Pregnancy and breastfeeding”);
• if you suffer from excessively low blood pressure (this only applies if you are taking doxazosin for benign prostatic enlargement);
• if you suffer from urinary leakage (urge incontinence) or lack of urine production (anuria). In this case, you should only take this medicine in combination with other medicines.

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

• at the beginning of therapy, because this medicine can cause a drop in blood pressure (orthostatic hypotension) characterized by dizziness and weakness, or, rarely, loss of consciousness. Your doctor should check your blood pressure in this case (See the section “Possible side effects”);
• if you have heart problems such as:
• fluid accumulation in the lungs (pulmonary edema) due to narrowing of the heart valves (aortic or mitral stenosis);
• problems with heart function (high-output heart 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 insufficiency). If you suffer from severe hepatic insufficiency, taking this medicine is not recommended (See the section “Use in people with liver problems”);
• if you have problems caused by diabetes (autonomic diabetic neuropathy);
• if you are taking medicines that affect liver activity such as cimetidine; if you are taking medicines used to treat impotence such as sildenafil, tadalafil and vardenafil. In this case, tell your doctor who will indicate the dose to be taken. Take these medicines 6 hours after taking DOXAFIN (see the section “Other medicines and DOXAFIN”);
• if you are going to undergo eye surgery (cataract surgery), because it may cause eye problems (iris flag syndrome);

This medicine may alter the results of urine tests.

Children
Doxafin is not recommended in children and adolescents under the age of 18 years, as the
safety and efficacy have not yet been established.

Other medicines and DOXAFIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
In particular, tell your doctor if you are taking any of the following medicines:

• medicines that dilate blood vessels (vasodilators and nitrates);
• medicines used to treat 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 impotence called PDE-5 inhibitors (See the section “Warnings and precautions”);
• medicines used for high blood pressure (alpha-blockers and other medicines used for the treatment of high blood pressure).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Take DOXAFIN during pregnancy only if necessary and under the direct supervision of your doctor for
the treatment of high blood pressure.
DOXAFIN is contraindicated if you are breastfeeding (See the section “Do not take DOXAFIN”).

Driving and using machines
DOXAFIN can impair your ability to drive and operate machinery, especially at the beginning of
treatment. If this happens, avoid driving and operating machinery.

DOXAFIN contains lactose
This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact
your doctor before taking this medicine.

3. How to take DOXAFIN

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Take the tablets once a day with a sufficient amount of water. Your doctor will indicate the
dose and the duration of treatment.

Treatment of high blood pressure:The recommended dose ranges from 1 to 8 mg per day. 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 be increased to 2 mg, once a day for one or two weeks. If necessary, your
doctor may advise you to increase the dose to 4, 8 and 16 mg per day according to your condition.

Treatment of benign prostatic hyperplasia:The recommended dose per day ranges from 2 to 4 mg per day.
At the beginning of therapy, take 1 mg (half a 2 mg tablet) for the first 8 days. From the ninth day to the
fourteenth day, take 2 mg per day (1 x 2 mg tablet). If necessary, your doctor may advise you to
increase the dose to 4 mg (1 DOXAFIN 4 mg tablet) and, subsequently, to the maximum recommended
dose of 8 mg per day (2 DOXAFIN 4 mg tablets).

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 the elderly and in people with kidney problems
These patients should use this medicine with caution, especially at the beginning of treatment, and it is
not necessary to modify the recommended dosage.

Use in people with liver problems
In these patients, it is necessary to increase the dosage with great caution.

If you take more DOXAFIN than you should
In case of overdose, a decrease in blood pressure may occur. In this case, the patient should be
immediately placed in a lying position with the head bent and a doctor should be contacted who will establish
appropriate therapy, monitoring kidney function in particular.
In case of accidental ingestion/intake of an excessive dose of DOXAFIN, immediately inform
your doctor or go to the nearest hospital.

If you forget to take DOXAFIN
Do not take a double dose to make up for a missed 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 resume treatment starting from 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 gets them.
The following side effects may occur:

Common(may affect up to 1 in 10 people)

• respiratory and urinary tract infection
• problems with sperm release (delayed ejaculation);
• apathy, malaise;
• dizziness, headache, drowsiness, vertigo;
• vision problems such as accommodation disturbance;
• swelling due to fluid retention (edema);
• palpitations; increased heart rate (tachycardia);
• low blood pressure (hypotension), feeling dizzy when standing up (postural hypotension);
• bronchitis, nasal congestion, cough, difficulty breathing (dyspnea), common cold (rhinitis);
• abdominal pain, digestive problems (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 retention in arms and legs (peripheral edema).

Uncommon(may affect up to 1 in 100 people)

• allergic reactions to drugs;
• gout, a disease caused by uric acid build-up;
• increased appetite, anorexia, decreased potassium levels in the blood (hypokalaemia);
• feeling of warmth and dryness (burning sensation);
• constipation, gas (flatulence), vomiting, diarrhoea, inflammation of the stomach and intestines (gastroenteritis);
• agitation, depression, anxiety, nervousness, insomnia, restless dreams, memory problems (amnesia), emotional problems;
• tremor, muscle stiffness;
• stroke (cerebrovascular accident);
• abnormal eye tearing, excessive sensitivity to light (photophobia);
• heart problems (angina pectoris, myocardial infarction);
• problems due to decreased blood flow (peripheral ischemia);
• decreased sensitivity (hypoesthesia);
• loss of consciousness (syncope);
• ringing in the ears (tinnitus);
• nosebleed (epistaxis);
• sore throat, cough;
• changes in liver function tests;
• skin irritation (skin rash);
• muscle and joint pain (arthralgia); joint swelling;
• difficulty urinating, frequent urination and blood in the urine;
• impotence;
• swelling and redness of the face due to fluid retention (facial edema), flushing, chills, fever, pallor, altered taste
• weight gain. Rare(may affect up to 1 in 1000 people)
• muscle cramps, muscle weakness;
• excessive urination (polyuria);
• decreased blood sugar levels (hypoglycaemia);
• eye inflammation (conjunctivitis);
• blood circulation problems in the brain (cerebrovascular disorders);
• swelling of the larynx due to fluid retention (laryngeal edema);
• stomach pain;
• sweating;
• decreased body temperature in the elderly, altered taste.

Very rare(may affect up to 1 in 10000 people)

• blood problems (leukopenia, thrombocytopenia);
• moderate to severe dizziness, which occurs during changes in head position (positional vertigo), altered sensation in the limbs (paresthesia);
• blurred vision;
• heart rate problems (bradycardia, cardiac arrhythmias);
• hot flashes;
• bronchospasm (constriction of the airways);
• liver problems (cholestasis, hepatitis, jaundice);
• skin irritation (urticaria);
• hair loss (alopecia);
• skin redness (purpura);
• increased urine production, problems urinating and needing to urinate at night (nocturia);
• increased breast mass in men,
• painful and persistent erection of the penis (priapism). Seek immediate medical attention;
• fatigue, malaise.

Not known(frequency cannot be estimated from available data)

• eye problems (iris flag syndrome);
• problems with sperm release (retrograde ejaculation).

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) can occur especially at high doses and at the beginning of treatment. These
effects can also occur when the medicine is restarted after a short interruption of treatment.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the pack after “Exp”.
The expiry date refers to the last day of that month.
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 DOXAFIN 2 mg tablets contains

• The active ingredient is doxazosin. 1 tablet contains 2.43 mg of doxazosin mesylate (equivalent to doxazosin base 2 mg).
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium glycolate starch, magnesium stearate, sodium lauryl sulfate.

What DOXAFIN 4 mg tablets contains

• The active ingredient is doxazosin. 1 tablet contains 4.85 mg of doxazosin mesylate (equivalent to doxazosin base 4 mg).
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium glycolate starch, magnesium stearate, sodium lauryl sulfate.

Description of DOXAFIN and contents of the pack
DOXAFIN 2 mg tablets - Pack containing 30 divisible 2 mg tablets in blisters.
DOXAFIN 4 mg tablets - Pack containing 20 divisible 4 mg tablets in blisters.

Marketing Authorisation 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 (Milano)-Italy