Dilur

Package leaflet: Information for the patient

DILUR 2 mg tablets, 4 mg tablets

Doxazosin
Equivalent 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DILUR is and what it is used for

DILUR contains the active substance doxazosin, which belongs to a group of medicines called
alpha-blockers, used to lower blood pressure and in urinary disorders in men.
DILUR is used to treat high blood pressure (essential arterial hypertension) or symptoms caused by
enlargement of the prostate in men (benign prostatic hyperplasia).

2. What you need to know before taking DILUR

Do not take DILUR

• if you are allergic to doxazosin, to other medicines belonging to the quinazoline group (e.g. prazosin, terazosin), or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced low blood pressure causing dizziness or lightheadedness when standing up from a sitting or lying position (orthostatic hypotension);
• if you have an enlarged prostate and at the same time suffer from urinary tract obstruction or blockage, chronic urinary tract infection, or bladder stones;
• if you are breastfeeding (only for the indication of hypertension) (See section Pregnancy and breastfeeding);
• if you have low blood pressure (applicable only during treatment for enlarged prostate);
• in monotherapy, if you suffer from reflux urinary incontinence (you do not feel the urge to urinate) or anuria (your body does not produce urine), with or without progressive renal failure.

Warnings and precautions
Talk to your doctor or pharmacist before taking DILUR.

• Especially at the beginning of treatment and when increasing the dose, you may experience dizziness and weakness or, rarely, loss of consciousness (syncope) due to a drop in blood pressure upon standing (orthostatic hypotension). If you feel dizzy or weak, you should

sit or lie down until you feel better. It is advisable to monitor your blood pressure at the beginning of treatment (See section 4).
Exercise particular caution when starting therapy with this medicine or when increasing the dose in the
following cases:

• if you are elderly, or if you have liver or kidney disease (See section 3);
• if your diet is low in salt;
• if you are taking diuretics (See section Other medicines and DILUR).

Take DILUR with caution:

• if you suffer from heart conditions (heart failure, pulmonary edema, right ventricular failure, severe ischemic heart disease, etc.);
• if you have severe liver disease, especially if you are taking medicines that affect liver metabolism (See section Other medicines and DILUR);
• if you have diabetic autonomic neuropathy, a diabetes-related condition affecting the nervous system;
• if you are taking medicines for male impotence (See section Other medicines and DILUR);
• if you are scheduled for cataract surgery (clouding of the lens) (See section 4); inform your ophthalmologist beforehand that you are currently or have previously used DILUR;
• if you are scheduled for blood or urine tests, inform your doctor or nurse that you are being treated with DILUR.

Children and adolescents
The use of DILUR is not recommended in children or adolescents under 18 years of age, as safety and efficacy have not yet been established.
Other medicines and DILUR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
You should be cautious and inform your doctor if you are taking any of the following medicines in particular:

• medicines used to treat male impotence (sildenafil, tadalafil, vardenafil, etc.), which may cause a drop in blood pressure if taken together with DILUR;
• other alpha-blockers and other medicines used to treat hypertension (high blood pressure), such as vasodilators and nitrates;
• medicines containing dopamine, ephedrine, phenylephrine, metaraminol, adrenaline (medicines known as sympathomimetics, used, for example, to treat heart conditions, low blood pressure, asthma, and nasal congestion);
• medicines that affect liver metabolism, such as cimetidine (See section Warnings and precautions).

Even though interactions are not known with the following medicines, you should consult your doctor
if you are taking any of these drugs:

• thiazide diuretics (See section Warnings and precautions), furosemide, beta-blockers (used in the treatment of high blood pressure);
• non-steroidal anti-inflammatory drugs (NSAIDs) (used to treat pain and inflammation);
• antibiotics (used to treat infections);
• oral hypoglycemics (used to lower blood sugar levels);
• uricosuric agents (used in the treatment of gout);
• anticoagulants (used to prevent blood clots).

Pregnancy and breastfeeding
The safety of doxazosin during pregnancy has not been established. Therefore, during pregnancy, DILUR should be used only if, in the opinion of your doctor, the benefits outweigh the risks.
DILUR must not be taken if you are breastfeeding. Alternatively, if you decide to take doxazosin, you must stop breastfeeding (See section Do not take DILUR).
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
DILUR may impair your ability to drive or operate machinery, especially at the beginning of treatment. If this occurs, and particularly if you experience dizziness or weakness, you must not drive or operate machinery.
DILUR contains lactose
DILUR 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 DILUR

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
You must take the tablets as a single daily dose with a sufficient amount of water.
The duration of treatment should be determined by your doctor.

• Treatment of arterial hypertension (high blood pressure): The usual dose of DILUR ranges from 1 to 8 mg daily. The maximum recommended dose is 16 mg daily. The initial dose is 1 mg taken at bedtime (half a tablet of DILUR 2 mg), and this dose should be maintained for one to two weeks. After this period, the dosage may be increased to 2 mg (one tablet of DILUR 2 mg) once daily and maintained for another one to two weeks. If necessary, the daily dose may be gradually increased further, always after the same time interval, to 4 mg (one tablet of DILUR 4 mg), 8 mg (two tablets of DILUR 4 mg), and 16 mg (four tablets of DILUR 4 mg) once daily, according to the patient's response and under medical supervision.
• Treatment of benign prostatic hyperplasia (enlarged prostate): At the beginning of treatment with DILUR, the following dosing schedule is recommended:
• days 1 to 8: 1 mg daily (half a tablet of DILUR 2 mg)
• days 9 to 14: 2 mg daily (one tablet of DILUR 2 mg). Depending on symptoms, your doctor may advise increasing the dose to 4 mg (one tablet of DILUR 4 mg) and subsequently to the maximum recommended dose of 8 mg (two tablets of DILUR 4 mg). The recommended interval between dose increases is 1 to 2 weeks. The recommended dose is 2–4 mg once daily.

Use in patients with liver problems
If you have liver problems, you must take DILUR with caution (see section 2).
Use in elderly patients
If you are elderly, you may take the usual dose, but you should be cautious at the beginning of treatment (see section 2).
Use in patients with impaired kidney function
If you have kidney problems, you may take the usual dose, but you should be cautious at the beginning of treatment (see section 2).
If you take more DILUR than you should
If you take an excessive dose of DILUR, you may experience a drop in blood pressure and should immediately lie down with your legs raised and your head lowered.
In case of accidental ingestion or overdose of DILUR, contact your doctor immediately or go to the nearest hospital.
If you forget to take DILUR
Do not take a double dose to make up for the missed tablet.
If you stop taking DILUR
If you interrupt treatment with DILUR for several days, treatment should be resumed starting from the initial dose of 1 mg.
If you have any doubts about how to use 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 side effects that may occur are listed below and are mostly temporary and generally tolerated during long-term treatment:

Common (may affect up to 1 in 10 people):

• Infections of the respiratory tract (nose, throat, lungs) and urinary tract
• Delayed ejaculation, apathy (lack of motivation)
• Drowsiness, dizziness, headache
• Vision disturbances
• Palpitations (sensation of rapid heartbeat), tachycardia (increased heart rate), oedema (swelling due to fluid retention)
• Low blood pressure (hypotension), low blood pressure when standing up from a sitting or lying position (postural hypotension) (See section Warnings and precautions), dizziness
• Bronchitis, cough, breathing difficulties, runny nose due to inflammation of the nasal lining (rhinitis), nasal congestion
• Abdominal pain, dyspepsia (indigestion), dry mouth, nausea
• Itching
• Back pain, muscle pain
• Cystitis (bladder inflammation), urinary incontinence (inability to retain urine)
• Feeling of weakness, chest pain, flu-like symptoms, swelling of the extremities due to fluid retention

Uncommon (may affect up to 1 in 100 people):

• Allergic reactions
• Gout (a metabolic disease affecting limbs), increased appetite, anorexia, decreased blood potassium levels, sensation of throat dryness
• Restlessness, depression, anxiety, insomnia, nervousness, restless dreams, memory loss, increased sensitivity to minor emotional stimuli
• Stroke (cerebrovascular accident), decreased sensitivity to touch, sudden loss of consciousness (syncope), tremor, muscle rigidity
• Unusual tearing, excessive sensitivity to light
• Ringing in the ears
• Heart problems (angina, myocardial infarction)
• Circulatory problems (peripheral ischemia)
• Nosebleeds, sore throat
• Constipation, flatulence, vomiting, diarrhoea, inflammation of the stomach and intestine (gastroenteritis)
• Blood tests showing changes in liver function
• Skin rashes
• Joint pain
• Difficulty urinating, frequent need to urinate, blood in urine
• Impotence
• Pain, facial swelling, pallor, facial flushing, taste disturbances, chills, fever
• Weight gain

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

• Low blood sugar levels (hypoglycaemia)
• Circulatory problems in the brain
• Swelling of the larynx (first part of the airways)
• Sweating
• Muscle cramps, muscle weakness
• Excessive urine production
• Decreased body temperature in elderly patients

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

• Blood disorders: reduction in white blood cells which may be associated with increased susceptibility to infections (leucopenia), reduction in platelets which may be associated with sudden bleeding (thrombocytopenia)
• Dizziness caused by change in position, tingling or numbness in hands and feet (paraesthesia)
• Blurred vision, eye inflammation (conjunctivitis)
• Decreased heart rate (bradycardia) and irregular heartbeat (arrhythmias)
• Hot flushes
• Breathing problems (bronchospasm)
• Liver disorders such as cholestasis (biliary disorders), hepatitis, jaundice
• Urticaria, hair loss, red or purple spots (purpura)
• Urination disorders (increased urine output, excessive need to urinate at night)
• Breast development in men (gynaecomastia)
• Persistent painful erection of the penis (priapism). Seek immediate medical attention
• Fatigue, malaise

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

• Eye problems during cataract surgery (intraoperative floppy iris syndrome) (See section Warnings and precautions)
• Cloudy urine after ejaculation (retrograde ejaculation)

In some cases, increases in blood levels of nitrogen and creatinine and a reduction in red blood cells may occur.
In the initial phase of treatment, low blood pressure when standing up from a sitting or lying position and, rarely, sudden loss of consciousness (See Warnings and precautions), 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 [appropriate reporting system as per national guidelines]. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DILUR

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 you no longer use. This will help protect the environment.

6. Package contents and other information

What DILUR contains
DILUR 2 mg tablets

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

DILUR 4 mg tablets

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

Description of the appearance of DILUR and contents of the pack
DILUR 2 mg tablets
White, oval-shaped tablets with a score line.
Carton containing 2 blisters of 15 divisible 2 mg tablets each.
DILUR 4 mg tablets
White, rhomboid-shaped tablets with a score line.
Carton containing 2 blisters of 10 divisible 4 mg tablets each.

Marketing Authorization Holder:
SPA Società Prodotti Antibiotici S.p.A.
Via Biella, 8
20143 Milan
Italy

Manufacturer:
Doppel Farmaceutici S.r.l.
Via Volturno, 48
20089 Quinto de’ Stampi - Rozzano (MI)
Italy