DILUR 2 mg Коированная Таблетка

Содержание инструкции

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

DILUR 2 mg tablets, 4 mg tablets

Doxazosina
Generic medicine

Read this leaflet carefully before you start 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 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 DILUR is and what it is used for
• 2. What you need to know before you take 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 is DILUR and what is it used for

DILUR contains the active ingredient 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 the
symptoms caused by an enlarged prostate in men (benign prostatic hyperplasia).

2. What you need to know before you take 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 suffered from low blood pressure that causes dizziness or lightheadedness when you get up from a sitting or lying position (orthostatic hypotension);
• if you suffer from an enlarged prostate and at the same time have congestion or blockage of the urinary tract, a chronic urinary tract infection or bladder stones;
• if you are breastfeeding (only for the indication of hypertension) (See section Pregnancy and breastfeeding);
• if you suffer from low blood pressure (applicable only during the treatment of an enlarged prostate);
• as monotherapy, if you suffer from urinary incontinence due to overflow (you do not feel the urge to urinate) or anuria (your body does not produce urine), with or without progressive kidney failure.

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

• In particular at the beginning of treatment and when increasing the dosage, you may experience dizziness and weakness or, rarely, loss of consciousness (syncope) due to low blood pressure when getting up (orthostatic hypotension). If you feel dizzy or weak you should

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

• if you are elderly, if you suffer from liver or kidney diseases (See section 3);
• if you consume a low amount of salt with your diet;
• if you are taking diuretics (See section Other medicines and DILUR).

Always take DILUR with caution:

• if you suffer from diseases that affect the heart (heart failure, pulmonary edema, severe right ventricular failure, severe ischemic heart disease, etc.);
• if you suffer from severe liver diseases, especially if you are taking medicines that alter liver metabolism (See section Other medicines and DILUR);
• if you suffer from diabetic autonomic neuropathy, a disease associated with diabetes with effects on the nervous system;
• if you are taking medicines for erectile dysfunction (See section Other medicines and DILUR);
• if you are to undergo cataract surgery (clouding of the lens) (See section 4); inform your ophthalmologist beforehand that you are using or have previously used DILUR;
• if you are to undergo blood and 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 because
safety and efficacy have not yet been established.

Other medicines and DILUR
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
You need to be careful and inform your doctor if you are taking in particular one of the following
medicines:

• medicines used to treat erectile dysfunction in men (sildenafil, tadalafil, vardenafil, etc.), which can 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 sympathomimetic drugs that are used, for example, for the treatment of heart disease, low blood pressure, asthma and nasal congestion);
• medicines that alter liver metabolism such as cimetidine (See section Warnings and precautions).

Even if no interactions are known with the medicines listed below, 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 hypoglycemic agents (used to lower blood sugar levels)
• uricosuric agents (used for the treatment of gout)
• anticoagulants (used to prevent blood clots).

Pregnancy and breastfeeding
The safety of doxazosin during pregnancy has not been established. Consequently, during
pregnancy, DILUR should only be used if, according to the doctor, the benefits outweigh the risks.
DILUR should not be taken if you are breastfeeding. Alternatively, if you decide to take
doxazosin you should stop breastfeeding (See section Do not take DILUR).
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
DILUR can impair your ability to drive vehicles or use machines, especially at the beginning of
treatment. If this happens and, in particular, if you feel dizzy or weak, you should not drive or
use machines.

DILUR contains lactose
DILUR contains a sugar, lactose. If your doctor has diagnosed you with an intolerance to some
sugars, contact him before taking this medicine.

3. How to take DILUR

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
You should take the tablets in a single daily dose, with a sufficient amount of
water.
The duration of treatment must be established by the doctor.

• Treatment of arterial hypertension (high blood pressure):The usual dose of DILUR is from 1 to 8 mg per day. The maximum recommended dose is 16 mg per day. The initial dose is 1 mg before bedtime (half a DILUR 2 mg tablet) and this dose should be maintained for one to two weeks of treatment. After this period, the dosage may be increased to 2 mg (1 DILUR 2 mg tablet) once a day and maintained for another one to two weeks. If necessary, the daily dosage may be further gradually increased, always after the same interval of time, to 4 mg (1 DILUR 4 mg tablet), 8 mg (2 DILUR 4 mg tablets) and 16 mg (4 DILUR 4 mg tablets) once a day, based on the patient's response as directed by the attending physician.
• Treatment of benign prostatic hyperplasia (enlarged prostate):At the beginning of treatment with DILUR, the following dosage schedule is recommended:
• days 1 to 8: 1 mg per day (half a DILUR 2 mg tablet)
• days 9 to 14: 2 mg per day (1 DILUR 2 mg tablet). Depending on the symptoms, the doctor may advise increasing the dose to 4 mg (1 DILUR 4 mg tablet) and, subsequently, to the maximum recommended dose of 8 mg (2 DILUR 4 mg tablets). The recommended time interval between one dose increase and the next is from 1 to 2 weeks. The recommended dose is 2-4 mg once a day.

Use in patients with liver problems
If you suffer from liver problems you should take DILUR with caution (See section 2).

Use in elderly patients
If you are elderly you can take the usual dose but should be careful at the beginning of treatment (See
section 2).

Use in patients with impaired kidney function
If you have kidney problems you can take the usual dose but should be careful 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 lowering of blood pressure and will
need to lie down immediately with your legs raised and your head down.
In case of accidental ingestion/taking of an excessive dose of DILUR, immediately notify
your doctor 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 stop taking DILUR for a few days, restarting treatment should be done
starting from the initial dose of 1 mg.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects that may occur are listed below and are for the most part
temporary and generally tolerated during prolonged treatment:

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

• Respiratory tract infections (nose, throat, lungs) and urinary tract infections
• Delayed ejaculation, apathy (lack of motivation)
• Drowsiness, dizziness, headache
• Visual disturbances
• Palpitations (feeling of a fast-beating heart), tachycardia (increased heart rate), edema (swelling due to fluid retention)
• Lowering of blood pressure (hypotension), lowering of blood pressure when getting up from a sitting or lying position (postural hypotension) (See the Warnings and precautions section), dizziness
• Bronchitis, cough, difficulty breathing, runny nose caused by inflammation of the nasal lining (rhinitis), stuffy nose
• Abdominal pain, dyspepsia (impaired digestion), dry mouth, nausea
• Itching
• Back pain, muscle pain
• Cystitis (bladder inflammation), urinary incontinence (inability to control urination)
• 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 the joints), increased appetite, anorexia, decreased potassium levels in the blood, feeling of dryness in the throat
• Agitation, depression, anxiety, insomnia, nervousness, restless dreams, memory loss, easily upset by any minor emotion
• Stroke (cerebrovascular accident), decreased sensitivity to touch, sudden loss of consciousness (syncope), tremor, muscle stiffness
• Unusual tearing, excessive sensitivity to light
• Tinnitus (ringing in the ear)
• Heart problems (angina, myocardial infarction)
• Blood circulation problems (peripheral ischemia)
• Nosebleeds, sore throat
• Constipation, flatulence, vomiting, diarrhea, inflammation of the stomach and intestines (gastroenteritis)
• Blood tests showing changes in liver function
• Skin rashes
• Joint pain
• Difficulty urinating, frequent need to urinate, blood in the urine
• Impotence
• Pain, swelling of the face, pallor, flushing of the face, altered taste, chills, fever
• Weight gain

Rare(may affect up to 1 in 1000 people):

• Low blood sugar (hypoglycemia)
• Blood circulation disorders in the brain
• Swelling of the larynx (first part of the airways)
• Sweating
• Muscle cramps, muscle weakness
• Excessive urine production
• Decreased body temperature in the elderly

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

• Blood disorders: reduction of white blood cells which may be associated with an increased susceptibility to infections (leukopenia), reduction of platelets which may be associated with sudden bleeding (thrombocytopenia)
• Dizziness caused by changing position, tingling or numbness in the hands and feet (paresthesia)
• Blurred vision, eye inflammation (conjunctivitis)
• Decreased heart rate (bradycardia) and irregular heartbeats (arrhythmias)
• Hot flashes
• Breathing problems (bronchospasm)
• Liver disorders such as cholestasis (bile disorders), hepatitis, jaundice
• Hives, hair loss, red or purple spots (purpura)
• Urinary disorders (increased urine, excessive need to urinate at night)
• Development of breasts in men (gynecomastia)
• Painful persistent 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 (iris flag syndrome) (See the Warnings and precautions section)
• Emission of cloudy urine after ejaculation (retrograde ejaculation).

In some cases, increases in blood levels of nitrogen and creatinine and
decreases in red blood cells may occur. In the initial phase of treatment, lowering
of blood pressure when getting up from a sitting or lying position and, rarely, sudden
loss of consciousness (See Warnings and precautions) may occur, especially at high doses. These effects may
also occur when treatment is resumed after a short interruption.

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
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 which is stated on the packaging 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 eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DILUR contains
DILUR 2 mg tablets

• The active ingredient is doxazosin
• One tablet contains 2.43 mg of doxazosin 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 ingredient is doxazosin
• One tablet contains 4.85 mg of doxazosin 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
Oblong tablets, of a whitish colour, with a fracture line.
Pack containing 2 blisters of 15 divisible 2 mg tablets each.

DILUR 4 mg tablets
Rhomboid tablets, of a whitish colour, with a fracture line.
Pack containing 2 blisters of 10 divisible 4 mg tablets each.

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

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