SAIDOX 2 мг Таблетка

Содержание инструкции

1. SAIDOX 2 mg tablets, 4 mg tablets
   1. What SAIDOX is and what it is used for
   2. What you need to know before taking SAIDOX
   3. How to take SAIDOX
   4. Possible side effects
   5. How to store SAIDOX
   6. Package contents and other information

SAIDOX 2 mg tablets, 4 mg tablets

Doxazosina

Generic medicine
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 pass it on to others, even if they have the same symptoms as you, as it may 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 SAIDOX is and what it is used for
• 2. What you need to know before you take SAIDOX
• 3. How to take SAIDOX
• 4. Possible side effects
• 5. How to store SAIDOX
• 6. Contents of the pack and other information

1. What SAIDOX is and what it is used for

SAIDOX contains the active substance doxazosin, which belongs to a group of medicines deno-
minated alpha blockers. It is used for the treatment of high blood pressure (essential hypertension).
SAIDOX works by relaxing the blood vessels, allowing blood to pass more easily through them. This helps to lower blood pressure.
SAIDOX can also be used for benign prostatic hyperplasia, an enlargement of the
prostate gland.

2. What you need to know before taking SAIDOX

Do not take SAIDOX if:

• you are allergic to doxazosine, to other substances belonging to the quinazoline group (such as prazosin, terazosin,) or to any of the ingredients of this medicine (listed in section 6);
• you have suffered from a condition known as “orthostatic hypotension”, a form of low blood pressure that causes dizziness or a feeling of lightheadedness when getting up from a sitting or lying position;
• you have an enlargement of the prostate gland (benign prostatic hyperplasia) and also have difficulty urinating, or a chronic urinary tract infection or bladder stones;
• you are breastfeeding;
• you suffer from a particular form of urinary incontinence in which there is involuntary loss of urine that occurs as a result of an overly full bladder, or if you do not produce an adequate amount of urine (anuria), with or without a progressive loss of kidney function.

Warnings and precautions
Talk to your doctor or pharmacist before taking SAIDOX.
When you start taking SAIDOX you may experience a feeling of weakness, dizziness and, rarely, fainting caused by a drop in blood pressure when getting up from a sitting or lying position. If you feel weak, dizzy or faint, you should sit or lie down until you feel better and avoid situations where you could fall or get injured. Your doctor may decide to measure your blood pressure regularly at the beginning of treatment to reduce the possibility of these side effects occurring.
If you are about to undergo eye surgery for cataracts (clouding of the lens), tell your ophthalmologist before the operation that you are using or have previously used SAIDOX. SAIDOX may cause complications during surgery that can be managed if the specialist is warned in advance.
Tell your doctor or pharmacist before taking SAIDOX if any of the following conditions apply to you, because in these cases SAIDOX must be used with caution:

• If you suffer from heart diseases such as:
• fluid accumulation in the lungs (pulmonary edema) due to a narrowing of the heart valves (aortic or mitral stenosis);
• problems with heart function (heart failure with high cardiac output per minute, right heart failure due to pulmonary embolism or pericardial effusion; left ventricular heart failure with low filling pressure);
• if you suffer from severe ischemic heart disease, a excessive or sudden drop in blood pressure can worsen your condition.
• If you suffer from or have suffered from a liver disease or if you are taking medicines that affect liver activity (e.g. cimetidine).
• If you are taking medicines for the treatment of erectile dysfunction (impotence), called phosphodiesterase 5 inhibitors (such as sildenafil, tadalafil and vardenafil), as both medicines have the effect of lowering blood pressure by dilating blood vessels. The simultaneous use of SAIDOX and these other medicines could cause an excessive drop in blood pressure (see Other medicines and SAIDOX). To reduce the likelihood of symptoms occurring, you should start therapy with SAIDOX first, taking a daily dose regularly. Then, when therapy with SAIDOX is stabilized, you can start taking medicines for erectile dysfunction.
• If you suffer from a condition caused by a complication of diabetes (diabetic autonomic neuropathy).

Painful, prolonged erections of the penis –can occur very rarely. If this happens, contact your doctor immediately.
Before starting therapy with SAIDOX, your doctor may perform some tests to rule out other diseases such as prostate cancer, which may cause the same symptoms as benign prostatic hyperplasia.

Children and adolescents
SAIDOX is not recommended for use in children and adolescents under 18 years of age as the safety and efficacy of the treatment have not been established.

Other medicines and SAIDOX
Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicines.
Tell your doctor or pharmacist before use if you are taking any of the following medicines, as they may affect the effect of SAIDOX:

• Some medicines used to treat high blood pressure or enlarged prostate (called alpha-blockers) may enhance the blood pressure lowering effect of doxazosine.
• Some medicines used for erectile dysfunction (impotence) (called phosphodiesterase type 5 inhibitors, such as sildenafil, tadalafil and vardenafil) can cause an excessive drop in blood pressure accompanied by symptoms (see Warnings and precautions).
• Medicines for the treatment of bacterial or fungal infections, such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used to treat HIV, such as indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medicine used to treat depression.
• Some pain relievers (NSAIDs) may reduce the effect of doxazosine.
• Medicines used as antacids (cimetidine) may alter the amount of doxazosine available.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine
Pregnancy
The safety of use of SAIDOX during pregnancy has not been established. Therefore, if you are pregnant, your doctor will prescribe SAIDOX only if the potential benefits outweigh the risks.
Breastfeeding
Do not take SAIDOX if you are breastfeeding. Breastfeeding must be stopped if you need to start treatment with SAIDOX.

Driving and using machines
Be careful if you drive or operate machinery. These tablets may impair your ability to drive or operate machinery safely, especially at the beginning of treatment.
They may cause you to feel weak or dizzy. If you experience these symptoms, do not drive or operate machinery and contact your doctor immediately.

SAIDOX contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

SAIDOX contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take SAIDOX

Take this medicine following the instructions of your doctor exactly. If you have doubts, consult your doctor or pharmacist.
SAIDOX must be used in a single daily dose and can be taken regardless of whether it is in the morning or evening.
High blood pressure
The recommended dose of SAIDOX 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 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 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 time interval, to 4, 8 and 16 mg once a day, based
on the patient's response as directed by the treating physician.
Benign prostatic hyperplasia
If you are taking SAIDOX for the treatment of enlarged prostate, the recommended dose is 1
mg (half a 2 mg tablet) per day, from the first to the eighth day of taking it and 2 mg per day
(1 x 2 mg tablet) from the ninth to the fourteenth day.
If necessary, as directed by the treating physician, this dose may be increased to 4 mg (1
SAIDOX 4 mg tablet) and subsequently to the maximum recommended dose of 8 mg (2
SAIDOX 4 mg tablets).
The recommended time interval between one dosage increase and the next is from 1 to 2
weeks.
The usual recommended daily dose is 2-4 mg.

If you take more SAIDOX than you should
If you take more SAIDOX than prescribed by your doctor, contact your doctor or
pharmacist immediately or go to the nearest hospital emergency room.
Taking too many tablets together can make you feel unwell, as your blood pressure may
drop excessively. If this happens, lie down.

If you forget to take SAIDOX
If you forget to take SAIDOX, skip the dose completely. Do not take a double dose to
make up for the missed dose.

If you stop taking SAIDOX
Do not stop taking the medicine unless after consulting your doctor, even if
you feel better. It is very important to continue the therapy as prescribed by your doctor.
If you stop taking SAIDOX for a few days, you should resume treatment at the
initial dose of 1 mg.

4. Possible side effects

Like all medicines, SAIDOX can cause side effects, although not everybody gets them.
If you experience any of these symptoms, STOP treatment with SAIDOX and call an ambu-
lance immediately:

• chest pain, chest discomfort (angina, myocardial infarction);
• feeling of difficulty breathing (dyspnea), accompanied by discomfort and a feeling of tight- ness in the chest (bronchospasm);
• sudden headache, feeling of fainting, weakness in the arms, legs, or problems with speech that may be symptoms of a stroke;
• swelling of the face and allergic reactions.

Immediatelyinform your doctor if you experience any of the following
symptoms after taking SAIDOX:

• fast, slow, or irregular heartbeat;
• awareness of your heartbeat (palpitations);
• yellowing of the skin or eyes (jaundice);
• low number of white blood cells or platelets in the blood. These situations can result in re- spectively an increased predisposition to infection or increased bruising or a tendency to bleed.

The following side effects have also been observed and reported during treatment with
SAIDOX, with the following frequencies:

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

• Respiratory and urinary tract infections.
• Drowsiness, dizziness and headache.
• Palpitations, fast heartbeat (tachycardia).
• Low blood pressure (hypotension) or postural hypotension.
• Bronchitis, cough, difficulty breathing (dyspnea), allergic rhinitis.
• Abdominal pain, difficulty digesting (dyspepsia), dry mouth, nausea.
• Itching.
• Back pain, muscle pain (myalgia).
• Cystitis, involuntary urination (incontinence).
• Reduced muscle strength (asthenia), chest pain, flu-like symptoms, swelling of different parts of the body due to fluid accumulation (peripheral edema).

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

• Allergic reaction to the drug. Rheumatic disease affecting the joints (gout), increased appetite, anorexia.
• Agitation, depression, anxiety, insomnia, nervousness.
• Stroke, decreased sensitivity (hypoesthesia), temporary loss of consciousness (syncope), tremor.
• Tinnitus (ringing in the ears).
• Feeling of tightness and pain in the chest (angina pectoris), myocardial infarction.
• Nose bleeding (epistaxis).
• Constipation, gas formation in the intestines, vomiting, diarrhea, inflammation of the stomach and intestines.
• Abnormal results of liver enzymes and function.
• Skin rash.
• Joint pain (arthralgia).
• Difficulty urinating, frequent urination, blood in the urine.
• Impotence.
• Pain, swelling of the face.
• Weight gain.

Rare side effects(may affect up to 1 in 1,000)

• Muscle cramps, muscle weakness.
• Excessive urine production (polyuria).

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

• Decreased white blood cells and platelets (leukopenia, thrombocytopenia).
• Dizziness when changing position, tingling (paresthesia).
• Blurred vision.
• Slow heartbeat (bradycardia), irregular heartbeat (cardiac arrhythmias).
• Hot flashes.
• Difficulty breathing due to spasm of the respiratory tract muscles (bronchospasm).
• Reduced bile flow (cholestasis), liver inflammation (hepatitis), yellowing of the skin or eyes (jaundice).
• Skin manifestations: hives, hair loss (alopecia), bruises under the skin (purpura).
• Increased urine excretion, difficulty urinating, frequent need to urinate at night (nocturia).
• Development of breasts in men (gynecomastia), persistent and painful erection (priapism).
• Fatigue, malaise.
• Painful persistent erection of the penis. Seek immediate medical attention.

Side effects with unknown frequency

• Increased risk of complications during cataract surgery (iris flag syndrome).
• Changes in ejaculation.

Rarely, the following may occur:
Increased plasma levels of nitrogen and creatinine, decreased red blood cells.
In the initial phase of treatment, orthostatic hypotension and, rarely loss of consciousness, especially at high doses, may occur.
These effects can 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 adverse-reaction .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store SAIDOX

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 “Expiry”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 SAIDOX contains
The active ingredient is doxazosin.

SAIDOX 2 mg tablets
Each tablet contains:

Active ingredient: doxazosin mesylate 2.43 mg (equivalent to doxazosin base 2 mg).
Excipients: Microcrystalline cellulose, lactose monohydrate, sodium glycolate starch, magne-
sium stearate, sodium lauryl sulfate.

SAIDOX 4 mg tablets
Each tablet contains:
Active ingredient: doxazosin mesylate 4.85 mg (equivalent to doxazosin base 4 mg).
Microcrystalline cellulose, lactose monohydrate, sodium glycolate starch, magnesium stearate, sodium
lauryl sulfate.

Description of the appearance of SAIDOX and package contents
Scorable tablets.
Package containing 30 scorable tablets of 2 mg in blisters.
Package containing 20 scorable tablets of 4 mg in blisters.

Marketing authorisation holder and manufacturer
S.F. GROUP srl
Via Tiburtina, n° 1143 - 00156 Rome

Manufacturer
Doppel Farmaceutici S.r.l. Via Volturno, 48 20089 Quinto de’ Stampi - Rozzano (Milan)
Lachifarma S.r.l. – Salento Chemical Pharmaceutical Laboratory – S.S. 16 Adriatica – Industrial Zone
73010 Zollino (LE)