Saidox

Package leaflet: Information for the patient

SAIDOX 2 mg tablets, 4 mg tablets

Doxazosin
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 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 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. 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 called alpha blockers. It is used to treat high blood pressure (essential hypertension).
SAIDOX works by relaxing the blood vessels, allowing blood to pass through them more easily. This helps to lower blood pressure.
SAIDOX may also be used for benign prostatic hyperplasia, a condition involving enlargement of the prostate gland.

2. What you should know before taking SAIDOX

Do not take SAIDOX if:

• you are allergic to doxazosin, to other substances belonging to the quinazoline group (such as prazosin, terazosin), or to any of the components of this medicine (listed in section 6);
• you have suffered from a condition known as "orthostatic hypotension", a form of low blood pressure causing dizziness or lightheadedness when standing up from a sitting or lying position;
• you have an enlarged prostate gland (benign prostatic hyperplasia) and also have difficulty urinating, or have a chronic urinary tract infection or bladder stones;
• you are breastfeeding;
• you have a specific type of urinary incontinence in which involuntary urine leakage occurs due to an overfilled bladder, or if you are not producing an adequate amount of urine (anuria), with or without 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 weakness, dizziness, and rarely fainting due to a drop in blood pressure upon standing from a sitting or lying position. If you feel weak, dizzy, or faint, sit or lie down until you feel better and avoid situations where you might fall or get injured. Your doctor may decide to monitor your blood pressure regularly at the beginning of treatment to reduce the likelihood of these side effects.
If you are scheduled for cataract surgery (a clouding of the lens), inform your ophthalmologist before the procedure that you are currently taking or have previously taken SAIDOX. SAIDOX may cause complications during surgery, which can be managed if the specialist is informed in advance.
Inform your doctor or pharmacist before taking SAIDOX if any of the following conditions apply to you, as SAIDOX should be used with caution in these cases:

• If you have heart conditions such as:
  • fluid accumulation in the lungs (pulmonary edema) due to narrowing of heart valves (aortic or mitral stenosis);
  • heart function problems (heart failure with high cardiac output, right-sided heart failure due to pulmonary embolism or pericardial effusion; left ventricular heart failure with low filling pressure);
  • if you have severe ischemic heart disease, excessive or sudden lowering of blood pressure may worsen your condition.
• If you have or have had liver disease or if you are taking medicines that affect liver function (e.g., cimetidine).
• If you are taking medicines for erectile dysfunction (impotence), called phosphodiesterase 5 inhibitors (such as sildenafil, tadalafil, and vardenafil), because both types of medicines lower blood pressure by dilating blood vessels. Taking SAIDOX together with these medicines may cause excessive lowering of blood pressure (see Other medicines and SAIDOX). To reduce the likelihood of symptoms, you should first start SAIDOX therapy and take it regularly at a daily dose. Only after SAIDOX therapy has been stabilized should you begin taking medicines for erectile dysfunction.
• If you have a condition caused by a diabetic complication (autonomic diabetic neuropathy).

Prolonged painful erections of the penis – may occur very rarely. If this happens, contact a doctor immediately.
Before starting SAIDOX therapy, your doctor may perform tests to rule out other diseases such as prostate cancer, which could cause symptoms similar to 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Inform your doctor or pharmacist before use if you are taking any of the following medicines, as they may affect the action of SAIDOX:

• Certain medicines used to treat high blood pressure or prostate enlargement (called alpha-blockers) may enhance the blood pressure-lowering effect of doxazosin.
• Certain medicines used for erectile dysfunction (impotence) (called phosphodiesterase type 5 inhibitors, such as sildenafil, tadalafil, and vardenafil) may cause excessive lowering of blood pressure accompanied by symptoms (see Warnings and precautions).
• Medicines used to treat 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-relieving medicines (NSAIDs) may reduce the effect of doxazosin.
• Medicines used as antacids (cimetidine) may alter the amount of doxazosin available in the body.

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 taking this medicine.
Pregnancy
The safety of using SAIDOX during pregnancy has not been established. Therefore, 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 discontinued if you need to start treatment with SAIDOX.

Driving and using machines
Be careful if driving or operating machinery. These tablets may impair your ability to drive or operate machinery safely, especially at the beginning of treatment. They may cause weakness or dizziness. 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 them 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 exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
SAIDOX should be taken as a single daily dose and may be taken either in the morning or in the evening.

High blood pressure
The recommended dose of SAIDOX is 1 to 8 mg per day. The maximum recommended dose is 16 mg per day.
The initial dose is 1 mg taken at bedtime (half a 2 mg tablet), and this dose should be maintained for one to two weeks. After this period, the dose may be increased to 2 mg once daily and maintained for another one to two weeks. If necessary, the daily dose may be further increased gradually, always after the same time interval, to 4 mg, 8 mg, and up to 16 mg once daily, according to the patient's response and under the direction of 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) daily from day 1 to day 8, and 2 mg daily (one 2 mg tablet) from day 9 to day 14.
If necessary and as directed by your treating physician, this dose may be increased to 4 mg (one SAIDOX 4 mg tablet) and subsequently to the maximum recommended dose of 8 mg (two SAIDOX 4 mg tablets).
The recommended interval between dose increases is 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 department.
Taking too many tablets at once may make you feel unwell due to excessive lowering of blood pressure. If this occurs, lie down in a supine position.

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

If you stop taking SAIDOX
Do not stop taking this medicine unless advised by your doctor, even if you feel better. It is very important to continue treatment as prescribed.
If you stop treatment with SAIDOX for a few days, you must restart treatment at the initial dose of 1 mg.

4. Possible side effects

Like all medicines, SAIDOX can cause side effects, although not everyone experiences them.
If you experience any of the following symptoms, STOP taking SAIDOX and call an ambulance
immediately:

• Chest pain (angina, myocardial infarction);
• Shortness of breath (dyspnoea), accompanied by discomfort and tightness in the chest (bronchospasm);
• Sudden headache, feeling faint, weakness in the arms or legs, or difficulty speaking, which could be signs of a stroke;
• Swelling of the face and allergic reactions.

Inform your doctor immediately if, after taking SAIDOX, you experience any of the following
symptoms:

• Fast, slow, or irregular heartbeat;
• Awareness of your own heartbeat (palpitations);
• Yellowing of the skin or eyes (jaundice);
• Low number of white blood cells or platelets in the blood. These conditions may lead to an increased susceptibility to infections or increased bruising or tendency to bleed, respectively.

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 (cephalalgia).
• Palpitations, fast heartbeat (tachycardia).
• Low blood pressure (hypotension) or postural hypotension.
• Bronchitis, cough, difficulty breathing (dyspnoea), allergic rhinitis (rhinitis).
• Abdominal pain, indigestion (dyspepsia), dry mouth, nausea.
• Itching (pruritus).
• Back pain, muscle pain (myalgia).
• Cystitis, involuntary urination (incontinence).
• Reduced muscle strength (asthenia), chest pain, influenza-like symptoms, swelling of different body parts due to fluid accumulation (peripheral oedema).

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

• Allergic reaction to the medicine. Rheumatic disease affecting the joints (gout), increased appetite, anorexia.
• Agitation, depression, anxiety, insomnia, nervousness.
• Cerebrovascular accident (stroke), decreased sensation (hypoesthesia), temporary loss of consciousness (syncope), tremor.
• Tinnitus (ringing in the ears).
• Feeling of tightness and pain in the chest (angina pectoris), myocardial infarction.
• Nosebleeds (epistaxis).
• Constipation, intestinal gas formation, vomiting, diarrhoea, inflammation of the stomach and intestine.
• Abnormal liver enzyme levels and liver function test results.
• Skin rash.
• Joint pain (arthralgia).
• Difficulty urinating, frequent urination, presence of blood in the urine.
• Impotence.
• Pain, swelling of the face.
• Weight gain.

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

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

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

• Reduction in white blood cells and platelets (leucopenia, thrombocytopenia).
• Dizziness upon changing position, tingling sensation (paraesthesia).
• Blurred vision.
• Slow heartbeat (bradycardia), changes in heartbeat rhythm (cardiac arrhythmias).
• Hot flushes.
• Breathing difficulties due to spasms of the respiratory tract muscles (bronchospasm).
• Reduced bile flow (cholestasis), inflammation of the liver (hepatitis), yellowing of the skin or eyes (jaundice).
• Skin manifestations: urticaria, hair loss (alopecia), bruising under the skin (purpura).
• Increased urine excretion, difficulty urinating, repeated need to urinate during the night (nocturia).
• Breast development in men (gynaecomastia), prolonged and painful erection (priapism).
• Fatigue, malaise.
• Prolonged and painful penile erection. Seek immediate medical advice.

Side effects with unknown frequency

• Increased risk of complications during cataract surgery (intraoperative floppy iris syndrome).
• Ejaculation disorders.

Rarely, the following may occur:
Increased plasma levels of nitrogen and creatinine, reduction in red blood cells.
In the initial phase of treatment, orthostatic hypotension and, rarely, loss of consciousness may occur, especially at high doses.
These effects may also occur when treatment is resumed after a brief interruption.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via
avverse.
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 stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. Contents of the pack and other information

What SAIDOX contains
The active substance is doxazosin.
SAIDOX 2 mg tablets
Each tablet contains:
Active substance: doxazosin mesylate 2.43 mg (equivalent to 2 mg of doxazosin base).
Excipients: Microcrystalline cellulose, lactose monohydrate, sodium glycolate starch, magnesium stearate, sodium lauryl sulfate.
SAIDOX 4 mg tablets
Each tablet contains:
Active substance: doxazosin mesylate 4.85 mg (equivalent to 4 mg of doxazosin base).
Microcrystalline cellulose, lactose monohydrate, sodium glycolate starch, magnesium stearate, sodium lauryl sulfate.
Description of the appearance of SAIDOX and contents of the pack
Scored tablets.
Carton containing 30 scored tablets of 2 mg in blister packs.
Carton containing 20 scored tablets of 4 mg in blister packs.
Marketing Authorization Holder and Manufacturer
S.F. GROUP srl
Via Tiburtina, No. 1143 - 00156 Rome
Manufacturer
Doppel Farmaceutici S.r.l., Via Volturno, 48, 20089 Quinto de’ Stampi - Rozzano (Milan)
Lachifarma S.r.l. – Laboratorio Chimico Farmaceutico Salentino – S.S. 16 Adriatica – Industrial Zone, 73010 Zollino (LE)
March 2023