Apo-doxan 4

Package Leaflet: Information for the Patient

Apo-Doxan 4, 4 mg, tablets
Doxazosin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Apo-Doxan 4 and what is it used for
• 2. Important information before taking Apo-Doxan 4
• 3. How to take Apo-Doxan 4
• 4. Possible side effects
• 5. How to store Apo-Doxan 4
• 6. Contents of the pack and other information

1. What is Apo-Doxan 4 and what is it used for

Apo-Doxan 4 belongs to a group of medicines called alpha-adrenergic blockers. It works by relaxing blood vessels, reducing peripheral resistance, which leads to a decrease in blood pressure.
Apo-Doxan 4 is also an antagonist of alpha-adrenergic receptors in the prostate and bladder. It reduces symptoms associated with difficulty in urinating and improves urodynamic test results (related to urine flow).
Apo-Doxan 4 is indicated for the treatment of:

• essential hypertension,
• symptomatic benign prostatic hyperplasia (BPH).

2. Important information before taking Apo-Dan 4

When not to take Apo-Doxan 4

• if you are allergic to the active substance or to quinazoline derivatives (such as prazosin, terazosin), or to any of the other ingredients of this medicine (listed in section 6),
• in patients with a history of orthostatic hypotension,
• in patients with benign prostatic hyperplasia with concurrent upper urinary tract obstruction, chronic urinary tract infections, or bladder stones,
• in patients with hypotension.

Apo-Doxan 4 is contraindicated in monotherapy in patients with urinary retention, anuria without progressive renal failure, or with it.

Warnings and precautions

Before starting treatment with Apo-Doxan 4, discuss it with your doctor or pharmacist.

• At the beginning of treatment, orthostatic hypotension may occur, manifested by dizziness, weakness, and rarely fainting. Your doctor may recommend blood pressure monitoring at the start of therapy.
• In patients with severe heart disease (pulmonary edema caused by aortic stenosis or mitral stenosis, heart failure with high minute volume, right ventricular heart failure caused by pulmonary embolism or pericardial effusion, left ventricular heart failure with low filling pressure), rapid and significant blood pressure reduction may exacerbate angina pectoris symptoms.
• In patients with proven liver dysfunction, doxazosin administration is not recommended.
• In patients taking PDE-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil - drugs used for erectile dysfunction), as symptomatic hypotension may occur.
• Prolonged, painful erections can occur very rarely. In such cases, you should contact your doctor immediately.
• Before starting treatment with Apo-Doxan 4, your doctor may perform tests to rule out other diseases, including prostate cancer, which can cause symptoms similar to those of benign prostatic hyperplasia.

Use in patients undergoing cataract surgery
During cataract surgery in some patients taking Apo-Doxan 4, "intraoperative floppy iris syndrome" (a variant of small pupil syndrome) has been observed. You should tell your ophthalmologist about taking alpha-adrenergic blockers before the procedure.
You should consult your doctor, even if the above warnings refer to situations that occurred in the past.

Children and adolescents

Apo-Doxan 4 is not recommended for use in children and adolescents under 18 years of age, as the safety and efficacy of this age group have not been established.

Apo-Doxan 4 and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Ask your doctor or pharmacist before taking Apo-Doxan 4 if you are taking any of the following medicines, as they may affect the action of Apo-Doxan 4:

• PDE-5 inhibitors used to treat erectile dysfunction, such as sildenafil, tadalafil, vardenafil (see "Warnings and precautions");
• blood pressure-lowering medicines;
• antibiotics or antifungals, such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole;
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, saquinavir;
• nefazodone, a medicine used to treat depression,
• vasodilators or nitrates (medicines used for heart disease).

The blood pressure-lowering effect of doxazosin may be weakened by:

• NSAIDs (non-steroidal anti-inflammatory drugs),
• estrogens,
• sympathomimetics.

Doxazosin may weaken the effect of dopamine, ephedrine, epinephrine, metaraminol, methoxyamine, and phenylephrine on blood pressure, as well as on blood vessels. Since there are no data on interactions with drugs affecting liver metabolism (e.g., cimetidine), it is recommended to exercise particular caution when administering these drugs with doxazosin.
In vitro studies have shown that doxazosin does not affect the binding of digoxin, warfarin, phenytoin, or indomethacin to plasma proteins.
During clinical trials with doxazosin, no interactions were found with thiazide diuretics, furosemide, beta-adrenergic blockers, non-steroidal anti-inflammatory drugs, antibiotics, oral hypoglycemic agents (used in diabetes), uricosuric agents, and anticoagulants. Doxazosin may increase plasma renin activity and urinary vanillylmandelic acid excretion. This should be taken into account when interpreting laboratory test results.
Doxazosin enhances the blood pressure-lowering effect of other alpha-adrenergic blockers and other antihypertensive drugs.
Clinical trials have shown that doxazosin has a beneficial effect on lipids, significantly reducing total triglyceride, total cholesterol, and LDL fraction levels in plasma. Treatment with doxazosin has a beneficial effect on hypertension and lipid levels, resulting in a reduced risk of coronary heart disease.
Some patients taking alpha-adrenergic blockers for high blood pressure or prostate enlargement may experience dizziness or a feeling of emptiness in the head, which can be caused by a sudden drop in blood pressure when changing body position when sitting or standing. Some patients have experienced these symptoms when taking alpha-adrenergic blockers with drugs used for erectile dysfunction (impotence). To minimize the risk of these symptoms, it is recommended to take daily doses of alpha-adrenergic blockers regularly before starting treatment with drugs for erectile dysfunction.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
The use of doxazosin has not been evaluated in pregnant women.
Doxazosin passes into human milk in small amounts. Breastfeeding women should not take this medicine unless their doctor decides otherwise.

Driving and using machines

Due to individual reactions to doxazosin, the ability to perform activities such as driving vehicles and operating machines, or performing specific types of work that require maintaining balance, may be impaired, especially at the beginning of treatment, after dose increase, switching to another medicine, or when consuming alcohol.

Apo-Doxan 4 contains lactose.

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Apo-Doxan 4 contains sodium.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Apo-Doxan 4

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Essential hypertension
The initial dose is 1 mg once daily. Depending on the efficacy, after 1-2 weeks, your doctor may increase the dose to 2 mg of doxazosin once daily, then to 4 mg of doxazosin once daily, and finally to 8 mg of doxazosin once daily. The average maintenance dose is between 2 and 4 mg of doxazosin once daily.
The maximum recommended dose is 16 mg of doxazosin per day.
To start treatment, the following dosing schedule is recommended:
day 1-8: 1 mg of doxazosin in the morning
day 9-14: 2 mg of doxazosin in the morning
Then, the dose can be increased to the effective maintenance dose.
Benign prostatic hyperplasia (BPH)
The initial dose is 1 mg once daily. If necessary, after 1-2 weeks, your doctor may increase the dose to 2 mg of doxazosin once daily, and then to 4 mg of doxazosin once daily.
The maximum recommended dose is 8 mg of doxazosin per day.
To start treatment, the following dosing schedule is recommended:
day 1-8: 1 mg of doxazosin once daily
day 9-14: 2 mg of doxazosin once daily
Then, the dose can be increased individually to the effective maintenance dose.

Use in children and adolescents

Apo-Doxan 4 is not recommended for use in children and adolescents under 18 years of age.

Patients with renal impairment

No dose adjustment is necessary in patients with renal impairment. However, the dose should be as low as possible, and any dose increase should be done under close medical supervision.

Patients with hepatic impairment

Caution should be exercised. There is no clinical experience with the use of the medicine in patients with severe liver dysfunction.

Elderly patients

No dose adjustment is necessary in elderly patients. However, the dose should be as low as possible, and any dose increase should be done under close medical supervision.

Overdose of Apo-Doxan 4

After an overdose, hypotension may occur.
If you have taken more Apo-Doxan 4 than recommended, contact your doctor.
Depending on the symptoms, your doctor will provide appropriate treatment. Since doxazosin is 98% bound to plasma proteins, dialysis is not recommended as a treatment for overdose.

Missed dose of Apo-Doxan 4

If you forget to take Apo-Doxan 4, take it as soon as possible, unless it is almost time for your next dose. In this case, take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Apo-Doxan 4 can cause side effects, although not everybody gets them.
The following side effects may occur:
Common side effects(which may occur in more than 1 in 100 patients) Respiratory tract infections, urinary tract infections, drowsiness, dizziness, headache, accommodation disorders, vertigo of labyrinthine origin, palpitations, tachycardia, chest pain, hypotension, orthostatic hypotension, edema, bronchitis, cough, dyspnea, rhinitis, abdominal pain, nausea, dry mouth, itching, back pain, muscle pain, cystitis, urinary incontinence, increased need to urinate, frequent urination, weakness, flu-like symptoms, generalized edema, peripheral edema.
Uncommon side effects(which may occur in more than 1 in 1,000 patients) Allergic reactions, anorexia, gout, increased appetite, anxiety, insomnia, nervousness, agitation, depression, emotional lability, stroke, paresthesia, fainting, tremor, apathy, lacrimation, photophobia, tinnitus, myocardial infarction, fainting, angina pectoris, peripheral hypoperfusion, pharyngitis, epistaxis, constipation, flatulence, vomiting, gastritis, diarrhea, abnormal liver function tests, increased liver enzyme activity, rash, arthralgia, dysuria, urinary frequency disorders, hematuria, impotence, pain, fever, chills, facial edema, hot flashes, pallor, hypokalemia, weight gain.
Rare side effects(which may occur in more than 1 in 10,000 patients) Cerebrovascular disorders, laryngeal edema, polyuria, hypoglycemia.
Very rare side effects(which may occur in less than 1 in 10,000 patients) Leukopenia, thrombocytopenia, anemia, hypersensitivity, muscle stiffness, taste disorders, nightmares, memory loss, orthostatic dizziness, paresthesia, blurred vision, bradycardia, arrhythmias, flushing, bronchospasm, hepatitis, cholestasis, jaundice, urticaria, alopecia, purpura, muscle cramps, muscle weakness, urinary disorders, increased creatinine levels in urine and plasma, increased diuresis, nocturia, gynecomastia, fatigue, malaise, decreased body temperature in elderly patients.
Prolonged, painful erections. You should seek medical attention immediately.
Frequency not known(cannot be estimated from the available data) Intraoperative floppy iris syndrome, retrograde ejaculation.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Apo-Doxan 4

Store in a temperature below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Expiry date".
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Apo-Doxan 4 contains

• The active substance is doxazosin. Each tablet contains 4 mg of doxazosin in the form of doxazosin mesylate.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate.

What Apo-Doxan 4 looks like and contents of the pack

White, biconvex tablets with a rhomboid shape, with "APO" on one side and "D4" on the other.
The pack contains 30 or 60 tablets.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok.27
01-909 Warsaw
Poland

Manufacturer:

Generis Farmacêutica, S.A.

Rua João de Deus, no 19
Venda Nova, 2700-487 Amadora
Portugal

Importer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
To obtain more detailed information, contact the marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

Tel.: (22) 311 20 00

Date of last revision of the leaflet: 05.2023