APO-DOXAN 2 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Apo-Doxan 2 and what is it used for
3. Important information before taking Apo-Doxan 2
   1. When not to take Apo-Doxan 2
   2. Warnings and precautions
   3. Children and adolescents
   4. Apo-Doxan 2 and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and operating machinery
   7. Apo-Doxan 2 contains lactose.
   8. Apo-Doxan 2 contains sodium.
4. How to take Apo-Doxan 2
   1. Use in children and adolescents
   2. Patients with renal impairment
   3. Patients with hepatic impairment
   4. Elderly patients
   5. Overdose of Apo-Doxan 2
   6. Missed dose of Apo-Doxan 2
5. Possible side effects
   1. Reporting side effects
6. How to store Apo-Doxan 2
7. Package contents and other information
   1. What Apo-Doxan 2 contains
   2. What Apo-Doxan 2 looks like and what the package contains
   3. Marketing authorization holder and manufacturer/importer
   4. Marketing authorization holder:
   5. Aurovitas Pharma Polska Sp. z o.o.
   6. Manufacturer:
   7. Generis Farmacêutica, S.A.
   8. Importer:
   9. APL Swift Services (Malta) Limited
   10. Aurovitas Pharma Polska Sp. z o.o.
   11. Date of last revision of the leaflet: 05.2023

Leaflet attached to the packaging: patient information

Apo-Doxan 2, 2 mg, tablets
Doxazosin

Read the 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 2 and what is it used for
• 2. Important information before taking Apo-Doxan 2
• 3. How to take Apo-Doxan 2
• 4. Possible side effects
• 5. How to store Apo-Doxan 2
• 6. Package contents and other information

1. What is Apo-Doxan 2 and what is it used for

Apo-Doxan 2 belongs to a group of medicines called alpha-adrenergic blockers. It works by dilating blood vessels, reducing peripheral resistance, which leads to a decrease in blood pressure. Apo-Doxan 2 is also an antagonist of alpha-adrenergic receptors in the prostate and urinary bladder. It reduces symptoms associated with difficulty in urinating and improves urodynamic test results (related to urine flow).
Apo-Doxan 2 is indicated for the treatment of:

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

2. Important information before taking Apo-Doxan 2

When not to take Apo-Doxan 2

• 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 2 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 2, 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 lowering of blood pressure may worsen angina pectoris symptoms.
• In patients with known liver dysfunction, doxazosin administration is not recommended.
• In patients taking PDE-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil - drugs used to treat 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 2, 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 tamsulosin, "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 have occurred in the past.

Children and adolescents

Apo-Doxan 2 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 2 and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Ask your doctor or pharmacist before taking Apo-Doxan 2 if you are taking any of the following medicines, as they may affect the action of Apo-Doxan 2:

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

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, methoxamine, 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 not shown that doxazosin affects 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, NSAIDs, antibiotics, oral hypoglycemic agents (used in diabetes), uricosuric agents, and anticoagulants. Doxazosin may increase plasma renin activity and vanillylmandelic acid excretion in urine. 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 may 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 to treat erectile dysfunction (impotence). To minimize the risk of these symptoms, it is recommended to take alpha-adrenergic blockers regularly before starting treatment with erectile dysfunction drugs.

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 operating machinery

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

Apo-Doxan 2 contains lactose.

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

Apo-Doxan 2 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 2

This medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Essential hypertension
The initial dose is 1 mg once daily. Depending on the effectiveness, 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 should be increased to an 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 individually increased to an effective maintenance dose.

Use in children and adolescents

Apo-Doxan 2 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 of the medicine should be as low as possible, and any dose increase should be done under close medical supervision.

Patients with hepatic impairment

Particular caution is necessary. There is a lack of 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 of the medicine should be as low as possible, and any dose increase should be done under close medical supervision.

Overdose of Apo-Doxan 2

After an overdose, hypotension may occur.
If you have taken more Apo-Doxan 2 than recommended, contact your doctor.
Depending on the symptoms, your doctor will administer the appropriate treatment. Since doxazosin is 98% bound to plasma proteins, dialysis is not indicated as a treatment for overdose.

Missed dose of Apo-Doxan 2

If you forget to take Apo-Doxan 2, 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 2 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, 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 instability, stroke, paresthesia, fainting, tremor, apathy, lacrimation, photophobia, tinnitus, myocardial infarction, fainting, angina pectoris, peripheral ischemia, pharyngitis, epistaxis, constipation, flatulence, vomiting, gastritis, diarrhea, abnormal liver function test results, 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, Poland, 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 2

Store in a temperature below 25°C.
Keep the medicine out of 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 that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Apo-Doxan 2 contains

• The active substance of the medicine is doxazosin. Each tablet contains 2 mg of doxazosin in the form of doxazosin mesylate.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate.

What Apo-Doxan 2 looks like and what the package contains

White, biconvex, capsule-shaped tablets with "APO" on one side and "D2" on the other.
The package contains 30 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