APO-DOXAN 1 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Apo-Doxan 1 and what is it used for
3. Important information before taking Apo-Doxan 1
   1. When not to take Apo-Doxan 1
   2. Warnings and precautions
   3. Children and adolescents
   4. Apo-Doxan 1 and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and operating machines
   7. Apo-Doxan 1 contains lactose.
   8. Apo-Doxan 1 contains sodium.
4. How to take Apo-Doxan 1
   1. Use in children and adolescents
   2. Patients with renal impairment
   3. Patients with hepatic impairment
   4. Elderly patients
   5. Overdose of Apo-Doxan 1
   6. Missed dose of Apo-Doxan 1
5. Possible side effects
   1. Reporting side effects
6. How to store Apo-Doxan 1
7. Contents of the packaging and other information
   1. What Apo-Doxan 1 contains
   2. What Apo-Doxan 1 looks like and contents of the pack
   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 1, 1 mg, tablets
Doxazosin

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a 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 the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Apo-Doxan 1 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 1 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).
The Apo-Doxan 1 medicine is indicated for the treatment of:

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

2. Important information before taking Apo-Doxan 1

When not to take Apo-Doxan 1

• if the patient is 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 arterial hypotension.

Apo-Doxan 1 is contraindicated in monotherapy in patients with urinary retention, anuria without progressive renal failure, or with it.

Warnings and precautions

Before starting to take Apo-Doxan 1, you should discuss it with your doctor or pharmacist.

• At the beginning of treatment, orthostatic hypotension may occur, manifested by dizziness, weakness, and rarely fainting. The doctor may recommend blood pressure monitoring at the start of therapy.
• In patients with severe heart diseases (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 failure, the use of doxazosin is not recommended.
• In patients taking PDE-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil - medicines used for erectile dysfunction), as symptomatic hypotension may occur.
• Prolonged, painful erections can occur very rarely. In such a case, you should immediately contact your doctor.
• Before starting treatment with Apo-Doxan 1, the doctor may perform tests to rule out other diseases, including prostate cancer, which can cause the same symptoms as benign prostatic hyperplasia.Use in patients undergoing cataract surgery During cataract surgery in some patients taking tamsulosin currently or previously, "intraoperative floppy iris syndrome" (a variant of small pupil syndrome) has been observed. Before the procedure, you should tell the ophthalmologist about taking alpha-adrenergic blockers. You should consult a doctor, even if the above warnings concern situations that have occurred in the past.

Children and adolescents

The use of Apo-Doxan 1 is not recommended in children and adolescents under 18 years of age, as the safety and efficacy of this age group have not been established.

Apo-Doxan 1 and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
You should ask your doctor or pharmacist before taking Apo-Doxan 1 if you are taking any of the following medicines, as they may change the effect of Apo-Doxan 1:

• 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 medicines, e.g., indinavir, nelfinavir, ritonavir, saquinavir;
• nefazodone, a medicine used to treat depression,
• vasodilators or nitrates (medicines used for heart diseases).

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 medicines affecting liver metabolism (e.g., cimetidine), it is recommended to exercise particular caution when administering these medicines 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, non-steroidal anti-inflammatory drugs, 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 medicines.
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 artery 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 due to a rapid change in body position when sitting or standing. Some patients have experienced these symptoms when taking alpha-adrenergic blockers with medicines used for erectile dysfunction (impotence). To minimize the risk of these symptoms, it is recommended to regularly take daily doses of alpha-adrenergic blockers before starting to take medicines for erectile dysfunction.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should 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 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 increasing the dose, switching to another medicine, or when consuming alcohol.

Apo-Doxan 1 contains lactose.

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

Apo-Doxan 1 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 1

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Essential hypertension
The initial dose is 1 mg once a day. Depending on the effectiveness, after 1-2 weeks, the doctor may increase the dose to 2 mg of doxazosin once a day, then to 4 mg of doxazosin once a day, and finally to 8 mg of doxazosin once a day. The average maintenance dose is between 2 and 4 mg of doxazosin once a day.
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, it is recommended to increase the dose to an effective maintenance dose.
Benign prostatic hyperplasia (BPH)
The initial dose is 1 mg once a day. If necessary, after 1-2 weeks, the doctor may increase the dose to 2 mg of doxazosin once a day, and then to 4 mg of doxazosin once a day.
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 a day
day 9-14: 2 mg of doxazosin once a day
Then, the dose can be individually increased to an effective maintenance dose.

Use in children and adolescents

The use of Apo-Doxan 1 is not recommended in children and adolescents under 18 years of age.

Patients with renal impairment

There is no need to adjust the dose 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 should be exercised. There is a lack of clinical experience with the use of the medicine in patients with severe liver failure.

Elderly patients

There is no need to adjust the dose 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 1

In case of overdose, hypotension may occur.
If a higher dose of Apo-Doxan 1 than recommended is taken, you should contact your doctor.
Depending on the symptoms, the doctor will administer the appropriate treatment. Since doxazosin is 98% bound to plasma proteins, dialysis as a treatment for overdose is not indicated.

Missed dose of Apo-Doxan 1

If you miss a dose of Apo-Doxan 1, you should take it as soon as possible, unless it is almost time for the next dose. In this case, you should 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 1 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, vomiting, pruritus, 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, lachrymation, photophobia, tinnitus, myocardial infarction, fainting, angina pectoris, peripheral hypoperfusion, 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 spasms, 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 immediately seek medical attention.
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 any side effects not listed in the leaflet, you should 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, Phone: +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 the medicine.

5. How to store Apo-Doxan 1

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

6. Contents of the packaging and other information

What Apo-Doxan 1 contains

• The active substance of the medicine is doxazosin. Each tablet contains 1 mg of doxazosin in the form of doxazosin mesylate.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate.

What Apo-Doxan 1 looks like and contents of the pack

White, round, biconvex tablets with "APO" on one side and "D1" on the other.
The pack 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, you should contact the marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

Phone: (22) 311 20 00

Date of last revision of the leaflet: 05.2023