Zoxon 1

Patient Information Leaflet

ZOXON 1, 1 mg, tablets
ZOXON 2, 2 mg, tablets
ZOXON 4, 4 mg, tablets
Doxazosinum
Please read this leaflet carefully before using the medicine, because it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Zoxon is and what it is used for

Zoxon belongs to a group of medicines called alpha-adrenergic blocking agents. It acts by dilating blood vessels, reducing peripheral resistance, thereby lowering arterial blood pressure.
Zoxon is also an antagonist of alpha1-adrenergic receptors located in the prostate gland and urinary bladder. It reduces symptoms related to impaired urine flow and improves urodynamic test results (related to urine flow).
Zoxon is indicated for the treatment of:

• essential hypertension,
• clinical symptoms of benign prostatic hyperplasia (BPH).

2. Important information before using Zoxon

When not to use Zoxon

• if the patient is allergic to doxazosin, other medicines in the same group (known as quinazoline derivatives, such as prazosin and terazosin) or any of the other ingredients of this medicine (listed in section 6),
• in patients with a history of orthostatic hypotension,
• in patients with mild benign prostatic hyperplasia associated with upper urinary tract congestion, chronic urinary tract infections or bladder stones,
• in patients with arterial hypotension.

Zoxon is contraindicated in monotherapy in patients with bladder overdistension, anuria
without progressive renal failure or with it.
Warnings and precautions
Before starting treatment with Zoxon, discuss this with your doctor or pharmacist.

• At the beginning of treatment, orthostatic hypotension may occur, manifesting as dizziness, feeling of weakness or, rarely, fainting. Your doctor may recommend monitoring blood pressure at the beginning of therapy.
• In patients with severe heart disease (pulmonary edema caused by aortic stenosis or mitral stenosis, heart failure with high cardiac output, right ventricular heart failure due to pulmonary embolism or pericardial effusion, left ventricular heart failure with low filling pressure), rapid and significant reduction in blood pressure may exacerbate angina symptoms.
• In patients with diagnosed liver impairment, doxazosin administration is not recommended.
• In patients concurrently taking PDE-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil
• medicines used in impotence), symptomatic arterial hypotension may occur.
• Prolonged, painful erections may very rarely occur. In such a case, contact your doctor immediately.
• Before starting treatment with Zoxon, your doctor may perform tests to exclude other diseases, including prostate cancer, which causes symptoms similar to those of benign prostatic hyperplasia.

Use in patients undergoing cataract surgery
During cataract surgery, in some patients currently or previously taking
tamsulosin, "intraoperative floppy iris syndrome" (a variant of small pupil syndrome) has been observed. Before the procedure, inform the ophthalmologist about taking alpha-adrenergic blocking agents.
Consult your doctor, even if the above warnings concern conditions occurring in the past.
Children and adolescents
Zoxon is not recommended for use in children and adolescents under 18 years of age due to lack of data on safety and efficacy in this age group.
Zoxon and other medicines
Ask your doctor or pharmacist before taking Zoxon if the patient is using
the following medicines, as they may alter the effect of Zoxon:

• medicines known as PDE-5 inhibitors, used in the treatment of erectile dysfunction, e.g., sildenafil, tadalafil, vardenafil (see section "Warnings and precautions");
• medicines that lower blood pressure;
• medicines used to treat bacterial or fungal infections, e.g., clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole;
• medicines used in the treatment of HIV, e.g., indinavir, nelfinavir, ritonavir, saquinavir;
• nefazodone, a medicine used in the treatment of depression,
• vasodilators or nitrates (medicines used in heart diseases).

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

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

Doxazosin may reduce the effect of dopamine, ephedrine, epinephrine, metaraminol, methoxamine, and phenylephrine on blood pressure and blood vessels. Since there are no data on interactions with medicines affecting hepatic metabolism (e.g., cimetidine), particular caution is advised when administering these medicines with doxazosin.
In vitro studies have not shown doxazosin to affect the plasma protein binding of digoxin, warfarin, phenytoin or indomethacin.
During clinical trials with doxazosin, no interactions were observed with thiazide diuretics, furosemide, beta-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 excretion of vanillylmandelic acid. This should be taken into account when interpreting laboratory test results.
Zoxon enhances the blood pressure-lowering effect of other alpha-adrenergic blocking agents and other antihypertensive medicines.
Clinical studies 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 favorably affects arterial hypertension and lipid levels, thereby reducing the risk of coronary artery disease.
Some patients taking alpha-adrenergic blocking agents for high blood pressure or enlarged prostate may experience dizziness or a feeling of emptiness in the head, which may be caused by a sudden drop in blood pressure due to rapid change in body position when sitting or standing up. Some patients experienced these symptoms while taking alpha-adrenergic blocking agents together with medicines used for erectile dysfunction (impotence). To reduce the likelihood of these symptoms, it is recommended to regularly take daily doses of alpha-adrenergic blocking agents before starting treatment with erectile dysfunction medicines.
Inform your doctor or pharmacist about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.
Zoxon with food and drink
Swallow the tablet whole, without chewing, with water.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using 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 use this medicine unless otherwise decided by the doctor.
Driving and operating machinery
Due to individual responses to doxazosin, the ability to perform such activities as driving vehicles and operating machinery, or performing specific types of work requiring maintenance of balance, may be impaired, especially at the beginning of treatment, after dose increase, switching to another medicine, or when consuming alcohol concurrently.
Zoxon contains anhydrous lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Zoxon

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Essential hypertension
The initial dose is 1 mg once daily. Depending on efficacy, after 1–2 weeks your doctor may increase the dose to 2 mg doxazosin once daily, then to 4 mg doxazosin once daily, and finally up to 8 mg doxazosin once daily. The average maintenance dose is 2 to 4 mg doxazosin once daily.
The maximum recommended dose is 16 mg doxazosin per day.
The following dosing schedule is recommended when starting treatment:
Days 1–8: 1 mg doxazosin in the morning
Days 9–14: 2 mg doxazosin in the morning
Thereafter, the dose should be increased gradually to an effective maintenance dose.

Benign prostatic hyperplasia (BPH)
The initial dose is 1 mg once daily. If necessary, after one to two weeks your doctor may increase the dose to 2 mg doxazosin once daily, and subsequently to 4 mg doxazosin once daily.
The maximum recommended dose is 8 mg doxazosin once daily.
The following dosing schedule is recommended when starting treatment:
Days 1–8: 1 tablet of Zoxon 1 mg (1 mg doxazosin) once daily
Days 9–14: 2 tablets of Zoxon 1 mg (2 mg doxazosin) once daily
Thereafter, the dose may be individually increased to an effective maintenance dose.

Use in children and adolescents
Zoxon is not recommended for use in children and adolescents under 18 years of age.

Patients with renal impairment
Dose adjustment is not necessary in patients with impaired renal function. However, the dose should be kept as low as possible, and any dose increase should be performed under strict medical supervision.

Patients with hepatic impairment
Extreme caution should be exercised. There is no clinical experience with the use of this medicine in patients with severe hepatic impairment.

Elderly patients
Dose adjustment is not necessary in elderly patients. However, the dose should be kept as low as possible, and any dose increase should be performed under strict medical supervision.

Use of a higher than recommended dose of Zoxon
Hypotension may occur following overdose.
If you take more Zoxon than prescribed, contact your doctor immediately. Depending on the symptoms present, your doctor will initiate appropriate treatment. Since doxazosin is 98% protein-bound, dialysis is not indicated as a treatment for overdose.

Missed dose of Zoxon
If you forget to take a dose of Zoxon, take it as soon as possible, unless it is almost time for your next scheduled dose. In that case, take the next dose at the regular time. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
The following adverse effects may occur during treatment with doxazosin:

Common adverse effects (may occur in up to 1 in 10 people):

• respiratory tract infections, urinary tract infections,
• drowsiness, dizziness, headache,
• eye accommodation disorders,
• vertigo (vestibular dizziness),
• palpitations, rapid heartbeat (tachycardia), chest pain,
• hypotension, low blood pressure upon standing (orthostatic hypotension), swelling,
• bronchitis, cough, dyspnea, nasal mucositis,
• abdominal pain, indigestion, dry mouth, nausea,
• itching,
• back pain, muscle pain,
• cystitis, urinary incontinence, increased urge to urinate, frequent urination,
• asthenia, influenza-like symptoms, generalized edema, peripheral edema.

Uncommon adverse effects (may occur in up to 1 in 100 people):

• allergic reactions,
• gout, increased appetite, loss of appetite (anorexia), thirst,
• restlessness, depression, anxiety, insomnia, nervousness, emotional lability,
• stroke, hypoaesthesia, fainting, tremor, apathy,
• lacrimation, photophobia,
• tinnitus,
• angina pectoris, myocardial infarction, fainting,
• peripheral ischemia,
• epistaxis, pharyngitis,
• constipation, bloating and flatulence, vomiting, gastritis and enteritis, diarrhea,
• abnormal liver function test results, increased liver enzyme activity,
• rash,
• joint pain,
• difficulty in urination, urinary frequency disorders, haematuria,
• impotence,
• pain, facial swelling, chills, fever, hot flushes, pallor,
• weight gain, hypokalaemia.

Rare adverse effects (may occur in up to 1 in 1,000 people):

• cerebrovascular disorders,
• laryngeal edema, polyuria,
• hypoglycaemia.

Very rare adverse effects (may occur in up to 1 in 10,000 people):

• leukopenia, thrombocytopenia, anaemia,
• hypersensitivity, muscle stiffness, taste disturbances, nightmares, memory loss, orthostatic dizziness (dizziness upon changing body position), paresthesia,
• blurred vision,
• slowed heart rate (bradycardia), heart rhythm disorders (cardiac arrhythmias),
• flushing,
• bronchospasm,
• cholestasis, hepatitis, jaundice,
• urticaria, alopecia, purpura,
• muscle cramps, muscle weakness,
• increased urine output (increased diuresis), urinary disorders, nocturia, increased creatinine concentration in urine and plasma,
• gynaecomastia,
• feeling of fatigue, malaise,
• decreased body temperature in elderly patients.

Prolonged, painful erection. Seek immediate medical advice.
Frequency not known (frequency cannot be estimated from the available data):

• intraoperative floppy iris syndrome,
• retrograde ejaculation.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Poland. Tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the Marketing Authorization Holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Zoxon

Keep the medicine in a dry place, at a temperature between 10°C and 25°C. Protect from
light.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines you no longer use. This practice helps protect the
environment.

6. Contents of the pack and other information

What Zoxon contains

• The active substance is doxazosin in the form of doxazosin mesylate. Each tablet contains 1 mg, 2 mg or 4 mg of doxazosin.
• Other ingredients are: microcrystalline cellulose, anhydrous lactose, sodium carboxymethyl starch, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate.

What Zoxon looks like and contents of the pack
Zoxon 1: almost white tablets with an imprint "ZX" and "1" on one side.
Zoxon 2: almost white, oblong tablets of approximately 9 mm x 4.5 mm, with a break line and an imprint "ZX" and "2" on one side.
Zoxon 4: almost white, oblong tablets of approximately 12 mm x 6 mm, with a break line and an imprint "ZX" and "4" on one side.
Tablets are packed in blisters made of Al/PVC/PVDC foil in cardboard boxes.
Pack sizes:
Zoxon 1: 15 or 30 tablets,
Zoxon 2: 10, 30 or 90 tablets,
Zoxon 4: 30, 90 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.
For further information, contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92 00