ZOXON 1 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. ZOXON 1, 1 mg, tablets
3. ZOXON 2, 2 mg, tablets
4. ZOXON 4, 4 mg, tablets
   1. Contents of the pack:
5. What is Zoxon and what is it used for
6. Before you take Zoxon
   1. When not to take Zoxon
   2. Warnings and precautions
   3. Children and adolescents
   4. Zoxon with other medicines
   5. Zoxon with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Zoxon contains lactose and sodium
7. How to take Zoxon
   1. Use in children and adolescents
   2. Patients with renal impairment
   3. Patients with hepatic impairment
   4. Elderly patients
   5. Overdose
   6. Missed dose
8. Possible side effects
   1. Reporting of side effects
9. How to store Zoxon
10. Contents of the pack and other information
    1. What Zoxon contains
    2. What Zoxon looks like and contents of the pack
    3. Marketing authorization holder and manufacturer:
    4. For further information, please contact the representative of the marketing authorization holder in Poland:
    5. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

ZOXON 1, 1 mg, tablets

ZOXON 2, 2 mg, tablets

ZOXON 4, 4 mg, tablets

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

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

• 1. What is Zoxon and what is it used for
• 2. Before you take 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 is Zoxon and what is it used for

Zoxon belongs to a group of medicines called alpha-adrenergic blockers. It works by relaxing the blood vessels, reducing peripheral resistance, which leads to a decrease in blood pressure.
Zoxon is also an antagonist of alpha1-adrenergic receptors in the prostate and bladder. It reduces the symptoms associated with difficulty in urinating and improves urodynamic test results (related to urine flow).
Zoxon is indicated for the treatment of:

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

2. Before you take Zoxon

When not to take Zoxon

• if you are allergic to doxazosin, other medicines of 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 benign prostatic hyperplasia with concomitant congestion of the upper urinary tract, chronic urinary tract infections, or bladder stones,
• in patients with arterial hypotension.

Zoxon is contraindicated in monotherapy in patients with overflow incontinence, anuria without progressive renal failure, or with it.

Warnings and precautions

Before starting treatment with Zoxon, discuss it with your doctor or pharmacist.

• At the beginning of treatment, orthostatic hypotension may occur, manifested by dizziness, weakness, or 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 cause worsening of angina symptoms.
• In patients with proven liver failure, doxazosin administration is not recommended.
• In patients taking PDE-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil
• drugs used for impotence), as symptomatic hypotension may occur.
• Prolonged, painful erections can occur very rarely. In such a case, you should immediately consult a doctor.
• Before starting treatment with Zoxon, 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 or previously 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.
You should consult your doctor, even if the above warnings refer to situations that have occurred in the past.

Children and adolescents

Zoxon is not recommended for use in children and adolescents under 18 years of age due to the lack of data on safety and efficacy in this age group.

Zoxon with other medicines

You should ask your doctor or pharmacist before taking Zoxon if you are taking any of the following medicines, as they may change the effect of Zoxon:

• 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 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, methoxamine, and phenylephrine on blood pressure, as well as vessels. Since there are no data on interactions with liver metabolism-affecting drugs (e.g., cimetidine), caution is advised 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, 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.
Zoxon 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 hypertension 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 rapid changes in 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.
You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Zoxon with food and drink

The tablet should be swallowed whole, without chewing, with a glass of water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The use of doxazosin has not been assessed 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 tasks such as driving vehicles and operating machines, or performing specific types of work that require balance, may be impaired, especially at the beginning of treatment, after dose increase, switching to another medicine, or when consuming alcohol.

Zoxon contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Zoxon

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask 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 of doxazosin once daily, then to 4 mg of doxazosin once daily, and finally to 8 mg of doxazosin once daily. The average dose in maintenance treatment is from 2 to 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
morning
1 mg of doxazosin
day 9-14
morning
2 mg of doxazosin
Then the dose should 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 tablet of Zoxon 1 mg (1 mg of doxazosin) once daily
day 9-14
2 tablets of Zoxon 1 mg (2 mg of doxazosin) once daily
Then the dose can be individually increased to the 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

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

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

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

In case of overdose, hypotension may occur.
If you have taken more Zoxon 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 as a treatment for overdose is not indicated.

Missed dose

If you forget to take a dose of Zoxon, 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 a forgotten dose.

4. Possible side effects

Like all medicines, Zoxon can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with doxazosin:

• Common side effects(may affect up to 1 in 10 people):
• respiratory tract infections, urinary tract infections,
• drowsiness, dizziness, headache,
• accommodation disorders of the eye,
• vertigo of labyrinthine origin,
• palpitations, rapid heart rate (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(may affect up to 1 in 100 people):

• allergic reactions,
• gout, increased appetite, anorexia, thirst,
• agitation, depression, anxiety, insomnia, nervousness, emotional instability,
• stroke, hypoaesthesia, fainting, tremor, apathy,
• lacrimation, photophobia,
• tinnitus,
• angina pectoris, myocardial infarction, fainting,
• peripheral ischemia,
• epistaxis, pharyngitis,
• constipation, flatulence, eructation, vomiting, gastritis, enteritis, diarrhea,
• abnormal liver function test results, increased liver enzyme activity,
• rash,
• arthralgia,
• urination disorders, frequent urination, nocturia, increased creatinine levels in urine and plasma,
• gynaecomastia,
• fatigue, malaise,
• decreased body temperature in elderly patients.

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

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

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

• leukopenia, thrombocytopenia, anaemia,
• hypersensitivity, muscle stiffness, taste disorders, nightmares, memory loss, orthostatic dizziness (dizziness after changing body position), paresthesia,
• blurred vision,
• bradycardia, arrhythmia,
• flushing,
• bronchospasm,
• cholestasis, hepatitis, jaundice,
• hirsutism, alopecia, purpura,
• muscle cramps, muscle weakness,
• increased diuresis, urination disorders, nocturia, increased creatinine levels in urine and plasma,
• gynaecomastia,
• fatigue, malaise,
• decreased body temperature in elderly patients.

Prolonged, painful erections. You should seek medical attention immediately.
Frequency not known(frequency cannot be estimated from the available data):

• intraoperative floppy iris syndrome,
• retrograde ejaculation.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw. Tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
You can also report side effects 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 Zoxon

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package in order to protect from light.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. These measures will help 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. One tablet contains 1 mg, 2 mg, or 4 mg of doxazosin.
• The other ingredients are: microcrystalline cellulose, lactose anhydrous, sodium carboxymethylcellulose, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate.

What Zoxon looks like and contents of the pack

Zoxon 1: almost white tablets with the inscription "ZX" and "1" on one side.
Zoxon 2: almost white, elongated tablets with a size of about 9 mm x 4.5 mm, with a dividing line and the inscription "ZX" and "2" on one side.
Zoxon 4: almost white, elongated tablets with a size of about 12 mm x 6 mm, with a dividing line and the inscription "ZX" and "4" on one side.
Tablets are packaged in Al/PVC/PVDC foil blisters in a cardboard box.
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 authorization holder and manufacturer:

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.

For further information, please contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92 00

Date of last revision of the leaflet: