Package leaflet: Information for the user

DOZOX
4 mg, tablets
Doxazosinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What DOZOX is and what it is used for
Important information before taking DOZOX
How to take DOZOX
Possible side effects
How to store DOZOX
Contents of the pack and other information

1. What DOZOX is and what it is used for
DOZOX belongs to a group of medicines called alpha-adrenergic blockers. It works by dilating blood vessels, thereby reducing peripheral resistance, which leads to a reduction in arterial blood pressure.
DOZOX is also an antagonist of alpha-adrenergic receptors located in the prostate gland and urinary bladder. It reduces symptoms related to impaired urine flow and improves urodynamic test results (concerning urine flow).
DOZOX is used in the treatment of:

high blood pressure (essential hypertension)
clinical symptoms of benign prostatic hyperplasia (BPH)

2. Important information before taking DOZOX

When DOZOX must not be used

if the patient is allergic to doxazosin 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 accompanied by upper urinary tract congestion, chronic urinary tract infections, or urinary stones
in patients with arterial hypotension DOZOX is contraindicated as monotherapy in patients with bladder overdistension, anuria without progressive renal failure, or with progressive renal failure.

Warnings and precautions
Before starting treatment with DOZOX, discuss the following with your doctor or pharmacist:

at the beginning of treatment, orthostatic hypotension may occur, manifesting as dizziness, weakness, and rarely fainting. Your doctor may recommend monitoring of blood pressure at the start of therapy.
in patients with severe heart disease (pulmonary edema caused by aortic stenosis or mitral valve sten nosis, heart failure with high cardiac output, right ventricular failure due to pulmonary embolism or pericardial effusion, left ventricular failure with low filling pressure), rapid and significant reduction in blood pressure may worsen symptoms of cardiac insufficiency
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 for erectile dysfunction), symptomatic arterial hypotension may occur
prolonged and sometimes painful erections – very rare. In such a case, immediate medical help should be sought.
before starting treatment with DOZOX, your doctor may perform tests to rule out other diseases, including prostate cancer, which may cause 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, an "intraoperative floppy iris syndrome" (a variant of small pupil syndrome) has been observed. Inform your ophthalmologist about taking alpha-adrenergic blocking agents before the procedure. Consult your doctor, even if the above warnings concern conditions from the past.
Children and adolescents
The use of doxazosin is not recommended in children and adolescents under 18 years of age, as the safety and efficacy in this age group have not been established.
DOZOX and other medicines
Please consult your doctor or pharmacist before taking DOZOX if you are taking any of the following medicines, as they may alter the effect of DOZOX:

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

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

non-steroidal anti-inflammatory drugs (NSAIDs)
estrogens
sympathomimetics

Doxazosin may reduce the effect of dopamine, ephedrine, epinephrine, metaraminol, methoxamine, and phenylephrine on blood pressure and blood vessels. Due to lack of data on interactions with drugs affecting hepatic metabolism (e.g., cimetidine), particular caution is advised when these drugs must be administered together with doxazosin.
In vitro studies have not shown that doxazosin affects the protein binding of digoxin, warfarin, phenytoin, or indomethacin.
In clinical studies, no interactions were observed between doxazosin and thiazide diuretics, furosemide, beta-adrenergic blockers, non-steroidal anti-inflammatory drugs, antibiotics, oral hypoglycemic agents (used in diabetes), uricosuric agents, or anticoagulants.
Doxazosin may increase plasma renin activity and urinary excretion of vanillylmandelic acid. This should be considered when interpreting laboratory test results.
Doxazosin enhances the blood pressure-lowering effect of other alpha-adrenergic blockers and other antihypertensive agents.
Clinical studies have shown that doxazosin favorably affects lipids, significantly reducing total triglyceride, total cholesterol, and LDL cholesterol levels in plasma. Treatment with doxazosin beneficially affects hypertension and lipid levels, thereby reducing the risk of coronary artery disease.
Some patients taking alpha-adrenergic blockers 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 have experienced these symptoms while taking alpha-adrenergic blockers together with medicines for erectile dysfunction (impotence). To reduce the possibility of these symptoms, it is recommended to take alpha-adrenergic blockers regularly every day before starting treatment with erectile dysfunction medicines.
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of doxazosin in pregnant women has not been evaluated.
Breastfeeding
Doxazosin passes into human milk in small amounts. Breastfeeding women should not take this medicine unless otherwise decided by a doctor.
Driving and operating machinery
Due to individual responses to doxazosin, the ability to perform such activities as driving vehicles or operating machinery, or performing certain types of work requiring balance, may be impaired, especially at the beginning of treatment, after dose increase, switching to another medicine, or when consuming alcohol.
DOZOX contains lactose and sodium
If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to use DOZOX

This medicine should always be used as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
Recommended dose
Essential hypertension
The initial dose is 1 mg once daily. Depending on efficacy, after 1 to 2 weeks the physician may
increase the dose to 2 mg of doxazosin once daily, then to 4 mg once daily, and finally up to 8 mg
of doxazosin once daily. The average maintenance dose ranges from 2 mg to 4 mg of doxazosin
once daily. The maximum recommended daily dose is 16 mg.
The following dosing schedule is recommended when starting treatment:
Day 1–8: 1 mg doxazosin in the morning
Day 9–14: 2 mg doxazosin in the morning
Thereafter, the dose may be increased individually to an effective maintenance dose.
Benign prostatic hyperplasia (BPH)
The initial dose is 1 mg once daily. If necessary, after 1 to 2 weeks the physician may increase
the dose to 2 mg of doxazosin once daily, and subsequently to 4 mg of doxazosin once daily.
The maximum recommended dose is 8 mg of doxazosin once daily.
The following dosing schedule is recommended when starting treatment:
Day 1–8: 1 mg doxazosin once daily
Day 9–14: 2 mg doxazosin once daily
Thereafter, the dose may be individually increased to an effective maintenance dose.
When using DOZOX 4 mg tablets, it is not possible to achieve a dose of 1 mg of doxazosin.
Therefore, in cases where a 1 mg dose is required, alternative products containing the appropriate
dose of doxazosin should be used.
Use in children and adolescents
The use of doxazosin 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 impaired renal function. However, the dose
should be 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 insufficiency.
Elderly patients
There is no need to adjust the dose in elderly patients. However, the dose should be as low as
possible, and any dose increase should be performed under strict medical supervision.
Use of a higher than recommended dose of DOZOX
Hypotension may occur after overdose. If a dose higher than recommended is taken, contact your
doctor immediately.
Depending on the symptoms present, the doctor will initiate appropriate treatment. Since doxazosin
is 98% protein-bound, dialysis is not indicated as a treatment method for overdose.
Missed dose of DOZOX
If a patient forgets to take a dose, they should take it as soon as possible, unless it is almost time
for the next dose. In that case, the next tablet should be taken the following day at the usual time.
Do not take a double dose to make up for a missed tablet.
Discontinuation of DOZOX
Abrupt discontinuation of DOZOX treatment may lead to recurrence of symptoms present before
treatment initiation. Therefore, treatment should not be stopped suddenly. The dose should be
gradually reduced under physician supervision. In case of any doubts, always consult your doctor
or pharmacist.
If you have any further questions regarding the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Common adverse reactions (may occur in 1 to 10 out of 100 patients)

respiratory tract infections, bronchitis, dyspnea
urinary tract infections, cystitis, urinary incontinence (involuntary urination), feeling of increased need to urinate, frequent urination
headache, dizziness
somnolence, fatigue
sensation of dizziness or spinning (vestibular vertigo)
palpitations, tachycardia
low blood pressure, orthostatic hypotension
cough, rhinitis
abdominal pain, dyspepsia, dry mouth, nausea
pruritus
back pain, muscle pain
influenza-like symptoms
chest pain
edema, generalized edema, peripheral edema
accommodation disorders

Uncommon adverse reactions (may occur in 1 to 10 out of 1000 patients)

allergic reactions
blood in urine, pain during urination, disturbances in urination frequency
joint inflammation (gout), joint pain
agitation, depression, anxiety, insomnia, restlessness, emotional lability, apathy
decreased sensitivity to touch, fainting, tremor
increased appetite, weight gain, anorexia, thirst
nosebleeds
skin rash
constipation, flatulence, gastritis, diarrhea, vomiting
tinnitus
angina pectoris, myocardial infarction
abnormal liver function test results, increased liver enzyme activity
facial edema
inability to achieve erection
stroke
lacrimation, photophobia
peripheral ischemia
pharyngitis
pain, fever, chills
sudden facial flushing, pallor
low serum potassium concentration

Rare adverse reactions (may occur in 1 to 10 out of 10,000 patients)

cerebrovascular disorders
laryngeal edema
increased volume of urine output
low serum glucose concentration

Very rare adverse reactions (may occur in less than 1 out of 10,000 patients)

dizziness upon standing from sitting or lying position
low white blood cell count, low platelet count, anemia
blurred vision
bradycardia, irregular heartbeat
wheezing (bronchospasm)
hepatitis, disorders related to bile flow, jaundice
hot flushes
urticaria, alopecia, subcutaneous bleeding, hypersensitivity
disturbances in urination, need to urinate at night, increased volume of urine output
increased creatinine concentration in urine and serum
gynecomastia (breast enlargement in males)
prolonged, painful erection. Immediate medical advice should be sought.
malaise, feeling of fatigue
muscle stiffness, sensation of tingling and numbness in limbs, muscle weakness, muscle cramps
taste disturbances
nightmares, memory loss
decreased body temperature in elderly patients

Frequency not known (frequency cannot be estimated from available data)

low volume or absence of semen during ejaculation, cloudy urine after orgasm (retrograde ejaculation)
during cataract removal surgery (lens opacification), eye disorders (floppy iris syndrome) may occur. See section "Warnings and precautions".

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

5. How to store DOZOX

Keep this medicine out of sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the packaging after: ,,EXP".
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use. This will help
protect the environment.

6. Contents of the packaging and other information

What Dozox contains

The active substance is doxazosin. One tablet of Dozox contains 4.85 mg of doxazosin mesylate, equivalent to 4 mg of doxazosin.
Other ingredients: microcrystalline cellulose, lactose, sodium carboxymethyl starch (type A), magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica.

What Dozox looks like and contents of the pack
Dozox is a prolonged-release, white, oblong tablet, with a score line and engraved markings
“D” and “4” on one side. The tablet can be divided into equal doses.
The tablets are packed in PVC/PVDC/Aluminium blisters.
Pack sizes: 20, 30 or 90 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Manufacturer
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13
4042 Debrecen
Hungary

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel: +48 12 262 32 36
e-mail: [email protected]