Dozox

Package Leaflet: Information for the User

DOZOX

4 mg, tablets

Doxazosin

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, 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 signs of illness 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 DOZOX and what is it used for

• 2. Before you take DOZOX
• 3. How to take DOZOX
• 4. Possible side effects
• 5. How to store DOZOX
• 6. Contents of the pack and other information

1. What is DOZOX and what is it used for

DOZOX belongs to a group of medicines called alpha-blockers. These medicines relax the blood vessels, which lowers blood pressure and makes it easier for the heart to pump blood around the body.
DOZOX is also an alpha-adrenergic blocking agent that acts on the prostate and bladder neck muscles. It helps to improve urine flow and reduces the symptoms of benign prostatic hyperplasia (enlargement of the prostate gland).
DOZOX is used to treat:

• high blood pressure (essential hypertension)
• symptoms of an enlarged prostate gland (benign prostatic hyperplasia)

2. Before you take DOZOX

When not to take DOZOX

• if you are allergic to doxazosin, quinazolines (such as prazosin, terazosin), or any of the other ingredients of this medicine (listed in section 6)
• if you have orthostatic hypotension (a fall in blood pressure that occurs when you stand up from sitting or lying down)
• if you have an enlarged prostate gland with symptoms of urinary obstruction, persistent infection of the urinary tract, or kidney stones
• if you have urinary incontinence due to overfilling of the bladder (no sensation of urge to urinate) or anuria (no urine production) with or without kidney problems
• if you have low blood pressure
• if you are breast-feeding

Warnings and precautions

Before taking DOZOX, tell your doctor or pharmacist if:

• at the start of treatment, you may experience orthostatic hypotension, which can cause dizziness, weakness, and rarely fainting. Your doctor may monitor your blood pressure at the start of therapy.
• if you have severe heart disease (pulmonary edema caused by aortic stenosis or mitral stenosis, heart failure with high cardiac output, right ventricular failure caused by pulmonary embolism or pericardial effusion, left ventricular failure with low filling pressure), a rapid and significant decrease in blood pressure can worsen symptoms of angina pectoris
• if you have liver dysfunction, doxazosin is not recommended
• if you are taking PDE-5 inhibitors (such as sildenafil, tadalafil, vardenafil) for erectile dysfunction, as this can cause symptomatic hypotension
• rarely, prolonged and painful erections have been reported. If an erection lasts for more than 4 hours, seek medical help immediately.
• before starting treatment with DOZOX, your doctor may perform tests to rule out other conditions, including prostate cancer, which can cause symptoms similar to those of benign prostatic hyperplasia

Taking DOZOX during cataract surgery
If you are undergoing cataract surgery, tell your doctor about your current or past use of DOZOX. DOZOX may cause complications during surgery, which your doctor can manage if they are prepared.

Children and adolescents

DOZOX should not be used in children and adolescents under 18 years of age, as the safety and efficacy of doxazosin in this age group have not been established.

DOZOX and other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, as they may interact with DOZOX:

• PDE-5 inhibitors (such as sildenafil, tadalafil, vardenafil) for erectile dysfunction (see section "Warnings and precautions")
• other medicines that lower blood pressure
• antibiotics or antifungals (such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole)
• HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir, saquinavir)
• nefazodone (an antidepressant)
• vasodilators or nitrates (used to treat heart conditions)

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. As there are no data on interactions with drugs that affect liver metabolism (such as cimetidine), caution should be exercised when administering these drugs with doxazosin.
In vitro studies have shown that doxazosin does not affect the binding of digoxin, warfarin, phenytoin, or indomethacin to plasma proteins.
In clinical studies, no interactions have been observed between doxazosin and thiazide diuretics, furosemide, beta-blockers, NSAIDs, antibiotics, oral hypoglycemic agents (used in diabetes), uricosuric agents, or anticoagulants.
Doxazosin may increase plasma renin activity and urinary vanillylmandelic acid excretion. This should be taken into account when interpreting laboratory results.
Doxazosin enhances the blood pressure-lowering effect of other alpha-blockers and other antihypertensive agents.
Clinical studies have shown that doxazosin has a beneficial effect on lipids, significantly reducing total triglycerides, total cholesterol, and LDL fraction 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-blockers for hypertension or enlarged prostate gland may experience dizziness or a feeling of emptiness in the head, which can be caused by low blood pressure. Some patients may experience these symptoms when taking erectile dysfunction medications with alpha-blockers. To minimize the likelihood of these symptoms, the patient should take their usual daily dose of alpha-blocker before taking an erectile dysfunction medication.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The use of doxazosin has not been studied in pregnant women.
Breast-feeding
Doxazosin passes into human milk in small amounts. Breast-feeding women should not take this medicine unless their doctor decides it is necessary.

Driving and using machines

Due to individual reactions to doxazosin, the ability to perform tasks that require attention, such as driving vehicles or operating machinery, may be impaired, especially at the start of treatment, after a dose increase, or when switching to another medicine or consuming alcohol.

DOZOX 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.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take DOZOX

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose

Hypertension

The initial dose is 1 mg once daily. Depending on the response, your doctor may increase the dose to 2 mg of doxazosin once daily after 1 to 2 weeks. This dose is also maintained for 1 to 2 weeks. If necessary, the dose may be further increased to 4 mg or 8 mg once daily until the desired blood pressure reduction is achieved.
The maximum recommended daily dose is 16 mg.
To start treatment, the following dosing schedule is recommended:
day 1-8:
morning
1 mg doxazosin
day 9-14, morning
2 mg doxazosin
Then, the dose can be increased to the effective maintenance dose.

Benign prostatic hyperplasia

The initial dose is 1 mg once daily. If necessary, after 1 to 2 weeks, your doctor may increase the dose to 2 mg of doxazosin once daily. If after 1 to 2 weeks, a satisfactory effect has not been achieved, the dose may be increased to 4 mg once daily.
In some cases, the dose may be increased to a maximum of 8 mg once daily.
To start treatment, the following dosing schedule is recommended:
day 1-8:
1 mg doxazosin once daily
day 9-14, 2 mg doxazosin once daily
Then, the dose can be individually increased to the effective maintenance dose.
When using DOZOX, 4 mg, tablets, it is not possible to achieve a dose of 1 mg doxazosin. Therefore, if a dose of 1 mg is required, another medicine with the appropriate dose of doxazosin should be used.

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 no clinical experience with the use of this 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.

Use in children and adolescents

The safety and efficacy of doxazosin in children have not been established.

Overdose

If you take more than the prescribed dose, you may experience hypotension. If you have taken more than the prescribed dose, contact your doctor immediately.
Depending on the symptoms, your doctor will provide the necessary treatment. Since doxazosin is highly bound to plasma proteins, dialysis is not likely to be effective in treating overdose.

Missed dose

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In this case, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

Stopping treatment

If you stop taking DOZOX suddenly, your condition may worsen. Therefore, do not stop taking this medicine without consulting your doctor. The dose should be gradually reduced by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects(may affect up to 1 in 10 people)

• respiratory tract infections, bronchitis, dyspnea
• urinary tract infections, cystitis, urinary incontinence (involuntary urination), increased need to urinate, frequent urination
• headache, dizziness
• fatigue, weakness
• feeling of dizziness or spinning (vertigo)
• palpitations, rapid heart rate
• low blood pressure, orthostatic hypotension
• cough, rhinitis
• abdominal pain, nausea, dry mouth, vomiting
• pruritus
• back pain, muscle pain
• flu-like symptoms
• chest pain
• edema, generalized edema, peripheral edema
• accommodation disorders

Uncommon side effects(may affect up to 1 in 100 people)

• allergic reactions
• hematuria, dysuria, urinary frequency disorders
• arthritis (gout), arthralgia
• agitation, depression, anxiety, insomnia, nervousness, emotional lability, apathy
• decreased sensitivity to touch, syncope, tremor
• increased appetite, weight gain, anorexia, thirst
• epistaxis
• skin rash
• constipation, flatulence, gastrointestinal inflammation, diarrhea, vomiting
• tinnitus
• angina pectoris, myocardial infarction
• abnormal liver function tests, increased liver enzyme activity
• facial edema
• erectile dysfunction
• stroke
• lacrimation, photophobia
• peripheral vascular insufficiency
• pharyngitis
• pain, fever, chills
• flushing
• pallor
• hypokalemia

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

• cerebrovascular disorders
• laryngeal edema
• polyuria
• hypoglycemia

Very rare side effects(may affect less than 1 in 1,000 people)

• orthostatic dizziness when standing up from a sitting or lying position
• leukopenia, thrombocytopenia, anemia
• blurred vision
• bradycardia, irregular heart rhythm
• wheezing (bronchospasm)
• hepatitis, bile duct obstruction, jaundice
• hot flashes
• urticaria, alopecia, erythema multiforme, hypersensitivity
• urinary disorders, nocturia, increased urine volume
• increased creatinine levels in urine and plasma
• gynecomastia
• prolonged and painful erections. Seek medical help immediately.
• malaise, fatigue
• muscle stiffness, paresthesia, muscle weakness, muscle cramps
• dysgeusia
• nightmares, amnesia
• hypothermia in elderly patients

Unknown frequency(cannot be estimated from the available data)

• reduced or absent semen during ejaculation (retrograde ejaculation), cloudy urine after orgasm
• during cataract surgery (lens opacity), eye disorders (floppy iris syndrome) may occur. See section "Warnings and precautions".

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 Pharmacovigilance Department, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 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 DOZOX

Keep this medicine out of the sight and reach of children.
Store in a temperature below 30°C.
Do not use this medicine after the expiry date which is stated on the packaging 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 dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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.
• The other ingredients are: microcrystalline cellulose, lactose, sodium carboxymethylcellulose (type A), magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica.

What DOZOX looks like and contents of the pack

DOZOX is available as white, oval tablets with a score line and the marking "D" "4" on one side. The tablet can be divided into equal doses.
The tablets are packaged in PVC/PVDC/Aluminum blisters.
Package sizes: 20, 30, or 90 tablets in a cardboard box.
Not all package sizes may be marketed.

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Manufacturer

TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13
4042 Debrecen
Hungary
For more information on this medicine, contact the representative of the marketing authorization holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel: +48 12 262 32 36
e-mail: [email protected]
Date of last revision of the leaflet:May 2022