Cardura

Package Leaflet: Information for the User

CARDURA, 1 mg, tablets

CARDURA, 2 mg, tablets

CARDURA, 4 mg, tablets

(Doxazosin)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is CARDURA and what is it used for

CARDURA belongs to a group of medicines called alpha-adrenergic blockers. It works by relaxing blood vessels, reducing peripheral resistance, which leads to a decrease in blood pressure.
CARDURA is also an antagonist of alpha-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).
CARDURA is indicated for the treatment of:

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

2. Important information before taking CARDURA

When not to take CARDURA

• 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.

CARDURA is contraindicated in monotherapy in patients with urinary retention, anuria without progressive renal failure, or with it.

Warnings and precautions

Before starting treatment with CARDURA, the patient should discuss it with their 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 lowering of blood pressure may worsen angina symptoms.
• In patients with known 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 cases, the patient should immediately contact their doctor.
• Before starting treatment with CARDURA, the 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 having taken tamsulosin, "intraoperative floppy iris syndrome" (a variant of small pupil syndrome) has been observed. The patient should inform the ophthalmologist about the use of alpha-adrenergic blockers.
The patient should consult their doctor, even if the above warnings refer to situations that have occurred in the past.

Children and adolescents

CARDURA is not recommended for use in children and adolescents under 18 years of age, as its safety and efficacy in this age group have not been established.

CARDURA and other medicines

The patient should ask their doctor or pharmacist before taking CARDURA if they are taking any of the following medicines, as they may affect the action of CARDURA:

• 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 protease inhibitors, 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 drugs affecting liver metabolism (e.g., cimetidine), caution is advised 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 trials, no interactions have been found between CARDURA and thiazide diuretics, furosemide, beta-adrenergic blockers, NSAIDs, antibiotics, oral hypoglycemic agents (used in diabetes), uricosuric agents, and anticoagulants.
Doxazosin may increase plasma renin activity and urinary vanillylmandelic acid excretion. This should be taken into account when interpreting laboratory test results.
CARDURA enhances the blood pressure-lowering effect of other alpha-adrenergic blockers and other antihypertensive agents.
Clinical trials have shown that doxazosin has a beneficial effect on lipids, significantly reducing total triglyceride, total cholesterol, and LDL fraction levels in plasma. Doxazosin treatment 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 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 when changing 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.
The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The use of CARDURA 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 using machines

Due to individual reactions to doxazosin, the ability to perform activities such as driving or 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.

CARDURA contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

CARDURA contains sodium

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

3. How to take CARDURA

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Essential hypertension
The initial dose is 1 mg once daily. Depending on efficacy, the doctor may increase the dose to 2 mg of doxazosin once daily after 1-2 weeks, then to 4 mg of doxazosin once daily, and finally to 8 mg of doxazosin once daily. The average maintenance dose is between 2 and 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, the doctor may increase the dose to 2 mg of doxazosin once daily after 1-2 weeks, 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 CARDURA 1 mg (1 mg of doxazosin) once daily
day 9-14
2 tablets of CARDURA 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

CARDURA 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 is advised. There is no 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 of CARDURA

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

Missed dose of CARDURA

If the patient forgets to take CARDURA, they should take it as soon as possible, unless it is almost time for the next dose. In this case, the patient should take the next dose at the scheduled time. The patient should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, CARDURA can cause side effects, although not everybody gets them.
Common side effects(which may occur in more than 1 in 100 patients)
Respiratory tract infections, urinary tract infections, somnolence, 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, pollakiuria, weakness, flu-like symptoms, generalized edema, peripheral edema.
Uncommon side effects(which may occur in more than 1 in 1000 patients)
Allergic reactions, anorexia, gout, increased appetite, anxiety, insomnia, nervousness, agitation, depression, emotional lability, cerebrovascular accident, paresthesia, syncope, tremor, apathy, lacrimation, photophobia, tinnitus, myocardial infarction, syncope, angina pectoris, peripheral ischemia, pharyngitis, epistaxis, constipation, flatulence, vomiting, gastritis, diarrhea, abnormal liver function tests, increased liver enzyme activity, rash, arthralgia, dysuria, urinary frequency disorders, hematuria, impotence, pain, fever, chills, facial edema, hot flushes, 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, cardiac 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. The patient should seek medical attention immediately.
Frequency not known(cannot be estimated from the available data)
Intraoperative floppy iris syndrome, retrograde ejaculation.

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Urzędowy Rejestr Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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 or its representative.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store CARDURA

The medicine should be stored out of sight and reach of children.
Do not store above 30°C. Store in a dry place.
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 month stated.

6. Contents of the pack and other information

What CARDURA contains

The active substance of the medicine is doxazosin in the form of doxazosin mesylate.
The other ingredients are: microcrystalline cellulose, lactose, sodium carboxymethylcellulose, magnesium stearate, sodium lauryl sulfate.

What CARDURA looks like and contents of the pack

CARDURA, 1 mg: white, round, biconvex tablets with "CN 1" embossed on one side and "VLE" on the other side of the tablet.
CARDURA, 2 mg: white, oblong, biconvex tablets with a score line and "CN 2" embossed on one side and "VLE" on the other side of the tablet.
CARDURA, 4 mg: white, biconvex tablets with a diamond shape and a score line, and "CN 4" embossed on one side and "VLE" on the other side of the tablet.
The pack contains 30 tablets in Al/PVC/PVDC blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder
Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands
Manufacturer
Pfizer Manufacturing Deutschland GmbH, Mooswaldallee 1, 79090 Freiburg, Germany
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

tel. 22 546 64 00
Date of last revision of the leaflet:11/2024