Cardura

Patient Information Leaflet

CARDURA, 1 mg, tablets
CARDURA, 2 mg, tablets
CARDURA, 4 mg, tablets
(Doxazosinum)
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• 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 effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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 blocking agents. It works by dilating blood vessels, reducing peripheral resistance, thereby lowering arterial blood pressure.
CARDURA is also an antagonist of alpha-adrenergic receptors located in the prostate gland and urinary bladder. It reduces symptoms related to urinary outflow obstruction and improves urodynamic test results (concerning urine flow).
CARDURA is indicated for the treatment of:

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

2. Important information before using CARDURA

When not to use 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 mild benign prostatic hyperplasia accompanied by congestion of the upper urinary tract, chronic urinary tract infections, or bladder stones,
• in patients with arterial hypotension.

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

• At the beginning of treatment, orthostatic hypotension may occur, manifesting as dizziness, feeling of weakness, and rarely fainting. Your doctor may recommend monitoring blood pressure at the start 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.
• Administration of doxazosin is not recommended in patients with known hepatic impairment.
• In patients concurrently taking PDE-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil – drugs used for erectile dysfunction), symptomatic arterial hypotension may occur.
• Prolonged, painful erections may very rarely occur. In such a case, contact your doctor immediately.
• Before starting treatment with CARDURA, 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, an "intraoperative floppy iris syndrome" (a variant of small pupil syndrome) has been observed. Inform your ophthalmologist that you are taking alpha-adrenergic blocking agents before the procedure.
Consult your doctor, even if the above warnings concern conditions that occurred in the past.
Children and adolescents
Use of CARDURA is not recommended in children and adolescents under 18 years of age, as safety and efficacy have not yet been established in this age group.
CARDURA with other medicines
Ask your doctor or pharmacist before taking CARDURA if you are using any of the following medicines, as they may alter the effect of CARDURA:

• medicines known as PDE-5 inhibitors, used to treat 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 to treat HIV, e.g., indinavir, nelfinavir, ritonavir, saquinavir;
• nefazodone, a medicine used to treat depression;
• vasodilators or nitrates (medicines used for heart conditions).

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 drugs affecting hepatic metabolism (e.g., cimetidine), particular caution is advised when administering these drugs together with doxazosin.
In vitro studies have not shown doxazosin to affect the plasma protein binding of digoxin, warfarin, phenytoin, or indomethacin.
In clinical trials, no interactions were observed between CARDURA and 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 considered when interpreting laboratory test results.
CARDURA 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 levels, total cholesterol, and LDL cholesterol fraction in plasma. Treatment with doxazosin favorably affects 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 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.
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 using 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 use this medicine unless otherwise directed by a doctor.
Driving and using machines
Due to individual responses to doxazosin, the ability to perform activities such as driving vehicles or 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.
CARDURA contains lactose
If a patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
CARDURA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use CARDURA

This medicine should always be taken exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Essential hypertension
The initial dose is 1 mg once daily. Depending on efficacy, after 1–2 weeks the physician 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 in long-term treatment is
2 to 4 mg of doxazosin once daily.
The maximum recommended dose is 16 mg of 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
Afterwards, 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 the physician 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 CARDURA 1 mg (1 mg doxazosin) once daily
Days 9–14: 2 tablets of CARDURA 1 mg (2 mg doxazosin) once daily
Afterwards, the dose may be individually increased to an 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
There is no need to adjust the dose in patients with impaired kidney 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 is required. Clinical experience with the use of this medicine in patients
with severe liver dysfunction is lacking.
Elderly patients
There is no need to adjust the dose 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 CARDURA
Hypotension may occur following overdose.
If a higher than recommended dose of CARDURA has been taken, contact your doctor immediately.
Depending on the symptoms present, the physician will initiate appropriate treatment. Since doxazosin
is 98% protein-bound, dialysis is not indicated as a treatment method for overdose.
Missed dose of CARDURA
If a patient forgets to take CARDURA, they should take it as soon as possible, unless it is almost
time for the next dose. In that case, the patient should take the next dose at the scheduled time.
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.

Common adverse reactions (may occur in more than 1 in 100 patients):
Respiratory tract infections, urinary tract infections, drowsiness, dizziness, headache, accommodation disorders, labyrinthine vertigo, palpitations, tachycardia, chest pain, hypotension, orthostatic hypotension, oedema, bronchitis, cough, dyspnoea, rhinitis, abdominal pain, dyspepsia, dry mouth, nausea, pruritus, back pain, muscle pain, cystitis, urinary incontinence, increased sense of urgency to urinate, frequency of urination, fatigue, influenza-like symptoms, generalized oedema, peripheral oedema.

Uncommon adverse reactions (may occur in more than 1 in 1,000 patients):
Allergic reactions, anorexia, gout, thirst, increased appetite, anxiety, insomnia, nervousness, restlessness, agitation, depression, emotional lability, stroke, hypotension, fainting, tremor, apathy, lacrimation, photophobia, tinnitus, myocardial infarction, fainting, angina pectoris, peripheral ischaemia, pharyngitis, epistaxis, constipation, bloating and flatulence, vomiting, gastritis and enteritis, diarrhoea, abnormal liver function test results, increased liver enzyme activity, rash, arthralgia, dysuria, urinary frequency disorders, haematuria, impotence, pain, fever, chills, facial oedema, hot flushes, pallor, hypokalaemia, weight gain.

Rarely reported adverse reactions (may occur in more than 1 in 10,000 patients):
Cerebrovascular disorders, laryngeal oedema, polyuria, hypoglycaemia.

Very rarely reported adverse reactions (may occur in fewer than 1 in 10,000 patients):
Leukopenia, thrombocytopenia, anaemia, hypersensitivity, muscle stiffness, taste disturbances, nightmares, memory loss, orthostatic dizziness, paraesthesia, blurred vision, bradycardia, cardiac arrhythmias, flushing, bronchospasm, hepatitis, cholestasis, jaundice, urticaria, alopecia, purpura, muscle cramps, muscle weakness, urinary disorders, increased creatinine concentration in urine and plasma, increased diuresis, nocturia, gynaecomastia, feeling of fatigue, malaise, decreased body temperature in elderly patients.

Prolonged, painful erection. Seek urgent medical advice.

Frequency not known (cannot be estimated from available data):
Intraoperative floppy iris syndrome, retrograde ejaculation.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +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 authorisation holder or its representative.

Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store CARDURA medicine

Keep this medicine 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 container following: EXP.
The expiry date refers to the last day of the stated month.

6. Contents of the pack and other information

What the medicine CARDURA contains
The active substance is doxazosin in the form of doxazosin methanesulfonate.
Other components are: microcrystalline cellulose, lactose, sodium carboxymethyl starch, magnesium stearate, sodium lauryl sulfate.

What the medicine CARDURA looks like and contents of the pack
CARDURA, 1 mg: white, round, biconvex tablets, embossed with "CN 1" on one side and "VLE" on the other side of the tablet.
CARDURA, 2 mg: white, oblong, biconvex tablets with a score line and embossed with "CN 2" on one side and "VLE" on the other side of the tablet.
CARDURA, 4 mg: white, biconvex, diamond-shaped tablets with a score line and embossed with "CN 4" on one side and "VLE" on the other side of the tablet.
Pack contains 30 tablets in Al/PVC/PVDC blisters.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
Manufacturer
Pfizer Manufacturing Deutschland GmbH, Mooswaldallee 1, 79108 Freiburg im Breisgau, Germany

For further information, please contact the representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00