CARDURA 4 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. CARDURA XL, 4 mg, prolonged-release tablets
3. CARDURA XL, 8 mg, prolonged-release tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
4. What is CARDURA XL and what is it used for
5. Important information before taking CARDURA XL
   1. When not to take CARDURA XL
   2. Warnings and precautions
   3. Before starting treatment with CARDURA XL, your doctor may perform tests to rule out other diseases, including prostate cancer, which can cause symptoms similar to those of benign prostatic hyperplasia.
   4. Children and adolescents
   5. CARDURA XL and other medicines
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. CARDURA XL contains sodium
6. How to take CARDURA XL
   1. Taking CARDURA XL with food and drink
   2. Taking CARDURA XL in children and adolescents
   3. Patients with renal impairment
   4. Patients with hepatic impairment
   5. Elderly patients
   6. Overdose of CARDURA XL
   7. Missed dose of CARDURA XL
7. Possible side effects
   1. Reporting side effects
8. How to store CARDURA XL
9. Contents of the pack and other information
   1. What CARDURA XL contains
   2. What CARDURA XL looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Mylan Healthcare Sp. z o.o.

Package Leaflet: Information for the User

CARDURA XL, 4 mg, prolonged-release tablets

CARDURA XL, 8 mg, prolonged-release tablets

(Doxazosin)

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

• Keep this package 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 experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is CARDURA XL and what is it used for

Doxazosin, the active substance of CARDURA XL, 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 XL is also an antagonist of alpha-adrenergic receptors in the prostate and neck (urethral portion) of the bladder. It reduces symptoms associated with difficulty in urinating and improves urodynamic test results (related to urine flow).
CARDURA XL is indicated for the treatment of:

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

2. Important information before taking CARDURA XL

When not to take CARDURA XL

if you are allergic to the active substance or to quinazolines (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 concomitant upper urinary tract obstruction, chronic urinary tract infections, or bladder stones,
in patients with a history of gastrointestinal obstruction, oesophageal obstruction, or narrowing of the gastrointestinal tract to any degree,
in patients with hypotension.
CARDURA XL is contraindicated in monotherapy in patients with overflow incontinence, anuria without progressive renal failure or with it.

Warnings and precautions

Before starting treatment with CARDURA XL, discuss it with your doctor or pharmacist.
At the beginning of treatment, orthostatic hypotension may occur, manifested by dizziness, weakness, and rarely syncope. Your 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 failure caused by pulmonary embolism or pericardial effusion, left ventricular failure with low filling pressure), rapid and significant lowering of blood pressure may cause worsening of 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 erectile dysfunction), as symptomatic hypotension may occur.
Prolonged, painful erections can occur very rarely. In such cases, you should immediately contact your doctor.

Before starting treatment with CARDURA XL, your doctor may perform tests to rule out other diseases, including prostate cancer, which can cause symptoms similar to those of benign prostatic hyperplasia.

During cataract surgery
During cataract surgery in some patients taking tamsulosin, "intraoperative floppy iris syndrome" (a variant of small pupil syndrome) has been observed. Before the procedure, inform your ophthalmologist about the use of alpha-adrenergic blockers.

Children and adolescents

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

CARDURA XL and other medicines

Ask your doctor or pharmacist before taking CARDURA XL if you are taking any of the following medicines, as they may affect the action of CARDURA XL:

• 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 diseases).

Doxazosin is bound to plasma proteins by 98%. In vitro studies have not shown any effect of doxazosin on the binding of digoxin, warfarin, phenytoin, or indomethacin to plasma proteins.
During the administration of standard doxazosin in clinical trials, 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.
CARDURA XL 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 lightheadedness, which may be caused by a sudden drop in blood pressure when changing body position while sitting or standing. Some patients have experienced these symptoms when taking alpha-adrenergic blockers with erectile dysfunction medications (impotence). To minimize the risk of these symptoms, it is recommended to take daily doses of alpha-adrenergic blockers regularly before starting erectile dysfunction medications.
Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
The use of CARDURA XL 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 the active substance, the ability to perform activities 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.

CARDURA XL contains sodium

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

3. How to take CARDURA XL

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Swallow the tablets whole, do not chew, divide, or crush them. The active substance in CARDURA XL tablets is inside an inert, non-absorbable coating that allows controlled, slow release of the medicine from the tablet. After passing through the gastrointestinal tract, the empty tablet shell is excreted. The presence of tablet residues in the stool should not be a cause for concern.
Essential hypertension
For most patients, blood pressure normalization occurs during treatment with a dose of 4 mg once daily. Optimal effect may occur within 4 weeks. Then, if necessary and depending on the patient's response, the doctor may increase the dose to 8 mg of doxazosin per day. The maximum recommended dose is 8 mg of doxazosin per day.
Benign prostatic hyperplasia (BPH)
Treatment should be started with a dose of 4 mg once daily. Depending on the patient's response, the doctor may increase the dose to 8 mg of doxazosin once daily. The maximum recommended dose is 8 mg of doxazosin once daily.
CARDURA XL can be taken by patients with benign prostatic hyperplasia, regardless of whether they have hypertension or not. Changes in blood pressure values in patients with normal blood pressure and benign prostatic hyperplasia are usually very small. The use of CARDURA XL in monotherapy (as the only medicine) is effective in the treatment of patients with benign prostatic hyperplasia and hypertension.

Taking CARDURA XL with food and drink

CARDURA XL can be taken with or without food.

Taking CARDURA XL in children and adolescents

The use of CARDURA XL is not recommended 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. In patients with known liver failure, doxazosin administration is not recommended (see section 2).

Elderly patients

No dose adjustment is necessary in elderly patients.

Overdose of CARDURA XL

In case of overdose, hypotension may occur.
If you have taken more CARDURA XL than prescribed, contact your doctor.
Depending on the symptoms, the doctor will provide appropriate treatment. Since doxazosin is bound to plasma proteins by 98%, dialysis as a treatment for overdose is not indicated.

Missed dose of CARDURA XL

If you forget to take a dose, 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 the missed dose.

4. Possible side effects

Like all medicines, CARDURA XL can cause side effects, although not everybody gets them.
Common side effects(which may affect up to 1 in 10 people)
Respiratory tract infections, urinary tract infections, dizziness, headache, somnolence, vertigo, palpitations, tachycardia, hypotension, orthostatic hypotension, bronchitis, cough, dyspnea, rhinitis, abdominal pain, nausea, dry mouth, pruritus, back pain, muscle pain, cystitis, urinary incontinence, weakness, chest pain, flu-like symptoms, peripheral edema.
Uncommon side effects(which may affect up to 1 in 100 people)
Allergic reactions, anorexia, gout, increased appetite, anxiety, depression, insomnia, stroke, paresthesia, syncope, tremor, tinnitus, angina pectoris, myocardial infarction, epistaxis, constipation, diarrhea, flatulence, vomiting, gastritis, abnormal liver function tests, skin rash, arthralgia, dysuria, hematuria, urinary frequency disorders, impotence, pain, facial edema, weight gain.
Rare side effects(which may affect up to 1 in 1,000 people)
Gastrointestinal obstruction.
Very rare side effects(which may affect less than 1 in 1,000 people)
Leukopenia, thrombocytopenia, agitation, nervousness, orthostatic dizziness, paresthesia, blurred vision, bradycardia, arrhythmias, flushing, bronchospasm, cholestasis, hepatitis, jaundice, alopecia, purpura, urticaria, muscle spasms, muscle weakness, urinary disorders, nocturia, polyuria, increased diuresis, gynecomastia, fatigue, malaise.
Prolonged, painful erections. Seek medical attention immediately.
Frequency not known(cannot be estimated from the available data)
Intraoperative floppy iris syndrome, retrograde ejaculation.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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. Side effects can also be reported to the marketing authorization holder or its representative.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CARDURA XL

Keep this medicine out of the sight and reach of children.
Store in a temperature below 30°C, protect from moisture.
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.

6. Contents of the pack and other information

What CARDURA XL contains

The active substance is doxazosin in the form of doxazosin mesylate.
The other ingredients are:
active layer:polyethylene oxide, hypromellose, red iron oxide (E 172), magnesium stearate;
osmotic layer:polyethylene oxide, sodium chloride, hypromellose, red iron oxide (E 172), magnesium stearate;
membrane coating:cellulose acetate, macrogol 3350;
outer coating:Opadry White YS-2-7063 (hypromellose, macrogol 3350, titanium dioxide);
printing ink:Black Ink S-1-17823 (pharmaceutical glaze, black iron oxide (E 172)).

What CARDURA XL looks like and contents of the pack

Prolonged-release tablets.
CARDURA XL, 4 mg: round, biconvex, white film-coated tablets with a hole and engraved "CXL 4" on one side.
CARDURA XL, 8 mg: round, biconvex, white film-coated tablets with a hole and engraved "CXL 8" on one side.
The pack contains 30 or 100 tablets in Al/PVC/PVDC or Al/Al blisters in a cardboard box.

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, Betriebsstätte Freiburg Mooswaldallee 1, 79090 Freiburg, Germany
For further information, please contact the marketing authorization holder's representative:

Mylan Healthcare Sp. z o.o.

tel. 22 546 64 00
Date of last revision of the package leaflet:09/2023