DOXANORM 2 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Doxanorm, 1 mg, tablets
3. Doxanorm, 2 mg, tablets
4. Doxanorm, 4 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Contents of the Package Leaflet
5. What Doxanorm is and what it is used for
6. Important information before taking Doxanorm
   1. When not to take Doxanorm
   2. Warnings and precautions
   3. Before starting treatment with Doxanorm, 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. Doxanorm and other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Doxanorm contains lactose
   9. Doxanorm contains sodium
7. How to take Doxanorm
   1. Use in children and adolescents
   2. Overdose of Doxanorm
   3. Missed dose of Doxanorm
8. Possible side effects
   1. Reporting side effects
9. How to store Doxanorm
10. Contents of the pack and other information
    1. What Doxanorm contains
    2. What Doxanorm looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer
    5. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Doxanorm, 1 mg, tablets

Doxanorm, 2 mg, tablets

Doxanorm, 4 mg, tablets

Doxazosin

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

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

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

1. What Doxanorm is and what it is used for

Doxanorm 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.
Doxanorm is also an antagonist of alpha-adrenergic receptors in the prostate and bladder. It reduces symptoms associated with difficulty in urinating and improves urodynamic test results (related to urine flow).
Doxanorm is indicated for the treatment of:

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

2. Important information before taking Doxanorm

When not to take Doxanorm

• if you are allergic to doxazosin or quinazoline derivatives (such as prazosin, terazosin), or 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 breastfeeding women
• in patients with hypotension.

Doxanorm is contraindicated in monotherapy in patients with overflow incontinence, anuria without progressive renal failure or with it.

Warnings and precautions

Before starting treatment with Doxanorm, discuss it with your doctor or pharmacist.

• At the beginning of treatment, orthostatic hypotension may occur, manifested by dizziness, weakness, and rarely fainting. Your doctor may recommend blood pressure monitoring at the start of therapy.
• In patients with severe heart disease (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 pectoris symptoms.
• In patients with known liver dysfunction, doxazosin administration is not recommended.
• In patients taking PDE-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil) concurrently, symptomatic hypotension may occur.
• Prolonged and sometimes painful erections - occur very rarely. If an erection lasts more than 4 hours, seek medical attention immediately.

Before starting treatment with Doxanorm, your 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 Doxanorm currently or previously, "intraoperative floppy iris syndrome" (a variant of small pupil syndrome) has been observed. Tell your ophthalmologist about taking alpha-adrenergic blockers before the procedure.
Consult your doctor, even if the above warnings refer to situations that have occurred in the past.

Children and adolescents

Doxanorm 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.

Doxanorm and other medicines

Tell your doctor about all medicines you are taking, have recently taken, or plan to take.
The blood pressure-lowering effect of doxazosin may be enhanced by:

• other blood pressure-lowering medicines
• vasodilators or nitrates (medicines used for heart conditions)
• PDE-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil).

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 vessels. Since there are no data on interactions with liver metabolism-affecting drugs (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.
During clinical trials with doxazosin, no interactions were found with 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 considered when interpreting laboratory test results.
Doxazosin enhances the blood pressure-lowering effect of other alpha-adrenergic blockers and other antihypertensive drugs.
Clinical trials have shown that doxazosin has a beneficial effect on lipids, significantly reducing total triglyceride, total cholesterol, and LDL fraction levels in plasma. Doxanorm 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 due to rapid changes in body position when sitting or standing. Some patients have experienced these symptoms when taking alpha-adrenergic blockers with erectile dysfunction drugs (impotence). To minimize the risk of these symptoms, it is recommended to take daily doses of alpha-adrenergic blockers regularly before starting erectile dysfunction drugs.
Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Pregnancy, breastfeeding, and fertility

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 Doxanorm has not been evaluated in pregnant women.
Doxanorm is contraindicated during breastfeeding.
Your doctor will decide whether to stop breastfeeding or discontinue the medicine.

Driving and using machines

Due to individual reactions to doxazosin, the ability to perform tasks such as driving vehicles and operating machines, or performing specific types of work that require maintaining balance, may be impaired, especially at the beginning of treatment, after dose increase, switching to another medicine, or when consuming alcohol.

Doxanorm contains lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

Doxanorm 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 Doxanorm

Always take this medicine exactly as your doctor has told you.
If you are not sure, ask your doctor or pharmacist.
Essential hypertension
The initial dose is 1 mg once daily. Depending on efficacy, after 1-2 weeks, your doctor may increase the dose to 2 mg of doxazosin once daily, then to 4 mg of doxazosin once daily, and finally to 8 mg of doxazosin once daily. The average dose in maintenance therapy is from 2 to 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: 1 mg of doxazosin in the morning
day 9-14: 2 mg of doxazosin in the morning
Then, the dose can be increased to the effective maintenance dose.
Benign prostatic hyperplasia (BPH)
The initial dose is 1 mg once daily. If necessary, after 1-2 weeks, your doctor may increase the dose to 2 mg of doxazosin once daily, 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 mg of doxazosin once daily
day 9-14: 2 mg of doxazosin once daily
Then, the dose can be increased individually to the effective maintenance dose.
Oral administration.
Swallow the tablets whole with water. The duration of treatment is determined by your doctor.

Use in children and adolescents

Doxanorm is not recommended for use in children and adolescents under 18 years of age.
Elderly patients
No dose adjustment is necessary in elderly patients. However, the dose should be as low as possible, and any dose increase should be done under close medical supervision.
Patients with liver function disorders
Caution is advised. There is no clinical experience with the use of the medicine in patients with severe liver dysfunction.
Patients with kidney function disorders
No dose adjustment is necessary in patients with kidney function disorders. However, the dose should be as low as possible, and any dose increase should be done under close medical supervision.

Overdose of Doxanorm

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

Missed dose of Doxanorm

If you forget to take a dose of Doxanorm, take it as soon as possible, unless it is almost time for the 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Doxanorm can cause side effects, although not everybody gets them.
The following side effects may occur when taking this medicine:
Common side effects (may affect up to 1 in 10 people)

• respiratory tract infections, urinary tract infections
• drowsiness, dizziness, headache
• accommodation disorders
• vertigo of labyrinthine origin
• palpitations, tachycardia, chest pain
• hypotension, orthostatic decreases in blood pressure (occurring as a result of changing position from lying or sitting to standing), edema
• bronchitis, cough, dyspnea, rhinitis (nasal congestion)
• abdominal pain, nausea, dry mouth, vomiting
• pruritus
• back pain, muscle pain
• cystitis, urinary incontinence, increased need to urinate, frequent urination
• weakness, flu-like symptoms, generalized edema, peripheral edema.

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

• allergic reactions
• anorexia, gout, thirst, increased appetite
• anxiety, insomnia, nervousness, agitation, depression, emotional lability
• stroke, hypoaesthesia, syncope, tremor, apathy
• lacrimation, photophobia
• tinnitus
• myocardial infarction, syncope, angina pectoris
• peripheral ischemia
• pharyngitis, epistaxis
• constipation, flatulence, eructation, vomiting, gastroenteritis, diarrhea
• abnormal liver function tests, increased liver enzyme activity
• rash
• arthralgia
• dysuria (pain when urinating), urinary frequency disorders, hematuria
• impotence
• pain, fever, chills, facial edema, hot flushes, pallor
• hypokalemia (decreased potassium levels in the blood), weight gain.

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

• cerebrovascular disorders
• hypoglycemia (low blood sugar)
• polyuria
• angioedema.

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

• leukopenia and thrombocytopenia, anemia
• hypersensitivity, muscle stiffness, taste disorders, nightmares, memory loss, orthostatic dizziness (related to changing body position from lying or sitting to standing), paresthesia (tingling, numbness, prickling)
• blurred vision
• bradycardia, cardiac arrhythmias
• flushing
• bronchospasm
• hepatitis, cholestasis, jaundice
• urticaria, alopecia, purpura
• muscle cramps, muscle weakness
• urinary disorders, increased creatinine levels in urine and plasma, increased urine output, nocturia
• gynecomastia (breast enlargement in men)
• prolonged and sometimes painful erections. Seek medical attention immediately.
• fatigue, malaise, decreased body temperature in elderly patients.

Side effects with unknown frequency (cannot be estimated from the available data)

• intraoperative floppy iris syndrome during cataract surgery (see "Warnings and precautions")
• retrograde ejaculation.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Doxanorm

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

6. Contents of the pack and other information

What Doxanorm contains

• The active substance is doxazosin (in the form of doxazosin mesylate).
• The other ingredients are: microcrystalline cellulose, lactose, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, sodium lauryl sulfate, magnesium stearate.

What Doxanorm looks like and contents of the pack

Doxanorm is available as tablets.
The packaging (cardboard box) contains 3 blisters of 10 tablets (30 tablets).

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

ICN Polfa Rzeszów S.A.
ul. Przemysłowa 2
35-959 Rzeszów
Bausch Health Poland sp. z o.o.
ul. Przemysłowa 2
35-959 Rzeszów

Date of last revision of the leaflet: