Doxanorm

Patient Information Leaflet

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

• Keep this leaflet for future reference.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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 any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

• Essential hypertension
• Clinical symptoms of benign prostatic hyperplasia (BPH)

2. Important information before using Doxanorm

When not to use Doxanorm

• if the patient is 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 mild benign prostatic hyperplasia associated with congestion of the upper urinary tract, chronic urinary tract infections, or bladder stones
• in breastfeeding women
• in patients with arterial hypotension.

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

• At the beginning of treatment, orthostatic hypotension may occur, manifesting as dizziness, 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 symptoms of cardiac insufficiency.
• Administration of doxazosin is not recommended in patients with diagnosed liver failure.
• In patients concurrently taking PDE-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil—medicines used for erectile dysfunction), symptomatic arterial hypotension may occur.
• Prolonged and sometimes painful erections—very rare. If an erection lasts longer than 4 hours, seek immediate medical attention.
• Before starting treatment with Doxanorm, your doctor may perform tests to rule out other diseases, including prostate cancer, which may cause 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.
Before the procedure, inform your ophthalmologist about taking alpha-adrenergic blocking agents.
Consult your doctor even if the above warnings refer to conditions occurring in the past.
Children and adolescents
Doxanorm is not recommended for use in children and adolescents under 18 years of age, as safety and efficacy have not yet been established in this age group.
Doxanorm and other medicines
Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you 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 effects 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 shown that doxazosin does not affect the plasma protein binding of digoxin, warfarin, phenytoin, or indomethacin.
In clinical trials, no interactions were observed between doxazosin and thiazide diuretics, furosemide, beta-blockers, non-steroidal anti-inflammatory drugs, antibiotics, oral hypoglycemic agents (used in diabetes), uricosuric agents, or anticoagulants.
Doxazosin may increase plasma renin activity and urinary excretion of vanillylmandelic acid. This should be taken into account when interpreting laboratory test results.
Doxazosin enhances the blood pressure-lowering effects of other alpha-adrenergic blocking agents and other antihypertensive medicines.
Clinical studies have shown that doxazosin has a beneficial effect on lipids, significantly reducing serum levels of total triglycerides, total cholesterol, and LDL fraction. 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 sensation 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 up. Some patients experienced these symptoms while taking alpha-adrenergic blocking agents together with medicines used for erectile dysfunction (impotence). To reduce the likelihood of these symptoms, it is recommended to take daily doses of alpha-adrenergic blocking agents regularly before starting treatment with erectile dysfunction medicines.
Inform 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, breastfeeding, and fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.
The use of Doxanorm has not been evaluated in pregnant women.
Doxanorm is contraindicated during lactation.
Your doctor will decide whether to discontinue breastfeeding or stop the medication.
Driving and operating machinery
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 balance, may be impaired, especially at the beginning of treatment, after dose increase, when switching to another medicine, or when consuming alcohol.
Doxanorm contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Doxanorm contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Doxanorm

This medicine should always be used exactly as directed by the physician.
In case of doubt, consult a doctor or pharmacist.

Arterial hypertension
The initial dose is 1 mg once daily. Depending on the effectiveness, 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 to 8 mg doxazosin once daily. The average maintenance dose is 2 to 4 mg doxazosin once daily.
The maximum recommended dose is 16 mg doxazosin per day.
The following dosing schedule is recommended when starting treatment:
Day 1–8: 1 mg doxazosin in the morning
Day 9–14: 2 mg doxazosin in the morning
Thereafter, the dose should be increased gradually to an effective maintenance dose.

Mild 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:
Day 1–8: 1 mg doxazosin once daily
Day 9–14: 2 mg doxazosin once daily
Thereafter, the dose may be individually increased to an effective maintenance dose.

Oral administration
The tablets should be swallowed whole with water. The duration of treatment is determined by the physician.

Use in children and adolescents
Doxanorm is not recommended for use in children and adolescents under 18 years of age.

Elderly patients
There is no need to adjust the dose in elderly patients. However, the dose should be as low as possible, and any dose increase should be carried out under strict medical supervision.

Patients with hepatic impairment
Extreme caution should be exercised. There is no clinical experience with the use of this medicine in patients with severe hepatic insufficiency.

Patients with renal impairment
There is no need to adjust the dose in patients with renal impairment. However, the dose should be as low as possible, and any dose increase should be carried out under strict medical supervision.

Use of a higher than recommended dose of Doxanorm
Hypotension may occur after overdose.
If a higher than recommended dose of Doxanorm has been taken, contact a physician 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 Doxanorm
If a patient forgets to take Doxanorm, 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. A double dose should not be taken to make up for a missed dose.

If there are any further doubts concerning the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
The following adverse reactions may occur during treatment with this medicine:

Common adverse reactions (may occur in more than 1 in 100 people)

• Respiratory tract infections, urinary tract infections
• Drowsiness, dizziness, headache
• Accommodation disorders
• Vertigo
• Palpitations, tachycardia, chest pain
• Hypotension, orthostatic hypotension (occurring as a result of changing position from lying or sitting to standing), oedema
• Bronchitis, cough, dyspnoea, rhinitis (nasal congestion)
• Abdominal pain, dyspepsia, dry mouth, nausea
• Itching
• Back pain, muscle pain
• Cystitis, urinary incontinence, feeling of increased need to urinate, frequency of urination
• Weakness, symptoms similar to flu symptoms, generalized oedema, peripheral oedema.

Uncommon adverse reactions (may occur in more than 1 in 1000 people)

• Allergic reactions
• Anorexia, gout, thirst, increased appetite
• Anxiety, insomnia, nervousness, agitation, depression, emotional lability
• Stroke, hypoaesthesia, 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 (pain during urination), urinary frequency disorders, haematuria
• Impotence
• Pain, fever, chills, facial swelling, hot flushes, pallor
• Hypokalaemia (decreased potassium levels in blood), weight gain.

Rare adverse reactions (may occur in more than 1 in 10,000 people)

• Cerebrovascular disorders
• Hypoglycaemia (decreased glucose levels in blood)
• Polyuria
• Laryngeal oedema.

Very rare adverse reactions (may occur in less than 1 in 10,000 people)

• Decreased white blood cell and platelet count, anaemia
• Hypersensitivity, muscle stiffness, taste disturbances, nightmares, memory loss, orthostatic dizziness (related to change in body position from lying or sitting to standing), paraesthesia (tingling, numbness, pricking sensations)
• Blurred vision
• Bradycardia (slowed heart rate), cardiac arrhythmias
• Flushing
• Bronchospasm
• Hepatitis, cholestasis, jaundice
• Urticaria, alopecia, purpura
• Muscle cramps, muscle weakness
• Urinary disorders, increased creatinine concentration in urine and plasma, increased urine output, nocturia
• Gynaecomastia (enlargement of breasts in males)
• Prolonged, painful erection. Immediate medical advice should be sought.
• Feeling of fatigue, malaise, decreased body temperature in elderly patients.

Adverse reactions with unknown frequency (cannot be estimated from available data)

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Doxanorm

Store below 30°C.
Keep in a place inaccessible and out of sight 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Doxanorm contains

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

What Doxanorm looks like and contents of the pack
Doxanorm is in the form of tablets.
The pack (cardboard box) contains 3 blisters of 10 tablets (30 tablets).
Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer
ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-105 Rzeszów
Poland