Doxar

Leaflet attached to the packaging: information for the user

DOXAR, 1 mg, tablets

DOXAR, 2 mg, tablets

DOXAR, 4 mg, tablets

(Doxazosin)

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Doxar and what is it used for
• 2. Important information before using Doxar
• 3. How to use Doxar
• 4. Possible side effects
• 5. How to store Doxar
• 6. Contents of the packaging and other information

1. What is Doxar and what is it used for

Doxar 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.
Doxar is also an antagonist of alpha1-adrenergic receptors in the prostate and bladder. It reduces symptoms associated with difficulty in urinating and improves urodynamic test results (related to urine flow).
Doxar is indicated for the treatment of:

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

2. Important information before using Doxar

When not to use Doxar

• If the patient is allergic to the active substance or to quinazoline derivatives (e.g. prazosin, terazosin) or to any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever had orthostatic hypotension
• If the patient has benign prostatic hyperplasia with concurrent upper urinary tract obstruction; chronic urinary tract infections or bladder stones.
• If the patient has arterial hypotension.
• In breastfeeding women (only for the indication: hypertension).

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

Warnings and precautions

Before starting treatment with Doxar, the patient should discuss it with their doctor or pharmacist.

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

At the beginning of treatment, orthostatic hypotension may occur, manifested by dizziness, weakness, and rarely, loss of consciousness (syncope). The doctor may recommend blood pressure monitoring at the beginning of treatment.
Patients with the following severe heart diseases should exercise caution when using doxazosin:

• pulmonary edema caused by aortic stenosis or mitral stenosis,
• heart failure with high minute volume,
• right heart failure caused by pulmonary embolism or pericardial effusion,
• left heart failure with low filling pressure. Rapid and significant lowering of blood pressure can exacerbate angina pectoris.

In patients with known severe liver dysfunction, the use of doxazosin is not recommended.
In patients taking PDE-5 inhibitors (e.g. sildenafil, tadalafil, vardenafil - drugs used for erectile dysfunction) because symptomatic hypotension may occur.
Prolonged, painful erections can occur very rarely. In such cases, the patient should immediately consult a doctor.
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 a doctor, even if the above warnings refer to situations that have occurred in the past.

Children and adolescents

The use of Doxar 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.

Doxar and other medicines

The patient should tell their doctor about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
The patient should ask their doctor or pharmacist before using Doxar if they are taking any of the following medicines, as they may affect the action of Doxar:

• PDE-5 inhibitors used to treat erectile dysfunction, e.g. sildenafil, tadalafil, vardenafil (see "Warnings and precautions").
• blood pressure lowering medicines,
• antibiotics used to treat bacterial or fungal infections, e.g. clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole
• medicines used to treat HIV infection, e.g. indinavir, nelfinavir, ritonavir, saquinavir;
• nefazodone, a medicine used to treat depression,
• vasodilating medicines or nitrates (medicines used for heart diseases).

Doxar enhances the blood pressure lowering effect of other alpha-adrenergic blockers and antihypertensive medicines.
The blood pressure lowering effect of Doxar may be weakened by:

• non-steroidal anti-inflammatory drugs (NSAIDs)
• estrogens,
• sympathomimetic medicines. Doxazosin may weaken the effect of the following medicines: dopamine, ephedrine, epinephrine, phenylephrine (cough and cold medicines may contain phenylephrine or ephedrine), metaraminol, (a medicine used to treat hypotension), methoxamine for blood pressure, and vessels.

It is recommended to exercise particular caution when using doxazosin with medicines that affect liver metabolism, e.g. cimetidine.
In vitro studies have not shown that doxazosin affects the binding of digoxin (a medicine used for heart failure and arrhythmias), warfarin (an anticoagulant), phenytoin (an antiepileptic and antiarrhythmic medicine), or indomethacin (a medicine used for rheumatoid arthritis) to plasma proteins.
During clinical trials with Doxar, no interactions were found with thiazide diuretics, furosemide (an antihypertensive and diuretic), beta-adrenergic blockers (medicines used for coronary heart disease, arrhythmias, and hypertension), non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen), antibiotics, oral hypoglycemic agents (used for diabetes), uricosuric agents, and anticoagulants. Doxazosin may increase plasma renin activity and urinary excretion of vanillylmandelic acid. This should be taken into account when interpreting laboratory test results.
Doxar enhances the blood pressure lowering effect of other alpha-adrenergic blockers and other antihypertensive medicines.
Clinical trials have shown that doxazosin has a beneficial effect on lipids, significantly reducing total triglyceride, total cholesterol, and LDL fraction levels in plasma. Treatment with doxazosin 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 high blood pressure 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 while sitting or standing. Some patients have experienced these symptoms when taking alpha-adrenergic blockers with medicines 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 medicines for erectile dysfunction.
The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they 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 using this medicine.

Pregnancy

Hypertension treatment
The medicine may be used during pregnancy only if the doctor believes that the benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding

Doxazosin passes into breast milk in small amounts.
The use of doxazosin during breastfeeding is contraindicated.

Driving and operating machines

Due to individual reactions to doxazosin, the ability to drive vehicles and operate machines or perform certain 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.

Doxar contains lactose

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

Doxar contains sodium

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

3. How to use Doxar

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Method of administration
The medicine is taken orally. The tablets should be swallowed whole, with a glass of water.
Essential hypertension
Treatment with Doxar should be started with an initial dose of 1 mg per day. Depending on efficacy, after 1 to 2 weeks, the doctor may increase the dose to 2 mg of doxazosin once a day, then to 4 mg of doxazosin once a day, and finally to 8 mg of doxazosin once a day.
The average maintenance dose is 2 mg to 4 mg of doxazosin once a day.
The maximum recommended daily dose of the medicine is 16 mg of doxazosin.
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 should be increased to the maintenance dose.

Benign prostatic hyperplasia (BPH)
Treatment with Doxar should be started with an initial dose of 1 mg per day. If necessary, after one week, the doctor may increase the dose to 2 mg of doxazosin once a day, and then to 4 mg of doxazosin once a day.
The maximum recommended dose is 8 mg of doxazosin once a day.
To start treatment, the following dosing schedule is recommended:

• day 1-8, 1 tablet of Doxar 1 mg (1 mg of doxazosin) once a day
• day 9-14, 2 tablets of Doxar 1 mg (2 mg of doxazosin) once a day. Then, the dose can be individually increased to the maintenance dose.

Elderly patients

There is no need to adjust the dose of the medicine in elderly patients.
The dose of the medicine should be as low as possible, and its increase should be done under close medical supervision.

Patients with renal impairment

There is no need to adjust the dose of the medicine in patients with renal impairment.
The dose of the medicine should be as low as possible, and its increase should be done under close medical supervision.

Patients with hepatic impairment

There is a lack of clinical experience in patients with severe liver failure. Particular caution should be exercised when using Doxar in patients with liver function disorders.

Children and adolescents

The use of Doxar is not recommended in children and adolescents under 18 years of age.

Use of a higher than recommended dose of Doxar

In case of taking a higher dose than recommended, the patient should immediately consult their doctor or pharmacist.
In case of overdose leading to hypotension (blood pressure below 100 mmHg systolic and 60 mmHg diastolic), the patient should be placed on their back with their legs raised. Depending on the symptoms, the doctor will administer the appropriate treatment.
Due to the high degree of binding of doxazosin to plasma proteins, dialysis is not indicated.

Missed dose of Doxar

The patient should not take a double dose to make up for a missed dose.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.
In case of doubts about the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using Doxar and contact emergency services immediately

if the patient experiences any of the following side effects:

• myocardial infarction,
• weakness in the limbs or speech disorders, which may be symptoms of a stroke,
• swelling of the face, tongue, or throat, which may be symptoms of an allergic reaction to the medicine.

The patient should immediatelyconsult their doctor if they experience any of the following side effects:

• chest pain (angina pectoris),
• rapid breathing, difficulty breathing,
• rapid, slow, or irregular heartbeat,
• palpitations,
• syncope,
• yellowing of the whites of the eyes and skin (jaundice),
• decreased white blood cell or platelet count, which may increase the risk of bleeding or bruising.

In patients taking doxazosin, the following side effects have been reported:
Common side effects (occurring in 1 to 10 out of 100 patients):

• respiratory tract infections,
• urinary tract infections, cystitis, urinary incontinence,
• vertigo of labyrinthine origin, headache, accommodation disorders,
• drowsiness, dizziness,
• hypotension, orthostatic hypotension, edema,
• palpitations, tachycardia, chest pain,
• bronchitis, cough, dyspnea, rhinitis (rhinitis),
• abdominal pain, nausea, dry mouth, nausea,
• pruritus,
• back pain, muscle pain, weakness,
• cystitis, urinary incontinence, increased need to urinate,
• pollakiuria,
• chest pain,
• flu-like symptoms,
• generalized edema, peripheral edema.

Uncommon side effects (occurring in 1 to 10 out of 1,000 patients):

• allergic reactions,
• increased appetite, thirst, anorexia (loss of appetite),
• arthralgia, gout,
• excitement, anxiety, depression, insomnia, nervousness, emotional instability,
• stroke, hypesthesia,
• syncope, tremor, apathy,
• lacrimation, photophobia,
• tinnitus,
• peripheral hypoperfusion,
• angina pectoris, myocardial infarction,
• epistaxis, pharyngitis,
• constipation, diarrhea, flatulence and eructation, vomiting, gastroenteritis,
• increased liver enzyme activity, abnormal liver function test results,
• rash,
• urination disorders, hematuria, urination frequency disorders, impotence,
• pain, facial edema, fever, chills, hot flashes, pallor,
• hypokalemia (decreased potassium levels in the blood), weight gain.

Rare side effects (occurring in less than 1 in 10,000 patients):

• muscle cramps, muscle weakness,
• laryngeal edema,
• polyuria,
• hypoglycemia (low blood sugar).

Very rare side effects (occurring in less than 1 in 100,000 patients):

• leukopenia (low white blood cell count), thrombocytopenia (low platelet count),
• hypersensitivity, muscle stiffness, taste disorders, nightmares, memory loss,
• orthostatic dizziness (when standing up from a sitting or lying position),
• paresthesia (tingling or numbness in the limbs),
• blurred vision,
• flushing,
• bradycardia, arrhythmia (irregular heartbeat),
• bronchospasm,
• cholestasis, hepatitis, jaundice,
• alopecia, urticaria, purpura (red spots on the skin),
• urination disorders, nocturia, increased diuresis (urine production and excretion),
• increased creatinine levels in urine and plasma,
• gynecomastia (breast enlargement in men),
• painful, prolonged erection of the penis (priapism) - The patient should seek medical attention immediately.
• fatigue, malaise,
• decreased body temperature in elderly patients.

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

• intraoperative floppy iris syndrome,
• retrograde ejaculation.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist or nurse. 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Doxar

Store in a temperature below 25°C.
Store in a place out of sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Doxar contains

The active substance of the medicine is doxazosin mesylate, which is equivalent to 1 mg, 2 mg, or 4 mg of doxazosin.
Other ingredients of the medicine are: microcrystalline cellulose, lactose, sodium carboxymethylcellulose, magnesium stearate, sodium lauryl sulfate.

What Doxar looks like and contents of the pack

White, round, biconvex tablets with a smooth surface.
Doxar, 1 mg, tablets - 30 tablets in a cardboard box.
Doxar, 2 mg, tablets - 30 tablets in a cardboard box.
Doxar, 4 mg, tablets - 30 or 120 tablets in a cardboard box.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel. (22) 345 93 00.
Poland

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland
Date of last revision of the leaflet:April 2023