Doxonex

Package leaflet: Information for the patient

Doxonex, 2 mg, tablets
Doxonex, 4 mg, tablets
Doxazosinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Doxonex is and what it is used for

Doxonex contains doxazosin, which blocks alpha-adrenergic receptors. By blocking these receptors in the bladder muscles, prostate gland, and its capsule, doxazosin relieves symptoms associated with benign prostatic hyperplasia. By blocking receptors in blood vessels, it lowers blood pressure.
Doxonex is indicated for the treatment of:

• Mild enlargement of the prostate gland causing difficulties in urination;
• High blood pressure when previously used medications have not been effective. It may be used in combination with other antihypertensive medicines (a diuretic, a beta-blocker, a calcium channel blocker, or an angiotensin-converting enzyme inhibitor).

2. Important information before using Doxonex

When not to use Doxonex:

• if the patient is allergic to doxazosin, similar medicines (e.g. prazosin, terazosin), or any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced orthostatic hypotension (dizziness, feeling of weakness, or rarely loss of consciousness when changing to an upright position);
• if the patient has mild enlargement of the prostate gland and at the same time has urinary tract obstruction, chronic urinary tract infections, or bladder stones;
• if the patient has mild benign prostatic hyperplasia and at the same time has low blood pressure;
• if the patient has urinary incontinence due to bladder overfilling (lack of urge to urinate) or anuria (lack of urine production), with or without kidney failure;
• if a woman with high blood pressure is breastfeeding.

Warnings and precautions
Special caution is required when using Doxonex:

• at the beginning of treatment, as some patients may experience orthostatic hypotension with dizziness, feeling of weakness, or rarely loss of consciousness. Patients should avoid sudden rising. Blood pressure monitoring at the beginning of treatment is recommended to assess the risk of orthostatic hypotension;
• in patients with certain severe heart diseases, such as pulmonary edema caused by heart valve disorders or heart failure;
• in patients with liver disease (see section 3).

Eye surgery
Inform the ophthalmic surgeon before planned cataract surgery if Doxonex is currently being used or has been used in the past. Doxonex may cause complications during surgery, which can be prevented if the ophthalmic surgeon is adequately prepared in advance.

Children and adolescents
The efficacy and safety of doxazosin in children and adolescents have not been established.

Doxonex with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to take.

• In some patients being treated for high blood pressure or enlarged prostate gland, medicines such as doxazosin may cause dizziness or feeling of fainting (due to low blood pressure) when quickly sitting or standing up. In some patients, these symptoms occurred when medicines such as doxazosin were taken together with drugs used for erectile dysfunction (impotence), e.g. sildenafil, tadalafil, vardenafil. To reduce the likelihood of these symptoms, patients should be on a regular daily dose of doxazosin before starting treatment for erectile dysfunction. Additionally, treatment with drugs for erectile dysfunction should be initiated at the lowest possible dose, and a six-hour interval should be maintained after taking doxazosin.
• Doxazosin may enhance the effects of other medicines used for high blood pressure.

Taking with food and drink
This medicine can be taken regardless of meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Doxonex may be used during pregnancy only if, in the opinion of the doctor, the potential benefits to the mother outweigh any possible risks to the fetus.
The medicine is contraindicated in breastfeeding women (see section "When not to use Doxonex").

Driving and operating machinery
This medicine may impair the ability to drive and operate machinery, especially at the beginning of treatment.

Doxonex contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Doxonex

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
your doctor or pharmacist.
The medicine may be taken during meals or independently of meals. Tablets should be swallowed
whole with sufficient liquid.
Doxazosin is intended for long-term use.
Recommended dose:
Mild benign prostatic hyperplasia
The initial dose of Doxonex is 1 mg (half a 2 mg tablet) once daily. If necessary,
your doctor may increase the dose to 2 mg, then to 4 mg, and up to a maximum of 8 mg. The dose
should be increased gradually by your doctor every 1–2 weeks. The usual recommended dose
ranges from 2 mg to 4 mg daily.
In the treatment of benign prostatic hyperplasia, doxazosin can be used in patients
with either high or normal blood pressure. As with other similar medicines, your doctor may recommend
monitoring blood pressure at the beginning of treatment.
High blood pressure
Doxonex is taken once daily. The initial dose is 1 mg. After 1–2 weeks of treatment, your doctor may
increase the dose to 2 mg, and then, if necessary, to 4 mg. If needed, your doctor may further increase
the dose up to the maximum recommended daily dose of 8 mg.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Do not change the dose on your own.
Use of Doxonex in elderly patients (over 65 years of age)
Dose adjustment is not necessary. However, the dose should be as low as possible, and any dose
increase should be carried out under strict medical supervision.
Use in patients with impaired liver function
As with all medicines that are entirely metabolized by the liver, caution should be exercised when
administering Doxonex to patients with impaired liver function.
Doxazosin is not recommended in patients with severe hepatic impairment.
Use in patients with impaired kidney function
There is no need to adjust the dose in patients with impaired renal function. However,
the dose should be as low as possible, and any dose increase should be performed under
strict medical supervision. Doxonex should not be used in patients with severe renal impairment.
Missed dose of Doxonex
If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed
dose. Do not take a double dose to make up for a missed dose.
Taking more than the recommended dose of Doxonex
Taking too many Doxonex tablets may cause dizziness or fainting.
If you take more than the recommended dose, seek medical advice immediately from your doctor or
the nearest hospital.
Stopping treatment with Doxonex
Do not stop treatment suddenly, as this may cause serious changes in blood pressure.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may be serious.
You must stop taking Doxonex and contact emergency medical services immediately if any of the following occur:

• heart attack (severe chest pain);
• weakness in limbs or speech disturbances, which may be signs of stroke;
• swelling of the face, tongue or throat, which may be symptoms of an allergic reaction to the medicine.

Contact your doctor immediately if any of the following occur:

• chest pain (angina pectoris);
• shortness of breath, difficulty breathing;
• fast, slow or irregular heartbeat;
• palpitations;
• fainting;
• yellowing of the whites of the eyes and skin (jaundice);
• decreased number of white blood cells or platelets, which may increase the risk of bleeding or bruising;
• presence of blood in the urine.

Other adverse reactions
Contact your doctor or pharmacist if any of the following adverse reactions occur:
Common (occur in less than 1 in 10 out of 100 patients):

• respiratory tract infections (e.g. bronchitis, pneumonia);
• urinary tract infections (e.g. cystitis);
• drowsiness, central dizziness, headache;
• labyrinthine dizziness (sensation of spinning);
• low blood pressure (hypotension);
• cough, runny nose;
• abdominal pain, indigestion, dry mouth, nausea;
• itching;
• back pain, muscle pain;
• cystitis, urinary incontinence;
• fatigue, flu-like symptoms, fluid retention (oedema).

Uncommon (occur in less than 1 in 10 out of 1,000 patients):

• gout (a disease characterized by increased uric acid levels in the blood and inflammatory changes in tissues around joints), increased appetite, loss of appetite (anorexia);
• restlessness, depression, anxiety, insomnia, nervousness;
• abnormally reduced sensitivity of the body to touch, tremor;
• tinnitus;
• nosebleeds;
• constipation, bloating, vomiting, gastritis and enteritis, diarrhoea;
• abnormal liver enzyme activity;
• skin rash;
• joint pain;
• frequent urination, pain during urination;
• impotence;
• generalized pain, facial swelling;
• weight gain.

Rare (occur in less than 1 in 10 out of 10,000 patients):

• muscle weakness or cramps;
• increased urine output.

Very rare (occur in less than 1 in 10,000 patients):

• dizziness upon standing from sitting or lying down;
• sensation of numbness, tingling in the limbs (paraesthesia);
• blurred vision;
• hot flushes;
• bronchospasm;
• impaired bile flow (cholestasis), hepatitis;
• urticaria (pale or red, irregular, raised skin lesions with intense itching);
• hair loss, purpura (rash caused by bleeding under the skin);
• frequent urination, need to urinate at night, urinary disturbances;
• breast enlargement in males;
• prolonged, painful erection; urgent medical advice should be sought;
• feeling of fatigue, malaise.

Frequency not known (cannot be estimated from available data):

• retrograde ejaculation;
• intraoperative floppy iris syndrome (see section 2 – "Eye surgery").

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

5. How to store Doxonex

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
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.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
Medicines must 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 Doxonex contains

• The active substance is doxazosin. Each tablet contains either 2 mg or 4 mg of doxazosin (as doxazosin mesylate).
• The other ingredients are: microcrystalline cellulose, lactose, sodium carboxymethyl starch, magnesium stearate, colloidal anhydrous silica, sodium lauryl sulfate.

What Doxonex looks like and contents of the pack
Doxonex 2 mg is a white, elongated tablet marked with "D2" and a division line on one side. The tablet can be divided into equal doses.
Doxonex 4 mg is a white, elongated tablet marked with "D4" and a division line on one side. The tablet can be divided into equal doses.
One pack contains 30 tablets.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01