Doxonex

Package Leaflet: Information for the Patient

Doxonex, 2 mg, Tablets

Doxonex, 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Doxonex and what is it 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 is Doxonex and what is it used for

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

• mild prostate enlargement causing difficulty urinating;
• high blood pressure, when other previously used medicines have not been effective. It can be used with other high blood pressure medicines (diuretics, beta-adrenergic blockers, calcium channel blockers, or angiotensin-converting enzyme inhibitors).

2. Important information before taking Doxonex

When not to take Doxonex:

• if you are allergic to doxazosin or similar medicines (e.g., prazosin, terazosin) or any of the other ingredients of this medicine (listed in section 6);
• if you have had orthostatic hypotension (dizziness, weakness, or rarely loss of consciousness when changing body position to standing) in the past;
• if you have mild prostate enlargement and at the same time obstruction in the upper urinary tract, chronic urinary tract infections, or bladder stones;
• if you have mild prostate enlargement and at the same time arterial hypotension;
• if you have urinary incontinence due to overflow (no need to urinate) or anuria (no urine production) with or without renal failure;
• if you are a nursing mother with high blood pressure.

Warnings and precautions

Particular caution should be exercised when taking Doxonex:

• at the beginning of treatment, as orthostatic hypotension with dizziness, weakness, or rarely loss of consciousness may occur in some patients. Patients should avoid sudden standing. It is recommended to monitor blood pressure at the beginning of treatment to determine the risk of orthostatic hypotension;
• in patients with certain severe heart diseases, such as pulmonary edema caused by heart valve defects or heart failure;
• in patients with liver disease (see section 3).

Eye surgery
Inform the ophthalmic surgeon before planned cataract surgery about the use of Doxonex, as it may cause complications during surgery that can be prevented if the ophthalmic surgeon prepares accordingly.

Children and adolescents

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

Doxonex and other medicines

Inform your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

• In some patients taking medicines for high blood pressure or prostate enlargement, such as doxazosin, dizziness or fainting may occur when sitting or standing up quickly (caused by low blood pressure). In some patients, these symptoms occurred when medicines like doxazosin were taken with medicines used for erectile dysfunction (impotence), such as sildenafil, tadalafil, or vardenafil. To reduce the likelihood of these symptoms, it is recommended to take the daily dose of doxazosin regularly before starting treatment for erectile dysfunction. Additionally, it is recommended to start treatment with erectile dysfunction medicines at the lowest possible dose and maintain a 6-hour interval after taking doxazosin.
• Doxazosin enhances the effect of other high blood pressure medicines.

Using with food and drink

The medicine can be taken with or without food.

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.
Doxonex can be used during pregnancy only if, in the doctor's opinion, the potential benefits to the mother outweigh the potential risk to the fetus.
The medicine is contraindicated in nursing mothers (see section "When not to take Doxonex").

Driving and using machines

The medicine may impair the ability to drive and use machines, especially at the beginning of treatment.

Doxonex contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Doxonex

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The medicine can be taken with or without food. Swallow the tablets whole with a sufficient amount of liquid.
Doxazosin is intended for long-term use.
Recommended dose:

Mild prostate enlargement

The initial dose of Doxonex is 1 mg (half a 2 mg tablet) once a day. If necessary, your doctor may increase the dose to 2 mg, then to 4 mg, and up to 8 mg. The dose should be increased gradually by your doctor every 1-2 weeks. The usual recommended dose is 2-4 mg per day.
Doxazosin can be used in patients with both high and normal blood pressure. As with other similar medicines, your doctor will recommend monitoring blood pressure at the beginning of treatment.

High blood pressure

Doxonex is taken once a day. 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 necessary, your doctor may further increase the dose up to the maximum recommended daily dose of 8 mg.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor. Do not change the dose yourself.

Taking Doxonex in elderly patients (over 65 years)

No dose adjustment is necessary. However, the dose of the medicine should be as low as possible, and any dose increase should be done under close medical supervision.

Taking the medicine in patients with liver function disorders

As with all medicines metabolized entirely by the liver, caution should be exercised when taking Doxonex in patients with liver function disorders.
Doxazosin is not recommended in patients with severe liver failure.

Taking the medicine in patients with kidney function disorders

No dose adjustment is necessary in patients with kidney function disorders. However, the dose of the medicine should be as low as possible, and any dose increase should be done under close medical supervision. In patients with severe kidney failure, the medicine should not be used.

Missing a dose of Doxonex

If you miss a dose, take it as soon as possible. If it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed dose.

Taking more than the recommended dose of Doxonex

Taking too many Doxonex tablets may cause dizziness or fainting. If you have taken more than the recommended dose, seek medical attention immediately.

Stopping treatment with Doxonex

Do not stop treatment suddenly, as it may cause serious changes in blood pressure. If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

The following side effects may be serious.

Stop taking Doxonex and contact emergency services immediately if you experience:

• heart attack (severe chest pain);
• 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.

Consult your doctor immediately if you experience:

• chest pain (angina pectoris);
• shortness of breath, difficulty breathing;
• rapid, slow, or irregular heartbeat;
• palpitations;
• fainting;
• 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;
• blood in the urine.

Other side effects

Inform your doctor or pharmacist if you experience any of the following side effects:

Common (affecting less than 1 in 10 people):

• respiratory tract infections (e.g., bronchitis, pneumonia);
• urinary tract infections (e.g., cystitis);
• drowsiness, dizziness of central origin, headaches;
• vertigo (feeling of spinning);
• low blood pressure (hypotension);
• cough, runny nose;
• abdominal pain, nausea, dry mouth, vomiting;
• itching;
• back pain, muscle pain;
• cystitis, urinary incontinence;
• weakness, flu-like symptoms, fluid retention (edema).

Uncommon (affecting less than 1 in 100 people):

• gout (a disease characterized by increased uric acid levels in the blood and inflammation of tissues around the joints), increased appetite, anorexia;
• agitation, depression, anxiety, insomnia, nervousness;
• abnormal sensitivity to touch, tremors;
• tinnitus;
• nasal bleeding;
• constipation, bloating, vomiting, gastritis, diarrhea;
• abnormal liver enzyme activity;
• skin rash;
• joint pain;
• frequent urination, pain during urination;
• impotence;
• generalized pain, facial edema;
• weight gain.

Rare (affecting less than 1 in 1,000 people):

• muscle weakness or cramps;
• increased urine production.

Very rare (affecting less than 1 in 10,000 people):

• orthostatic dizziness;
• paresthesia (tingling or numbness in the limbs);
• blurred vision;
• hot flashes;
• bronchospasm;
• cholestasis, hepatitis;
• hives (pale or red, irregular, raised patches with severe itching);
• hair loss, purpura (a rash caused by bleeding under the skin);
• frequent urination, nocturia, urinary disorders;
• breast enlargement in men;
• prolonged, painful erections; seek medical attention immediately;
• fatigue, malaise.

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

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 gather more information on the safety of this medicine.

5. How to store Doxonex

Keep the medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
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 Doxonex contains

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

What Doxonex looks like and contents of the pack

Doxonex 2 mg is a white, oblong tablet with the inscription "D2" and a dividing line on one side. The tablet can be divided into equal doses.
Doxonex 4 mg is a white, oblong tablet with the inscription "D4" and a dividing line on one side. The tablet can be divided into equal doses.
One pack of the medicine contains 30 tablets.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of last revision of the leaflet: