Doxazosin aurovitas

Doxazosin Aurovitas, 2 mg, tablets
Doxazosin Aurovitas, 4 mg, tablets
Doxazosinum
Read the entire leaflet before taking the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• If the patient experiences any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Doxazosin Aurovitas is and what it is used for

Doxazosin belongs to a group of medicines known as vasodilators.
These substances cause dilation of blood vessels, resulting in a reduction of blood pressure.
Doxazosin may additionally reduce the tone of the smooth muscle tissue of the prostate gland and urinary tract.
Doxazosin is used in the treatment of:

• high blood pressure (hypertension);
• symptoms caused by benign enlargement of the prostate gland.

2. Information before taking Doxazosin Aurovitas

When not to take Doxazosin Aurovitas

• if the patient is allergic to doxazosin, other medicines in the same group (quinazoline derivatives, for example prazosin and terazosin) or any of the other ingredients of this medicine (listed in section 6),
• if the patient is known to have orthostatic hypotension, a form of low blood pressure which causes dizziness or fainting when standing up from a sitting or lying position,
• if the patient has an enlarged prostate gland with one of the following conditions: any form of urinary obstruction or blockage, persistent urinary tract infection, or bladder stones,
• if the patient has an enlarged prostate gland (benign prostatic hyperplasia) and low blood pressure,
• if the patient has overflow incontinence (without the sensation of needing to pass urine) or anuria (the body does not produce urine), with or without kidney-related problems.

Warnings and precautions
Before starting Doxazosin Aurovitas, discuss with your doctor or pharmacist if the patient:

• has serious heart problems, such as significant heart failure or painful chest discomfort (angina),
• is on a strict low-salt diet,
• is taking diuretics (water tablets),
• has impaired kidney or liver function.

If the patient is undergoing eye surgery due to cataract (clouding of the lens), inform the ophthalmologist before surgery about current or past use of Doxazosin Aurovitas. This is because Doxazosin Aurovitas may cause complications during surgery, which can be prevented if the ophthalmologist is informed in advance.

Important information about Doxazosin Aurovitas
The risk of a rapid drop in blood pressure is highest at the beginning of treatment or during dose increases. Symptoms of this may include dizziness and, less commonly, fainting upon changing position. To reduce the risk of such events, the doctor will closely monitor blood pressure at the start of treatment and during dose escalation. Therefore, during initial treatment, avoid situations where dizziness or fainting could lead to injury.
Doxazosin Aurovitas may also affect the results of certain blood and urine tests. If the patient is due to have blood or urine tests, inform the healthcare provider about taking Doxazosin Aurovitas.

Children and adolescents
The efficacy and safety of Doxazosin Aurovitas in children and adolescents under 18 years of age have not been established.

Doxazosin Aurovitas with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

• Some patients taking alpha-blocker medicines for high blood pressure or an enlarged prostate may experience dizziness or lightheadedness due to low blood pressure when standing up quickly. In some patients, these symptoms may occur when taking medications for erectile dysfunction together with alpha-blockers. To reduce the likelihood of such symptoms, the regular daily dose of alpha-blockers should be established before starting erectile dysfunction medication.
• Doxazosin Aurovitas may lower blood pressure further if the patient is already taking other antihypertensive medicines, such as terazosin and prazosin.
• Medicines 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.
• Nitrates (medicines used in heart conditions), such as glyceryl trinitrate and isosorbide mononitrate: these may enhance the blood pressure-lowering effect.
• Certain painkillers used for rheumatism (non-steroidal anti-inflammatory drugs), such as naproxen, ibuprofen, and other anti-inflammatory painkillers: these may reduce the blood pressure-lowering effect.
• Medicines that may also affect liver metabolism, e.g. cimetidine (a medicine used for stomach problems).

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, thinks she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.

If the patient is pregnant or suspects she may be pregnant, she should contact her doctor before taking Doxazosin Aurovitas. Doxazosin Aurovitas may be used during pregnancy only if the doctor considers that the benefits to the mother outweigh the potential risks to the fetus.

Small amounts of doxazosin, the active substance in Doxazosin Aurovitas, may pass into human milk. Breastfeeding women should not take this medicine unless otherwise directed by a doctor.

Driving and using machines
Doxazosin may occasionally cause dizziness or fainting. In such cases, caution should be exercised when performing tasks requiring alertness, such as driving, operating machinery, or working at heights. If in doubt about whether doxazosin affects the ability to drive, this should be discussed with the doctor.

Doxazosin Aurovitas contains lactose
This medicine contains lactose. If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Doxazosin Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to take Doxazosin Aurovitas

This medicine should always be taken as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Recommended dose:

HYPERTENSION

The starting dose is 1 mg once daily (every 24 hours), as a single dose. After 1–2 weeks, the dose is usually increased to 2 mg as a single daily dose (every 24 hours). This dose should also be taken for 1–2 weeks. If necessary, the dose may be further increased to 4 mg, 8 mg, and up to 16 mg once daily, until adequate blood pressure control is achieved.
The maximum dose is 16 mg per day.
The initial dose should preferably be taken at bedtime. This way, if dizziness occurs, it will be less bothersome.

BENIGN PROSTATIC HYPERPLASIA (ENLARGED PROSTATE)

The starting dose is 1 mg once daily (every 24 hours), as a single dose. The usual daily dose is then 2 mg or 4 mg. In some cases, this dose may be increased up to a maximum of 8 mg per day.

The tablets should be taken once daily (every 24 hours) as a single dose. Swallow the tablets with a large amount of water.

Taking more Doxazosin Aurovitas than prescribed

If you take more tablets than prescribed, contact your doctor and/or pharmacist immediately. If you experience severe dizziness or feel faint, lie down immediately with your head low.

If you forget to take Doxazosin Aurovitas

If you forget to take a tablet, skip the missed dose and take the next tablet at your usual time. Do not take a double dose to make up for a forgotten tablet. If you have any doubts, consult your doctor or pharmacist.

Stopping Doxazosin Aurovitas

If doxazosin treatment is stopped abruptly, symptoms present before starting treatment may return. Therefore, abrupt discontinuation of the medicine is not recommended. Your doctor will gradually reduce the dose. If you have any doubts, always consult your doctor or pharmacist.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Some adverse effects may be serious:
You should stop taking the medicine and immediately contact your doctor or go to
the emergency department of your nearest hospital if any of the following
adverse effects occur:

• Allergic reactions such as wheezing, shortness of breath, severe dizziness or collapse, swelling of the face or throat, severe skin rash with red patches or blisters.
• Chest pain (angina), rapid or irregular heartbeat, heart attack or stroke (symptoms may include sudden collapse, numbness or weakness of arms and legs, headache, dizziness and disorientation, visual disturbances, difficulty swallowing, slurred speech and loss of speech).
• Yellowing of the skin or whites of the eyes associated with liver disorders (jaundice).
• Unusual bruising or bleeding due to low platelet count.
• Presence of blood in the urine.
• Hepatitis (liver inflammation - may cause nausea, vomiting, loss of appetite, malaise, fever).
• Cholestasis (blocked bile flow - may cause itching of the skin, pale stools and dark urine). These adverse effects occur uncommonly (in 1 to 10 patients per 1,000) or rarely (in 1 to 10 patients per 10,000).

Other adverse effects:
Common: (occur in less than 1 in 10 patients):

• Respiratory tract infections (nose, throat, lungs)
• Urinary tract infections (symptoms may include: pain or burning during urination or frequent urination), urinary incontinence (loss of control over urination)
• Dizziness, drowsiness, headache
• Sensation of dizziness or spinning (vertigo)
• Awareness of irregular heartbeat (palpitations), increased heart rate
• Low blood pressure and low blood pressure upon changing position from sitting or lying to standing (orthostatic hypotension)
• Bronchitis, cough, shortness of breath, nasal congestion and/or nasal discharge
• Abdominal pain, indigestion, dry mouth, nausea
• Itching
• Back pain, muscle pain
• Cystitis, increased need to urinate
• Fatigue, chest pain, flu-like symptoms
• Swelling around the ankles, feet or fingers (peripheral edema), generalized edema, accommodation disorders.

Uncommon: (occur in less than 1 in 100 patients):

• Gout, increased appetite, anorexia (loss of appetite), thirst
• Restlessness, depression, anxiety, insomnia, emotional lability, nervousness, tremor, apathy
• Tearing, photophobia
• Stroke, reduced sense of touch, fainting
• Ringing or noises in the ears
• Sore throat, nosebleeds
• Constipation, bloating, vomiting, gastritis and enteritis, diarrhea
• Abnormal liver function test results, increased liver enzyme activity
• Skin rash
• Joint pain
• Pain or difficulty urinating, pallor
• Difficulty achieving erection (impotence)
• Facial pain or swelling
• Weight gain, hypokalemia, hypoglycemia.

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

• Cerebrovascular disorders
• Laryngeal edema.

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

• Orthostatic dizziness (dizziness upon standing from sitting or lying position), tingling or numbness in hands and feet (paresthesia), hypersensitivity, muscle stiffness, taste disturbances, nightmares, memory loss
• Decreased white blood cell count (may cause frequent infections, with symptoms such as fever, severe chills, sore throat or mouth ulcers), anemia
• Blurred vision
• Decreased heart rate
• Hot flushes
• Bronchospasm (difficulty breathing, wheezing or coughing)
• Muscle cramps, muscle weakness
• Polyuria (increased urine volume)
• Increased blood urea and creatinine levels
• Urticaria, hair loss (alopecia), skin rash caused by bleeding under the skin (purpura)
• Urination disorders, need to urinate at night, increased urine volume
• Transient breast enlargement in men (gynecomastia)
• Feeling of tiredness (fatigue), malaise (general feeling of being unwell), decreased body temperature in elderly patients
• Prolonged, painful erection. Immediate medical advice should be sought.

Not known: (frequency cannot be estimated from available data):

• During cataract surgery (clouding of the eye lens), eye-related complications may occur. See section "When to be cautious with Doxazosin Aurovitas".
• Low volume or absence of semen during ejaculation at orgasm, cloudy urine after orgasm (retrograde ejaculation).

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

5. How to store Doxazosin Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton: Expiry
date. The expiry date refers to the last day of the specified month.
No special storage instructions apply.
Medicines must not be disposed of via the sewage system 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 Doxazosin Aurovitas contains

• The active substance is doxazosin. Each 2 mg tablet contains 2 mg of doxazosin in the form of doxazosin mesilate. Each 4 mg tablet contains 4 mg of doxazosin in the form of doxazosin mesilate.
• Other ingredients are: microcrystalline cellulose, lactose, sodium carboxymethyl starch (Type A), magnesium stearate.

What Doxazosin Aurovitas looks like and contents of the pack
2 mg tablets:
white to off-white, uncoated, capsule-shaped tablets, with the imprints ‘D O’ separated by a division line on one side and ‘2’ on the other. The tablet can be divided into equal doses.
4 mg tablets:
white to off-white, uncoated, rhombus-shaped tablets, with the imprints ‘D O’ separated by a division line on one side and ‘4’ on the other. The tablet can be divided into equal doses.
Blister packs:
Pack sizes: 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100 and 140 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa Street 13D, unit 27
01-909 Warsaw
e-mail: [email protected]
Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG 3000
Malta