Doxazosin Aurovitas

Patient Information Leaflet: User Information

Doxazosin Aurovitas, 2 mg, tablets

Doxazosin Aurovitas, 4 mg, tablets

Doxazosin

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

• You should keep this leaflet, so you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further questions.
• This medicine has been prescribed specifically for you. 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 not mentioned in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

Doxazosin belongs to a group of medicines called vasodilators.
These substances cause the blood vessels to dilate, which lowers blood pressure.
Doxazosin may also reduce the tension of the prostate and urinary tract tissue.
Doxazosin is used to treat:

• high blood pressure;
• symptoms caused by an enlarged prostate.

2. Important information before taking Doxazosin Aurovitas

When not to take Doxazosin Aurovitas

andlow blood pressure,

Warnings and precautions

Before starting to take Doxazosin Aurovitas, you should discuss it with your doctor or pharmacist
if you:

• have severe heart disease, such as significant weakening of heart function or troublesome chest pain (angina pectoris),
• are on a strict low-salt diet,
• are taking diuretics,
• have kidney or liver function disorders.

If you are having eye surgery for cataracts (clouding of the lens), you should tell your ophthalmologist before the surgery that you are taking or have taken 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 likelihood of a too rapid drop in blood pressure is highest at the beginning of treatment or when increasing the dose. Symptoms of this condition may include dizziness and, less often, fainting when changing position. To reduce the risk of such situations, your doctor will carefully check your blood pressure at the beginning of treatment and when increasing the dose. You should therefore avoid situations at the beginning of treatment where dizziness or fainting could lead to injury.
Doxazosin Aurovitas may also affect the results of some blood and urine tests. If you are going to have a blood or urine test, you should inform your doctor that you are taking Doxazosin Aurovitas.
Children and adolescents
The efficacy and safety of Doxazosin Aurobindo in children and adolescents under 18 years of age have not been established.

Doxazosin Aurovitas and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

• In some patients taking alpha-blockers for the treatment of high blood pressure or enlarged prostate, dizziness or fainting may occur, which may be due to low blood pressure when sitting or standing up quickly. In some patients, these symptoms occur while taking medicines for erectile dysfunction with alpha-blockers. To reduce the likelihood of these symptoms, you should take your regular daily dose of alpha-blockers before starting to take medicines for erectile dysfunction.
• Doxazosin Aurovitas may further lower your blood pressure if you are already taking other medicines for high blood pressure, such as terazosin and prazosin.
• Medicines used to treat bacterial or fungal infections, such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used to treat HIV infection, such as indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medicine used to treat depression.
• Nitrates (medicines used for heart conditions), such as nitroglycerin and isosorbide dinitrate: they may enhance the blood pressure-lowering effect.
• Some painkillers used for rheumatism (non-steroidal anti-inflammatory drugs), such as naproxen, ibuprofen, and other anti-inflammatory painkillers: they may reduce the blood pressure-lowering effect.
• Medicines that may also affect liver metabolism, such as cimetidine (a medicine used for stomach disorders).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
If you are pregnant or think you may be pregnant, you should contact your doctor before taking Doxazosin Aurovitas. Doxazosin Aurovitas can be used during pregnancy only if your doctor considers that the benefits to the mother outweigh the potential risk to the fetus.
Small amounts of doxazosin, the active substance of Doxazosin Aurovitas, may pass into human milk. Breastfeeding women should not take this medicine unless their doctor decides otherwise.

Driving and using machines

Doxazosin may occasionally cause dizziness or fainting. In such cases, you should be careful when performing activities that require attention, such as driving vehicles, operating machines, and working at heights. If you are unsure whether doxazosin affects your ability to drive, you should discuss this with your doctor.

Doxazosin Aurovitas contains lactose

This medicine contains lactose. If you have been previously diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

Doxazosin Aurovitas contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Doxazosin Aurovitas

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
Recommended dose:
HYPERTENSION
The initial dose is 1 mg once daily (every 24 hours), in a single dose. After 1-2 weeks, the dose is usually increased to 2 mg in a single daily dose (every 24 hours).
This dose is also taken for 1-2 weeks. If necessary, the dose can be further increased to 4, 8, and 16 mg once daily, until adequate blood pressure reduction is achieved.
The maximum dose is 16 mg per day.
The initial dose should preferably be taken before bedtime. This is because if dizziness occurs, it will be less troublesome.
ENLARGED PROSTATE
The initial dose is 1 mg once daily (every 24 hours), in a single dose. The usual daily dose is then 2 mg or 4 mg. In some cases, this dose can be increased to a maximum of 8 mg per day.
The tablets should be taken in a single dose each day (every 24 hours). The tablets should be swallowed with a large amount of water.

Taking a higher dose of Doxazosin Aurovitas than recommended

If you have taken more than the prescribed dose, you should immediately consult your doctor and/or pharmacist. If you experience severe dizziness or feel like fainting, you should lie down immediately, keeping your head low.

Missing a dose of Doxazosin Aurovitas

If you forget to take a tablet, you should skip this dose and take the next tablet at the usual time. If you are unsure, you should consult your doctor or pharmacist. You should not take a double dose to make up for a missed dose.

Stopping treatment with Doxazosin Aurovitas

If you stop taking doxazosin suddenly, the symptoms that occurred before the start of treatment may return. Therefore, it is not recommended to stop taking the medicine suddenly. Your doctor will gradually reduce the dose. If you have any further questions about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be serious:
You should stop taking the medicine and contact your doctor or the emergency department of your nearest hospital immediately if you experience any of the following side effects:

• Allergic reactions, such as wheezing, shortness of breath, severe dizziness or fainting, swelling of the face or throat, severe skin rash with red spots or blisters.
• Chest pain (angina pectoris), rapid or irregular heartbeat, heart attack, or stroke (symptoms may include falling, numbness or weakness of arms and legs, headache, dizziness, and disorientation, vision disturbances, difficulty swallowing, and slurred speech or loss of speech).
• Yellowing of the skin or whites of the eyes due to liver disorders (jaundice).
• Unusual bruising or bleeding due to a low platelet count.
• Blood in the urine.
• Hepatitis (liver disease with nausea, vomiting, loss of appetite, feeling unwell, fever).
• Cholestasis (blocked bile flow - may cause itching, pale stools, and dark urine). These side effects are not very common (occurring in 1 to 10 patients per 1,000) or rare (occurring in 1 to 10 patients per 10,000).

Other side effects:

Common (occurring 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
• feeling of dizziness or spinning (vertigo)
• feeling of irregular heartbeat (palpitations), increased heart rate
• low blood pressure and low blood pressure due to a change in position from sitting or lying down to standing (orthostatic hypotension)
• bronchitis, cough, shortness of breath, stuffy nose and/or runny nose
• abdominal pain, indigestion, dry mouth, nausea
• itching
• back pain, muscle pain
• urinary tract infection, increased need to urinate
• weakness, chest pain, flu-like symptoms
• swelling in the ankle, foot, or toe area (peripheral edema), generalized swelling, accommodation disorders.

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

• gout, increased appetite, loss of appetite (anorexia), thirst
• agitation, depression, anxiety, insomnia, emotional instability, nervousness, tremors, apathy
• tearfulness, photophobia
• stroke, decreased sensation, fainting
• ringing or buzzing in the ears
• pharyngitis, nosebleeds
• constipation, bloating, vomiting, gastroenteritis, diarrhea
• abnormal liver function test results ,increased liver enzyme activity
• skin rash
• joint pain
• pain or difficulty urinating, pallor
• difficulty achieving an erection (impotence)
• facial pain or swelling
• weight gain, hypokalemia, hypoglycemia.

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

• cerebrovascular disorders
• laryngeal edema.

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

• orthostatic dizziness (dizziness when standing up from a sitting or lying position), tingling or numbness of hands and feet (paresthesia), hyperesthesia, muscle stiffness, taste disturbances, nightmares, memory loss
• decreased white blood cell count (which may cause frequent infections, with symptoms such as fever, chills, severe headache, or sore throat), anemia
• blurred vision
• decreased heart rate
• hot flashes
• bronchospasm (difficulty breathing, wheezing, or coughing)
• muscle cramps, muscle weakness
• polyuria (increased amount of urine excreted)
• increased urea and creatinine levels in the blood
• hives, hair loss (alopecia), rash due to bleeding under the skin (purpura)
• urinary disorders, need to urinate at night, increased urine volume
• temporary breast enlargement in men (gynecomastia)
• feeling of tiredness (fatigue), general feeling of being unwell (malaise), decreased body temperature in elderly patients
• prolonged and painful erection. You should seek medical attention immediately.

Unknown frequency (frequency cannot be estimated from available data):

• during cataract surgery (clouding of the lens), eye disorders may occur. See section "When to be careful when taking Doxazosin Aurovitas".
• a small amount or absence of semen during ejaculation at the time of orgasm, cloudy urine after orgasm (retrograde ejaculation).

Reporting side effects

If you experience any side effects, including those not mentioned in this leaflet, you should tell your doctor or pharmacist. 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, you can help provide more information on the safety of this medicine.

5. How to store Doxazosin Aurovitas

The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date stated on the blister and carton after: Expiry date. The expiry date refers to the last day of the given month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Doxazosin Aurovitas contains

• The active substance of the medicine is doxazosin. Each 2 mg tablet contains 2 mg of doxazosin in the form of doxazosin mesylate. Each 4 mg tablet contains 4 mg of doxazosin in the form of doxazosin mesylate.
• The medicine also contains: microcrystalline cellulose, lactose, sodium carboxymethylcellulose (Type A), magnesium stearate.

What Doxazosin Aurovitas looks like and contents of the pack

2 mg tablets:
white to off-white, capsule-shaped tablets with 'D O' engraved on one side, separated by a score line, and '2' on the other side. The tablet can be divided into equal doses.
4 mg tablets:
white to off-white, rhomboid tablets with 'D O' engraved on one side, separated by a score line, and '4' on the other side. The tablet can be divided into equal doses.
Blisters:
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 authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 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

Date of last revision of the leaflet: 05/2024