Doxazosin Aurobindo

Leaflet accompanying the packaging: information for the user

Doxazosin Aurobindo, 1 mg, tablets

Doxazosin

Read the 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 not mentioned in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Doxazosin Aurobindo 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 tissues.
Doxazosin is used to treat:

• high blood pressure;
• symptoms of an enlarged prostate.

2. Important information before taking Doxazosin Aurobindo

When not to take Doxazosin Aurobindo

• if you are allergic to doxazosin, other quinazoline medicines (such as prazosin and terazosin) or any of the other ingredients of this medicine (listed in section 6); this may be itching, redness of the skin or difficulty breathing;
• if you are breastfeeding;
• if you are under 18 years old;
• if you have an enlarged prostate (benign prostatic hyperplasia) and low blood pressure;
• if you have "orthostatic hypotension", a form of low blood pressure that causes dizziness or fainting when standing up from a sitting or lying position;
• if you have an enlarged prostate with one of the following conditions: congestion or obstruction of the urinary tract, chronic urinary tract infection, or bladder stones;
• if you have urinary incontinence due to overflow (no feeling of needing to urinate) or anuria (the body does not produce urine) with or without kidney function disorders.

Warnings and precautions

Before starting to take Doxazosin Aurobindo, discuss it with your doctor or pharmacist if:

• you are pregnant or planning to become pregnant
• you have liver disease
• you are taking other medicines
• you have heart disease

If you are having eye surgery for cataracts (clouding of the lens), tell your ophthalmologist before surgery that you are taking or have taken Doxazosin Aurobindo. This is because Doxazosin Aurobindo may cause complications during surgery, which can be prevented if the ophthalmologist is informed in advance.
Before starting to take Doxazosin Aurobindo, your doctor may order tests to rule out conditions such as prostate cancer, which may cause the same symptoms as benign prostatic hyperplasia (enlarged prostate).
Persistent painful erections can occur very rarely. In such a case, seek medical attention immediately.
After starting to take Doxazosin Aurobindo, fainting or dizziness due to low blood pressure may occur when standing up from a sitting or lying position. If you feel weak or dizzy, sit or lie down until you feel better and avoid situations where you may fall or injure yourself. Your doctor may regularly check your blood pressure at the beginning of treatment to reduce the likelihood of these effects.

Doxazosin Aurobindo with other medicines

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. Some medicines may interact with Doxazosin Aurobindo.

• 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 standing up quickly or getting up. In some patients, these symptoms occur while taking medicines for erectile dysfunction with alpha-blockers. To reduce the likelihood of these symptoms, take the regular daily dose of alpha-blockers before starting to take medicines for erectile dysfunction.
• Doxazosin Aurobindo may further lower blood pressure if you are already taking other blood pressure medicines.
• 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.

Doxazosin Aurobindo with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

Before taking any medicine, consult your doctor or pharmacist.
The safety of doxazosin in pregnant women has not been established. If you are pregnant or think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Do not breastfeed while taking Doxazosin Aurobindo.

Driving and using machines

Doxazosin may occasionally cause dizziness or fainting. In such a case, be careful when performing tasks that require attention, such as driving vehicles, operating machines, and working at heights. If in doubt about whether doxazosin affects your ability to drive, discuss this with your doctor.

Doxazosin Aurobindo contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Doxazosin Aurobindo contains sodium

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

3. How to take Doxazosin Aurobindo

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

• The recommended dose of Doxazosin Aurobindo is one tablet taken once a day.
• If you are taking Doxazosin Aurobindo for the first time, the normal dose is 1 mg per day. Your doctor may increase this dose after a few weeks to the usual dose of 2 mg or 4 mg. In some cases, it may be increased to a maximum of 8 mg per day if you are being treated for enlarged prostate or up to 16 mg if you are being treated for high blood pressure.
• Doxazosin Aurobindo can be taken in the morning or evening.
• It is best to take the tablets at the same time every day, with a glass of water.
• Doxazosin Aurobindo can be taken with or without food.
• Take the tablets as directed by your doctor or according to the markings on the blister pack.
• It is important to continue taking the tablets. They help control your blood pressure.
• Do not change the dose or stop taking the tablets without consulting your doctor first.
• Do not wait until you have finished the medicine before visiting your doctor.

Using Doxazosin Aurobindo in children

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

Taking more than the recommended dose of Doxazosin Aurobindo

Taking too many tablets at once may cause you to feel unwell.
Taking several tablets can be dangerous. Tell your doctor or go to the nearest hospital immediately.

Missing a dose of Doxazosin Aurobindo

If you forget to take a tablet, skip that dose and take the next tablet at the usual time. Do not take a double dose to make up for the missed dose.

4. Possible side effects

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

Stop taking Doxazosin Aurobindo and contact your doctor immediately

or contact the emergency department of the nearest hospitalif you experience any of the following side effects:

• Heart attack
• Weakness of the arms, legs, or problems with speech, which may be symptoms of a stroke
• Swelling of the face, tongue, or throat, which may be a sign of an allergic reaction to this medicine

You should immediatelycontact your doctor if you experience any of the following side effects:

• Shortness of breath, difficulty breathing (common: may affect up to 1 in 10 people)
• Increased or decreased heart rate (common: may affect up to 1 in 10 people)
• Feeling of irregular heartbeat (palpitations) (common: may affect up to 1 in 10 people)
• Chest pain (angina pectoris) (uncommon: may affect up to 1 in 100 people)
• Irregular heartbeat (very rare: may affect up to 1 in 10,000 people)
• Yellowing of the skin or eyes (jaundice) (very rare: may affect up to 1 in 10,000 people)
• Low white blood cell or platelet count, which may cause bruising or bleeding easily (very rare: may affect up to 1 in 10,000 people)
• Persistent painful erections. Seek medical attention immediately (very rare: may affect up to 1 in 10,000 people)

Patients treated with Doxazosin Aurobindo have reported the following side effects.
If any of the side effects get worse or if you notice any side effects not listed in this leaflet, please tell your doctor.

Common: may affect up to 1 in 10 people

• Dizziness, feeling of spinning or rotation of the environment (dizziness), headache
• Low blood pressure
• Swelling of the feet, ankles, or toes
• Bronchitis, cough, respiratory tract infections (nose, throat, lungs)
• Stuffy nose, sneezing, and (or) runny nose caused by infection of the nasal mucosa (rhinitis)
• Abdominal pain, nausea
• Urinary tract infection, urinary incontinence (loss of control over urination), cystitis
• Drowsiness, general weakness
• Nausea, heartburn, dry mouth
• Itching
• Back pain, muscle pain
• Flu-like symptoms
• accommodation disorders

Uncommon: may affect up to 1 in 100 people

• Constipation, diarrhea, gastritis, which may cause diarrhea and vomiting
• Pain or discomfort when urinating, increased frequency of urination, presence of blood in the urine
• Gout (gouty arthritis), joint pain, general pain, thirst
• Swelling of the face, general swelling, chills, fever, paleness
• Insomnia, restlessness, anxiety, depression, or nervousness, emotional instability, apathy
• Decreased or changed sense of touch or feeling in hands and feet
• Increased or decreased appetite, weight gain, hypokalemia (low potassium levels in the blood)
• Nosebleeds, pharyngitis
• Rash
• Ringing or buzzing in the ears, tremors
• Impotence
• Increased liver enzyme activity, which may affect some medical tests
• Stroke
• Lacrimation, photophobia

Rare: may affect up to 1 in 1,000 people

• Decreased frequency of urination
• Muscle cramps, muscle weakness, muscle stiffness
• Hypoglycemia (low blood sugar)
• Vascular disorders of the brain
• Laryngeal edema
• Low body temperature in elderly patients

Very rare: may affect up to 1 in 10,000 people

• Weakness, dizziness caused by standing up from a sitting or lying position
• Hepatitis or bile disorders
• Hives, hair loss, red or purple spots on the skin, purpura
• Numbness or tingling of hands and feet, nightmares, memory loss, taste disorders
• Fatigue, general malaise
• Wheezing
• Blurred vision
• Hot flashes
• Urinary disorders, need to urinate at night, increased urine output
• Discomfort or swelling of the breasts in men

Frequency not known: frequency cannot be estimated from the available data

• Small or no semen during ejaculation during orgasm, cloudy urine after orgasm (retrograde ejaculation).
• During cataract surgery (clouding of the lens), eye disorders may occur. See "Warnings and precautions".

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack, bottle, and carton after EXP. The expiry date refers to the last day of the month.
There are no special precautions for the storage of the medicinal product.
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 Doxazosin Aurobindo contains

• The active substance is doxazosin. Each tablet contains 1 mg of doxazosin (as doxazosin mesylate).
• The other ingredients are: microcrystalline cellulose, lactose, sodium carboxymethylcellulose (Type A), magnesium stearate.

What Doxazosin Aurobindo looks like and contents of the pack

Tablets
White to off-white, round, biconvex tablets with "D O" engraved on one side and "1" on the other.
PVC/PVDC/Aluminum blisters:
Pack sizes: 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100, and 140 tablets
HDPE containers with PP closure:
Pack sizes: 100 tablets
Not all pack sizes may be marketed.

Marketing authorization holder:

Aurobindo Pharma (Malta) Limited
Vault 14, Level 2
Valletta Waterfront
Floriana, FRN 1913
Malta
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG 3000
Malta
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
Doxazosin Aurovitas
Germany:
Doxazosin Aurobindo 1mg Tabletten
Italy:
Doxazosin Aurobindo 2mg/ 4mg compresse
Poland:
Doxazosin Aurobindo
Spain:
DOXAZOSINA AUROBINDO 2mg comprimidos EFG

Date of last revision of the leaflet: 04/2024