DOXAZOSIN Aurovitas 4 mg Tablets

2. What you need to know before you take Doxazosina Aurovitas

Do not take Doxazosina Aurovitas

• If you are allergic to doxazosina, to any other medicine of the same group (known by the name of quinazolines to which belong medicines such as prazosina and terazosina) or to any of the other components of this medicine (included in section 6).
• If you have a history of a condition known as “orthostatic hypotension” which is a form of low blood pressure that makes you feel dizzy or faint when you get up from a sitting or lying position.
• If you have an enlarged prostate with one of the following symptoms: congestion or blockage of the urine conduit, long-term infection of the urine conduit or stones (kidney stones) in the urine bladder.
• If you have an enlarged prostate (benign prostatic hyperplasia) andyou have low blood pressure.
• If you have overflow incontinence (you do not feel the urge to urinate) or anuria (your body does not produce urine) with or without kidney problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxazosina Aurovitas if:

• You suffer from serious heart problems such as, for example, severely reduced heart function or a limited and painful sensation in the chest (angina pectoris);
• You are on a strict low-salt diet;
• You are using diuretics;
• You have kidney or liver problems.

Inform your eye specialist that you are using or have used Doxazosina Aurovitas if you are going to have cataract surgery (cloudy lens in the eye). Doxazosina Aurovitas may cause complications during the intervention that can be controlled by the specialist if they have been previously warned.

Important information about Doxazosina Aurovitas

The possibility of a sudden drop in blood pressure is greater at the beginning of treatment or when the dose is increased. This may manifest as dizziness or, more rarely, fainting when changing posture. To reduce the risk of this happening, the doctor should check blood pressure at the beginning of treatment and when the dose is increased. Situations in which dizziness or fainting may cause injury should be avoided at the beginning of treatment.

Doxazosina Aurovitas may also affect the results of some blood and urine tests. Warn that you are taking Doxazosina Aurovitas if you are going to have blood or urine tests.

Other medicines and Doxazosina Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

• Some patients who take alpha-blocker medicines for the treatment of high blood pressure or for prostate enlargement may experience dizziness or fainting that can be caused by a drop in blood pressure when sitting or standing up suddenly. Certain patients have experienced these symptoms when taking medicines for erectile dysfunction (impotence) with alpha-blockers. To reduce the possibility of these symptoms occurring, the daily dose of alpha-blocker should be regularized before taking medicines to treat erectile dysfunction.
• Doxazosina may further lower blood pressure if you are already taking other medicines to treat high blood pressure, such as terazosina and prazosina.
• Medicines to treat bacterial or fungal infections, for example, clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used in the treatment of HIV, for example, indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medicine used to treat depression.
• Nitrates (medicines for heart problems) such as nitroglycerin and isosorbide nitrate, as they may increase the effect of lowering blood pressure.

• Certain pain relievers for rheumatism (known as non-steroidal anti-inflammatory medicines) such as naproxen, ibuprofen, or any other anti-inflammatory pain reliever, as they may reduce the effect of lowering blood pressure.
• Medicines that may also affect liver metabolism, such as cimetidine (a medicine for stomach problems).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are pregnant or think you may be, you should contact your doctor before taking Doxazosina Aurovitas. Doxazosina Aurovitas should only be used during pregnancy if your doctor decides that the benefit to the mother outweighs the possible risk to the fetus.

Small amounts of doxazosina may pass into breast milk. You should not use doxazosina during breastfeeding unless your doctor recommends it.

Driving and using machines

Doxazosina may cause dizziness or fainting. If this happens, be careful during activities that require attention, such as driving, operating machinery, and working at heights. Consult your doctor if you are unsure whether doxazosina will have a negative effect on your ability to drive.

Doxazosina Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Doxazosina Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially, “sodium-free”.

3. How to take Doxazosina Aurovitas

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

BLOOD PRESSURE

The initial dose is 1 mg per day (every 24 hours) in a single dose. After 1 to 2 weeks, the dose is usually increased to 2 mg taken in a single daily dose (every 24 hours). This dose is maintained for 1 to 2 weeks. If necessary, the dose can be further increased up to 4, 8, or 16 mg per day, until the desired reduction in blood pressure is achieved. The maximum daily dose is 16 mg.

The initial dose should be taken preferably before going to bed; any dizziness that may be experienced will be a minor problem.

ENLARGED PROSTATE

The initial dose is 1 mg per day (every 24 hours) in a single dose. After that, the usual dose is 2 mg or 4 mg per day. In some circumstances, the dose may be increased up to a maximum of 8 mg per day.

The tablets should be taken every day as a single dose (every 24 hours). The tablets should be taken with plenty of water.

If you take more Doxazosina Aurovitas than you should

Consult your doctor immediately or go to the emergency department of the nearest hospital, taking this leaflet with you or call the Toxicology Information Service (telephone 91-562.04.20), indicating the medicine and the amount ingested. If you feel extremely dizzy or think you may faint, lie down with your head towards your feet.

If you forget to take Doxazosina Aurovitas

If you forget to take a dose, take your normal dose when it is time for your next dose. Consult your doctor or pharmacist if you are unsure. Do not take a double dose to make up for forgotten doses.

If you stop taking Doxazosina Aurovitas

If treatment with doxazosina is suddenly interrupted, the problems that existed before starting treatment may return. Therefore, it is advised not to interrupt this treatment suddenly. The doctor will gradually decrease the dose. Always consult your doctor or pharmacist if you are unsure.

If you have any other questions about the use of this product, ask 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 can be serious:

Stop taking this medicine and go to a doctor or the nearest hospital immediately, if you notice any of the following side effects:

• Allergic reactions such as wheezing, difficulty breathing, severe dizziness or fainting, swelling of the face or throat, or severe skin rash with red spots or blisters.
• Chest pain (angina pectoris), increased heart palpitations or irregular heartbeats, heart attack, or stroke (symptoms may include fainting, numbness or weakness of the arms or legs, headache, dizziness, and confusion, visual disturbance, difficulty swallowing, stuttering, or loss of speech).
• Yellowing of the skin or the whites of the eyes, caused by liver problems (jaundice).
• Bruises or unusual bleeding caused by a low platelet count.
• Blood in the urine.
• Hepatitis (liver disease with nausea, vomiting, loss of appetite, general malaise, fever).
• Cholestasis (bile flow blocked – can cause itchy skin, light-colored stools, and dark urine).

These side effects are uncommon (affect less than 1 in 100 patients) or rare (affect less than 1 in 1,000 patients).

Other side effects:

Common (may affect up to 1 in 10 people):

• Respiratory infection (nose, throat, lungs).
• Urinary infection (symptoms may include pain or burning when you urinate or a frequent need to urinate), urinary incontinence (inability to control the flow of urine).
• Dizziness, drowsiness (somnolence), headache.
• Feeling of dizziness or spinning (vertigo).
• Feeling of irregular heartbeats (palpitations), increased heart rate.
• Drop in blood pressure and low blood pressure as a result of changing position from sitting or lying down (postural hypotension).
• Inflammation of the airways, cough, difficulty breathing, stuffy nose and/or fluid secretion from the nose.
• Abdominal pain, indigestion, dry mouth, feeling of nausea.
• Itching (pruritus).
• Back pain, muscle pain (myalgia).
• Bladder inflammation (cystitis), increased urine production.
• Feeling of weakness (asthenia), chest pain, flu-like symptoms.
• Swelling of the ankles, feet, or toes (peripheral edema), generalized edema.
• Accommodation disorders.

Uncommon(may affect up to 1 in 100 patients):

• Gout, increased appetite, anorexia (loss of appetite), thirst.
• Agitation, depression, anxiety, difficulty sleeping (insomnia), emotional instability, nervousness, tremors, apathy.
• Abnormal tear flow, photophobia.
• Stroke, reduced sense of touch, fainting.
• Ringing or noise in the ears (tinnitus).
• Pharyngitis, nosebleeds.
• Constipation, flatulence, vomiting (feeling of nausea), inflammation of the gastrointestinal tract, diarrhea.
• Abnormal liver function tests, increased liver enzymes.
• Skin rash.
• Joint pain.
• Pain or difficulty urinating, pallor.
• Difficulty having an erection (impotence).
• Pain, swelling of the face.
• Weight gain, hypokalemia, hypoglycemia.

Rare(may affect up to 1 in 1,000 patients):

• Cerebrovascular disorders
• Laryngeal edema.

Very rare(may affect up to 1 in 10,000 patients):

• Postural dizziness (dizziness as a result of standing up after sitting or lying down), tingling or numbness of hands and feet (paresthesia), hyperesthesia, muscle stiffness, altered taste, nightmares, memory loss.
• Decreased white blood cells (symptoms may include frequent infections such as fever, chills, sore throat, or mouth ulcers), anemia.
• Blurred vision.
• Slow heart rate.
• Hot flashes.
• Bronchospasm (difficulty breathing, wheezing, or coughing).
• Muscle spasms, muscle weakness.
• Polyuria (elimination of large amounts of urine).
• High levels of urea and creatinine in the blood.
• Hives (urticaria), hair loss (alopecia), rash caused by bleeding under the skin (purpura).
• Disorders of urination, need to urinate at night, increased volume of urine produced.
• Temporary breast growth in men (gynecomastia).
• Feeling tired (fatigue), indisposition (feeling of general malaise), decreased body temperature in elderly patients.
• Prolonged and painful erection of the penis. Consult a doctor urgently.

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

• Eye problems that may occur during cataract surgery (cloudy lens in the eye). See section “Be especially careful with Doxazosina Aurovitas”.
• Low or no ejaculation during orgasm, cloudy urine after orgasm (retrograde ejaculation).

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Doxazosina Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister pack and the carton after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Doxazosina Aurovitas

• The active substance is doxazosina. Each tablet contains 4 mg of doxazosina (as doxazosina mesylate).
• The other components (excipients) are: microcrystalline cellulose, lactose, sodium carboxymethyl starch (type A) (derived from potato starch), and magnesium stearate.

Appearance of the product and contents of the pack

White to off-white, rhomboid-shaped tablets, scored with “D O” on one side separated by a notch and a “4” on the other.

The tablet can be divided into equal doses.

Doxazosina Aurovitas 4 mg tablets are available in blister packs.

Package sizes: 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100, and 140 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Malta: Doxazosin Aurobindo 4 mg tablets

Poland: Doxazosin Aurovitas

Portugal: Doxazosina Aurovitas

Spain: Doxazosina Aurovitas 4 mg tablets EFG

Date of the last revision of this leaflet:September 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).