Doxazosin Aurovitas 4 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Doxazosina Aurovitas 4 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Doxazosina Aurovitas belongs to a group of medicines called vasodilators. These substances cause the blood vessels to dilate, thereby reducing blood pressure. Doxazosina may also reduce tension in the muscle tissues of the prostate and urinary tract.

Doxazosina is used to treat:

• High blood pressure.
• Symptoms of enlarged prostate.

2. What you need to know before taking Doxazosina Aurovitas

Do not take Doxazosina Aurovitas

• If you are allergic to doxazosin, to any other medicine in the same group (known as quinazolines, which includes medicines such as prazosin and terazosin), or to any of the other ingredients of this medicine (listed in section 6).
• If you have a history of a condition known as "orthostatic hypotension," which is a form of low blood pressure that may make you feel dizzy or lightheaded when standing up from a sitting or lying position.
• If you have an enlarged prostate with any of the following symptoms: urinary tract obstruction or blockage, long-standing urinary tract infection, or bladder stones.
• If you have an enlarged prostate (benign prostatic hyperplasia) and 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

Talk to your doctor or pharmacist before taking Doxazosina Aurovitas if:

• You have serious heart problems, such as severely reduced heart function or a feeling of tightness and pain in the chest (angina pectoris);
• You are on a strict low-salt diet;
• You are taking diuretics;
• You have kidney or liver problems.

Inform your ophthalmologist (eye specialist) that you are taking or have previously taken Doxazosina Aurovitas if you are scheduled for cataract surgery (surgery for a cloudy lens in the eye). Doxazosina Aurovitas may cause complications during the procedure, which can be managed by the specialist if they are informed in advance.

Important information about Doxazosina Aurovitas

The risk of a sudden drop in blood pressure is higher at the beginning of treatment or when the dose is increased. This may present as dizziness or, more rarely, fainting when changing posture. To reduce the risk of this happening, your doctor should check your blood pressure at the start of treatment and when the dose is increased. At the beginning of treatment, avoid situations where dizziness or fainting could lead to injury.

Doxazosina Aurovitas may also affect the results of certain blood and urine tests. Inform your healthcare provider that you are taking Doxazosina Aurovitas if you are scheduled for blood or urine tests.

Other medicines and Doxazosina Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or lightheadedness caused by a drop in blood pressure when standing up quickly. Some patients have experienced these symptoms when taking erectile dysfunction (impotence) medications together with alpha-blockers. To reduce the risk of these symptoms, your daily dose of alpha-blocker should be stabilized before starting erectile dysfunction medication.

• Doxazosin may further lower 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, 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 mononitrate, as they may increase the blood pressure-lowering effect.

• Certain painkillers for rheumatism (known as non-steroidal anti-inflammatory drugs) such as naproxen, ibuprofen, or any other anti-inflammatory painkiller, as they may reduce the blood pressure-lowering effect.

• Medicines that may also affect liver metabolism, such as cimetidine (a medicine for stomach problems).

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or think you might be, 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 doxazosin may pass into breast milk. You should not use doxazosin while breastfeeding unless your doctor advises you to do so.

Driving and using machines

Doxazosina may occasionally cause dizziness or fainting. If this occurs, you should be cautious when performing activities that require alertness, such as driving, operating machinery, or working at heights. Consult your doctor if you are unsure whether doxazosin may negatively affect your ability to drive.

Doxazosina Aurovitas contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain 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 instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

HIGH BLOOD PRESSURE

The initial dose is 1 mg once daily (every 24 hours). After 1 to 2 weeks, the dose is usually increased to 2 mg taken as a single daily dose (every 24 hours). This dose is maintained for 1 to 2 weeks. If necessary, the dose may be further increased 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 preferably be taken before going to bed, as any dizziness that may occur would then be less problematic.

ENLARGED PROSTATE SIZE

The initial dose is 1 mg once daily (every 24 hours). The usual maintenance dose is then 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

Contact your doctor immediately or go to the nearest hospital emergency department, taking this leaflet with you or call the Toxicology Information Service (telephone 91-562.04.20), stating the medicine and the amount taken. If you feel extremely dizzy or think you might faint, lie down with your head low.

If you forget to take Doxazosina Aurovitas

If you forget to take a dose, take your usual dose at the next scheduled time. 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 doxazosin is stopped abruptly, the problems present before starting treatment may return. Therefore, it is advisable not to stop this treatment suddenly. Your doctor will gradually reduce the dose. Always consult your doctor or pharmacist if you are unsure.

If you have any further questions about the use of this product, ask 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:

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

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

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

Other adverse effects:

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

• Respiratory infection (nose, throat, lungs).
• Urinary tract infection (symptoms may include: pain or burning sensation when urinating or frequent need to urinate), urinary incontinence (inability to control urine flow).
• Dizziness, drowsiness (somnolence), headache.
• Sensation of dizziness or spinning (vertigo).
• Sensation of irregular heartbeat (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, nasal congestion and/or nasal discharge.
• 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 ankles, feet or fingers (peripheral edema), generalized edema.
• Accommodation disorders.

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

• Gout, increased appetite, anorexia (loss of appetite), thirst.
• Restlessness, depression, anxiety, difficulty sleeping (insomnia), emotional instability, nervousness, tremor, apathy.
• Abnormal tear flow, photophobia.
• Stroke, reduced sense or sensation of touch, fainting.
• Ringing or noise in the ears (tinnitus).
• Pharyngitis, nosebleed.
• Constipation, flatulence, vomiting (feeling of nausea), gastrointestinal tract inflammation, diarrhea.
• Abnormal liver function tests, increased liver enzymes.
• Skin rash.
• Joint pain.
• Pain or difficulty urinating, pallor.
• Difficulty achieving 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 upon standing up after sitting or lying down), tingling or numbness in hands and feet (paresthesia), hyperesthesia, muscle stiffness, taste disturbances, nightmares, memory loss.
• Decrease in white blood cells (symptoms may include frequent infections such as fever, severe chills, sore throat or mouth ulcers), anemia.
• Blurred vision.
• Slowing of the heartbeat.
• Hot flushes.
• Bronchospasm (difficulty breathing, wheezing or coughing).
• Muscle spasms, muscle weakness.
• Polyuria (passing large amounts of urine).
• Elevated blood levels of urea and creatinine.
• Hives (urticaria), hair loss (alopecia), rash caused by bleeding under the skin (purpura).
• Urination disorders, need to urinate at night, increased urine volume produced.
• Temporary breast enlargement in men (gynecomastia).
• Feeling tired (fatigue), malaise (general feeling of discomfort), decreased body temperature in elderly patients.
• Persistent and painful penile erection. Seek urgent medical advice.

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

• Eye problems that may occur during cataract surgery (cloudy eye lens). See section “Take special care with Doxazosin Aurovitas”.
• Reduced or absent ejaculation during orgasm, cloudy urine after orgasm (retrograde ejaculation).

Reporting of adverse effects:

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

5. Storage of 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 after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers 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 doxazosin. Each tablet contains 4 mg of doxazosin (as doxazosin 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

Uncoated tablets, white to off-white, rhomboid-shaped, marked with “D O” on one side separated by a score line and a “4” on the other side.

The tablet can be divided into equal doses.

Doxazosina Aurovitas 4 mg tablets are available in blister packs.

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

Only some pack 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 medicinal product 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 comprimidos EFG

Date of the most recent review of this leaflet: September 2023

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