Doxazosin Neo Aurovitas Spain 4 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Doxazosina Neo Aurovitas Spain 4mg prolonged-release tablets EFG

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

• Keep this leaflet. 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 must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Doxazosina Neo Aurovitas Spain belongs to a group of medicines called alpha-blockers. It is used to treat high blood pressure or symptoms caused by an enlarged prostate in men.

Doxazosina Neo Aurovitas Spain may be used to treat high blood pressure (hypertension) by relaxing the blood vessels, allowing blood to flow through them more easily. This helps lower blood pressure.

In patients with an enlarged prostate, Doxazosina Neo Aurovitas Spain is taken to treat difficulty urinating, such as weak stream and/or frequent urination. These symptoms are common in patients with an enlarged prostate. Doxazosina Neo Aurovitas Spain works by relaxing the muscle around the outlet of the bladder and the prostate, making it easier to urinate.

2. What you need to know before taking Doxazosina Neo Aurovitas Spain

Do not take Doxazosina Neo Aurovitas Spain

• If you are allergic to doxazosin, to other quinazolines (e.g., prazosin, terazosin), or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include skin rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.
• If you have benign prostatic hyperplasia (enlarged prostate) and also have bladder stones or suffer from obstructions or infections in the urinary tract.
• If you have benign prostatic hyperplasia (enlarged prostate) with urinary incontinence, have difficulty urinating, or experience worsening kidney problems.
• If you have any type of obstruction in the gastrointestinal tract.
• If you have a history of orthostatic hypotension (a drop in blood pressure occurring when standing up too quickly).
• If you have abnormally low blood pressure (this only applies if you are being treated for an enlarged prostate).

Warnings and precautions

Talk to your doctor or pharmacist before taking Doxazosina Neo Aurovitas Spain.

• If you have undergone surgery.
• At the beginning of treatment, you may experience fainting or dizziness due to low blood pressure when standing up from a sitting or lying position. If you feel like fainting or feel dizzy, sit or lie down until you feel better. Your doctor will monitor your blood pressure at the start of treatment.
• If you have an acute heart disease, swelling and/or fluid accumulation in the lungs (pulmonary edema), or heart failure.
• If you have acute heart failure due to a blood clot or fluid accumulation around the heart.
• If you have severe liver problems.
• If you are a man using medications to treat erectile dysfunction, such as sildenafil, tadalafil, or vardenafil, since taking these together with doxazosin may cause a decrease in blood pressure. Your doctor will advise you on the necessary interval between taking these medications and doxazosin.
• If you are scheduled for cataract surgery (loss of transparency of the lens). Before the operation, inform your ophthalmologist that you are currently using or have previously used Doxazosina Neo Aurovitas Spain. Doxazosina Neo Aurovitas Spain may cause complications during surgery, which can be managed if your specialist is informed in advance.
• If you undergo blood or urine tests; remember to inform your doctor or nurse that you are being treated with Doxazosina Neo Aurovitas Spain.

Before starting treatment with doxazosin, your doctor may perform tests to rule out other conditions such as prostate cancer, which can cause the same symptoms as benign prostatic hyperplasia.

Doxazosina Neo Aurovitas Spain is a modified-release tablet. This medicine contains a non-absorbable coating specifically designed to allow the medicine to be released slowly. Since the empty coating is eliminated from the body through intestinal movements, you may occasionally notice in your stools something that looks like an empty tablet. This is normal and should not be a cause for concern.

Children and adolescents

The use of Doxazosina Neo Aurovitas Spain is not recommended in children or adolescents under 18 years of age, as safety and efficacy have not yet been established.

Other medicines and Doxazosina Neo Aurovitas Spain

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Your treatment may be affected if Doxazosina Neo Aurovitas Spain is taken with other medicines.

It is especially important that your doctor knows if you are being treated with the following medicines:

• Medicines to treat erectile dysfunction in men (sildenafil, tadalafil, vardenafil); when taken together with doxazosin, they may cause a decrease in blood pressure.
• Some patients taking alpha-blockers for high blood pressure or an enlarged prostate may experience dizziness, which may be caused by low blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking erectile dysfunction medicines (impotence) together with alpha-blockers. To reduce the likelihood of these symptoms occurring, you should already be taking a regular daily dose of an alpha-blocker before starting erectile dysfunction medicines.
• Other medicines that lower blood pressure, as their blood pressure-lowering effect may be increased.
• Anti-inflammatory medicines of the NSAID type (non-steroidal anti-inflammatory drugs), as they may reduce the effects of Doxazosina Neo Aurovitas Spain.
• Cimetidine, a medicine used to treat stomach ulcers; if taken together with doxazosin, it may increase the effect of doxazosin. Consult your doctor.
• 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.

Pregnancy, breastfeeding, and fertility

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

Doxazosin may appear in breast milk in small amounts. You should not take this medicine while breastfeeding unless your doctor advises you to do so.

Driving and using machines

Be cautious if driving or using machines. The tablets may affect your ability to drive or operate machinery safely, especially when you first start taking them. If this occurs, do not drive or use machines and contact your doctor immediately.

Doxazosina Neo Aurovitas Spain contains sodium

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

3. How to take Doxazosin Neo Aurovitas Spain

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Oral use.

The tablets must be swallowed whole with a glass of water. Do not chew, break, or crush the tablets.

The tablets may be taken with or without food.

Doxazosin Neo Aurovitas Spain can be used if you have high blood pressure, as well as if you suffer from benign prostatic hyperplasia (enlargement of the prostate gland). Both conditions will be treated simultaneously.

Adults, including elderly people:

• Treatment of high blood pressure in adult men and women

The recommended dose is 4 mg of doxazosin (1 prolonged-release tablet) once daily. If necessary, the dose may be increased to 8 mg of doxazosin (2 prolonged-release tablets) once daily. It may take up to 4 weeks to achieve the optimal effect.

• Treatment of symptoms of benign prostatic hyperplasia (enlargement of the prostate gland) in adult men

The recommended dose is 4 mg of doxazosin (1 prolonged-release tablet) once daily. If necessary, the dose may be increased to 8 mg of doxazosin (2 prolonged-release tablets) once daily.

• Patients with impaired liver function

A dose reduction may be required. Always follow your doctor's instructions.

If you take more Doxazosin Neo Aurovitas Spain than you should

If you (or someone else) swallow many tablets at the same time, or if you suspect a child has swallowed any tablets, go to the nearest hospital or contact your doctor immediately.

In case of overdose, symptoms such as headache, dizziness, fainting, loss of consciousness, difficulty breathing, low blood pressure, palpitations, rapid or irregular heartbeat, or discomfort may occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Doxazosin Neo Aurovitas Spain

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for forgotten doses. Take the next dose at the usual time.

If you stop taking Doxazosin Neo Aurovitas Spain

Continue taking Doxazosin Neo Aurovitas Spain for as long as your doctor has recommended, and do not stop taking it or change the dose without consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Tell your doctor immediately and stop taking the medicine if you experience an allergic reaction to the medicine. If you develop a skin rash, swelling of the face, lips, tongue, throat, difficulty breathing or swallowing, stop taking Doxazosin Neo Aurovitas Spain and contact your doctor immediately; you may require urgent medical attention or hospitalization.

Contact your doctor immediately if you have a heart attack. This is an uncommon but very serious adverse effect.

Contact your doctor immediately if you develop hepatitis (liver disease with nausea, vomiting, loss of appetite, malaise, fever, itching, yellowing of the skin and eyes, and darkening of the urine) or jaundice (yellowing of the skin and whites of the eyes) or experience narrowing of the airways. This is a rare but very serious adverse effect.

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

• Respiratory infection.
• Urinary infection.
• Dizziness and weakness, and rarely fainting.
• Headache.
• Drowsiness.
• Loss of balance when standing up quickly.
• Palpitations (irregular heartbeat) or very rapid heartbeats.
• Low blood pressure.
• Dizziness, especially when standing up suddenly.
• Bronchitis.
• Cough.
• Difficulty breathing.
• Runny or stuffy nose, sneezing, facial pain or pressure.
• Abdominal pain (stomach ache and discomfort).
• Indigestion and heartburn.
• Dry mouth.
• Nausea.
• Itching.
• Back pain.
• Muscle pain.
• Inflammation of the urinary bladder (cystitis).
• Involuntary loss of urine.
• Chest pain.
• Weakness and loss of strength.
• Fluid retention in the legs.
• Flu-like symptoms.

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

• Loss of appetite.
• Gout.
• Increased appetite.
• Generalized fear.
• Anxiety.
• Mental state characterized by extreme sadness (depression).
• Difficulty sleeping.
• Stroke (inability to move one or more limbs on one side of the body, inability to understand or speak, or inability to see one side of the visual field).
• Decreased sense of touch.
• Loss of consciousness.
• Fainting.
• Involuntary tremors.
• Ringing in the ears.
• Pain in the center of the chest (angina pectoris).
• Constipation.
• Nosebleeds.
• Gas.
• Vomiting.
• Diarrhea.
• Abnormal liver function tests (detected by blood tests).
• Gastroenteritis.
• Skin rash.
• Joint pain.
• Blood in the urine.
• Pain when urinating.
• Urinating more frequently.
• Reduced sexual potency in men (impotence).
• Pain.
• Swelling of the face.
• Weight gain.

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

• Obstruction of the gastrointestinal tract.

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

• Decrease in white blood cells (may lead to more infections (such as fever, chills, sore throat or mouth ulcers) or in platelets (may lead to increased bleeding or bruising) in the blood.
• Excitement or restlessness (agitation).
• Nervousness.
• Numbness.
• Postural dizziness.
• Blurred vision.
• Slowing of the heartbeat.
• Irregular heartbeat.
• Narrowing of the airways, for example, asthma (may cause difficulty breathing, wheezing, or coughing).
• Impairment in bile flow.
• Sudden flushing.
• Hair loss, baldness (alopecia).
• Itchy skin rash.
• Red or purple skin discoloration (purpura).
• Muscle cramps.
• Tingling or pins and needles.
• Frequent urination at night.
• Increased amount of urine.
• Problems urinating.
• Persistent and painful erection of the penis. Seek medical advice urgently.
• Enlargement of the breasts in men.
• Tiredness.
• Feeling of general discomfort.

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

• Intraoperative floppy iris syndrome (IFIS) that may occur during cataract surgery.
• Taste disturbances.
• Retrograde ejaculation – occurs when semen is redirected into the urinary bladder instead of being ejaculated through the urethra as normally happens.

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Doxazosin Neo Aurovitas Spain

No special storage conditions are required.

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

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

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

6. Contents of the pack and other information

Composition of Doxazosina Neo Aurovitas Spain

• The active substance is doxazosin (each tablet contains 4.85 mg of doxazosin mesylate, equivalent to 4 mg of doxazosin).
• The other components are: polyethylene oxide, microcrystalline cellulose, povidone K29-32, butylated hydroxytoluene (E321), all-rac-alpha-tocopherol, anhydrous colloidal silica, sodium stearyl fumarate, methacrylic acid-ethyl acrylate copolymer, hydrated colloidal silica, macrogol 1300-1600 and titanium dioxide (E171).

Appearance of the medicine and contents of the pack

Doxazosina Neo Aurovitas Spain prolonged-release tablets are round, biconvex, white tablets, marked with “DL”.

Packs contain 10, 28, 30, 50, 90, 98 or 100 prolonged-release tablets.

Only certain 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:

Aurobindo Pharma B.V.

Baarnsche Dijk 1

LN Baarn, 3741

The Netherlands

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the European Economic Area member states under the following names:

Spain: Doxazosina Neo Aurovitas Spain 4 mg prolonged-release tablets EFG

The Netherlands: Doxazosine Aurobindo Retard 4 mg, tabletten met verlengde afgifte

Portugal: Doxazosina Ritisca

Date of the most recent revision of this leaflet: July 2023

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