Leaflet: information for the user

Doxazosina Neo Aurovitas Spain 4mg prolonged-release tablets EFG

Read this leaflet carefully before you start taking this medicine,because 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.Do not give it to others even if they have the same symptoms as you,as it may harm them.
• If you experience any side effects,consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know beforestarting totake Doxazosina Neo Aurovitas Spain

3.How to take Doxazosina Neo Aurovitas Spain

4.Possible side effects

5.Storage of Doxazosina Neo Aurovitas Spain

6.Contents of the pack and additional information

Doxazosina Neo Aurovitas Spain belongs to a group of medications called alpha-blockers. They are 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 blood vessels to allow blood to pass through them more easily. This helps to lower blood pressure.

In patients with an enlarged prostate, Doxazosina Neo Aurovitas Spain is taken to treat the ability to urinate when it is scarce and/or frequent. This is common in patients who have an enlarged prostate. Doxazosina Neo Aurovitas Spain acts by relaxing the muscle around the exit of the bladder and the prostate, facilitating the ability to urinate.

Do not take Doxazosina Neo Aurovitas Spain

• If you areallergicto doxazosina, other quinazolines (e.g., prazosina, terazosina), or any of the other components of this medication (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 havebenign prostatic hyperplasiaand also if you havekidney stonesor suffer fromobstructions or infectionsin the urinary tract.
• If you havebenign prostatic hyperplasia and urinary incontinence, havedifficulty urinatingor worsen thekidney problems.
• If you have any type of obstruction of the digestive tract.
• If you have a history of orthostatic hypotension (a drop in blood pressure caused by standing up too quickly).
• If you have abnormally low blood pressure (only applicable if you are being treated for an enlarged prostate).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxazosina Neo Aurovitas Spain.

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

Doxazosina Neo Aurovitas Spain is a modified-release tablet. This medication contains a non-absorbable coating that has been specially designed to allow the medication to be released slowly. As the empty coating is eliminated from the body by intestinal movements, you may occasionally see in your stool something that appears to be an empty tablet. This is normal and should not cause concern.

Children and adolescents

Do not recommend the use of Doxazosina Neo Aurovitas Spain in children or adolescents under 18 years old as its safety and efficacy have not been established.

Other medications and Doxazosina Neo Aurovitas Spain

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

It is especially important that your doctor knows if you have been treated with the following medications:

• Medications to treat erectile dysfunction in men (sildenafilo, tadalafilo, and vardenafilo); taken at the same time as doxazosina may cause a decrease in blood pressure.
• Some patients taking alpha-blockers for the treatment of high blood pressure or benign prostatic hyperplasia 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 medications for erectile dysfunction (impotence) with alpha-blockers. To reduce the likelihood of these symptoms occurring, you should be taking a regular daily dose of alpha-blockers before starting to take medications for erectile dysfunction.
• Other medications that lower blood pressure, as the effect of blood pressure lowering of these medications may be increased.
• Nonsteroidal anti-inflammatory drugs (NSAIDs), as they may reduce the effects of Doxazosina Neo Aurovitas Spain.
• Cimetidine, a medication used to treat stomach ulcers; if taken at the same time as doxazosina, it will increase the effect of doxazosina. Consult your doctor.
• Medications to treat bacterial or fungal infections, for example, claritromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medications used to treat HIV, for example, indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medication used to treat depression.

Pregnancy, breastfeeding, and fertility

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

Doxazosina may appear in breast milk in small amounts. Do not take this medication while breastfeeding your baby unless your doctor recommends it.

Driving and operating machinery

Be careful if you drive or use machines. The tablets may affect your ability to drive or use machines safely, especially when you start taking them for the first time. If this happens, do not drive or use machines and contact your doctor immediately.

Doxazosina Neo Aurovitas Spain contains sodium

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

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

Oral route.

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

The tablets can be takenwith or without food.

Doxazosina 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). Both conditions will be treated at the same time.

Adults including elderly people:

• Treatment of high blood pressure in adult men and women

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

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

The recommended dose is 4 mg of doxazosina (1 prolonged-release tablet) once a day. If necessary, the dose can be increased to 8 mg of doxazosina (2 prolonged-release tablets) once a day.

• Patients with liver function impairment

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

If you take more Doxazosina Neo Aurovitas Spain than you should

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

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount administered.

If you forget to take Doxazosina 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 the missed dose.Take the next dose at the usual time.

If you interrupt treatment withDoxazosina Neo Aurovitas Spain

Continue taking Doxazosina Neo Aurovitas Spain for the time recommended by your doctor, and do not stop taking it or change the dose without consulting your doctor.

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

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

Inform your doctor immediately and stop taking the medicine if you experience amedication allergy. If a skin rash appears, facial swelling, lip, tongue, throat swelling, difficulty breathing or swallowing, stop taking Doxazosina Neo Aurovitas Spain and contact your doctor immediately, you may need urgent medical attention or hospitalization.

Contact your doctor immediately if you have a heart attack. It is a rare but very serious side effect.

Contact your doctor immediately if you develop hepatitis (liver disease with nausea, vomiting, loss of appetite, discomfort, fever, itching, yellowish discoloration of the skin and eyes, and darkening of urine color) or jaundice (yellowish discoloration of the skin and white of the eyes) or experience narrowing of the airways. It is a rare but very serious side effect.

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

• Respiratory infection.
• Urinary tract infection.
• Dizziness and weakness and rarely fainting.
• Headache.
• Sleepiness.
• Loss of balance when getting up quickly.
• Palpitations (abnormal heartbeat) or very rapid heartbeat.
• Low blood pressure.
• Dizziness, especially when standing up suddenly.
• Bronchitis.
• Cough.
• Difficulty breathing.
• Runny nose or nasal congestion, sneezing, facial pain or pressure.
• Abdominal pain (stomach pain and discomfort).
• Indigestion and stomach acid.
• Dry mouth.
• Nausea.
• Itching.
• Back pain.
• Muscle pain.
• Urinary tract inflammation (cystitis).
• Involuntary urine loss.
• Chest pain.
• Weakness and loss of strength.
• Fluid retention in the legs.
• Symptoms similar to the flu.

Poorly frequent(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.
• Tinnitus (ringing in the ears).
• Chest pain in the center (angina pectoris).
• Constipation.
• Nasal bleeding.
• Gas.
• Vomiting.
• Diarrhea.
• Anomalous liver function analysis (detected by blood tests).
• Gastroenteritis.
• Skin rash.
• Joint pain.
• Blood in the urine.
• Painful urination.
• Urinating more frequently.
• Reduced sexual potency in men (impotence).
• Pain.
• Facial swelling.
• Weight gain.

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

• Obstruction of the digestive tract.

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

• Decrease in white blood cells (may cause more infections (such as fever, chills, sore throat or ulcers in the mouth) or platelets (may cause more bleeding or bruises) in the blood.
• Excitement or restlessness (agitation).
• Nervousness.
• Numbness.
• Dizziness related to posture.
• Blurred vision.
• Slowing of the heartbeat.
• Irregular heartbeat.
• Narrowing of the airways, for example, asthma (may cause difficulty breathing, wheezing, or coughing).
• Alteration in bile passage.
• Sudden redness.
• Loss of hair, baldness (alopecia).
• Skin rash with itching.
• Red or purple discoloration of the skin (purpura).
• Muscle cramps.
• Tickling or pins and needles.
• Urinating frequently at night.
• Increased urine volume.
• Difficulty urinating.
• Persistent and painful erection of the penis. Consult a doctor urgently.
• Increased breast size in men.
• Fatigue.
• General feeling of discomfort.

Frequency unknown(frequency cannot be estimated from available data):

• Intraoperative iris flaccid syndrome (SIFI) that may develop during cataract surgery.
• Alterations in taste.
• Retrograde ejaculation - semen is redirected to the urinary bladder instead of being ejaculated through the urethra as normally occurs.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medication does not require special storage conditions.

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

Do not use this medication after the expiration date that appears on the packaging and the blister pack after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Doxazosina Neo Aurovitas Spain

Appearance of the product and content of the packaging

The prolonged-release tablets of Doxazosina Neo Aurovitas Spain are round, biconvex, white in color, with the mark “DL”.

The packaging contains 10, 28, 30, 50, 90, 98, or 100 prolonged-release tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing:

Aurobindo Pharma B.V

Baarnsche Dijk 1

3741 LN Baarn

Netherlands

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

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

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

Netherlands Doxazosine Aurobindo Retard 4 mg , tablets with prolonged release

Portugal Doxazosina Ritisca

Date of the last review of this leaflet: july 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/