Leaflet: information for the user

Doxazosina Neo Aurovitas Spain 8 mg 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 is Doxazosina Neo Aurovitas Spain and what it is used for

2.What you need to know before starting to take 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

Your doctor may have prescribed Doxazosina Neo Aurovitas Spain because you have high blood pressure, which can increase the risk of heart disease or heart attack if not controlled. The active ingredient in the tablets, doxazosina, belongs to a group of medicines known as alpha-1 antagonists. These medicines work by dilating your blood vessels, which makes it easier for your heart to pump blood through them. This helps to lower your blood pressure and reduce the risk of heart disease.

You may also have been prescribed Doxazosina Neo Aurovitas Spain for the treatment of symptoms of benign prostatic hyperplasia (BPH). This condition means that the prostate, which is located below the bladder in men, has increased in size. This makes it difficult to empty the bladder. Doxazosina Neo Aurovitas Spain works by relaxing the muscle around the exit of the bladder and the prostate gland, which makes it easier to empty the bladder.

Doxazosina, contained in Doxazosina Neo Aurovitas Spain, may also be approved for the treatment of other diseases not listed in this leaflet. Consult your doctor, pharmacist or other healthcare professional if you have any questions and always follow their instructions.

Do not take Doxazosina Neo Aurovitas Spain

• If you are allergic to doxazosina or any of the other components of this medication (listed in section 6).
• If you are allergic to other medications in the same class as doxazosina, such as prazosina and terazosina.
• If you have low blood pressure or if you have ever had a drop in blood pressure that caused dizziness or fainting when standing up after lying down or sitting.
• If you have a benign enlargement of the prostate and at the same time an obstruction of the upper urinary tract, chronic urinary tract infection, or bladder stones.
• If you have or have had an obstruction of the digestive tract.
• If you are using this medication for the treatment of Benign Prostatic Hyperplasia (BPH) and have low blood pressure.
• If you have incontinence due to overflow or no urine production with or without worsening of renal function.

Warnings and precautions

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

• At the beginning of treatment. You may experience a drop in blood pressure accompanied by dizziness, weakness, and in rare cases, fainting. Avoid any situation that may cause injuries in the event of these symptoms appearing.
• If you suffer from an acute heart disease, such as heart failure.
• If you suffer from liver disease. In the case of severe liver disease, the use of Doxazosina Neo Aurovitas Spain is not recommended.
• If you are also taking medications for the treatment of erectile dysfunction (PDE-5 inhibitors, e.g. sildenafilo, tadalafilo, vardenafilo), as it may cause a significant drop in blood pressure. This is more likely to occur at the beginning of treatment with the PDE-5 inhibitor. This means that you must have stabilized on your doxazosina treatment before starting treatment with PDE-5 inhibitors. Your doctor may consider the use of an initial lower dose of PDE-5 inhibitor.
• If you are to undergo eye surgery because you have cataracts (opacity of the crystalline lens), inform your eye specialist before the operation that you are taking or have previously taken Doxazosina Neo Aurovitas Spain. This is because Doxazosina Neo Aurovitas Spain may cause complications during the operation that can be avoided if your eye specialist is informed in advance.

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

You may occasionally observe that there are remnants of tablets in your feces. This is normal. The active substance of the prolonged-release tablets is contained in a non-absorbable coating that has been specially designed to release the substance slowly into the body. When this process is completed, the empty coating is eliminated from the body through the feces.

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

Children and adolescents

Doxazosina Neo Aurovitas Spain is not recommended for use in children or adolescents under 18 years of age 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.

Some patients taking alpha-blockers for the treatment of high blood pressure or for prostate enlargement may experience dizziness or vertigo, which may be caused by a drop in blood pressure when sitting or standing up quickly. Certain patients have experienced these symptoms when taking medications for erectile dysfunction (impotence) together with alpha-blockers. In order to reduce the likelihood of these symptoms occurring, the daily dose of your alpha-blocker should be regularized before starting to use medications for erectile dysfunction.

Inform your doctor if you are taking any of the following medications in particular:

• Other alpha-blockers and other medications used in the treatment of high blood pressure.
• Non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen.
• Medications used to treat bacterial or fungal infections, for example, claritromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medications used in the treatment of HIV, for example, indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medication used to treat depression.

Pregnancy, breastfeeding, and fertility

Only for the indication of hypertension:

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. The experience of using doxazosina during pregnancy is limited.

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

Consult your doctor or pharmacist before using any medication.

There are no reports on the effects caused by doxazosina on male reproduction.

Driving and operating machinery

Doxazosina Neo Aurovitas Spain may cause dizziness. Be especially careful when taking the first dose, if your dose is increased, or if you restart the medication after an interruption in treatment. If you feel dizzy or vertigo, do not drive or operate machinery.

It is your responsibility to assess whether you are in a condition to drive or perform tasks that require special vigilance. One of the factors that may affect your ability in this regard is the use of medications, due to their effects and/or adverse reactions. The description of these effects and adverse reactions can be found in other sections. Therefore, read all the information in this prospectus. Consult with your doctor or pharmacist if you have any doubts.

Doxazosina Neo Aurovitas Spain contains sodium

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

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

Administration Form

Doxazosina Neo Aurovitas Spain has been produced in a special way that makes the active ingredient release slowly throughout the day. Choose the time of day that is most convenient for you and take your tablets at that time every day.

The tablets must be swallowed whole with a sufficient amount of liquid. Do not chew, break, or crush the tablets.

Treatment of High Blood Pressure and Symptoms of Benign Prostatic Hyperplasia:

Adults (including elderly patients)

The usual dose of doxazosina is 4 mg per day, although your doctor may increase your dose to 8 mg of doxazosina (one tablet) per day.

The maximum recommended dose is 8 mg of doxazosina per day. It may take up to 4 weeks to achieve optimal effect.

Patients with Liver Problems

Your doctor may reduce your dose or monitor your progress carefully. Doxazosina is not recommended for use in patients with severe liver problems.

If You Take More Doxazosina Neo Aurovitas Spain than You Should

If you take too many tablets or if, for example, a child takes the medication by mistake, contact your doctor, or go to the emergency room of a hospital immediately. If you have taken too many tablets, you may experience dizziness or vertigo due to a drop in blood pressure. Lie down on your back with your feet higher than your head.

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 ingested.

If You Forget to Take Doxazosina Neo Aurovitas Spain

If you forget to take a dose, do not worry. Simply take the tablet the next day when it is due. Do not take a double dose to make up for the missed doses.

If You Interrupt Treatment with Doxazosina Neo Aurovitas Spain

Continue taking the tablets until your doctor tells you to stop treatment.

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

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

Some side effects can be serious:

Stop taking this medicine and consult your doctor immediately or go to the nearest hospital if you experience any of the following:

• Allergic reactions such as sneezing, difficulty breathing, severe dizziness or fainting, swelling of the face or throat, or severe skin rash with red spots or blisters (may affect up to 1 in 100 people).
• Chest pain (angina; may affect up to 1 in 100 people), rapid or irregular heartbeat (may affect up to 1 in 10,000 people), heart attack or myocardial infarction (may affect up to 1 in 100 people).
• Yellowing of the skin or white of the eyes (jaundice) caused by liver problems (may affect up to 1 in 10,000 people).

Frequent side effects: may affect up to 1 in 10 people

• palpitations (strong heartbeats), increased heart rate,
• dizziness, headache, drowsiness,
• sensation of vertigo or spinning,
• inflammation of the airways (bronchitis), cough, difficulty breathing (dyspnea), rhinitis (itching, discharge, and nasal congestion),
• abdominal discomfort, stomach discomfort (dyspepsia), dry mouth, nausea,
• inflammation of the bladder (cystitis), loss of bladder control,
• itching on the skin,
• back pain, muscle pain,
• lung infection (respiratory tract infection), kidney or bladder infection (urinary tract infection),
• low blood pressure, sudden drop in blood pressure when standing up,
• weakness, flu-like symptoms, swelling, particularly of the feet and lower extremities (edema).

Rare side effects: may affect up to 1 in 100 people

• weight gain,
• reduced sensitivity, fainting, tremors,
• tinnitus (ringing in the ears),
• nasal bleeding,
• constipation, diarrhea, gas, vomiting, inflammation of the stomach and intestines,
• painful urination, blood in the urine, increased frequency of urination,
• skin eruptions,
• joint pain and stiffness (arthralgia),
• increased or decreased appetite, gout (painful form of arthritis),
• face swelling (facial edema),
• increased levels of liver enzymes,
• difficulty achieving an erection,
• anxiety, depression, insomnia.

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

• Obstruction of the digestive tract.

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

• reduced heart rate,
• reduced levels of certain blood cells (leucopenia, thrombocytopenia),
• dizziness when standing up, numbness with lack of sensation,
• blurred vision,
• constriction of the airways with difficulty breathing or sneezing (bronchospasm),
• problems urinating, increased need to urinate at night, increased production and volume of urine,
• hair loss, unusual bleeding or bruising, rash,
• muscle cramps, muscle weakness,
• seizures,
• fatigue, usually with discomfort,
• blockage of bile excretion from the liver (cholestasis), inflammation of the liver (hepatitis),
• breast growth in men,
• persistent and painful erection of the penis.Consult a doctor urgently,
• agitation, nervousness.

Unknown frequency: the frequency cannot be estimated from the available data

• complications (“Intraoperative Flaccid Iris Syndrome”) during cataract surgery (see section 2 “Warnings and precautions”),
• retrograde ejaculation – occurs when semen is redirected to the urinary bladder instead of being normally ejaculated through the urethra.

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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance 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.

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 blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Doxazosina Neo Aurovitas Spain

• The active ingredient is doxazosin (as mesilate). Each prolonged-release tablet contains 8 mg of doxazosin (as mesilate).

• The other components are:

Tablet core: polyethylene oxide (MW 900,000), polyethylene oxide (MW 200,000); microcrystalline cellulose, povidone (K29-32), butylhydroxytoluene (E321), all-rac-?-tocopherol, anhydrous colloidal silica, sodium stearate fumarate.

Tablet coating: 30% dispersion of methacrylic acid-ethyl acrylate copolymer (1:1), hydrated colloidal silica, macrogol 1300-1600, titanium dioxide (E171).

Appearance of the product and contents of the package

The tablets are white, round, biconvex, with the letters “DH” engraved on one face.

The medicine is packaged in:

• PVC/PVDC/aluminum blisters of 7, 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 tablets.
• Calendar blisters: 7, 14, 28, 56, and 98 tablets.
• Unit-dose packaging: 50 x 1 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holderof 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

Or

Arrow Generiques

26 Avenue Tony Garnier

69007 Lyon

France

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

SpainDoxazosina Neo Aurovitas Spain 8 mg prolonged-release tablets EFG

FranceDoxazosine Arrow LP 8 mg, prolonged-release tablet

IrelandRaporsin 8 mg Prolonged Release Tablets

NetherlandsDoxazosine Aurobindo Retard 8 mg, tablets with prolonged release

PortugalDoxazosina Ritisca

Date of the last review of this leaflet:July 2023

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