Prospecto: information for the user

Doxazosina Neo Vir 4 mg prolonged-release tablets EFG

Read this prospectus carefully before starting to take the medicine because it contains important information for you.

- Keep this prospectus, as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medicine has been prescribed only for you and should not be given to other people,

although they may have the same symptoms, as it may harm them.

- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are

not listed in this prospectus. See section 4.

2. What you need to know before taking Doxazosina Neo Vir

3. How to take Doxazosina Neo Vir

4. Possible adverse effects

5. Storage of Doxazosina Neo Vir

6. Contents of the package and additional information

The active ingredient in its tablets, doxazosina, belongs to a group of medications known as alpha antagonists.

It is used to treat high blood pressure or the symptoms of Benign Prostatic Hyperplasia (BPH), which is caused by the enlargement of the prostate in men.

Your doctor may have prescribed doxazosina because your blood pressure is high (hypertension), which, if left uncontrolled, can increase the risk of cardiovascular disease or stroke. Doxazosina works by relaxing blood vessels, causing them to dilate and helping your heart pump blood through them more easily. This contributes to reducing your blood pressure and the risk of cardiovascular disease or stroke.

You may have been prescribed doxazosina to treat Benign Prostatic Hyperplasia (BPH) syndrome that causes prostate enlargement, which is located just below the bladder. The symptoms are poor and/or frequent urination. Doxazosina acts by relaxing the muscle that surrounds the bladder outlet, allowing urine to pass more easily.

Do not take Doxazosina Neo Vir

- If you are allergic (hypersensitive) to doxazosina or to any of the other ingredients of this medicine or to any quinazoline (e.g. prazosina, terazosina) (see section 6).

- If you have had low blood pressure when standing up

- If you have Benign Prostatic Hyperplasia (BPH) and have constant infections in the urinary tract or bladder stones

- If you have or have had intestinal obstruction

- If you are taking this product to treat symptoms of Benign Prostatic Hyperplasia and have low blood pressure

Do not take doxazosina as the only therapy if you have a severe kidney disorder (anuria or progressive renal insufficiency) or suffer from loss of bladder control (urinary incontinence).

Warnings and precautions

Particularly at the beginning of therapy, you may experience a drop in blood pressure when standing up (postural hypotension) characterized by dizziness and weakness or, rarely, loss of consciousness (syncope). Your doctor may monitor your blood pressure regularly at the start of therapy to minimize the risk of these effects. You should avoid situations that could cause harm as a result of the dizziness or weakness that occurs during the start of therapy with doxazosina.

Consult your doctor or pharmacist before starting to take doxazosina:

• if you have an acute heart condition, such as heart failure.
• if you have liver disease. Since there is no experience in patients with severe liver disease, use in these patients is not recommended.

• if you are a man and use medications to treat erectile dysfunction such as sildenafilo, tadalafilo, and vardenafilo, as taking these medications at the same time as doxazosina may cause a drop in blood pressure. Your doctor will advise you on the necessary interval between taking these medications and doxazosina.

if you are to undergo eye surgery for cataracts (cloudy lens), inform your eye specialist before the operation that you are using or have used doxazosina previously. This is because doxazosina may cause complications (Intraoperative Iris Flaccidity Syndrome) during the surgical intervention that can be treated if your specialist is prepared in advance.

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.

Children and Adolescents

Doxazosina is not recommended for use in children or adolescents under 18 years of age as its efficacy and safety have not been established in this population.

Use of Doxazosina Neo Vir with other medications

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

If you take doxazosina with medications used to lower blood pressure (alpha-blockers and other antihypertensives), doxazosina may increase its effect.

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

- Medications used to treat bacterial or fungal infections, for example, claritromicina, itraconazol, ketoconazol, telitromicina, voriconazol.

- Medications used in the treatment of HIV, for example, indinavir, nelfinavir, ritonavir, saquinavir.

- Nefazodona, a medication used to treat depression.

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication, including those acquired without a prescription.

Taking Doxazosina Neo Vir with food and drinks

This medication can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Only for the indication of hypertension:

Doxazosina should not be taken if you are pregnant or if you are trying to become pregnant.

Small amounts of doxazosina, the active ingredient of this medication, may pass into breast milk. Do not use doxazosina during breastfeeding, unless your doctor advises you to.

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

Driving and operating machines

You may feel dizzy, tired, or have blurred vision after taking your medication. If this happens, do not drive or operate machines. These effects are more likely to occur when you start taking the tablets or if your dose is increased or you have not taken them for a while.

Doxazosina Neo Vir contains sodium.

This medication contains less than 1 mmol of sodium (23 mg) per prolonged-release tablet, that is, it is essentially 'sodium-free'.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

For treating high blood pressure and symptoms of benign prostatic hyperplasia:

Adults (including elderly patients)

The usual dose of doxazosina is one tablet (4 mg of doxazosina) once a day, althoughyourdoctor may increase your dose up to a maximum of two tablets aday.

Children and adolescents

Doxazosina is not recommended for use in children and adolescents under 18 years old.

Patients with liver problems

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

Method of administration

Doxazosina can be taken with or without food, before, during, or after meals. The tablets should be swallowed whole with a sufficient amount of liquid. The tablets have been specially formulated to release doxazosina slowly. Do not chew or crush the tablets. Doxazosina can be taken at any time of the day. Choose a time that suits you and take the tablets at that time every day. Do not stop taking them until your doctor tells you to.

If you take more Doxazosina Neo Vir than you should

It is essential that you follow the dose on the label of your medication. If you or someone else ingests several of these tablets together, or if a child takes one of these tablets, contact your doctor, pharmacist, or hospital emergency unit immediately. Always carry the box and any remaining tablets with you, as this will speed up identification of the tablets. Symptoms of overdose include a feeling of dizziness or dizziness due to a drop in blood pressure.

If hypotension occurs due to overdose, you or the affected person should lie down immediately with the head down.

If you forgot to take Doxazosina Neo Vir

If you forget to take a dose, take the tablet the next day at the usual time. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Doxazosina Neo Vir

It is essential that you continue taking your tablets. They will help you control your blood pressure.

Do not change your dose or stop taking the tablets without first consulting your doctor.

Do not wait until your tablets run out to see 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.

Some side effects can be serious:

If any of the following side effects occur, stop taking this medicine and tell your doctor immediately or go to the nearest hospital emergency department:

- Allergic reactions such as wheezing, difficulty breathing, extreme dizziness or fainting, facial or throat inflammation, or a severe skin rash with red spots or blisters (affects 1 to 10 patients per 1,000).

- Chest pain (angina; affects 1 to 10 patients per 1,000), irregular heartbeats (affects fewer than 1 patient per 10,000), heart attack or stroke (affects 1 to 10 patients per 1,000)

- Yellowing of the skin or white of the eyes (jaundice), caused by liver problems (affects fewer than 1 patient per 10,000)

Other side effects:

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

• Palpitations (strong heartbeats), increased heart rate

• Dizziness, headache, drowsiness

• Sensation of dizziness or "spinning"

• Inflammation of the respiratory tract (bronchitis), cough, difficulty breathing (dyspnea), rhinitis (itching, runny nose, and nasal congestion)

• Abdominal discomfort, stomach upset (dyspepsia), dry mouth, nausea

• Bladder inflammation, urinary incontinence

• Itching skin

• Back pain, muscle pain

• Pneumonia, kidney or bladder infection

• Low blood pressure, sudden drop in blood pressure when standing up

• Weakness, flu-like symptoms, swelling, especially in the feet and lower extremities (edema)

Poorly frequent (may affect up to 1 in 100 people):

• Weight gain

• Numbness, fainting, tremors

• Tinnitus (ringing in the ears)

• Nosebleeds

• Constipation, diarrhea, flatulence, vomiting, inflammation of the stomach and intestines

• Painful urination, blood in the urine, increased frequency of urination

• Skin rash

• Joint pain and stiffness (arthritis)

• Increased or decreased appetite, gout (painful form of arthritis)

• Swelling, especially of the face (facial edema)

• Increased liver enzyme levels

• Inability to achieve an erection

• Anxiety, depression, insomnia

Rare (may affect up to 1 in 1,000 people)

• Intestinal obstruction

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

• Decreased heart rate

• Decreased levels of certain blood cells (leucopenia, thrombocytopenia)

• Dizziness when standing up, sensation of tingling with numbness

• Blurred vision

• Narrowing of the airways with difficulty breathing or wheezing (bronchospasm)

• Urination problems, increased need to urinate at night, increased urine production and volume

• Hair loss, unusual bleeding or bruising under the skin, rash

• Muscle cramps, muscle weakness

• Flushing

• Fatigue, general feeling of discomfort

• Obstruction of bile excretion from the liver (cholestasis), inflammation of the liver (hepatitis)

• Enlargement of the breasts in men,

????Persistent and painful erection of the penis. Consult a doctor urgently

• Restlessness, nervousness

Not known: cannot be estimated from available data:

• Complications ("Flaccid Iris Intraoperative Syndrome") during cataract surgery (see section 2 "Warnings and precautions")

• Delayed ejaculation - occurs when semen is redirected to the urinary bladder instead of being ejaculated normally through the urethra.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, including possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: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 label after CAD. The expiration date is the last day of the month indicated.

The medication does not require special conditions for conservation.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging

and medicines that you do not need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medicines that you do not need. This will help protect the environment.

Composition of Doxazosina Neo Vir

-The active ingredient is doxazosina 4 mg (as mesilato de doxazosina).

-The other components are:

Core of the tablet:Macrogol 200, Macrogol 900, microcrystalline cellulose (E460), povidone, butylhydroxytoluene (E321),?-tocopherol, hydrated colloidal silica (E551) and sodium stearate fumarate.

Coating of the tablet:copolymer of methacrylic acid (Eudragit 30 D-55), hydrated colloidal silica (E551), macrogol 1300-1600 and titanium dioxide (E171).

Appearance of the product and content of the container

Doxazosina Neo Vir are white, round, biconvex tablets with “DL” engraved on one face.

They are available in blister packs of 14, 20, 28, 30, 50, 98 or 100 tablets.

Not all container sizes may be marketed.

Holder of the marketing authorization:

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

C/ Laguna, 66-68-70. Industrial Park Urtinsa II

28923– Alcorcón (Madrid)

Spain

Responsible for manufacturing

MERCKLE GMBH

Ludwig-Merckle-Strasse, 3

D-89143 Blaubeuren

Germany

Or

TEVA OPERATIONS POLAND SP.Z.O.O.

Ul. Mogilska 80

31-546 Krakow, Poland

Or

INDUSTRIA QUÍMICA Y FARMACEUTICA VIR. S.A.

C/ Laguna 66-68-70 Pol. Industrial Urtinsa II,

Alcorcón, 28923 Madrid, Spain

Last review date of this leaflet: October 2023