DOXAZOSIN NEO VIR 4 mg PROLONGED-RELEASE TABLETS

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

Children and Adolescents

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

Use of Doxazosin Neo Vir with other medicines

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

If you take doxazosin with medicines used to lower blood pressure (alpha-blockers and other antihypertensives), doxazosin may increase their effect.

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

• Medicines to treat bacterial or fungal infections, such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used in the treatment of HIV, such as indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medicine used to treat depression.

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine, including those obtained without a prescription.

Taking Doxazosin Neo Vir with food and drinks

This medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Only for the indication of hypertension:

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

Small amounts of doxazosin, the active substance of this medicine, may pass into breast milk. You should not use doxazosin during breastfeeding, unless your doctor advises you to.

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

Driving and using machines

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

Doxazosin Neo Vir contains sodium.

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

3. How to take Doxazosin Neo Vir

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, 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 doxazosin is one tablet (4 mg of doxazosin) once a day, although your doctor may increase your dose up to a maximum of two tablets a day.

Children and adolescents

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

Patient with liver problems

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

Method of administration

Doxazosin 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 doxazosin slowly. Do not chew or crush the tablets. Doxazosin can be taken at any time of 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 Doxazosin Neo Vir than you should

It is important to follow the dose on the label of your medicine. If you or someone else takes several of these tablets together, or if a child takes any of these tablets, contact your doctor, pharmacist, or the hospital emergency department immediately. Always carry the box and any remaining tablets with you, as this will help identify the tablets quickly. The symptoms of overdose include feeling dizzy or lightheaded due to a drop in blood pressure.

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

If you forget to take Doxazosin Neo Vir

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

If you stop taking Doxazosin Neo Vir

It is important that you keep taking your tablets. They will help you control your blood pressure.

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

Do not wait until you run out of tablets to see your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious:

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

• allergic reactions such as wheezing, difficulty breathing, extreme dizziness or collapse, swelling of the face or throat, or a severe skin rash with red patches or blisters (affects 1 to 10 patients in every 1,000).
• chest pain (angina pectoris; affects 1 to 10 patients in every 1,000), irregular heartbeats (affects less than 1 patient in every 10,000), heart attack, or stroke (1 to 10 patients in every 1,000)
• yellowing of the skin or whites of the eyes (jaundice), caused by liver problems (affects less than 1 patient in every 10,000)

Other side effects:

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

? palpitations (strong heartbeat), increased heart rate

? dizziness, headache, drowsiness

? feeling of dizziness or 'spinning'

? inflammation of the airways (bronchitis), cough, difficulty breathing (dyspnea), runny nose (rhinitis)

? abdominal discomfort, stomach upset (dyspepsia), dry mouth, nausea

? bladder inflammation, urinary incontinence

? itching of the skin

? back pain, muscle pain

? lung infection, kidney or bladder infection

? low blood pressure, sudden drop in blood pressure when standing up

? weakness, flu-like symptoms, swelling especially of the feet and lower limbs (edema)

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

? weight gain

? loss of sensitivity, fainting, tremor

? ringing in the ears (tinnitus)

? nosebleeds

? constipation, diarrhea, flatulence, vomiting, stomach and intestine inflammation

? painful urination, blood in the urine, increased frequency of urination

? skin rash

? joint pain and stiffness (arthralgia)

? increased or decreased appetite, gout (a painful form of arthritis)

? pain, swelling, especially of the face (facial edema)

? increased liver enzyme levels

? inability to get an erection

? anxiety, depression, insomnia

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

• blockage of the digestive tract

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

? slow heart rate

? decrease in certain blood cell counts (leukopenia, thrombocytopenia)

? dizziness when standing up, feeling of tingling with numbness

? blurred vision

? narrowing of the airways with difficulty breathing or wheezing (bronchospasm)

? urinary 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, feeling of general discomfort

? obstruction of bile flow from the liver (cholestasis), liver inflammation (hepatitis)

? breast enlargement in men,

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

? agitation, nervousness

Unknown: cannot be estimated from the available data:

? complications ("Intraoperative Floppy Iris Syndrome") during cataract surgery (see section 2 "Warnings and precautions")

? delayed ejaculation - this 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 side effects, consult your doctor, pharmacist, or nurse, including any possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Doxazosin Neo Vir 4 mg prolonged-release tablets

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 label after EXP. The expiry date is the last day of the month shown.

The medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and additional information

Composition of Doxazosin Neo Vir

- The active substance is doxazosin 4 mg (as doxazosin mesylate).

- The other ingredients are:

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

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

Appearance of the product and package contents

Doxazosin Neo Vir are white, round, biconvex tablets with "DL" engraved on one side.

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

Not all pack sizes may be marketed.

Marketing authorization holder:

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

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

28923– Alcorcón (Madrid)

Spain

Manufacturer

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

Date of the last revision of this leaflet: October 2023