DOXAZOSIN NEO VIR 4 mg PROLONGED-RELEASE TABLETS

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

Do not take Doxazosin Neo Vir

• if you are allergic (hypersensitive) to doxazosin or any of the other ingredients of this medicine or to any quinazoline (e.g., prazosin, terazosin) (listed in section 6).
• if you have had low blood pressure when standing up
• if you have Benign Prostatic Hyperplasia (BPH) and have frequent urinary tract infections 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

Doxazosin should not be taken as the only therapy if you have severe kidney disorder (anuria or progressive renal failure) or suffer from loss of bladder control (urinary incontinence).

Warnings and precautions

Particularly at the start 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 dizziness or weakness that occurs during the start of doxazosin therapy.

Consult your doctor or pharmacist before starting to take doxazosin:

• if you have acute heart disease, such as heart failure.
• if you suffer from 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 medicines to treat impotence, such as sildenafil, tadalafil, and vardenafil, as taking these medicines at the same time as doxazosin may cause a drop in blood pressure. Your doctor will advise you regarding the necessary interval between taking these medicines and doxazosin.

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