Doxazosin Neo Vir 4 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Doxazosina Neo Vir 4 mg prolonged-release tablets EFG

Read the entire 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 and must not be given to other people,

even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if

they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Doxazosina Neo Vir is and what it is used for

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

3. How to take Doxazosina Neo Vir

4. Possible adverse effects

5. How to store Doxazosina Neo Vir

6. Contents of the pack and other information

1. What Doxazosina Neo Vir is and what it is used for

The active substance in its tablets, doxazosin, belongs to a group of medicines known as alpha-blockers.

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

Your doctor may have prescribed doxazosin because your blood pressure is high (hypertension), which, if left uncontrolled, can increase the risk of heart disease or stroke. Doxazosin works by relaxing blood vessels, causing them to widen and helping your heart pump blood through them more easily. This helps reduce your blood pressure and the risk of heart disease or stroke.

You may have been prescribed doxazosin to treat Benign Prostatic Hyperplasia (BPH) syndrome, which causes enlargement of the prostate located just below the bladder. Symptoms include poor and/or frequent urination. Doxazosin acts by relaxing the muscle surrounding the outlet of the bladder, allowing urine to pass more easily.

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

Do not take Doxazosina Neo Vir

• if you are allergic (hypersensitive) to doxazosin or to any of the other ingredients of this medicine or to any quinazoline (e.g. prazosin, terazosin) (listed in section 6).
• if you have previously experienced low blood pressure upon 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 monotherapy if you have severe renal disorder (anuria or progressive renal failure) or suffer from bladder overflow incontinence.

Warnings and precautions

Particularly at the beginning of therapy, you may experience a drop in blood pressure upon standing (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 treatment to minimize the risk of these effects. You should avoid situations that could lead to injury as a result of dizziness or weakness occurring during the initial phase of doxazosin therapy.

Consult your doctor or pharmacist before starting doxazosin:

• 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 taking medications for erectile dysfunction such as sildenafil, tadalafil, or vardenafil, as taking these medications together with doxazosin may cause a drop in blood pressure. Your doctor will advise you on the necessary interval between taking these medications and doxazosin.

If you are scheduled for cataract eye surgery (cloudy lens), inform your ophthalmologist before the operation that you are currently taking or have previously taken doxazosin. This is because doxazosin could cause complications (Intraoperative Floppy Iris Syndrome) during surgery, which can be managed if your specialist is prepared in advance.

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

Children and adolescents

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

Use of Doxazosina Neo Vir with other medicines

Some patients taking alpha-blockers for high blood pressure or enlarged prostate may experience dizziness or lightheadedness caused by a drop in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking alpha-blockers together with medications for erectile dysfunction (impotence). To reduce the likelihood of these symptoms, your daily dose of alpha-blocker should be stabilized before starting medications for erectile dysfunction.

If you take doxazosin together with medicines used to lower blood pressure (alpha-blockers and other antihypertensives), doxazosin may enhance 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, for example, clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used in the treatment of HIV, for example, indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medicine used to treat depression.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Taking Doxazosina Neo Vir with food and drinks

This medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

For the indication of hypertension only:

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

Small amounts of doxazosin, the active substance in this medicine, may pass into breast milk. You should not take doxazosin while breastfeeding unless advised by your doctor.

If you are pregnant or breastfeeding, 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 experience blurred vision after taking this medicine. If this happens, you should not drive or operate machinery. These effects are more likely when you first start taking the tablets, when your dose is increased, or if you have missed doses.

Doxazosina Neo Vir contains sodium.

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

3. How to take Doxazosina Neo Vir

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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 daily. However, your doctor may increase your dose up to a maximum of two tablets per day.

Children and adolescents

The use of doxazosin is not recommended in children and adolescents under 18 years of age.

Patients with liver problems

Your doctor may reduce your dose or monitor your condition carefully. Doxazosin is not recommended for patients with severe liver problems.

Method of administration

Doxazosin may 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 unless instructed by your doctor.

If you take more Doxazosina Neo Vir than you should

It is important to follow the dosage instructions on your medicine label. 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 your hospital's emergency unit immediately. Always bring the pack and any remaining tablets with you, as this will allow faster identification of the medicine. Symptoms of overdose may include feeling dizzy or fainting 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 lowered.

If you forget to take Doxazosina Neo Vir

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

If you stop taking Doxazosina Neo Vir

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

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

Do not wait until you run out of tablets before seeing your doctor.

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

4. Possible adverse effects

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

Some adverse effects can be serious:

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

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

Other adverse 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 airways (bronchitis), cough, difficulty breathing (dyspnea), rhinitis (nasal itching, runny or blocked nose)
• abdominal discomfort, stomach upset (dyspepsia), dry mouth, nausea
• bladder inflammation, urinary incontinence
• skin itching
• back pain, muscle pain
• lung infection, kidney or bladder infection
• low blood pressure, sudden drop in blood pressure upon standing
• 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 sensation, fainting, tremor
• tinnitus (ringing in the ears)
• nosebleeds
• constipation, diarrhea, flatulence, vomiting, inflammation of the stomach and intestines
• pain when urinating, blood in the urine, increased frequency of urination
• skin rash
• joint pain and stiffness (arthralgia)
• increased or decreased appetite, gout (painful form of arthritis)
• pain, swelling, especially of the face (facial edema)
• increased levels of liver enzymes
• inability to achieve 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):

• decreased heart rate

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

• dizziness upon standing, tingling sensation with numbness

• blurred vision

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

• problems urinating, 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), liver inflammation (hepatitis)

• breast enlargement in men

• persistent and painful penile erection. Seek urgent medical advice

• restlessness, nervousness

Not known – frequency cannot be estimated from available data:

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

• delayed ejaculation – occurs when semen is redirected into the urinary bladder instead of being ejaculated normally through the urethra.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, including any possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 which is stated on the packaging, the box, and the label following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. 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 mesilate).

-The other components are:

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

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

Appearance of the medicinal product and contents of the pack

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

They are available in blister packs containing 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 most recent revision of this leaflet: October 2023