DOXAZOSIN VIR 4 mg TABLETS

Introduction

Package Leaflet: Information for the User.

DOXAZOSINA VIR 4 mg tablets EFG

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet.

Contents of the package leaflet

1. What is DOXAZOSINA VIR and what is it used for
2. What you need to know before taking DOXAZOSINA VIR
3. How to take DOXAZOSINA VIR
4. Possible side effects
5. Storage of DOXAZOSINA VIR
6. Contents of the pack and further information

1. What is DOXAZOSINA VIR and what is it used for

Doxazosin is indicated for the treatment of the following conditions:

??Arterial hypertension.

??Obstruction to urinary flow and symptoms associated with benign prostatic hyperplasia.

Doxazosin is a drug for the treatment of arterial hypertension (HTA) and benign prostatic hyperplasia (BPH). Doxazosin may be used in patients with BPH, whether they are hypertensive or normotensive. While changes in blood pressure in normotensive patients with BPH are clinically insignificant, patients who have both conditions, HTA and BPH, can be effectively treated.

2. What you need to know before taking DOXAZOSINA VIR

Do not take DOXAZOSINA VIR if:

• you are allergic (hypersensitive) to doxazosin or any of the other ingredients of DOXAZOSINA VIR.

Warnings and precautions

If you are going to undergo eye surgery for cataracts, please inform your doctor before the operation if you are taking or have taken DOXAZOSINA VIR previously. This is because DOXAZOSINA VIR may cause complications during the operation, which can be taken into account and controlled by your ophthalmologist if informed beforehand.

Treatment requires periodic monitoring by your doctor. If you notice symptoms such as dizziness, drowsiness, or palpitations, consult your doctor, who will consider adjusting the dose.

Treatment with doxazosin may cause marked hypotension, especially postural hypotension, associated with the administration of the first or initial doses. If this occurs, consult your doctor.

Use of DOXAZOSINA VIR with other medicines

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

Known hypersensitivity to quinazolines

Doxazosin did not present interaction when administered concomitantly with: warfarin, digoxin, phenytoin, and indomethacin. No adverse effects due to interaction have been observed when doxazosin was administered with other drugs used in the treatment of hypertension (thiazide diuretics, furosemide, beta-blockers), as well as with non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, oral antidiabetics, uricosuric agents, and anticoagulants.

Some patients who are receiving an alpha-blocker for the treatment of high blood pressure or prostatic hyperplasia may experience dizziness or fainting that can be caused by a decrease in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking medicines for erectile dysfunction (impotence) with alpha-blockers like DOXAZOSINA VIR. To reduce the likelihood of these symptoms occurring, you should be receiving your daily dose of alpha-blocker regularly before starting treatment for erectile dysfunction.

However, if you are taking any of the aforementioned drugs, you should consult your doctor.

Pregnancy, breastfeeding, and fertility:

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.

Because the safety of doxazosin during pregnancy and breastfeeding has not been established, its use is only advised when, in the doctor's judgment, there is no safer alternative therapy and when the disease itself poses a greater risk to the mother or fetus.

Driving and using machines:

The ability to perform activities such as operating machinery or driving vehicles may be impaired, especially at the start of treatment.

Important information about some of the ingredients of DOXAZOSINA VIR:

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take DOXAZOSINA VIR

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Remember to take your medicine.

This treatment has been indicated by your doctor specifically for you and your condition. The dose will be established by the doctor based on the needs of each patient. Depending on the individual response, the doctor may modify the dosage of doxazosin. Follow your doctor's instructions faithfully regarding the dose and method of use.

Doxazosin can be administered both in the morning and at night.

Arterial hypertension

Doxazosin is administered orally. The usual dose is 2-4 mg once a day. It is recommended to start treatment with the administration of 1 mg once a day for 1 or 2 weeks. According to the response of each patient, the dose can be increased to 2 mg, 4 mg, 8 mg, or 16 mg per day as the maximum dose, at intervals of 1 or 2 weeks between them, until the desired reduction in blood pressure is achieved in the patient.

Doxazosin can be administered with other medicines that your doctor has prescribed for the treatment of arterial hypertension.

Benign prostatic hyperplasia

Doxazosin is administered orally. The usual dose is 2-4 mg once a day. It is recommended to start treatment with the administration of 1 mg once a day. Depending on the response of each patient, the dose can be increased to 2 mg, 4 mg, or 8 mg per day as the maximum dose, at intervals of 1 or 2 weeks between them.

Use in children

There is no experience with the use of doxazosin in children.

Use in elderly patients

The safety and efficacy profile of doxazosin is similar in elderly patients (age = 65 years) and in young patients (age <65 years).< p>

Use in patients with renal insufficiency

Doxazosin can be used in this group of patients at the usually recommended doses.

Use in patients with hepatic insufficiency

As with any other drug metabolized entirely by the liver, doxazosin should be administered with caution in patients with evident hepatic insufficiency.

If you take more DOXAZOSINA VIR than you should:

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91.562.04.20, indicating the medicine and the amount taken.

Massive ingestion (overdose) of doxazosin can cause hypotension.

If you forget to take DOXAZOSINA VIR:

Do not take a double dose to make up for forgotten doses.

If you stop taking DOXAZOSINA VIR

Do not stop treatment without consulting your doctor.

4. Possible side effects

Like all medicines, DOXAZOSINA VIR can cause side effects, although not everybody gets them.

Doxazosin is a drug that is usually well tolerated.

The side effects are mainly due to the pharmacological properties of the preparation. Most side effects are transient or will be tolerated over continued treatment.

Frequent (<1%):fatigue/nausea, asthenia, headache, chest pain, somnolence, dizziness, postural dizziness, dizziness, edema, palpitations, muscle cramps, constipation, dyspepsia, breathing difficulties, nasal congestion, delayed ejaculation, apathy, frequent need to urinate, increased urination, accommodation problems.

Uncommon:facial/general edema, syncope, facial flushing, fever/chills, pallor, postural hypotension, arrhythmia, peripheral ischemia, angina pectoris, tachycardia, myocardial infarction, tremors, muscle weakness, anorexia, increased appetite, alopecia, epistaxis, bronchospasm, cough, pharyngitis, thirst, hypokalemia, gout, muscle pain, joint swelling/pain, muscle weakness, nightmares, memory loss, emotional instability, incontinence, urinary disorders, dysuria, abnormal ocular flow, photophobia, tinnitus, taste disorders.

Rare: may affect up to 1 in 1000:cerebrovascular disorders, depression, agitation, paresthesia, laryngeal edema, rash, itching, purpura, stomach pain, diarrhea, vomiting, jaundice, increased liver enzymes, hypoglycemia, blurred vision, impotence, priapism, dysgeusia, decreased body temperature in elderly patients.

Very rare: persistent and painful erection of the penis. Consult a doctor urgently.

Isolated cases:Increase in BUN and creatinine, decrease in erythrocytes, leukocytes, and platelets, postural hypotension, and, in rare cases, syncope at the beginning of treatment, especially at too high doses, but it can also appear if therapy is resumed after a short period of abandonment.

Reporting of side effects

If you experience any of the side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, Website: www.notificaRAM.es.

5. Storage of DOXAZOSINA VIR

Keep this medicine out of the sight and reach of children.

Do not use DOXAZOSINA VIR after the expiration date stated on the carton, after EXP. The expiration date is the last day of the month indicated.

Store at a temperature below 30°C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of DOXAZOSINA VIR

• The active ingredient of DOXAZOSINA VIR 4 mg tablets is Doxazosin (as mesylate). Each tablet contains 4 mg doxazosin.

The other ingredients (excipients) are: Microcrystalline cellulose, magnesium stearate, potato starch, anhydrous lactose, sodium lauryl sulfate, anhydrous colloidal silica.

Appearance of the product and pack contents

DOXAZOSINA VIR 4 mg is presented in the form of white, uncoated, oblong, and scored tablets.

The tablet can be divided into equal doses.

DOXAZOSINA VIR 4 mg tablets are available in blister packs containing 28 tablets.

Marketing authorization holder:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-70, Polígono Industria URTINSA II

28923 Alcorcón (Madrid)

Tel.: 91 486 29 90 Fax: 91 486 29 91

Manufacturer:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-70, Polígono Industria URTINSA II

28923 Alcorcón (Madrid)

Tel.: 91 486 29 90 Fax: 91 486 29 91

Or

INDUSTRIAL FARMACEUTICA CANTABRIA, S.A.

Pirita, 9. Torrejón de Ardoz (Madrid) - Spain

Or

ARENA PHARMACEUTICALS GMBH

Untere Brühlstrasse, 4

Zofingen - Switzerland

Date of the last revision of this package leaflet: November 2016.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.