User Information: Package Insert.

DOXAZOSINA VIR 4 mg Tablets EFG

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert.

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

2. What you need to know before starting to take DOXAZOSINA VIR

3. How to take DOXAZOSINA VIR

4. Possible side effects

5. Storage of DOXAZOSINA VIR

6. Contents of the pack and additional information

Doxazosina is indicated for the treatment of the following processes:

??Arterial hypertension.

??Obstruction of urine flow and associated symptoms with benign prostatic hyperplasia.

Doxazosina is a medication for the treatment of arterial hypertension (HTA) and benign prostatic hyperplasia (BPH). Doxazosina may be used in patients with BPH, whether hypertensive or normotensive. While modifications in blood pressure in normotensive patients with BPH are clinically insignificant, patients who meet both conditions, HTA and BPH, may be treated effectively.

Do not take DOXAZOSINA VIR if:

- you are allergic (hypersensitive) to doxazosina or to any of the other components of DOXAZOSINA VIR.

Warnings and precautions

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

The treatment requires regular monitoring by your doctor. In case you experience symptoms such as dizziness, drowsiness, or palpitations, consult with your doctor, who will consider adjusting the dose.

The treatment with doxazosina may cause significant hypotension, especially postural hypotension, associated with the administration of the first or first doses. In case of this eventuality, consult with your doctor.

Use of DOXAZOSINA VIR with other medications

Inform your doctor or pharmacist if you are using or have used recently other medications, even those acquired without a prescription.

Known hypersensitivity to quinazolines

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

Some patients receiving an alpha-blocker for the treatment of high blood pressure or prostate hypertrophy may experience dizziness or fainting that may be caused by a decrease in blood pressure when sitting or standing quickly. Some patients have experienced these symptoms when taking medications for erectile dysfunction (impotence) with alpha-blockers such as DOXAZOSINA VIR. In order 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 medications, you should consult your doctor.

Pregnancy, breastfeeding, and fertility:

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

Due to the lack of established safety of doxazosina during pregnancy and lactation, its use is only recommended when, in the opinion of the doctor, there is no safer alternative therapy and when the underlying disease poses a greater risk to the mother or fetus.

Driving and operating machinery:

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

Important information about some of the components of DOXAZOSINA VIR:

This medication contains Lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

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

Remember to take your medication.

This treatment has been indicated by your doctor specifically for you and your condition. The dosage will be established by the doctor based on the needs of each patient. Depending on the individual response, the doctor may modify the dosing of doxazosina. Follow faithfully the instructions of your doctor, as to the dosage and mode of use.

Hypertension

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

Arterial Hypertension

Doxazosina 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 may 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.

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

Benign Prostatic Hyperplasia

Doxazosina 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 may 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

No experience is available on the use of doxazosina in children.

Use in Elderly Patients

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

Use in Patients with Renal Insufficiency

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

Use in Patients with Liver Insufficiency

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

If you take more DOXAZOSINA VIR than you should:

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

A massive intake (overdose) of doxazosina may cause hypotension.

If you forgot to take DOXAZOSINA VIR:

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with DOXAZOSINA VIR

Do not interrupt treatment without consulting your doctor

Like all medications, DOXAZOSINA VIR may have adverse effects, although not everyone will experience them.

Doxazosina is a medication that is usually well tolerated.

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

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

Infrequent: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, sedation, hypokalemia, gout, muscle pain, joint swelling/pain, muscle weakness, nightmares, memory loss, emotional instability, incontinence, urinary alterations, dysuria, abnormal eye flow, photophobia, tinnitus, taste disturbances.

Rare: may affect up to 1 in 1000:cerebrovascular alterations, depression, agitation, paresthesia, laryngeal edema, urticaria, pruritus, 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.

Single cases:increase in BUN and creatinine, decrease in erythrocytes, leukocytes, and thrombocytes, 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 brief period of discontinuation.

Reporting Adverse Effects

If you experience any of these adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use, Website: www.notificaRAM.es

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

Do not use DOXAZOSINA VIR after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Keep at a temperature below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of DOXAZOSINA VIR

- The active ingredient of DOXAZOSINA VIR 4 mg tablets is Doxazosina (as mesilate). Each tablet contains 4 mg doxazosina.

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

Appearance of the product and content of the container

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.

Holder of the marketing authorization:

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

Responsible for manufacturing:

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

Last review date of this leaflet: November 2016.

More detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/