Doxazosin Vir 2 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user.
DOXAZOSIN VIR 2 mg tablets EFG
Read all of this 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, pharmacist or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet.
Contents of this leaflet
- What DOXAZOSIN VIR is and what it is used for
- What you need to know before taking DOXAZOSIN VIR
- How to take DOXAZOSIN VIR
- Possible side effects
- How to store DOXAZOSIN VIR
- Contents of the pack and other information
1. What DOXAZOSIN VIR is and what it is used for
Doxazosin is indicated in the treatment of the following conditions:
??Hypertension.
??Urinary flow obstruction and symptoms associated with benign prostatic hyperplasia.
Doxazosin is a medicinal product used for the treatment of hypertension (HT) 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—HT and BPH—can be effectively treated.
2. What you need to know before starting to take DOXAZOSIN VIR
Do not take DOXAZOSIN VIR if:
- you are allergic (hypersensitive) to doxazosin or to any of the other components of DOXAZOSIN VIR.
Warnings and precautions
If you are undergoing cataract eye surgery, please inform your doctor before the procedure if you are currently taking or have previously taken DOXAZOSIN VIR. This is because DOXAZOSIN VIR may cause complications during surgery, which can be anticipated and managed by your ophthalmologist if previously informed.
Treatment requires periodic monitoring by your doctor. If you experience symptoms such as dizziness, lightheadedness, or palpitations, consult your doctor, who may consider adjusting your dose.
Treatment with doxazosin may cause marked hypotension, particularly postural hypotension, especially after the first or initial doses. If this occurs, consult your doctor.
Use of DOXAZOSIN VIR with other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
Known hypersensitivity to quinazolines.
Doxazosin showed no interaction when administered concomitantly with warfarin, digoxin, phenytoin, or indomethacin. No adverse effects due to interactions have been observed when doxazosin was administered together 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 receiving an alpha-blocker for the treatment of high blood pressure or benign prostatic hyperplasia may experience dizziness or fainting, which may be caused by a drop in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking medications for erectile dysfunction (impotence) together with alpha-blockers such as DOXAZOSIN VIR. To reduce the likelihood of these symptoms occurring, you should already be regularly taking your daily dose of alpha-blocker before starting treatment for erectile dysfunction.
Nevertheless, if you are taking any of the above-mentioned medicines, you must consult your doctor.
Pregnancy, breast-feeding, and fertility:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Since the safety of doxazosin during pregnancy and breast-feeding has not been established, it is only recommended for use when, in the physician's judgment, no safer therapeutic alternative exists and when the underlying condition poses a greater risk to the mother or fetus.
Driving and using machines:
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 DOXAZOSIN VIR:
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take DOXAZOSINA VIR
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.
Remember to take your medicine.
This treatment has been prescribed by your doctor specifically for you and your condition. The dose will be determined by your doctor according to each patient's individual needs. Depending on the individual response, your doctor may adjust the doxazosina dosage. Always follow your doctor's instructions carefully regarding dose and method of use.
Doxazosin may be taken either in the morning or at night.
Hypertension
Doxazosin is administered orally. The usual dose is 2–4 mg once daily. Treatment should be initiated at a dose of 1 mg once daily for 1 or 2 weeks. Depending on the patient's response, the dose may be increased to 2 mg, 4 mg, 8 mg, or up to a maximum of 16 mg daily, with dose increases made at intervals of 1 or 2 weeks, until the desired reduction in blood pressure is achieved.
Doxazosin may be used in combination with other medications prescribed by your doctor for the treatment of hypertension.
Benign prostatic hyperplasia
Doxazosin is administered orally. The usual dose is 2–4 mg once daily. Treatment should be initiated at a dose of 1 mg once daily. Depending on the patient's response, the dose may be increased to 2 mg, 4 mg, or up to a maximum of 8 mg daily, with dose increases made at intervals of 1 or 2 weeks.
Use in children
There is no experience regarding 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 younger patients (age < 65 years).
Use in patients with renal impairment
Doxazosin may be used in this patient group at the normally recommended doses.
Use in patients with hepatic impairment
As with any other drug entirely metabolized by the liver, doxazosin should be administered with caution in patients with evident hepatic impairment.
If you take more DOXAZOSINA VIR than you should:
Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91.562.04.20, indicating the medicine and the amount taken.
Massive ingestion (overdose) of doxazosin may 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 adverse effects
Like all medicines, DOXAZOSIN VIR may have adverse effects, although not everyone will experience them.
Doxazosin is a drug that is generally 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 time with continued treatment.
Common (<1%): fatigue/nausea, asthenia, headache, chest pain, somnolence, dizziness, postural dizziness, vertigo, edema, palpitations, muscle cramps, constipation, dyspepsia, breathing difficulty, 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 disturbances, dysuria, abnormal eye discharge, photophobia, tinnitus, taste disturbances.
Rare: 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 penile erection. Seek medical advice 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 excessively high doses, but it may also occur if therapy is resumed after a short interruption.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human 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 expiry date which is stated on the packaging, following EXP. The expiry date refers to the last day of the month indicated.
Store below 30°C.
Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy's SIGRE point. If in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of DOXAZOSINA VIR
- The active substance in DOXAZOSINA VIR 2 mg tablets is doxazosin (as mesilate). Each tablet contains 2 mg of doxazosin.
The other components (excipients) are: microcrystalline cellulose, magnesium stearate, potato starch, anhydrous lactose, sodium lauryl sulfate, colloidal anhydrous silica.
Appearance of the product and contents of the pack
DOXAZOSINA VIR 2 mg is presented as white, uncoated, oblong, scored tablets.
The tablet can be divided into equal doses.
DOXAZOSINA VIR 2 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 most recent revision of this leaflet: November 2016
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/