Active ingredients: Doxazosin
BENUR 2 mg tablets
BENUR 4 mg compress
Why is Benur used? What is it for?
Benur contains the active substance doxazosin, which belongs to a group of medicines called prostatic urologicals. It is used to treat symptoms caused by an enlarged prostate, a gland in the male genital system.
In patients who have an enlarged prostate gland, Benur is used to treat low and / or frequent urine flow. Benur works by relaxing the muscle around the exit of the bladder and the prostate gland in order to facilitate the escape of urine.
Contraindications When Benur should not be used
Do not take Benur
- If you are allergic to doxazosin, other types of quinazolines (such as prazosin or terazosin) or any of the other ingredients of this medicine
- If you have suffered from a disease known as 'orthostatic hypotension', a form of low blood pressure that causes dizziness or lightheadedness when getting up from a sitting or lying position.
- If you have an enlarged prostate gland (benign prostatic hypertrophy) together with: any kind of congestion or blockage of the urinary tract, a persistent urinary tract infection or have stones in the bladder.
- If you suffer from too low blood pressure (hypotension).
- If you have a particular form of "urinary incontinence in which there is" involuntary loss of urine that occurs as a result of a bladder that is too full, or if you do not produce an adequate amount of urine, with or without a progressive loss of the capacity of the kidneys to function.
Precautions for use What you need to know before you take Benur
Talk to your doctor or pharmacist before taking Benur.
When you start taking Benur you may feel faint, dizzy and, rarely, fainting caused by a drop in blood pressure on getting up from a sitting or lying position. If you feel faint, dizzy or faint, you should sit down or lie down until you feel better and avoid situations in which you could fall or get injured. Your doctor may decide to measure your blood pressure regularly at the start of treatment to reduce the chance of these side effects.
If you are about to have eye surgery for cataracts (clouding of the lens), tell your eye doctor before the operation that you are using or have previously used Benur. Benur can cause complications during the surgery that can be managed. if the specialist is warned in advance.
Tell your doctor or pharmacist before taking Benur if any of the following apply to you, as Benur should be used with caution in these cases:
- If you have heart disease.
- If you have or have suffered from liver disease.
- If you are taking medicines to treat erectile dysfunction (impotence), called phosphodiesterase 5 inhibitors (eg sildenafil, tadalafil and vardenafil), as both medicines have the effect of lowering blood pressure by dilating the blood vessels Use of Benur and these other medicines at the same time could cause your blood pressure to drop too much (see Other medicines and Benur). To reduce the likelihood of symptoms occurring, you will need to start Benur therapy first by taking a regular daily dose. Then, when your Benur therapy has stabilized, you can start taking your erectile dysfunction medicines.
Prolonged and sometimes painful erections - this happens very rarely. If you have an "erection that lasts more than 4 hours, contact a doctor immediately.
Interactions Which drugs or foods can modify the effect of Benur
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The following medicines may interact with Benur if taken at the same time:
- Some medicines used to treat high blood pressure or enlarged prostate (called alpha blockers) may potentiate the blood pressure lowering effect of doxazosin.
- Some medicines used for erectile dysfunction (impotence) (called phosphodiesterase type 5 inhibitors, such as sildenafil, tadalafil and vardenafil) can cause excessive lowering of blood pressure accompanied by symptoms (see Warnings and precautions).
Warnings It is important to know that:
Pregnancy and breastfeeding
The use of Benur in women is not indicated.
Driving and using machines
Be careful if you drive or use machines. These tablets may impair your ability to drive or use machines safely, particularly at the start of treatment. They may make you feel faint or dizzy. If you experience these symptoms, do not drive or operate machinery and contact your doctor immediately.
Benur contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Dose, Method and Time of Administration How to use Benur: Posology
Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
The starting dose of Benur is 1 mg given as a single dose every day.
After a week or two, your doctor may increase the dose to 2 mg per day, based on the results of your tests on the functioning of the bladder and urethra (small duct in the last urinary tract that carries urine from the bladder to the bladder). l "external) or according to your symptoms caused by prostate enlargement. If necessary, after a further period of one or two weeks, the doctor may decide to increase the dose again to 4mg per day. The doctor, after a further period of one or two weeks and if necessary, you can increase the dose again to 8 mg per day, however 8 mg per day is the maximum recommended dose.
Benur can be taken either in the morning or in the evening.
Overdose What to do if you have taken too much Benur
If you take more Benur than you should
Taking too many tablets at the same time can make you feel unwell, as your blood pressure drops too much. If this happens, lie on your back. Taking many tablets can be dangerous. If you take more Benur than you should tell your doctor immediately or go to the nearest hospital emergency department.
If you forget to take Benur
If you forget to take Benur, skip the dose completely. Do not take a double dose to make up for a forgotten dose.
If you forget to take the tablets for a few days, however, restarting Benur will be done starting again with the lowest dose of 1 mg.
Side Effects What are the side effects of Benur
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of these symptoms, STOP taking Benur and call an ambulance immediately:
- chest pain, chest pain (angina, myocardial infarction);
- feeling of difficulty in breathing (dyspnoea), accompanied by discomfort and a feeling of tightness in the chest (bronchospasm);
- sudden headache, feeling faint, weakness in the arms, legs or trouble speaking which could be symptoms of a stroke;
- swelling of the face and allergic reactions.
Tell your doctor immediately if you experience any of the following symptoms after taking Benur:
- fast, slow, or irregular heartbeat;
- perception of one's heartbeat (palpitations);
- yellowing of the skin or eyes (jaundice);
- low number of white blood cells or platelets in the blood. These situations may lead to a greater predisposition to contract infections or greater bruising or bleeding, respectively.
The following adverse events have also been reported in patients treated with Benur.
Common side effects (may affect up to 1 in 10 people):
- sensation of spinning or spinning of the surrounding environment (vertigo), headache;
- low blood pressure or low blood pressure when passing from a sitting or lying position to a standing position;
- swelling of the feet, ankles or fingers; 3
- bronchitis, cough, respiratory tract infection (nose, throat, lungs);
- stuffy nose, sneezing and / or runny nose due to "inflammation of the nasal mucosa (rhinitis);
- abdominal pain, nausea;
- urinary tract infection, urinary incontinence (inability to control and hold urine), inflammation of the bladder (cystitis);
- drowsiness, generalized weakness;
- feeling of fullness and stomach discomfort, dry mouth;
- itch;
- chest pain, back pain, muscle aches;
- flu-like symptoms.
Uncommon side effects (may affect up to 1 in 100 people):
- constipation, wind, inflammation of the stomach and intestines (gastroenteritis) which can cause diarrhea and vomiting;
- pain or discomfort when urinating, needing to urinate more often than usual, blood in the urine;
- joint swelling and inflammation (gout), joint pain, generalized pain;
- swelling of the face;
- insomnia, agitation, anxiety, depression or nervousness;
- temporary loss of consciousness;
- reduced or altered sensitivity to the touch of hands and feet;
- increase or loss of appetite, weight gain;
- nosebleed;
- rash;
- ringing or ringing in the ears, tremor;
- inability / inability to achieve or maintain penile erection;
- increase in liver enzymes which can affect some medical tests.
Rare side effects (may affect up to 1 in 1,000 people):
- increased number of times you need to urinate;
- muscle cramps, muscle weakness.
Very rare side effects (may affect up to 1 in 10,000 people):
- hepatitis (inflammation of the liver) or biliary disorder (cholestasis);
- hives, hair loss, red or purple patches on the skin, due to bleeding under the skin or mucous membranes (purpura);
- feeling of tingling or numbness in the hands and feet;
- fatigue, generally feeling unwell;
- blurred vision;
- hot flashes;
- disturbed urination, urge to urinate at night, increased urinary volume;
- breast enlargement in men;
- persistent and painful erection of the penis;
- sudden dizziness accompanied by loss of balance.
Other side effects (frequency cannot be estimated from the available data):
- retrograde ejaculation (seminal fluid is ejaculated not externally but into the bladder), which can give cloudy urine after orgasm;
- eye problems may arise during cataract surgery (clouding of the lens). See section "Warnings and precautions".
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Italian Medicines Agency at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
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 carton after "Expiry". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What Benur contains
The active ingredient is doxazosin.
Each 2 mg tablet contains 2.43 mg of doxazosin mesylate equivalent to 2 mg of doxazosin.
Each 4 mg tablet contains 4.85 mg of doxazosin mesylate corresponding to 4 mg of doxazosin.
The other ingredients are: microcrystalline cellulose, lactose, sodium starch glycolate, magnesium stearate, sodium lauryl sulfate.
What Benur looks like and contents of the pack
Blister in PVC-PVDC / Aluminum opacified with titanium dioxide.
Carton containing 30 divisible tablets of 2 mg in blister packs.
Carton containing 20 divisible tablets of 4 mg in blister packs.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
BENUR TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
BENUR 2 mg tablets
One tablet contains:
Active principle:
Doxazosin mesylate 2.43 mg (equivalent to doxazosin 2 mg)
BENUR 4 mg tablets
One tablet contains:
Active principle:
Doxazosin mesylate 4.85 mg (equivalent to doxazosin 4 mg)
Excipient with known effect: lactose
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
BENUR (doxazosin) is indicated in the treatment of urinary flow obstructions and symptoms associated with benign prostatic hypertrophy (BPH). It can be used in both hypertensive and normotensive BPH patients. with BENUR (doxazosin) are not clinically significant In patients with hypertension and BPH both conditions have been effectively treated with BENUR (doxazosin) -based monotherapy.
04.2 Posology and method of administration
BENUR (doxazosin) can be administered either in the morning or in the evening.
BENUR (doxazosin) should be used once daily: the recommended starting dose is 1 mg (for this posology 2 mg divisible tablets are used) in order to minimize the potential risks of hypotension and / or syncope. Depending on the patient's urodynamics and BPH symptoms, the dose can be increased to 2 mg after 1 or 2 weeks of treatment (see section 4.4) and subsequently to 4 and 8 mg after the same time interval. The average dosage is 2-4 mg / day; the maximum recommended dose is 8 mg / day.
If the administration is interrupted for a few days, the resumption of treatment will be done starting from the initial dosage of 1 mg.
Patients with renal insufficiency
Since the pharmacokinetics of BENUR (doxazosin) does not vary in patients with renal insufficiency nor does the drug aggravate pre-existing renal impairment, the posology remains unchanged in this type of patient.
Patients with hepatic insufficiency: see section 4.4
Elderly: same dosage as for adults.
04.3 Contraindications
Doxazosin is contraindicated in:
1) patients with known hypersensitivity to quinazolines (for example: prazosin, terazosin, doxazosin), or to any of the excipients listed in section 6.1
2) patients with a history of orthostatic hypotension
3) patients with benign prostatic hyperplasia and concomitant upper urinary tract congestion, chronic urinary tract infection or bladder stones
4) patients with hypotension
Doxazosin is contraindicated as monotherapy in patients with regurgitation urinary incontinence or with anuria, with or without progressive renal failure.
04.4 Special warnings and appropriate precautions for use
Initiation of therapy: In relation to the alpha-blocking properties of doxazosin, postural hypotension manifested by dizziness and weakness or, rarely, loss of consciousness (syncope), particularly at the initiation of therapy, may occur in patients. Therefore, prudent medical practice is prudent. monitor blood pressure at the start of therapy to minimize the risk of postural effects. Such patients should be advised to avoid situations that could lead to injury in case of dizziness or weakness during the initial phase of treatment with doxazosin.
BENUR contains lactose therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Use in patients with acute cardiac disease: As with any other antihypertensive vasodilator it is prudent medical practice to exercise caution when administering doxazosin to patients with the following acute cardiac conditions:
- pulmonary edema due to aortic or mitral stenosis
- high-output heart failure
- right ventricular failure following pulmonary embolism or pericardial effusion
- left ventricular failure with reduced filling pressure
Use in patients with hepatic insufficiency: As with other drugs entirely metabolised by the liver, BENUR (doxazosin) should be administered with particular caution to patients with impaired hepatic function. Since no clinical experience is available in patients with severe hepatic impairment, the use of doxazosin in these patients is not recommended.
Use with PDE-5 inhibitors: Particular caution should be exercised when doxazosin is concomitantly administered with phosphodiesterase type 5 inhibitors (such as sildenafil, tadalafil and vardenafil), as both drugs have vasodilatory effects and this could cause symptomatic hypotension in some patients.
To reduce the risk of orthostatic hypotension, it is recommended to initiate treatment with phosphodiesterase-5 inhibitors only if the patient is haemodynamically stabilized with alpha-blockers. In addition, it is recommended that treatment be initiated with the lowest possible dose of PDE-5 inhibitor, respecting a 6-hour time interval from taking doxazosin. No studies have been conducted with doxazosin in prolonged-release formulations.
Use in patients undergoing cataract surgery: "Intra-operative Floppy Iris Syndrome" (IFIS, a variant of "floppy iris syndrome") has been observed during cataract surgery in some patients previously treated or treated with tamsulosin. . Isolated cases have occurred with other alpha-1 adrenergic antagonists and the possibility of a class effect cannot be ruled out. Since the appearance of this syndrome may increase surgical complications during cataract surgery, the ophthalmic surgeon should first proceed. with surgery should be aware of current or previous treatment with alpha-1 adrenergic antagonists.
Priapism: Prolonged erections and priapism with alpha-1 adrenergic antagonists including doxazosin have been reported in post-marketing experience. In the case of an erection that persists for more than 4 hours, the patient should immediately consult a physician. If priapism does not occur. treated immediately, it can cause damage to the penile tissue and a permanent loss of potency.
04.5 Interactions with other medicinal products and other forms of interaction
Co-administration of doxazosin with a PDE-5 inhibitor may cause symptomatic hypotension in some patients (see section 4.4 Special warnings and precautions for use). Studies with doxazosin in prolonged release formulations have not been conducted.
Most (98%) of plasma doxazosin is protein bound. Data in vitro on human plasma indicate that doxazosin has no effect on the protein binding of digoxin, warfarin, phenytoin or indomethacin.
Clinical experience has shown that the administration of doxazosin in standard formulations does not involve interactions with thiazide diuretics, furosemide, beta-blockers, NSAIDs, antibiotics, oral hypoglycemic agents, uricosuric agents and anticoagulants. However, no data from studies are available. drug interaction.
Doxazosin potentiates the hypotensive action of other alpha-blockers and other antihypertensive agents. In a clinical study open-labelA single dose of 1 mg / day of doxazosin on day 1 of a four-day regimen of oral cimetidine (400 mg twice daily) was administered in 22 healthy male volunteers, a randomized, placebo-controlled day), resulted in a 10% increase in the mean AUC of doxazosin and no statistically significant alteration in the mean Cmax and mean half-life of doxazosin.
The 10% increase in mean AUC for doxazosin with cimetidine remains within the range of inter-subject variation (27%) in mean AUC for doxazosin with placebo.
04.6 Pregnancy and lactation
This section is not applicable.
04.7 Effects on ability to drive and use machines
The ability to engage in activities such as using machines or driving may be impaired, especially at the start of therapy.
04.8 Undesirable effects
The following undesirable effects have been observed and reported during treatment with doxazosin with the following frequencies: very common (≥ 1/10), common (≥ 1/100 to
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
Should the overdose result in hypotension, the patient should be immediately placed in the supine position, with the head down.
In individual cases, other supportive measures may be taken if deemed appropriate.
If this measure is inadequate, the shock must first be treated with volume expanders. If necessary, a vasopressor agent should be used.
Renal function should be monitored and supported as needed. Since doxazosin is highly bound to plasma proteins, dialysis is not indicated.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: prostatic urologicals.
ATC code: G04BX49.
BENUR (doxazosin) exerts a competitive and selective block of postsynaptic alpha-1 adrenergic receptors which translates, from the haemodynamic point of view, into a reduction of peripheral vascular resistance.
The administration of BENUR (doxazosin) to patients with BPH leads to a significant improvement in urodynamics and symptoms. This effect on BPH is believed to be due to the selective blockade of alpha adrenal receptors located in the prostatic muscle stroma, capsule and in the neck of the bladder.
BENUR (doxazosin) induces positive effects on serum lipids, consisting of a significant increase in the HDL / total cholesterol ratio. It also determines a favorable reduction of triglycerides and total cholesterol and increases the sensitivity to insulin in diabetic patients.
An improvement in sexual function has been observed in patients suffering from benign prostatic hypertrophy with erectile dysfunction, probably in relation to an "inhibition of the receptors that control the blood outflow of the corpora cavernosa and the subsequent penile detumescence; this phenomenon has also been observed in patients hypertensive.
BENUR (doxazosin) has been shown to be an effective antagonist of the alpha-1 adrenergic receptor subtype 1A, which accounts for more than 70% of the alpha-1 receptor subtypes present in the prostate. This explains the effectiveness of the drug in patients with BPH.
BENUR (doxazosin) has demonstrated prolonged efficacy and tolerability (eg up to 48 months) in the long-term treatment of BPH.
BENUR (doxazosin) has not been shown to have negative metabolic effects so it can be administered in patients with asthma, diabetes, gout, in patients with left ventricular dysfunction and in the elderly.
05.2 Pharmacokinetic properties
Absorption
At therapeutic doses, BENUR (doxazosin) is well absorbed after oral administration with a plasma peak approximately 2 hours after administration.
Biotransformation / elimination
Plasma clearance is biphasic with a terminal half-life of approximately 22 hours, which justifies once-daily administration. BENUR (doxazosin) is extensively metabolised and less than 5% is excreted in the faeces as unchanged drug.
Studies performed in elderly patients and patients with renal insufficiency have shown no changes in the main pharmacokinetic parameters compared to younger patients with normal renal function. There are only limited data on patients with hepatic insufficiency and on the effects of drugs known to affect hepatic metabolism (eg cimetidine).
In a clinical study in 12 patients with moderate hepatic impairment, administration of a single dose of doxazosin caused an increase in AUC by 43% and a decrease in clearance by 40%.
As with all drugs entirely metabolised by the liver, BENUR (doxazosin) should be administered with caution in patients with hepatic impairment (see section 4.4).
Approximately 98% of doxazosin is bound to plasma proteins.
Doxazosin is metabolised primarily by O-demethylation and hydroxylation.
05.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity and gastrointestinal tolerability.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Microcrystalline cellulose, lactose, sodium starch glycolate, magnesium stearate, sodium laurisulfate.
06.2 Incompatibility
None.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions
06.5 Nature of the immediate packaging and contents of the package
Blister in PVC-PVDC / Aluminum opacified with titanium dioxide.
Carton containing 30 divisible tablets of 2 mg in blister packs.
Carton containing 20 divisible tablets of 4 mg in blister packs.
06.6 Instructions for use and handling
No special instructions.
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Pfizer Italia S.r.l.
Via Isonzo 71, 04100 - Latina
08.0 MARKETING AUTHORIZATION NUMBER
BENUR 2 mg divisible tablets - AIC n. 029467014
BENUR 4 mg divisible tablets - AIC n. 029467026
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
10.0 DATE OF REVISION OF THE TEXT
September 1995 / September 2010
