Active ingredients: Doxazosin
CARDURA 2 mg tablets
CARDURA 4 mg tablets
Indications Why is Cardura used? What is it for?
Cardura contains the active substance doxazosin, which belongs to a group of medicines called alpha blockers. It is used for the treatment of high blood pressure (essential hypertension).
Cardura works by relaxing blood vessels, allowing blood to pass through them more easily. This helps in lowering blood pressure
Contraindications When Cardura should not be used
Do not take Cardura
- 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 are breast-feeding.
- If you have an enlarged prostate gland (benign prostatic hyperplasia) together with difficulty passing urine, chronic urinary tract infection, or stones in the bladder.
- 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 a particular form of "urinary incontinence in which there is" involuntary loss of "urine that occurs as a result of an overfilled bladder, or if you do not produce an adequate amount of urine, with or without a progressive loss of capacity kidneys to function.
Precautions for use What you need to know before taking Cardura
Talk to your doctor or pharmacist before taking Cardura.
When you start taking Cardura 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 occurring. If you are about to have eye surgery for cataracts (a clouding of the lens), please tell your eye doctor before the operation that you are using or have previously used Cardura.
Cardura can cause complications during surgery that can be managed if the specialist is notified in advance.
Tell your doctor or pharmacist before taking Cardura if any of the following apply to you, as Cardura 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. blood vessels. Using Cardura and these other medicines at the same time could cause your blood pressure to drop too much (see Other medicines and Cardura). To reduce the likelihood of symptoms occurring, you will need to start Cardura therapy first by taking a regular daily dose. Then, when your Cardura therapy is 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 change the effect of Cardura
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The following medicines may interact with Cardura 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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The safe use of Cardura during pregnancy has not been established. Therefore, if you are pregnant, your doctor will only prescribe Cardura if the potential benefits outweigh the risks.
Feeding time
Do not take Cardura if you are breastfeeding. Breastfeeding should be discontinued if it is necessary for you to start treatment with Cardura.
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.
Cardura 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 Cardura: Posology
Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist
The starting dose of Cardura 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. If necessary, after a further period of one or two weeks, the doctor may decide to increase the dose again to 4mg per day.
After a further period of one or two weeks and if necessary, the doctor may increase the dose again to 8 mg per day, until the blood pressure is lowered to the desired level.
In some cases the dose may be increased to a maximum of 16 mg per day. The usual dose is 2 - 4 mg per day. The maximum recommended dose is 16 mg per day. If necessary, your doctor will tell you to take other medicines together with Cardura to achieve the desired effect.
Cardura can be taken either in the morning or in the evening
Overdose What to do if you have taken too much Cardura
If you take more Cardura 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 Cardura than you should tell your doctor immediately or go to the nearest hospital emergency room.
If you forget to take Cardura
If you forget to take Cardura, skip the dose completely. Do not take a double dose to make up for a forgotten dose.
Side Effects What are the side effects of Cardura
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of these symptoms, STOP treatment with Cardura 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 Cardura:
- 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 Cardura
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;
- 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 in 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.
Contents of the pack and other information
What Cardura 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.
Description of what Cardura 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
CARDURA TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
CARDURA 2 mg tablets
One tablet contains:
Active principle:
Doxazosin mesylate ....................... 2.43 mg
(equal to doxazosin 2 mg)
CARDURA 4 mg tablets
One tablet contains:
Active principle:
Doxazosin mesylate .................... 4.85 mg
(equal 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
Essential arterial hypertension.
04.2 Posology and method of administration
CARDURA (doxazosin) can be administered indifferently in the morning or in the evening.
CARDURA (doxazosin) should be used once daily: the initial dose is 1 mg (for this dosage use the 2 mg divisible tablets) in order to minimize the potential risks of hypotension and / or syncope. 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, until the desired hypotensive effect is achieved.
The usual dose is 2-4 mg / day.
The maximum recommended dose is 16 mg / day. If necessary, it is possible to combine it with a thiazide diuretic, a beta-blocker, a calcium channel blocker or an ACE inhibitor, according to the doctor's judgment.
Patients with renal insufficiency: Since the pharmacokinetics of CARDURA (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 patients.
Patients with hepatic insufficiency: see section 4.4.
Elderly: same dosage as for adults.
Children: The tolerability and efficacy of CARDURA (doxazosin) in children have not been established.
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) during lactation (see section 4.6)
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.
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 low filling pressure
Use in patients with hepatic insufficiency: As with other drugs entirely metabolised by the liver, CARDURA (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 may 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.
CARDURA contains lactose, therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
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
Pregnancy
As there are no adequate and well-controlled studies in pregnant women, the safety of doxazosin during pregnancy has not been established. Consequently, doxazosin should only be used during pregnancy if the potential benefits outweigh the risks. Although no teratogenic effects were observed in animal experiments, reduced fetal survival was observed in animals at extremely high doses (see section 5.3: Preclinical safety data).
Pregnancy
Alternatively, mothers should discontinue breastfeeding when treatment with doxazosin is necessary (see section 5.3: Preclinical safety data).
Doxazosin is contraindicated during lactation as the drug accumulates in the milk produced by female rats and there is no information on excretion of the drug in the milk of lactating women.
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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
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: Antihypertensives. Alpha-adrenergic receptor blockers
ATC code: C02CA04
CARDURA (doxazosin) exerts a competitive and selective block of post-synaptic alpha-1 adrenergic receptors which translates, from the haemodynamic point of view, into a reduction of peripheral vascular resistance.
The administration of CARDURA (doxazosin) in hypertensive patients, reducing the total peripheral resistance, determines a clinically significant lowering of blood pressure. This effect is believed to result from the selective blockade of alpha-1 adrenegic receptors located in the vascular bed.
The hypotensive action of the drug in a single dose manifests itself in a clinically appreciable way over the entire 24-hour period, with a maximum between 2 and 6 hours after taking the drug. similar pressure reductions in both supine and standing positions.
The reduction in pressure following drug intake is gradual and any orthostatic effects observed in the first days of therapy are comparable to those of the most widely used antihypertensive treatments.
Unlike non-selective alpha-adrenergic blocking drugs, long-term therapy with CARDURA (doxazosin) has not been shown to induce drug tolerance.
Only occasional and insignificant increases in plasma renin and episodes of tachycardia have been observed during long-term treatment. CARDURA (doxazosin) induces positive effects on serum lipids, consisting in a significant increase in the HDL cholesterol / total cholesterol ratio and also determines a favorable reduction in triglycerides and total cholesterol. Therefore it constitutes an advantage over diuretics and beta-blockers which negatively affect these parameters.
Hypertension and increased plasma lipids are both known to be associated with coronary artery disease. Therefore, the favorable effect that treatment with CARDURA (doxazosin) exerts not only on blood pressure but also on lipids should be correlated with a corresponding reduction in the risk of coronary artery disease.
Treatment with CARDURA (doxazosin) causes regression of left ventricular hypertrophy, inhibition of platelet aggregation and also enhances the capacity of the tissue plasminogen activator. CARDURA (doxazosin) increases insulin sensitivity in patients with impaired glucose metabolism.
In a controlled clinical trial in hypertensive patients, CARDURA (doxazosin) therapy was associated with an improvement in erectile dysfunction. In addition, fewer cases of erectile dysfunction have been reported in patients treated with CARDURA (doxazosin) than in patients treated with other antihypertensives.
CARDURA (doxazosin) has not been shown to have negative metabolic effects so it can be administered in asthmatic, diabetic, gouty patients, in those with left ventricular dysfunction and in the elderly.
An in vitro study demonstrated the antioxidant properties of the 6 "and 7" hydroxymetabolites of CARDURA (doxazosin) at concentrations equal to 5 micromolar.
05.2 Pharmacokinetic properties
Absorption
At therapeutic doses, CARDURA (doxazosin) is well absorbed after oral administration with a plasma peak between 2 and 4 hours.
Biotransformation / elimination
Plasma clearance is biphasic with a terminal half-life of approximately 22 hours, which justifies once-daily administration. CARDURA (doxazosin) is extensively metabolised and less than 5% is excreted in the faeces as unchanged drug.
Studies carried out 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 of 43% and a decrease in clearance of 40%.As with all drugs entirely metabolised by the liver, CARDURA (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. For further information see section 4.6.
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
CARDURA 2 mg tablets - 30 divisible tablets - AIC n. 026821013
CARDURA 4 mg tablets - 20 divisible tablets - AIC n. 026821025
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
May 2, 1989 - May 31, 2010
