Active ingredients: Potassium canrenoate
POTASSIUM CANRENOATE EG 100 mg film-coated tablets
Why is Potassium canrenoate used - Generic drug? What is it for?
What is POTASSIUM CANRENOATE EG and what it is used for
POTASSIUM CANRENOATE EG contains the active ingredient potassium canrenoate which belongs to a group of medicines called potassium-sparing diuretics which work by counteracting the action of aldosterone, which regulates sodium and potassium levels and the volume of fluids in the body.
POTASSIUM CANRENOATE EG is used to treat:
- elevated levels of aldosterone in the blood (primary aldosteronism);
- disorders caused by an accumulation of fluids in the body (edematous states) by secondary hyperaldosteronism such as heart problems (congestive heart failure), liver disease (liver cirrhosis in ascitic phase) or kidney (nephrotic syndrome);
- high blood pressure (essential arterial hypertension), if other treatments are not effective or tolerated.
Contraindications When Potassium canrenoate should not be used - Generic drug
Do not take POTASSIUM CANRENOATE EG
- if you are allergic to potassium canrenoate or any of the other ingredients of this medicine (listed in section 6);
- if you have severe kidney problems (acute and chronic kidney failure);
- if you are unable to urinate (anuria);
- if you have high levels of potassium in the blood (hyperkalaemia);
- if you have low levels of sodium in the blood (hyponatremia).
Precautions for use What you need to know before taking Potassium canrenoate - Generic drug
Talk to your doctor or pharmacist before taking POTASSIUM CANRENOATE STADA
During treatment with this medicine, and before surgery, your doctor will order tests to check the levels of mineral salts in your blood, as increases in potassium (hyperkalaemia), nitrogen (BUN) or substances may occur. acid in the blood (metabolic acidosis) or a decrease in sodium levels (hyponatremia). Your doctor will decide whether to discontinue therapy in case of major changes in blood salt levels.
Avoid taking potassium-rich foods while taking this medicine.
For those who carry out sporting activities: the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
Interactions Which drugs or foods can modify the effect of Potassium canrenoate - Generic drug
Other medicines and POTASSIUM CANRENOATE EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
POTASSIUM CANRENOATE EG if taken at the same time as the following drugs can enhance their effect:
- medicines used to lower blood pressure (antihypertensives);
- medicines that block ganglia, i.e. peripheral nerve centers (ganglionplegic medicines)
In these cases the doctor may consider a dose adjustment. Co-administration of POTASSIUM CANRENOATE EG with medicines used to relieve pain and inflammation (acetylsalicylic acid and its derivatives) reduces the diuretic (urine production) activity.
Warnings It is important to know that:
Children
In very early childhood this medicine should be administered only in case of real need and under direct medical supervision.
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 for advice before taking this medicine.
If you are pregnant, the medicine will be prescribed only in cases of real need and under the direct supervision of your doctor, who will assess whether the benefits for you outweigh the risks for the fetus.
This medicine should not be used during breastfeeding.
Driving and using machines
This medicine does not affect the ability to drive and use machines.
POTASSIUM CANRENOATE EG 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
Dosage and method of use How to use Potassium canrenoate - Generic drug: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The recommended dose ranges from 50 mg (half tablet) to 200 mg (2 tablets) per day, depending on the type and severity of the disease, according to medical prescription.
Use in elderly patients
In elderly patients, the dose should be carefully determined by the doctor, who will evaluate a "possible reduction in dosage."
If you take more POTASSIUM CANRENOATE than you should
If you accidentally take an overdose of this medicine, tell your doctor immediately or go to the nearest hospital. At the recommended doses there are no known cases of overdose.
If you forget to take POTASSIUM CANRENOATE EG
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Potassium canrenoate - Generic drug
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rarely, the following side effects may occur: nausea, abdominal pain (cramps);
- drowsiness;
Occasionally with the use of medicinal products containing substances similar to potassium canrenoate, the following side effects have been reported, all of which are generally reversible on discontinuation of treatment:
- allergic skin reactions such as rashes;
- increased body temperature;
- loss of muscle coordination (ataxia);
- breast growth in men (gynecomastia) and irregular menstruation in women;
- hair growth in women (hirsutism);
- transient change in sexual desire (libido disorders).
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 via the national reporting system at www.agenziafarmaco.it/it/responsabili. 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 "EXP". The expiry date refers to the last day of that month.
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 POTASSIUM CANRENOATE EG
- The active ingredient is potassium canrenoate. Each tablet contains 100 mg of potassium canrenoate.
- The other ingredients are: sodium bicarbonate, lactose, hydroxypropylcellulose, microcrystalline cellulose, talc, magnesium stearate, precipitated silica.
- The components of the coating film are: hydroxypropylcellulose, polyethylene glycol 4000, talc, titanium dioxide (E171).
Description of the appearance of POTASSIUM CANRENOATE EG and contents of the pack
Packs of 20 film-coated tablets.
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
POTASSIUM CANRENOATE EG 100 MG TABLETS COATED WITH FILM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains:
Active ingredient: potassium canrenoate 100mg.
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Film-coated tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Primary hyperaldosteronism, edematous states due to secondary hyperaldosteronism (congestive heart failure, liver cirrhosis in the ascitic phase, nephrotic syndrome) and essential arterial hypertension where other therapies have not been sufficiently effective or tolerated.
04.2 Posology and method of administration
According to medical opinion, 50-200 mg per day, in relation to the type and severity of the disease. In the treatment of elderly patients, the dosage must be carefully established by the doctor who will have to evaluate a possible reduction in the dosages indicated above.
04.3 Contraindications
Acute and chronic renal failure: anuria; hyperkalaemia, hyponatremia, hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use
Keep out of the reach of children. Since hyperkalaemia, hyponatremia, azotemic increases, states of metabolic acidosis can occur during the treatment, it is necessary to check the blood levels of sodium, potassium, chlorine and the alkaline reserve frequently. In case of surgery, these checks must be carried out before the surgery itself. The treatment must be suspended in the presence of a sodiumemia lower than 126 mEq / l and a potassium level higher than 5.5 mEq / l. diet rich in potassium In very early childhood, the product should be administered in cases of real need, under the direct supervision of the doctor.
This medicine contains lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
Antihypertensive drugs, especially if ganglionic, can be enhanced by the simultaneous administration of the product making it necessary to adjust the dosages. The simultaneous administration of acetylsalicylic acid and / or derivatives reduces the diuretic activity of the product.
04.6 Pregnancy and breastfeeding
In pregnant women, the product should be administered in cases of real need, under the direct supervision of the doctor. The product should not be used during breastfeeding.
04.7 Effects on ability to drive and use machines
POTASSIUM CANRENOATE EG has no effect on the ability to drive and use machines.
04.8 Undesirable effects
Rarely nausea, cramp-like abdominal pain, drowsiness. Occasionally, with the use of structurally related drugs, other symptoms have been reported such as allergic rash, temperature rises, tendency to ataxia, gynecomastia, mild androgenic effects (hirsutism), transient libido disturbances, menstrual irregularities, usually all reversible upon discontinuation of treatment.
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
No symptoms of overdose have been reported with oral administration of potassium canrenoate.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Potassium canrenoate is a derivative of spirolactones and chemically corresponds to potassium 3- (3-oxo-17-b-hydroxy-4,6-androstadien-17a-yl) propionate. The substance exerts diuretic activity by antagonizing aldosterone and mineralocorticoids with a competitive mechanism at the level of the distal convoluted tubule and collecting duct, with inhibition of the reabsorption of Na + and Cl- and in the absence of potassium-dispersing effects. Unlike spironolactone, the potassium canrenoate is water-soluble and, at the same doses, it is endowed with a more favorable and more ready activity. Due to the particular characteristics of bioavailability it is possible to use lower dosages with consequent reduction of side effects, a particularly advantageous feature during prolonged treatments.
05.2 Pharmacokinetic properties
After oral administration, potassium canrenoate induces markedly higher plasma levels of canrenone, the active metabolite of both substances, compared to spironolactone. This metabolite shows an elevated blood peak in man at the third-fourth hour, with levels still very high at the twelfth hour and a half-life of several hours. The main elimination routes are renal and biliary ones.
05.3 Preclinical safety data
From the toxicological point of view it has been shown that the substance has a low acute toxicity (LD50 = 135 mg / kg by the ip route and 1500 mg / kg by mouth in the mouse; 110 mg / kg by the iv route and 1656 mg / kg by mouth. in the rat) and chronic (rat os, rabbit sc, dog os) and is devoid of teratogenic effect and mutagenic activity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Sodium bicarbonate, lactose, hydroxypropylcellulose, microcrystalline cellulose, talc, magnesium stearate, precipitated silica; filming: hydroxypropylcellulose, polyethylene glycol 4000, talc, titanium dioxide (E171).
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
This medicine does not require any special precautions for
storage.
06.5 Nature of the immediate packaging and contents of the package
Carton containing PVC-PVDC aluminum blisters of 20 tablets.
06.6 Instructions for use and handling
No special instructions for use are required.
07.0 MARKETING AUTHORIZATION HOLDER
EG S.p.A. Via Pavia, 6 20136-Milan
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 035557014
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
16/01/2004
