Kanrenol

Package leaflet: Information for the patient

Kanrenol 25 mg tablets, 100 mg tablets, 200 mg film-coated tablets, 200 mg/2 ml powder and solvent for solution for injection

canrenoate potassium
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Kanrenol is and what it is used for
2. What you need to know before using Kanrenol
3. How to use Kanrenol
4. Possible side effects
5. How to store Kanrenol
6. Contents of the pack and other information

1. What Kanrenol is and what it is used for

Kanrenol contains the active substance potassium canrenoate, a compound that promotes urine production (diuretic action) by counteracting the activity of a hormone called aldosterone, which regulates sodium and potassium levels and fluid volume in the body.
Kanrenol is used in the following cases:

• Disease caused by increased production of the hormone aldosterone (primary hyperaldosteronism)
• Swelling due to fluid retention (edema) from secondary hyperaldosteronism, e.g. in cases of heart failure, liver diseases (hepatic cirrhosis with ascites), kidney disorders (nephrotic syndrome)
• High blood pressure of unknown cause, when other treatments have not been sufficiently effective or tolerated.

2. What you need to know before taking Kanrenol

Do NOT use Kanrenol

• if you are allergic to canrenate potassium or to any of the other ingredients of this medicine (listed in section 6)
• if you have acute or chronic kidney failure
• if you are unable to urinate (anuria)
• if you have high levels of potassium in your blood
• if you have low levels of sodium in your blood

Warnings and precautions
Talk to your doctor or pharmacist before taking Kanrenol.

• Your doctor will frequently perform blood tests, as during treatment you may develop increased potassium levels in the blood, decreased sodium levels in the blood, increased blood nitrogen levels (azotemia), and excessive production of acids in the metabolism (metabolic acidosis). If you undergo surgery, your doctor will perform these blood tests before the procedure.
• Your doctor will inform you whether treatment needs to be discontinued based on your blood sodium and potassium levels.

Children
In early infancy, this medicine should be administered only when strictly necessary and under direct medical supervision.

For athletes:
The use of this drug without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

Other medicines and Kanrenol
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Kanrenol may enhance the effect of the following medicines:

• antihypertensive medicines (used to lower blood pressure),
• ganglionic blocking agents (which block nerve ganglia, i.e. peripheral nerve centers).

In such cases, your doctor may adjust the dose of Kanrenol.
Concomitant administration of the following medicines reduces the diuretic activity (urine production) of Kanrenol:

• acetylsalicylic acid,
• acetylsalicylic acid derivatives.

Kanrenol with food and drinks
During treatment, you should avoid a diet rich in potassium.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, this medicine will be prescribed only if clearly needed and under direct medical supervision, with the doctor evaluating whether the benefits to you outweigh the risks to the fetus.
This medicine must not be used during breastfeeding.

Driving and using machines
Kanrenol has no effect or has negligible effects on the ability to drive vehicles or operate machinery.

Kanrenol tablets contain lactose, sodium, and castor oil
Kanrenol 25 mg and 100 mg tablets contain lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Kanrenol 25 mg and 100 mg tablets contain 2 mmol of sodium per tablet. This should be taken into account in patients with impaired kidney function or those on a low-sodium diet.
Kanrenol 25 mg and 100 mg tablets contain castor oil, which may cause gastrointestinal disturbances and diarrhoea.

3. How to use Kanrenol

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Kanrenol 25 mg and 100 mg tablets
The recommended dose is 50–200 mg daily, depending on the type and severity of the disease. Follow your doctor's prescription.

Kanrenol 200 mg film-coated tablets
The recommended dose is 50–200 mg daily, depending on the type and severity of the disease. Follow your doctor's prescription.

Kanrenol 200 mg/2 ml powder and solvent for injectable solution
The recommended dose is 200–600 mg daily (1–3 vials), administered slowly intravenously or by infusion.

• Shake well during preparation and before use;
• do not exceed the daily dose of 800 mg;
• do not inject more than 400 mg at a time.

Use in elderly patients
In elderly patients, the dosage must be carefully determined by the doctor, who may consider reducing the dose.

If you take more Kanrenol than you should
In case of accidental ingestion or overdose of Kanrenol, inform your doctor immediately or go to the nearest hospital.

If you forget to take Kanrenol
Do not take a double dose to make up for the missed dose.

If you stop using Kanrenol
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Side effects that have occurred rarely (may affect up to 1 in 1,000 people):

• nausea
• cramp-like abdominal pain
• drowsiness

Occasionally, with the use of medicines containing substances similar to potassium canrenoate, the following side effects have been reported:

• allergic skin rashes
• fever
• loss of coordination of movements (tendency to ataxia)
• breast enlargement in males (gynaecomastia)
• mild androgenic effects, e.g. excessive hair growth (hirsutism)
• temporary disturbance of sexual desire
• irregular menstrual cycle

All of these are generally reversible upon discontinuation of treatment.
The exact frequency of the side effects listed above is unknown.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Kanrenol

Do not store above 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Kanrenol contains
Kanrenol 25 mg tablets

• The active substance is potassium canrenoate. Each tablet contains 25 mg of potassium canrenoate.
• The other components are amberlite (potassium salt of methacrylic acid-divinylbenzene copolymer), microcrystalline cellulose, propylene glycol, shellac, hydroxypropylmethylcellulose (E 464), lactose, magnesium stearate, hydrogenated castor oil, precipitated silica, sodium bicarbonate, titanium dioxide.

Kanrenol 100 mg tablets

• The active substance is potassium canrenoate. Each tablet contains 100 mg of potassium canrenoate.
• The other components are amberlite (potassium salt of methacrylic acid-divinylbenzene copolymer), microcrystalline cellulose, propylene glycol, shellac, hydroxypropylmethylcellulose (E 464), lactose, magnesium stearate, hydrogenated castor oil, precipitated silica, sodium bicarbonate, titanium dioxide.

Kanrenol 200 mg film-coated tablets

• The active substance is potassium canrenoate. Each tablet contains 200 mg of potassium canrenoate.
• The other components are microcrystalline cellulose, magnesium stearate, sodium starch glycolate, povidone, methacrylic acid copolymer type C, triethyl citrate, polyethylene glycol 6000, titanium dioxide, simethicone, talc.

Kanrenol 200 mg/2 ml powder and solvent for solution for injection
Vial of powder

• The active substance is potassium canrenoate. Each vial of powder contains 200 mg of potassium canrenoate.
• The other component is tris(hydroxymethyl)aminomethane.

Vial of solvent
Each solvent vial contains 2 ml of water for injections.

Description of the appearance of Kanrenol and package contents
Kanrenol 25 mg tablets
Each pack contains a blister with 20 tablets.
Kanrenol 100 mg tablets
Each pack contains a blister with 20 tablets.
Kanrenol 200 mg film-coated tablets
Each pack contains a blister with 20 tablets.
Kanrenol 200 mg/2 ml powder and solvent for solution for injection
Each pack contains 6 vials of powder + 6 vials of solvent (2 ml each).

Marketing Authorization Holder
TEOFARMA S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)

Manufacturer
TEOFARMA S.r.l.
Viale Certosa, 8/A
27100 Pavia