Potassium canrenoate EG

Package leaflet: Information for the patient

POTASSIO CANRENOATO EG 100 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What POTASSIO CANRENOATO EG is and what it is used for
2. What you need to know before taking POTASSIO CANRENOATO EG
3. How to take POTASSIO CANRENOATO EG
4. Possible side effects
5. How to store POTASSIO CANRENOATO EG
6. Contents of the pack and other information

1. What POTASSIO CANRENOATO EG is and what it is used for

POTASSIO CANRENOATO EG 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.
POTASSIO CANRENOATO EG 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, for example in cases of heart failure, liver diseases (hepatic cirrhosis with ascites), or 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 POTASSIO CANRENOATO EG

Do not take POTASSIO CANRENOATO EG

• if you are allergic to canrenone 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 POTASSIO CANRENOATO EG.

• Your doctor will frequently perform blood tests, as during treatment you may experience increased potassium levels in the blood, decreased sodium levels in the blood, increased blood nitrogen levels (azotemia), and excessive acid production 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 those engaged in sports activities: using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

Other medicines and POTASSIO CANRENOATO EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
POTASSIO CANRENOATO EG may enhance the effect of the following medicines:

• antihypertensive medicines (used to lower blood pressure),
• ganglion-blocking agents (which block nerve ganglia, i.e. peripheral nerve centers),
• lithium-containing medicines (used in the treatment of certain mental disorders),
• medicines of the ACE inhibitor class (used to lower blood pressure and treat chronic heart conditions).

In such cases, your doctor may adjust the dosage of POTASSIO CANRENOATO EG.
Concomitant administration of the following medicines reduces the diuretic activity (urine production) of POTASSIO CANRENOATO EG:

• acetylsalicylic acid,
• acetylsalicylic acid derivatives.

POTASSIO CANRENOATO EG with food and drink
During treatment, avoid a diet rich in potassium.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
If you are pregnant, this medicine will be prescribed only when strictly necessary and under direct medical supervision; your doctor will evaluate whether the benefits to you outweigh the risks to the fetus.
This medicine must not be used during breastfeeding.
Driving and using machines
POTASSIO CANRENOATO EG has no effects or negligible effects on the ability to drive and operate machinery.
POTASSIO CANRENOATO EG contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take POTASSIO CANRENOATO EG

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is 50–200 mg daily, depending on the type and severity of the disease. Follow your
doctor's prescription.
Use in elderly patients
In elderly patients, the dose must be carefully determined by the doctor, who may consider reducing the dose.
If you take more POTASSIO CANRENOATO EG than you should
In case of accidental ingestion or overdose of POTASSIO CANRENOATO EG, inform your doctor immediately or go to the nearest hospital.
If you forget to take POTASSIO CANRENOATO EG
Do not take a double dose to make up for the missed dose.
If you stop treatment with POTASSIO CANRENOATO EG
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• nausea
• cramp-like abdominal pain;
• drowsiness
• dehydration

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

• allergic skin rashes;
• fever;
• loss of coordination of movements (tendency to ataxia);
• breast enlargement in males (gynecomastia);
• 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. You can also report side effects directly via the national reporting system 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.

5. How to store POTASSIUM CANRENOATE EG

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 medicines 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 POTASSIO CANRENOATO EG contains

• The active substance is potassio canrenoato. Each tablet contains 100 mg of potassio canrenoato.
• The other components are: sodium bicarbonate, lactose, hydroxypropylcellulose, microcrystalline cellulose, talc, magnesium stearate, precipitated silica.
• Components of the film coating: hydroxypropylcellulose, polyethylene glycol 4000, talc, titanium dioxide (E171).

Description of the appearance of POTASSIO CANRENOATO EG and package contents
Packaging containing 20 film-coated tablets.
Marketing Authorization Holder
EG S.p.A. – Via Pavia, 6 – 20136 Milan – Italy.
Manufacturer
Fine Foods & Pharmaceuticals NTM S.p.A. – Via Grignano, 43 – 24041 Brembate (BG) – Italy.