Patient Information Leaflet

Potassio Canrenoato Sandoz 100 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, as 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 may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Potassio Canrenoato Sandoz is and what it is used for
What you need to know before taking Potassio Canrenoato Sandoz
How to take Potassio Canrenoato Sandoz
Possible side effects
How to store Potassio Canrenoato Sandoz
Contents of the pack and other information

1. What Potassium Canrenoate Sandoz is and what it is used for

Potassium Canrenoate Sandoz contains the active substance potassium canrenoate, which belongs to a group of medicines called potassium-sparing diuretics that work by increasing the production and elimination of urine.
This medicine is indicated for the treatment of:

high levels of aldosterone in the blood (primary hyperaldosteronism);
conditions caused by fluid accumulation in the body (edematous states due to secondary hyperaldosteronism), such as heart problems (congestive heart failure), liver problems (hepatic cirrhosis with ascites), or kidney problems (nephrotic syndrome);
high blood pressure (essential arterial hypertension), when other treatments are ineffective or not tolerated.

2. What you need to know before taking Potassium Canrenoate Sandoz

Do not take Potassium Canrenoate Sandoz

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if you have severe kidney problems (acute or chronic renal failure);
if you have difficulty passing urine (anuria);
if you have high levels of potassium in your blood (hyperkalemia);
if you have low levels of sodium in your blood (hyponatremia);
if you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Potassium Canrenoate Sandoz.
During treatment with this medicine, and before undergoing surgery, your doctor will prescribe tests to monitor your blood electrolyte levels (such as sodium, potassium, chloride, and alkaline reserve), as increases in potassium levels (hyperkalemia), nitrogen (azotemia), or acidic substances in the blood (metabolic acidosis), or a decrease in sodium levels (hyponatremia) may occur. Your doctor will decide whether to discontinue treatment if significant changes in blood electrolyte levels occur.
Avoid consuming foods rich in potassium during treatment with this medicine.
For athletes: using this medicine without a therapeutic indication constitutes doping and may lead to a positive anti-doping test.

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

Other medicines and Potassium Canrenoate Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take this medicine with caution if you are taking the following medicines:

other medicines used to lower blood pressure (antihypertensives);
acetylsalicylic acid and its derivatives, used to relieve pain and inflammation.

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.

Pregnancy
Do not take this medicine during pregnancy unless strictly necessary and under medical supervision.

Breastfeeding
Do not take this medicine if you are breastfeeding.

Driving and using machines
This medicine does not impair your ability to drive or operate machinery.

Potassium Canrenoate Sandoz contains lactose and sodium
This medicine contains 106 mg of lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her 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 Potassium Canrenoate Sandoz

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose ranges from 50 mg (half a tablet) to 200 mg (2 tablets) daily, according to medical prescription.

Use in elderly patients
For elderly patients, the dose must be determined by the doctor according to the individual's health status.

If you take more Potassium Canrenoate Sandoz than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital emergency department.
Cases of overdose are not known.

If you forget to take Potassium Canrenoate Sandoz
Do not take a double dose to make up for the missed dose.
If you have any doubts about using this medicine, ask your doctor or pharmacist for advice.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur and are reversible upon discontinuation of treatment:

nausea, abdominal pain (cramps);
drowsiness;
allergic skin reactions such as rashes;
increase in body temperature (fever);
loss of muscular coordination (ataxia);
breast enlargement in men (gynecomastia) and irregular menstrual cycle in women;
excessive hair growth in women (hirsutism);
changes in sexual desire (libido disorders).

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 www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Potassio Canrenoato Sandoz

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 Potassio Canrenoato Sandoz contains
The active substance is: potassium canrenoate. Each tablet contains 100 mg of potassium
canrenoate.
The other components are: sodium bicarbonate, lactose, hydroxypropylcellulose, microcrystalline
cellulose, talc, magnesium stearate, precipitated silica, polyethylene glycol 4000, titanium
dioxide (E171).
Description of the appearance of Potassio Canrenoato Sandoz and package contents
Blister pack containing 20 film-coated tablets of 100 mg.
Marketing Authorization Holder
Sandoz S.p.A.
Largo Umberto Boccioni, 1
21040 Origgio (VA) - Italy
Manufacturer
Fine Foods & Pharmaceuticals NTM S.p.A.
Via R. Follereau, 25
24027 Nembro (BG)
Italy
Fine Foods & Pharmaceuticals NTM S.p.A.
Via Grignano, 43
24041 Brembate (BG)
Italy