POTASSIUM CANRENOATE PENSA

Package leaflet: information for the patient

POTASSIO CANRENOATO PENSA 100 mg film-coated tablets

Canrenoate potassium
Equivalent medicine
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 adverse effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

POTASSIO CANRENOATO PENSA contains the active substance potassium canrenoate, which belongs to a group of medicines called potassium-sparing diuretics. These act by counteracting the effects of aldosterone (a hormone responsible for increasing blood pressure), thereby promoting urine production and elimination.

This medicine is indicated for the treatment of:

• elevated levels of aldosterone in the blood (primary hyperaldosteronism);
• conditions caused by fluid accumulation in the body (edematous states) associated with increased aldosterone (secondary hyperaldosteronism), such as in cases of heart problems (congestive heart failure), liver (hepatic cirrhosis with ascites), or kidney disorders (nephrotic syndrome);
• high blood pressure (essential arterial hypertension), when other therapies have not been effective or are not tolerated.

2. What you need to know before taking POTASSIUM CANRENOATE PENSA

Do not take POTASSIUM CANRENOATE PENSA if:

• you are allergic to potassium canrenoate or to any of the other ingredients of this medicine (listed in section 6);
• you have kidney problems (acute or chronic renal failure);
• you have difficulty urinating (anuria);
• you have high levels of potassium in your blood (hyperkalemia);
• you have low levels of sodium in your blood (hyponatremia).

Warnings and precautions
Talk to your doctor or pharmacist before taking POTASSIUM CANRENOATE PENSA.
During treatment with this medicine, and before undergoing surgery, you must frequently have blood tests, as there may be an increase in blood potassium levels (hyperkalemia), nitrogen levels (azotemia), or acidic substances in the blood (metabolic acidosis), or a decrease in sodium levels (hyponatremia). Your doctor will decide whether to discontinue treatment if significant changes in the levels of these substances occur.
Avoid consuming foods rich in potassium during treatment with this medicine.
For athletes: using this medicine without a therapeutic need 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 PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The following medicines interact with POTASSIUM CANRENOATE PENSA:

• medicines used to lower blood pressure (antihypertensives), such as ACE inhibitors, angiotensin II receptor antagonists, and ganglion blockers;
• acetylsalicylic acid (aspirin) and/or acetylsalicylic acid derivatives, medicines used to reduce fever, relieve pain and inflammation, as they may reduce the diuretic activity of POTASSIUM CANRENOATE PENSA.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Pregnancy
This medicine should be administered only when strictly necessary and under direct medical supervision.
Breastfeeding
Do not take this medicine if you are breastfeeding.

Driving and operating machinery
This medicine does not impair your ability to drive vehicles or operate machinery.

POTASSIUM CANRENOATE PENSA contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

POTASSIUM CANRENOATE PENSA contains sodium
This medicine contains:

• less than 1 mmol (23 mg) of sodium per tablet (100 mg), i.e. essentially ‘sodium-free’;
• 34 mg of sodium per 200 mg dose. This corresponds to 1.7% of the maximum daily recommended dietary intake for an adult.

3. How to take POTASSIO CANRENOATO PENSA

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 mg - 200 mg daily, according to medical prescription, depending on the type and
severity of the condition.
Use in the elderly
For elderly patients, the dose must be carefully determined by the doctor, who will assess whether a reduction of the above doses is necessary.
If you take more POTASSIO CANRENOATO PENSA than you should
In case of accidental ingestion or overdose of this medicine, inform your doctor immediately or go to the nearest hospital.
Cases of overdose are not known.
If you forget to take POTASSIO CANRENOATO PENSA
Do not take a double dose to make up for a missed tablet.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.

The following side effects may occur:

Uncommon (may affect up to 1 in 100 people):

• loss of muscular coordination (ataxia);
• increased body temperature (fever);
• allergic skin rashes;
• breast enlargement in men (gynecomastia);
• temporary changes in sexual desire (libido disorders);
• irregular menstrual cycle in women;
• excessive hair growth in women (hirsutism).

Rare (may affect up to 1 in 1,000 people):

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

Not known (frequency cannot be estimated from the available data):

• vomiting;
• stomach and intestinal damage (peptic ulcer);
• bleeding from the stomach and vomiting blood (haematemesis);
• increased potassium levels in the blood (hyperkalaemia);
• reduced sodium levels in the blood (hyponatraemia);
• increased levels of acidic substances in the blood (metabolic acidosis);
• rare blood disorder (porphyria);
• increased nitrogen levels in the blood (azotaemia).

Many of the side effects listed above resolve and/or improve with a dose reduction.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may 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 PENSA

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.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What POTASSIO CANRENOATO PENSA contains

• The active substance is potassium canrenoate. One tablet contains 100 mg of potassium canrenoate.
• The other components are: sodium bicarbonate, lactose, hydroxypropylcellulose, microcrystalline cellulose, talc, magnesium stearate, precipitated silica, macrogol 4000, titanium dioxide (E171).

Description of the appearance of POTASSIO CANRENOATO PENSA and package contents
Pack containing 20 film-coated tablets.
Marketing Authorization Holder
Towa Pharmaceutical S.p.A. - Via Enrico Tazzoli, 6 - 20154 Milan – Italy
Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A. – Nembro production site – via R. Follereau, 25 –
24027 Nembro (BG) – Italy