Kadiur

Package leaflet: Information for the patient

Kadiur 50 mg + 5 mg film-coated tablets

canrenate potassium + butizide
Please read this leaflet carefully before 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Kadiur is and what it is used for

Kadiur contains the combination of two active substances, potassium canrenoate and butizide, which have a diuretic action, meaning they promote urine production without reducing blood potassium levels.
Kadiur is used in cases of swelling due to fluid accumulation (oedema) caused by increased production of a hormone called aldosterone, which regulates sodium and potassium levels and fluid volume in the body.
Kadiur is, for example, used in cases of swelling due to:

• liver diseases (hepatic cirrhosis with ascites)
• reduced heart function (congestive heart failure)
• kidney diseases (nephrotic oedema)

2. What you need to know before taking Kadiur

Do not take Kadiur:

• if you are allergic to potassium canrenoate, butizide, or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines of the same type (sulfonamide-derived drugs);
• if you have acute or chronic kidney problems;
• if you have severe liver problems;
• 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 Kadiur.
Contact your doctor if, during treatment with Kadiur, you experience any of the following symptoms:

• dry mouth,
• thirst,
• muscle weakness,
• drowsiness,
• restlessness,
• muscle cramps,
• low blood pressure,
• reduced urine output,
• increased heart rate,
• stomach and intestinal disturbances.

Your doctor may periodically request blood and urine tests to monitor your blood electrolyte levels.
If you are taking medicines called glucocorticoids or are undergoing treatment with ACTH, or if you have severe liver cirrhosis, your doctor will prescribe potassium supplementation and recommend a potassium-rich diet.
If you have an autoimmune disease called "lupus erythematosus", treatment with Kadiur may worsen your symptoms.
If you have diabetes, treatment with Kadiur may lead to increased levels of uric acid and glucose in your blood, possibly causing temporary changes in your health status.
If you are scheduled to undergo local or general anesthesia, inform your doctor that you are taking Kadiur.
If you have previously undergone a procedure called sympathectomy, Kadiur may cause a significant drop in blood pressure.
If you experience decreased vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to several weeks after taking Kadiur. If left untreated, these conditions may lead to permanent vision loss. If you have previously had an allergy to penicillin or a sulfonamide, you may be at higher risk of developing this condition.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Other medicines and Kadiur
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important that your doctor knows if you are taking any of the following medicines:

• medicines used to thin the blood (oral anticoagulants), as their effect may be reduced by concomitant use of Kadiur;
• tubocurarine (used in anesthesia), as Kadiur may enhance its effect;
• aspirin (acetylsalicylic acid) and/or its derivatives, as they may reduce the activity of Kadiur.

Kadiur may interfere with certain laboratory tests measuring calcium and phosphorus levels in the blood.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Kadiur should be used during pregnancy only if clearly needed and under direct medical supervision, with the doctor evaluating whether the benefits to you outweigh the risks to the fetus.

Breastfeeding
Kadiur should not be used during breastfeeding.

Driving and using machines
Rarely, treatment with Kadiur may affect your reflexes and reduce your ability to drive vehicles. Alcohol may increase this effect. Take these effects into account if you need to drive or operate machinery requiring a certain level of alertness.

Kadiur contains lactose and castor oil
Kadiur contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
Kadiur contains castor oil. This may cause gastrointestinal disturbances and diarrhea.

3. How to take Kadiur

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:
Adults
1–2 tablets per day.
If you take more Kadiur than you should
Rarely, during treatment with Kadiur, a reduction in salts in the body may occur.
In case of accidental ingestion of an excessive dose of Kadiur, inform your doctor immediately or go
to the nearest hospital.
If you forget to take Kadiur
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Kadiur
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 everyone gets them.
Many of the side effects listed below are temporary and/or improve with a reduction in dose.
If you experience severe symptoms, consult your doctor, who will decide whether to reduce the dose or discontinue treatment.

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

• Increased levels of uric acid in the blood
• Increased blood glucose levels
• Dizziness
• Altered colour vision (xanthopsia)
• Rapid drop in blood pressure upon changing from a lying or sitting position to standing (orthostatic hypotension)
• Inflammatory lesion, acute or chronic, of a blood or lymphatic vessel (angitic processes)
• Appearance of spots or redness on the skin following exposure to direct sunlight, including solarium use
• Sudden, involuntary muscle contractions
• Muscle weakness

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

• Drowsiness
• Reduced alertness (lethargy)
• Headache
• Fever
• Tendency to lose muscular coordination
• Stomach and intestinal disorders
• Appearance of spots and/or raised lesions on the skin
• Breast enlargement in men
• Erectile dysfunction
• Mild masculinizing effects

Side effects with unknown frequency

• Sudden onset of reduced distance vision (acute myopia), decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell 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 Kadiur

This medicine does not require any special storage conditions.
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 Kadiur contains

• The active substances are: canrenoate potassium and butizide. One coated tablet contains 50 mg of canrenoate potassium and 5 mg of butizide.
• The other components are: anhydrous colloidal silica, hydrogenated castor oil, sodium bicarbonate, amberlite (potassium salt of methacrylic acid-divinylbenzene copolymer), magnesium stearate, microcrystalline cellulose, lactose, titanium dioxide, propylene glycol, hypromellose.

Description of the appearance of Kadiur and contents of the pack
Kadiur is available as film-coated tablets containing 50 mg + 5 mg, in cardboard boxes containing 20 tablets and boxes containing 30 tablets.
Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A. Via San Giuseppe Cottolengo, 15 – 20143 Milan, Italy
Manufacturer
Doppel Farmaceutici S.r.l. - Quinto de’ Stampi - Rozzano - MI
Or:
Doppel Farmaceutici S.r.l. - Quinto de’ Stampi - Rozzano - MI (manufacturing and controls)
Laboratorio Farmacologico Milanese Srl - Caronno Pertusella – MI (packaging)