KADIUR 50 mg/5 mg Film-Coated Tablets

Содержание инструкции

1. Kadiur 50 mg + 5 mg film-coated tablets
   1. What is Kadiur and what is it 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

Kadiur 50 mg + 5 mg film-coated tablets

potassium canrenoate + butizide
Read this leaflet carefully before using 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Kadiur and what is it used for

Kadiur contains the association of the two active substances potassium canrenoate and butizide, substances with diuretic action, i.e. that promote urine production without reducing potassium levels in the blood.
Kadiur is used in case of swelling due to fluid accumulation (edema) caused by an increase in the production of a hormone called aldosterone, which regulates sodium, potassium levels and the volume of fluids
in the body.
Kadiur is used for example in case of swelling due to:

• liver diseases (hepatic cirrhosis in the ascitic phase)
• reduced heart function (congestive heart failure)
• diseases affecting the kidney (nephrotic edema)

2. What you need to know before taking Kadiur

Do not take Kadiur:

• if you are allergic to canrenoate potassium, 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 (sulphonamides);
• 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 you experience the following symptoms during treatment with Kadiur:

• dry mouth,
• thirst,
• muscle weakness,
• drowsiness,
• agitation,
• muscle cramps,
• low blood pressure,
• decreased urine output,
• increased heart rate,
• stomach and intestinal disorders.

The doctor may periodically have blood and urine tests done to check the levels of salts in the
blood.
If you are taking medicines called glucocorticoids or are undergoing treatment with ACTH, or if you suffer from
severe liver cirrhosis, your doctor will prescribe a potassium supplement and advise you to follow a diet high
in potassium.
If you suffer from an autoimmune disease called "lupus erythematosus", taking Kadiur
may worsen its symptoms.
If you have diabetes, you may experience an increase in uric acid levels in the blood and an increase in glucose levels in the blood following therapy with Kadiur, and consequently may experience
temporary changes in your health status.
If you are going to have local or general anesthesia, tell your doctor that you are taking Kadiur.
If you have undergone a procedure called sympathectomy, Kadiur may cause a significant decrease in
blood pressure.
If you have blurred vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and
can occur from a few hours to weeks after taking Kadiur. If left
untreated, they can lead to permanent vision loss. If you have previously had an allergy to
penicillin or a sulphonamide, you may be at higher risk of developing this condition.
For athletes: the use of the drug without therapeutic necessity constitutes doping and may
still result in a positive anti-doping test.

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

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

Kadiur may interfere with some laboratory tests to measure calcium and phosphorus in the blood.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask
your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Kadiur should only be used during pregnancy if absolutely necessary and under the direct supervision of
your doctor, who will assess whether the benefits outweigh the risks to the fetus.
Breastfeeding
Kadiur should not be used during breastfeeding.

Driving and using machines
In rare cases, treatment with Kadiur may affect reflexes and decrease the ability to drive vehicles.
Drinking alcohol may increase this effect. Keep this in mind if you need to drive
vehicles or operate machinery that requires a certain level of alertness.

Kadiur contains lactose and castor oil
Kadiur contains lactose. If your doctor has diagnosed you with intolerance to some sugars, contact
them before taking this medicine.
Kadiur contains castor oil. It may cause stomach upset and diarrhea.

3. How to take Kadiur

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is:

Adults
1–2 tablets daily.

If you take more Kadiur than you should
Rarely, a decrease in salts in the body may occur during therapy with Kadiur.
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 missed tablet.

If you stop taking Kadiur
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Many of the side effects listed below are temporary and/or improve with a reduction in the
dosage.
If you experience serious manifestations, consult your doctor, who will decide to reduce the dosage or discontinue
treatment.
Uncommon side effects (may affect up to 1 in 100 people):

• Increased levels of uric acid in the blood
• Increased glucose values in the blood
• Dizziness
• Altered color vision (xanthopsia)
• Rapid decrease in blood pressure when moving from a lying or sitting position to an upright position (orthostatic hypotension)
• Injury of an inflammatory, acute or chronic nature, of a blood or lymphatic vessel (angioitic processes)
• Appearance of spots or redness on the skin following exposure to direct sunlight, including solariums
• Sudden and involuntary muscle contractions
• Muscle weakness.

Rare side effects (may affect up to 1 in 1000 people):

• Drowsiness
• Decreased promptness of reflexes (torpor)
• Headache
• Fever
• Tendency to loss of muscle coordination
• Stomach and intestinal disorders
• Appearance of spots and/or bumps on the skin
• Enlargement of the breasts in men
• Erectile dysfunction
• Mild masculinizing effects.

Side effects with unknown frequency

• Rapid onset of distance vision reduction (acute myopia), decreased vision or eye pain due to high 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 get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after “Exp”. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Kadiur contains

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

Description of the appearance of Kadiur and contents of the pack
Kadiur is presented in the form of film-coated tablets of 50 mg + 5 mg in a pack of 20 tablets and
a pack of 30 tablets.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A. Via San Giuseppe Cottolengo, 15 – 20143 Milan
Manufacturer
Doppel Farmaceutici S.r.l. - Quinto de’ Stampi - Rozzano - MI
Or:
Doppel Farmaceutici S.r.l. - Quinto de’ Stampi - Rozzano - MI (production and controls)
Laboratorio Farmacologico Milanese Srl - Caronno Pertusella – MI (packaging)